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Ormco Orthodontic Appliance - HSA Registration DE0508772

Access comprehensive regulatory information for Ormco Orthodontic Appliance in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508772 and owned by Ormco Corporation. The device was registered on December 18, 2023.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS B
DE0508772
Ormco Orthodontic Appliance
HSA Registration Number: DE0508772
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Product Description

are intended for use during orthodontic treatment to correct the malocclusion or imperfect positioning of patient teeth.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Dental
Registration Information
Registration Number
DE0508772
Registration Date
December 18, 2023
Retention Due Date
December 17, 2025
Product Owner
Short Name
Ormco Corporation
Address
200 S Kraemer Blvd, Brea, California 92821, UNITED STATES
Registrant
Address
7500A BEACH ROAD, THE PLAZA, #09-308, SINGAPORE 199591
Importer
Address
13 STAMFORD ROAD, CAPITOL PIAZZA, #02-11, SINGAPORE 178905 13 STAMFORD ROAD, CAPITOL PIAZZA, #02-11, SINGAPORE 178905 73 UBI ROAD 1, OXLEY BIZHUB, #10-61/62, SINGAPORE 408733
Model Information
Model Name(s)
ARCH D-RECT BRAIDED UPR 016X022 ARCH D-RECT BRAIDED UPR 017X025 ARCH D-RECT BRAIDED UP 018X025 PK/10 ARCH D-RECT BRAIDED UPR 019X025 ARCH D-RECT BRAIDED LWR 016X022 ARCH D-RECT BRAIDED LWR 017X025 ARCH D-RECT BRAIDED LO 018X025 PK/10 ARCH D-RECT BRAIDED LWR 019X025 ARCH TMA RECT MAX .016 X.022 PK 10 ARCH LING.UNIV.TMA.0170 X.0250 PK 10 PREF ARCH NI-TI UPPER .016 SMALL PK10 PREF ARCH NI-TI UPPER .018 SMALL PK10 PREF ARCH NI-TI LOWER .016 SMALL PK10 PREF ARCH NI-TI LOWER .018 SMALL PK10 PREF ARCH NI-TI UPPER .014 SMALL PK10 PREF ARCH NI-TI UPPER .020 SMALL PK10 COPPER NITI 27 BAF .014 DIA U/L PK10 COPPER NITI 27 BAF .014 DIA L/L PK10 COPPER NITI 27 BAF .016 DIA U/L PK10 COPPER NITI 27 BAF .016 DIA L/L PK10 + 35 C COPPER NI-TI UP LG 016 PK/10 + 35 C COPPER NI-TI LO LG 016 PK/10 COPPER NITI 35 BAF.018 DIA.UP LG PK10 COPPER NITI 35 BAF.018 DIA.LO LG PK10 TRU-ARCH CUNITI NON-DIMP27D 014DIA LS PK10 TRU-ARCH CUNITI NON-DIMP27D 014DIA US PK10 TRU-ARCH CUNITI NON-DIMP35D 016DIA US PK10 TRU-ARCH CUNITI NON-DIMP27D 014DIA LL PK10 TRU-ARCH CUNITI NON-DIMP27D 018DIA LL PK10 TRU-ARCH CUNITI NON-DIMP35D 016DIA LL PK10 TRU-ARCH CUNITI NON-DIMP35D 018DIA LL PK10 TRU-ARCH CUNITI NON-DIMP27D 014DIA UL PK10 TRU-ARCH CUNITI NON-DIMP35D 016DIA UL PK10 TRU-ARCH CUNITI NON-DIMP35D 018DIA UL PK10 ARCH PREFORMED UPPER .016 DIA. PK/20 ARCH PREFORMED UPPER .018 