Ormco Orthodontic Appliances - HSA Registration DE0506728
Access comprehensive regulatory information for Ormco Orthodontic Appliances in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0506728 and owned by Ormco Corporation. The device was registered on March 15, 2022.
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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HSA Official Data
CLASS B
DE0506728
Ormco Orthodontic Appliances
HSA Registration Number: DE0506728
Product Description
Dental devices designed to influence the shape and/or function of the stomatognathic system through the application of physical force.
Device Classification
Device Class
CLASS B
Medical Speciality Area
Dental
Registration Information
Registration Number
DE0506728
Registration Date
March 15, 2022
Change Notification Approval Date
February 01, 2024
Retention Due Date
March 14, 2026
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)
STb STRAIGHTWIRE CUNITI .013 DIA SM PK10
STb STRAIGHTWIRE CUNITI .013 DIA MED PK10
STb STRAIGHTWIRE CUNITI .013 DIA LG PK10
STb STRAIGHTWIRE CUNITI .016 DIA SM PK10
STb STRAIGHTWIRE CUNITI .016 DIA MED PK10
STb STRAIGHTWIRE CUNITI .016 DIA LG PK10
STb STRAIGHTWIRE CUNITI .016 x .016 SM PK10
STb STRAIGHTWIRE CUNITI .016 x .016 MED PK10
STb STRAIGHTWIRE CUNITI .016 x .016 LG PK10
STb STRAIGHTWIRE CUNITI .014 DIA SM PK10
STb STRAIGHTWIRE CUNITI .014 DIA MED PK10
STb STRAIGHTWIRE CUNITI .014 DIA LG PK10
STb STRAIGHTWIRE CUNITI .018 x .018 SM PK10
STb STRAIGHTWIRE CUNITI .018 x .018 MED PK10
STb STRAIGHTWIRE CUNITI .018 x .018 LG PK10
PREF ARCH NI-TI UPPER .016 LARGE PK10
PREF ARCH NI-TI UPPER .018 LARGE PK10
PREF ARCH NI-TI LOWER .016 LARGE PK10
PREF ARCH NI-TI LOWER .018 LARGE PK10
PREF ARCH NI-TI UPPER .014 LARGE PK10
PREF ARCH NI-TI LOWER .014 SMALL PK10
PREF ARCH NI-TI LOWER .014 LARGE PK10
PREF ARCH NI-TI UPPER .020 LARGE PK10
PREF ARCH NI-TI LOWER .020 LARGE PK10
DAMON CUNITI W/STOPS .014 DIA. PK10
DAMON CUNITI W/STOPS .016 DIA PK10
DAMON CUNITI W/STOPS .018 DIA. PK10
DAMON CUNITI W/STOPS .013 DIA PK10
ARCH ALXLOOP TMA 17X25 S/U 34MM PK/5
ARCH ALXLOOP TMA 17X25 S/U 36MM PK/5
ARCH ALXLOOP TMA 17X25 M/U 38MM PK/5
ARCH ALXLOOP TMA 17X25 M/U 40MM PK/5
ARCH ALXLOOP TMA 17X25 L/U 42MM PK/5
ARCH ALXLOOP TMA 17X25 L/U 44MM PK/5
ARCH KIT-ALEX TMA LOOPED-UP .017X.025
ARCH ALEXANDER SZ 1 LWR 16 RD PK 10
ARCH ALEXANDER SZ 2 LWR 16 RD PK 10
ARCH ALEXANDER SZ 3 UPR 16 RD PK 10
ARCH ALEXAND SST LO SML 016X022 PK/10
ARCH ALEXAND SST LO LRG 016X022 PK/10
ARCH ALEXAND SST UPPER 016X022 PK/10
ARCH ALEXAND SST LO SML 017X025 PK/10
ARCH ALEXAND SST LO LRG 017X025 PK/10
ARCH ALEXAND SST UPPER 017X025 PK/10
ARCH ALXLOOP TMA 16X22 S/L 36MM PK/5
ARCH ALXLOOP TMA 16X22 S/L 38MM PK/5
ARCH ALXLOOP TMA 16X22 M/L 40MM PK/5