DIA. PK/20 ARCH PREFORMED LOWER .016 DIA. PK/20 ARCH PREFORMED LOWER .018 DIA. PK/20 ARCH P/F EDG SQ UPR 016 X 016 PK10 ARCH P/F EDG.RECT.UP.0160 X.0220 PK10 ARCH P/F EDG.RECT.UP.0170 X.0250 PK10 ARCH P/F EDG.RECT.UP.0190 X.0250 PK10 ARCH P/F EDG SQ LWR 016 X 016 PK10 ARCH P/F EDG.RECT.LO.0160 X.0220 PK10 ARCH P/F EDG.RECT.LO.0170 X.0250 PK10 ARCH P/F EDG.RECT.LO.0190 X.0250 PK10 NI-TI BROAD ARCH UPSML 0160 0220 PK10 NI-TI BROAD ARCH UPSML 0170 0250 PK10 NI-TI BROAD ARCH UPSML 0180 0250 PK10 NI-TI BROAD ARCH UPSML 0190 0250 PK10 TURBO ARCH UPPER .021 X.025 PACK/10 COPPER NiTi 35 BAF 17x17 UPSM PK/10 COPPER NITI 35 BAF .016X022UP SM PK10 COPPER NITI 35 BAF .017X025UP SM PK10 COPPER NITI 35 BAF .019X025UP SM PK10 COPPER NiTi 35 BAF 20x20 UPSM PK/10 COPPER NITI 35 BAF .017X.017-UPLG PK10 + 35 C COPPER NI-TI UP LG 16X22 PK/10 COPPER NITI 35 BAF .017X025UP LG PK10 COPPER NITI 35 BAF .019X025UP LG PK10 COPPER NITI 35 BAF .020X.020-UPLG PK10 COPPER NITI 40 BAF.016X.022UP LG PK10 COPPER NITI 40 BAF.017X.025UP LG PK10 COPPER NITI 40 BAF.019X.025UP LG PK10 COPPER NITI 40 BAF .021X.025UPLG PK10 TRU-ARCH CUNITI NON-DIMP27D 016x022US PK10 TRU-ARCH CUNITI NON-DIMP27D 017x025UL PK10 TRU-ARCH CUNITI NON-DIMP27D 019x025UL PK10 TRU-ARCH CUNITI NON-DIMP35D 016x022UL PK10 TRU-ARCH CUNITI NON-DIMP35D 017x025UL PK10 NI-TI BROAD ARCH LOSML 0160 0220 PK10 NI-TI BROAD ARCH LOSML 0170 0250 PK10 NI-TI BROAD ARCH LOSML 0180 0250 PK10 NI-TI BROAD ARCH LOSML 0190 0250 PK10 COPPER NiTi 35 BAF 17x17 LOSM PK/10 COPPER NITI 35 BAF .016X022LO SM PK10 COPPER NITI 35 BAF .017X025LO SM PK10 COPPER NITI 35 BAF .019X025LO SM PK10 COPPER NITI 35 BAF .021X.025LOSM PK10 COPPER NITI 35 BAF .020X.020-LOSM PK10 COPPER NiTi 35 BAF 17x17 LOLG PK/10 + 35 C COPPER NI-TI LO LG 16X22 PK/10 COPPER NITI 35 BAF .017X025LO LG PK10 COPPER NITI 35 BAF .019X025LO LG PK10 COPPER NITI 40 BAF.016X.022LO LG PK10 COPPER NITI 40 BAF.017X.025LO LG PK10 COPPER NITI 40 BAF.019X.025LO LG PK10 COPPER NITI 40 BAF .021X.025LOLG PK10 TRU-ARCH CUNITI NON-DIMP27D 016x022LS PK10 TRU-ARCH CUNITI NON-DIMP27D 017x025LL PK10 TRU-ARCH CUNITI NON-DIMP27D 019x025LL PK10 TRU-ARCH CUNITI NON-DIMP35D 016x022LL PK10 TRU-ARCH CUNITI NON-DIMP35D 017x025LL PK10 ARCH TMA REV.CURVE UPR .016X022 PK/10 ARCH TMA REV.CURVE UPR .017X025 PK/10 ARCH TMA REV.CURVE UPR .019X025 PK/10 TMA REV.CURVE/LOOPS 016X022 30MM PK/5 TMA REV.CURVE/LOOPS 016X022 32MM PK/5 TMA REV.CURVE/LOOPS 016X022 34MM PK/5 TMA REV.CURVE/LOOPS 016X022 36MM PK/5 TMA REV.CURVE/LOOPS 016X022 38MM PK/5 TMA REV.CURVE/LOOPS 017X025 30MM PK/5 TMA REV.CURVE/LOOPS 017X025 32MM PK/5 TMA REV.CURVE/LOOPS 017X025 36MM PK/5 TMA REV.CURVE/LOOPS 017X025 38MM PK/5 TMA REV.CURVE/LOOPS 019X025 30MM PK/5 TMA REV.CURVE/LOOPS 019X025 32MM PK/5 TMA REV.CURVE/LOOPS 019X025 34MM PK/5 TMA REV.CURVE/LOOPS 019X025 38MM PK/5 ARCH TMA REV.CURVE LWR 016X022 PK/10 ARCH TMA REV.CURVE LWR 017X025 PK/10 ARCH TMA REV.CURVE LWR 019X025 PK/10 ORTHOS CM SST 019 X 025 UPSM PK10 ORTHOS CM SST ARCH 016X022 LOLG PK10 ORTHOS CM SST ARCH 017X025 LOLG PK10 ORTHOS CM SST ARCH 019X025 LOLG PK10 ORTHOS CM SST 016 X 022 UPLG PK10 ORTHOS CM SST 017 X 025 UPLG PK10 ORTHOS CM SST 019 X 025 UPLG PK10 ORTHOS CM NITI ARCH.016 DIA LOLG PK10 ORTHOS CM NITI ARCH.016X.022LOLG PK10 ORTHOS CM NITI ARCH.016 DIA UPLG PK10 ORTHOS CM NITI ARCH.016X.022UPLG PK10 COMPRESSION SPRING NITI 010X030 PK 3 COMPRESSION SPRING NITI 012X030 PK3 COMPRESSION SPRING NITI 014X036 PK 3 EXT. SPRING LT NITI-010X030 PK 10 EXT. SPRING MED NITI-010X030 PK 10 EXT. SPRING HVY NITI-010X030 PK 10 DAMON NiTi 34mm PRE-TRQ 20 DEG 016 X 025 PK5 DAMON NiTi 34mm PRE-TRQ 20 DEG 017 X 025 PK5 DAMON NiTi 34mm PRE-TRQ 20 DEG 019 X 025 PK5 DAMON NiTi 38mm PRE-TRQ 20 DEG 016 X 025 PK5 DAMON NiTi 38mm PRE-TRQ 20 DEG 017 X 025 PK5 DAMON NiTi 38mm PRE-TRQ 20 DEG 019 X 025 PK5 DAMON SS POSTED 24MM 16X25 ND BULK10PK DAMON SS POSTED 26MM 16X25 ND BULK10PK DAMON SS POSTED 26MM 19X25 ND BULK10PK DAMON SS POSTED 28MM 16X25 ND BULK10PK DAMON SS POSTED 28MM 19X25 ND BULK10PK DAMON SS POSTED 30MM 16X25 ND BULK10PK DAMON SS POSTED 34MM 16X25 ND BULK10PK DAMON SS POSTED 34MM 19X25 ND BULK10PK DAMON SS POSTED 36MM 16X25 ND BULK10PK DAMON SS POSTED 36MM 19X25 ND BULK10PK DAMON SS POSTED 38MM 16X25 ND BULK10PK DAMON SS POSTED 38MM 19X25 ND BULK10PK DAMON SS POSTED 40MM 16X25 ND BULK10PK DAMON SS POSTED 40MM 19X25 ND BULK10PK DAMON SL SS 016X025 ND PPAK 10PK DAMON SL SS 19X25 ND PPK 10PK DAMON TMA - LOW FRIC 016X025 PK10 DAMON TMA - LOW FRIC 017X025 PK10 DAMON TMA - LOW FRIC 019X025 PK10 DAMON PURPLE TMA - LOW FRIC 016X025 PK5 DAMON PURPLE TMA - LOW FRIC 017X025 PK5 DAMON PURPLE TMA - LOW FRIC 019X025 PK5 DAMON HONEYDEW TMA - LOW FRIC 017X025 PK5 TRU-ARCH ALGN SE200 LM 16X22 NiTi ND 10PK TRU-ARCH ALGN SE200 LM 17X25 NiTi ND 10PK TRU-ARCH ALGN SE200 LM 18X25 NiTi ND 10PK TRU-ARCH ALGN SE200 LM 19X25 NiTi ND 10PK TRU-ARCH ALGN SE200 LM 014 NiTi ND 10PK TRU-ARCH ALGN SE200 LM 018 NiTi ND 10PK TRU-ARCH ALGN SE200 LM 016 NiTi ND 10PK TRU-ARCH ALGN SE200 UM 16X22 NiTi ND 10PK TRU-ARCH ALIGN SE200 UM 017X025 NiTi ND 10PK TRU-ARCH ALIGN SE200 UM 018X025 NiTi ND 10PK TRU-ARCH ALIGN SE200 UM 019X025 NiTi ND 10PK TRU-ARCH ALIGN SE200 UM 014 NiTi ND 10PK TRU-ARCH ALIGN SE200 UM 