ARCH ALXLOOP TMA 16X22 M/L 42MM PK/5
ARCH ALXLOOP TMA 16X22 L/L 44MM PK/5
ARCH ALXLOOP TMA 16X22 L/L 46MM PK/5
ARCH KIT-ALEX TMA LOOPED-LO .016X.022
SS BROAD ARCH ROUND.0140 UP SML PK/20
SS BROAD ARCH ROUND.0160 UP SML PK/20
SS BROAD ARCH ROUND.0180 UP SML PK/20
SS BROAD ARCH ROUND.0200 UP SML PK/20
SS BROAD ARCH ROUND.0140 UP LGE PK/20
SS BROAD ARCH ROUND.0160 UP LGE PK/20
SS BROAD ARCH ROUND.0180 UP LGE PK/20
SS BROAD ARCH ROUND.0200 UP LGE PK/20
TMA BROAD ARCH ROUND.016 UP SML PK/10
TMA BROAD ARCH ROUND.018 UP SML PK/10
TMA BROAD ARCH ROUND.016 UP LGE PK/10
TMA BROAD ARCH ROUND.018 UP LGE PK/10
TMA BROAD ARCH UP SML 0175 0175 PK/10
TMA BROAD ARCH UP SML 0210 0250 PK/10
TMA BROAD ARCH UP-LGE 0175 0175 PK/10
TMA BROAD ARCH UP LGE 0210 0250 PK/10
NI-TI BROAD ARCH UPLGE 0160 0220 PK10
NI-TI BROAD ARCH UPLGE 0170 0250 PK10
NI-TI BROAD ARCH UPLGE 0180 0250 PK10
NI-TI BROAD ARCH UPLGE 0190 0250 PK10
SS BROAD ARCH UP SML 0160X0220 PK/10
SS BROAD ARCH UP SML 0170X0250 PK/10
SS BROAD ARCH UP SML 0180X0250 PK/10
SS BROAD ARCH UP SML 0190X0250 PK/10
SS BROAD ARCH UP SML 0210X0250 PK/10
SS BROAD ARCH UP SML 0160X0160 PK/10
SS BROAD ARCH UP LGE 0160X0220 PK/10
SS BROAD ARCH UP LGE 0170X0250 PK/10
SS BROAD ARCH UP LGE 0180X0250 PK/10
SS BROAD ARCH UP LGE 0190X0250 PK/10
SS BROAD ARCH UP LGE 0210X0250 PK/10
SS BROAD ARCH UP LGE 0160X0160 PK/10
TURBO ARCH UPPER .017 X.025 PACK/10
BRD ARCH LOFRIC.TMA UPSM 016X022 PK10
BRD ARCH LOFRIC.TMA UPSM 017X025 PK10
BRD ARCH LOFRIC.TMA UPSM 019X025 PK10
BRD ARCH LOFRIC.TMA UPLG 016X022 PK10
BRD ARCH LOFRIC.TMA UPLG 017X025 PK10
BRD ARCH LOFRIC.TMA UPLG 019X025 PK10
DAMON CUNITI W/STOPS .014x.025 PK10
DAMON CUNITI W/STOPS .016x.025 PK10
DAMON CUNITI W/STOPS .018x.025 PK10
PURPLE TMA BAF .016X.022 UP SM PK-5
PURPLE TMA BAF .017X.025 UP SM PK-5
PURPLE TMA BAF .019X.025 UP SM PK-5
PURPLE TMA BAF .016X.022 UP LG PK-5
PURPLE TMA BAF .017X.025 UP LG PK-5
PURPLE TMA BAF .019X.025 UP LG PK-5
HONEY DEW TMA BAF .016X.022 UP SM PK5
HONEY DEW TMA BAF .017X.025 UP SM PK5
HONEY DEW TMA BAF .019X.025 UP SM PK5
HONEY DEW TMA BAF .016X.022 UP LG PK5
HONEY DEW TMA BAF .017X.025 UP LG PK5
HONEY DEW TMA BAF .019X.025 UP LG PK5
SS BROAD ARCH ROUND.0140 LO SML PK/20
SS BROAD ARCH ROUND.0160 LO SML PK/20
SS BROAD ARCH ROUND.0180 LO SML PK/20
SS BROAD ARCH ROUND.0200 LO SML PK/20
SS BROAD ARCH ROUND.0140 LO LGE PK/20
SS BROAD ARCH ROUND.0160 LO LGE PK/20
SS BROAD ARCH ROUND.0180 LO LGE PK/20
SS BROAD ARCH ROUND.0200 LO LGE PK/20
TMA BROAD ARCH ROUND.016 LO SML PK/10
TMA BROAD ARCH ROUND.018 LO SML PK/10
TMA BROAD ARCH ROUND.016 LO LGE PK/10
TMA BROAD ARCH ROUND.018 LO LGE PK/10
TMA BROAD ARCH LO SML 0175 0175 PK/10
TMA BROAD ARCH LO SML 0210 0250 PK/10
TMA BROAD ARCH LO LGE 0175 0175 PK/10
TMA BROAD ARCH LO LGE 0210 0250 PK/10
NI-TI BROAD ARCH LOLGE 0160 0220 PK10
NI-TI BROAD ARCH LOLGE 0170 0250 PK10
NI-TI BROAD ARCH LOLGE 0180 0250 PK10
NI-TI BROAD ARCH LOLGE 0190 0250 PK10
SS BROAD ARCH LO SML 0160X0220 PK/10
SS BROAD ARCH LO SML 0170X0250 PK/10
SS BROAD ARCH LO SML 0180X0250 PK/10
SS BROAD ARCH LO SML 0190X0250 PK/10
SS BROAD ARCH LO SML 0210X0250 PK/10
SS BROAD ARCH LO SML 0160X0160 PK/10
SS BROAD ARCH LO LGE 0160X0220 PK/10
SS BROAD ARCH LO LGE 0170X0250 PK/10
SS BROAD ARCH LO LGE 0180X0250 PK/10
SS BROAD ARCH LO LGE 0190X0250 PK/10
SS BROAD ARCH LO LGE 0210X0250 PK/10
SS BROAD ARCH LO LGE 0160X0160 PK/10
TURBO ARCH LOWER .017 X.025 PACK/10
TURBO ARCH LOWER .021 X.025 PACK/10
BRD ARCH LOFRIC.TMA LOSM 016X022 PK10
BRD ARCH LOFRIC.TMA LOSM 017X025 PK10
BRD ARCH LOFRIC.TMA LOSM 019X025 PK10
BRD ARCH LOFRIC.TMA LOLG 016X022 PK10
BRD ARCH LOFRIC.TMA LOLG 017X025 PK10
BRD ARCH LOFRIC.TMA LOLG 019X025 PK10
PURPLE TMA BAF .016X.022 LO SM PK-5
PURPLE TMA BAF .017X.025 LO SM PK-5
PURPLE TMA BAF .019X.025 LO SM PK-5
PURPLE TMA BAF .016X.022 LO LG PK-5
PURPLE TMA BAF .017X.025 LO LG PK-5
PURPLE TMA BAF .019X.025 LO LG PK-5
HONEYDEW TMA BAF.016X.022 LO SM PK-5
HONEYDEW TMA BAF.017X.025 LO SM PK-5
HONEYDEW TMA BAF.019X.025 LO SM PK-5
HONEYDEW TMA BAF.017X.025 LO LG PK-5
HONEYDEW TMA BAF.019X.025 LO LG PK-5
ARCH REV.CURVE NITI UP.016 DIA. PK10
ARCH REV.CURVE NITI UP.018 DIA. PK10
ARCH REV.CURVE NITI UP.016 X.022 PK10
ARCH REV.CURVE NITI UP .016 X.025 PK10
ARCH REV.CURVE NITI UP.017 X.025 PK10
ARCH REV.CURVE NITI UP.019 X.025 PK10
REV CURVE NiTi 34mm PRE-TRQ 20 DEG 016 X 025 PK5
REV CURVE NiTi 34mm PRE-TRQ 20 DEG 017 X 025 PK5
REV CURVE NiTi 34mm PRE-TRQ 20 DEG 019 X 025 PK5
REVERSE CURVE NiTi DAMON 016 X 025 PK5
REVERSE CURVE NiTi DAMON 017 X 025 PK5
REVERSE CURVE NiTi DAMON 019 X 025 PK5
REV CURVE NiTi 38mm PRE-TRQ 20 DEG 016 X 025 PK5
REV CURVE NiTi 38mm PRE-TRQ 20 DEG 017 X 025 PK5
REV CURVE NiTi 38mm PRE-TRQ 20 DEG 019 X 025 PK5
ARCH REV.CURVE NITI LO.016 DIA. PK10
ARCH REV.CURVE NITI LO.018 DIA. PK10
ARCH REV.CURVE NITI LO.016 X.022 PK10
ARCH REV.CURVE NITI LO .016 X.025 PK10
ARCH REV.CURVE NITI LO.017 X.025 PK10
ARCH REV.CURVE NITI LO.019 X.025 PK10
ORTHOS CM TMA ARCH 016X022 LOSM PK10
ORTHOS CM TMA ARCH 017X025 LOSM PK10
ORTHOS CM TMA ARCH 019X025 LOSM PK10
ORTHOS CM TMA ARCH 021X025 LOSM PK10
ORTHOS CM TMA 016 X 022 UPSM PK10
ORTHOS CM TMA 017 X 025 UPSM PK10
ORTHOS CM TMA 019 X 025 UPSM PK10
ORTHOS CM TMA 021 X 025 UPSM PK10
ORTHOS CM TMA ARCH 016X022 LOLG PK10
ORTHOS CM TMA ARCH 017X025 LOLG PK10
ORTHOS CM TMA ARCH 019X025 LOLG PK10
ORTHOS CM TMA ARCH 021X025 LOLG PK10
ORTHOS CM TMA 016 X 022 UPLG PK10
ORTHOS CM TMA 017 X 025 UPLG PK10
ORTHOS CM TMA 019 X 025 UPLG PK10
ORTHOS CM TMA 021 X 025 UPLG PK10
WIRE EDG SQ.016X.016X14.0 PK 10