018 NiTi ND 10PK TRU-ARCH ALIGN XF LM 012 NiTi ND 10PK TRU-ARCH ALIGN XF LM 014 NiTi ND 10PK TRU-ARCH ALIGN XF LM 016 NiTi ND 10PK TRU-ARCH ALIGN XF LM 018 NiTi ND 10PK TRU-ARCH ALIGN XF LS 016 NiTi ND 10PK TRU-ARCH ALIGN XF LM 018X025 NiTi ND 10PK TRU-ARCH ALIGN XF LS 016X016 NiTi ND 10PK TRU-ARCH ALIGN XF LS 019X025 NiTi ND 10PK TRU-ARCH ALIGN XF UM 012 NiTi ND 10PK TRU-ARCH ALIGN XF UM 016X022 NiTi ND 10PK TRU-ARCH ALIGN XF UM 018X025 NiTi ND 10PK TRU-ARCH ALIGN XF US 016X016 NiTi ND 10PK TRU-ARCH ALGN XF US 17X25 NiTi ND 10PK TRU-ARCH ALIGN XF UM 014 NiTi ND 10PK TRU-ARCH ALIGN XF UM 016 NiTi ND 10PK TRU-ARCH ALGN XF US 014 NiTi ND 10PK TRU-ARCH ALGN XF US 016 NiTi ND 10PK TRU-ARCH ALIGN XF UM 018 NiTi ND 10PK TRU-ARCH ALGN XF US 012 NiTi ND 10PK TRU-ARCH SS POSTED 26MM LM 019X025 ND BULK 10PK TRU-ARCH SS POSTED 28MM LM 018 ND BULK 10PK TRU-ARCH SS POSTED 30MM LM 019X025 ND BULK 10PK TRU-ARCH SS POSTED 32MM UM 019X025 ND BULK 10PK TRU-ARCH SS POSTED 34MM UM 018X025 ND BULK 10PK TRU-ARCH SS POSTED 34MM UM 019X025 ND BULK 10PK TRU-ARCH SS POSTED 36MM UM 018 ND BULK 10PK TRU-ARCH SS POSTED 36MM UM 019X025 ND BULK 10PK TRU-ARCH SS POSTED 38MM UM 018 ND BULK 10PK TRU-ARCH SS POSTED 38MM UM 019X025 ND BULK 10PK TRU-ARCH SS POSTED 40MM UM 019X025 ND BULK 10PK TRU-ARCH SS LS 017X025 ND PPAK 10PK TRU-ARCH SS LS 018X025 ND PPAK 10PK TRU-ARCH SS LS 019X025 ND PPAK 10PK TRU-ARCH SS LM 018 ND PPAK 10PK TRU-ARCH SS LM 020 ND PPAK 10PK TRU-ARCH SS LS 018 ND PPAK 10PK TRU-ARCH SS UM 018 ND PPAK 10PK TRU-ARCH SS UM 020 ND PPAK 10PK TRU-ARCH SS US 016 ND PPAK 10PK WIRE TMA ROUND .016 DIAX14IN LG PK 10 TMA WIRE RECT.017 X.025 14IN LG PK 10 TMA 14 INCH .019X.025 PK/10 MINI-TWIST ANGLED LIG.TIE.010 PK/1000 MINI-TWIST KOBAYASHI HOOK .012 PK/100 MINI-TWIST KOBAYASHI HOOK .014 PK/100 KOBAYASHI AUX TIE HOOK 014DIA PK/100 KOBAYASHI AUX TIE HOOK 016DIA PK/100 BITE TURBO BRACKET ASSY UP 3-3 UNIV STb LIGHT LINGUAL .018 +55/0/0 U7R TI B/T ORTHOS/DAMON .022 -27/0/6 U7L TI B/T ORTHOS/DAMON .022 -27/0/6 L6R TI-ORTHOS .022 -10/0/0 L7R TI-ORTHOS .022 -10/0/+5 L7L TI-ORTHOS .022 -10/0/+5 L1R DAMON Q2 022 -6/+2/0 STD/LOW  TQ L1L DAMON Q2 022 -6/+2/0 STD/LOW  TQ L2R DAMON Q2 022 -6/+4/0 STD/LOW TQ L2L DAMON Q2 022 -6/+4/0 STD/LOW TQ LABIAL/LINGUAL BUTTON-CLEAR PLASTIC LINGUAL CLEAT --MOLAR--ORMCO-- LINGUAL CLEAT -CUSP/BI--STD-- LINGUAL MOLAR SEATING LUG EACH CRIMPABLE STOP 2MM .019 I.D. X .030 O.D. PK40 CRIMPABLE STOP 2MM .030 I.D. X .041 O.D. PK40 DAMON TIEBACK MODULE SZ 1 GRAY PK40 DAMON TIEBACK MODULE SZ 1 CLEAR PK40 DAMON TIEBACK MODULE SZ 2 GRAY PK40 DAMON TIEBACK MODULE SZ 2 CLEAR PK40 ELASTIC SEPARATOR POSTERIOR PK/1000 POWER TUBE 025 CLEAR 25FT PKG ASSY POWER TUBE 030 CLEAR 25FT PKG ASSY POWER TUBE - CLEAR 025DIA 50FT SPOOL ARCH HOOK CRIMP RECT 22X28 2MM LING TUBE HORIZ W/WIN LOCK 036X072 SHEATH UR/LL W/3.2MM DG BALL HK 36X72 SHEATH UL/LR W/3.2MM DG BALL HK 36X72 SMALL CLEAT DIRECT BOND - 25 PACK CRIMPABLE BALL HOOKS - 50 PACK
Model Identifier(s)
201-0001 201-0002 201-0003 201-0004 201-0011 201-0012 201-0013 201-0014 202-0011 202-0020 205-0001 205-0003 205-0005 205-0007 205-0009 205-0013 205-0041 205-0043 205-0045 205-0047 205-0065 205-0067 205-0069 205-0071 205-6101 205-6201 205-6212 205-6301 205-6303 205-6312 205-6313 205-6401 205-6412 205-6413 206-0016 206-0018 207-0016 207-0018 208-1616 208-1622 208-1725 208-1925 209-1616 209-1622 209-1725 209-1925 210-0502 210-0503 210-0504 210-0505 210-0805 210-0921 210-0922 210-0923 210-0925 210-0927 210-0931 210-0932 210-0933 210-0935 210-0937 210-0952 210-0953 210-0955 210-0956 210-9103 210-9204 210-9205 210-9213 210-9214 211-0502 211-0503 211-0504 211-0505 211-0921 211-0922 211-0923 211-0925 211-0926 211-0927 211-0931 211-0932 211-0933 211-0935 211-0952 211-0953 211-0955 211-0956 211-9103 211-9204 211-9205 211-9213 211-9214 215-0003 215-0004 215-0005 215-0021 215-0022 215-0023 215-0024 215-0025 215-0031 215-0032 215-0034 215-0035 215-0041 215-0042 215-0043 215-0045 216-0003 216-0004 216-0005 219-1212 219-1308 219-1310 219-1312 219-1408 219-1410 219-1412 219-3303 219-3308 219-3403 219-3408 221-5510 221-5512 221-5514 222-5610 222-5612 222-5620 227-0341 227-0342 227-0343 227-0381 227-0382 227-0383 227-1026 227-1028 227-1029 227-1030 227-1031 227-1032 227-1036 227-1037 227-1038 227-1039 227-1040 227-1041 227-1042 227-1043 227-1067 227-1071 227-1111 227-1112 227-1113 227-1141 227-1142 227-1143 227-1152 227-3110 227-3112 227-3116 227-3118 227-3126 227-3129 227-3132 227-3136 227-3138 227-3142 227-3144 227-3152 227-3156 227-3207 227-3209 227-3211 227-3213 227-3219 227-3236 227-3249 227-3269 227-3286 227-3294 227-3306 227-3326 227-3334 227-3365 227-3369 227-3379 227-3383 227-3582 227-3640 227-7013 227-7016 227-7023 227-7028 227-7032 227-7033 227-7036 227-7038 227-7041 227-7043 227-7048 227-9013 227-9015 227-9016 227-9022 227-9023 227-9026 227-9040 227-9041 227-9043 266-0001 266-0011 266-0013 270-0001 271-0000 271-0001 271-0014 271-0016 350-0000 369-2102 449-0203 449-1203 449-2026 449-2027 449-2127 491-8816 491-8817 491-8826 491-8827 610-0010 613-0010 613-0012 615-0301 623-0262 623-0263 637-0011 637-0012 637-0021 637-0022 640-0080 640-4026 640-4031 640-6026 663-0222 672-3672 675-3672 676-3672 704-4014 704-9000