WIRE EDG REC .016X.022X14.0 PK 10
WIRE EDG REC .017X.022X14.0 PK 10
WIRE EDG REC .017X.025X 14.0 PK 10
WIRE EDG REC .018 X.022X14.0 PK 10
WIRE EDG REC .018X.025X14.0 PK 10
WIRE EDG REC .019X.025X14.0 PK 10
WIRE EDG REC .021X.025X14.0 PK 10
WIRE 14IN TRIPLEFLEX .0150 DIA PK/10
WIRE 14IN TRIPLEFLEX .0175 DIA PK/10
RESPOND WIRE .0150 DIAX14IN LGTH PK10
RESPOND WIRE .0170 DIAX14IN LGTH PK10
RESPOND WIRE .0190 DIAX14IN LGTH PK10
RESPOND WIRE .0210 DIAX14IN LGTH PK10
WIRE ROUND SPRING .012 DIAX14.0 PK 50
WIRE ROUND SPRING .014 DIAX14.0 PK 50
WIRE ROUND SPRING .016 DIAX14.0 PK 40
WIRE ROUND SPRING .018 DIAX14.0 PK 40
WIRE ROUND SPRING .020 DIAX14.0 PK 40
WIRE ROUND SPRING .028 DIAX14.0 PK 30
WIRE ROUND SPRING .030 DIAX14.0 PK 30
WIRE ROUND SPRING .032 DIAX14.0 PK 20
WIRE ROUND SPRING .036 DIAX14.0 PK 20
Model Identifier(s)
204-2101
204-2102
204-2103
204-2111
204-2112
204-2113
204-2121
204-2122
204-2123
204-2131
204-2132
204-2133
204-2141
204-2142
204-2143
205-0002
205-0004
205-0006
205-0008
205-0010
205-0011
205-0012
205-0014
205-0016
205-1902
205-1903
205-1904
205-1909
206-0070
206-0071
206-0072
206-0073
206-0074
206-0075
206-0076
207-0030
207-0031
207-0032
207-0035
207-0036
207-0037
207-0040
207-0041
207-0042
207-0070
207-0071
207-0072
207-0073
207-0074
207-0075
207-0076
210-0024
210-0026
210-0028
210-0030
210-0124
210-0126
210-0128
210-0130
210-0301
210-0302
210-0311
210-0312
210-0401
210-0405
210-0411
210-0415
210-0512
210-0513
210-0514
210-0515
210-0701
210-0702
210-0703
210-0704
210-0705
210-0706
210-0711
210-0712
210-0713
210-0714
210-0715
210-0716
210-0802
210-1402
210-1403
210-1404
210-1412
210-1413
210-1414
210-1905
210-1906
210-1907
210-4402
210-4403
210-4404
210-4412
210-4413
210-4414
210-5402
210-5403
210-5404
210-5412
210-5413
210-5414
211-0024
211-0026
211-0028
211-0030
211-0124
211-0126
211-0128
211-0130
211-0301
211-0302
211-0311
211-0312
211-0401
211-0405
211-0411
211-0415
211-0512
211-0513
211-0514
211-0515
211-0701
211-0702
211-0703
211-0704
211-0705
211-0706
211-0711
211-0712
211-0713
211-0714
211-0715
211-0716
211-0802
211-0805
211-1402
211-1403
211-1404
211-1412
211-1413
211-1414
211-4402
211-4403
211-4404
211-4412
211-4413
211-4414
211-5402
211-5403
211-5404
211-5413
211-5414
216-0116
216-0118
216-1622
216-1625
216-1725
216-1925
216-3416
216-3417
216-3419
216-3806
216-3807
216-3809
216-3816
216-3817
216-3819
217-0116
217-0118
217-1622
217-1625
217-1725
217-1925
219-2108
219-2110
219-2112
219-2113
219-2208
219-2210
219-2212
219-2213
219-2308
219-2310
219-2312
219-2313
219-2408
219-2410
219-2412
219-2413
252-1616
254-1622
254-1722
254-1725
254-1822
254-1825
254-1925
254-2125
264-0150
264-0175
264-1115
264-1117
264-1119
264-1121
266-1312
266-1314
266-1316
266-1318
266-1320
266-1328
266-1330
266-1332
266-1336