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3M Unitek Orthodontic Headgear System - HSA Registration DE0008289

Access comprehensive regulatory information for 3M Unitek Orthodontic Headgear System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0008289 and owned by 3M Unitek Corporation. The device was registered on January 26, 2012.

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
DE0008289
3M Unitek Orthodontic Headgear System
HSA Registration Number: DE0008289
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Product Description

Orthodontic Headgear System is intended for use in orthodontic treatment of malocclusions. Headgear System attaches to the orthodontic appliance system is order to exert pressure on the teeth from outside the mouth

Device Classification
Device Class
CLASS B
Medical Speciality Area
Dental
HSA Product Code
Refer to CRPNS
HS Code
90184900
Registration Information
Registration Number
DE0008289
Registration Date
January 26, 2012
Change Notification Approval Date
November 29, 2024
Retention Due Date
January 25, 2026
Product Owner
Short Name
3M Unitek
Address
3M Company, 2724 South Peck Road, Monrovia, California, 91016, UNITED STATES
Registrant
Address
10 ANG MO KIO STREET 65, TECHPOINT, #01-01, SINGAPORE 569059
Importer
Address
10 ANG MO KIO STREET 65, TECHPOINT, #03-01, SINGAPORE 569059 10 ANG MO KIO STREET 65, TECHPOINT, #03-01, SINGAPORE 569059 10 ANG MO KIO STREET 65, TECHPOINT, #01-01, SINGAPORE 569059 10 ANG MO KIO STREET 65, TECHPOINT, #01-01, SINGAPORE 569059 6 TAGORE DRIVE, TAGORE INDUSTRIAL BUILDING, #03-11, SINGAPORE 787623
Model Information
Model Name(s)
Facebow Super Short Sz 1 045 Facebow Super Short Sz 2 045 Facebow Super Short Sz 3 045 Facebow Super Short Sz 4 045 Facebow Super Short Sz 5 045 FACE BOW LONG O4O FACE BOW SHORT O4O Facebow Friction Stop Facebow Friction Stop Facebow Friction Stop Facebow Friction Stop Facebow Friction Stop FACE BOW LONG 062 SZ 1 SS FACE BOW W/HOOK SZ 2 SS FACE BOW W/HOOK SZ 3 SS FACE BOW W/HOOK SZ 4 SS FACE BOW W/HOOK SZ 5 SS FACE BOW W/HK FACE BOW LONG O45 W/HK Facebow Friction Stop SHORT BOW 15 DEG O4O LONG BOW 15 DEG O45 Facebow Friction Stop LONG BOW 15 DEG O51 Facebow Friction Stop LONG BOW 15 DEG O45 W/HK SHORT BOW 15 DEG O45 W/HK FACE BOW O45 LG W/KAHN SP FACE BOW O45 SH W/KAHN SP EARLY CHILD FACEBOW 0 51 EARLY CHILD FACEBOW 00 51 Facebow Level Anchorage Facebow Level Anchorage Facebow Level Anchorage Facebow Level Anchorage ZWEMER FACE BOW O4O UNIL ZWEMER FACE BOW O45 UNIL UNILATERAL FACE BOW O4O UNILATERAL FACE BOW O45 S5 BOW SH #1 040 S5 BOW SH #2 040 S5 BOW SH #3 040 S5 BOW SH #4 040 S5 BOW SH #5 040 Facebow Long Sz 1 045 Facebow Short Sz 1 045 S5 BOW 15 LG #1 045 Facebow Short Facebow Short Facebow Long Sz 2 045 Facebow Short Sz 2 045 S5 BOW 15 LG #2 045 Facebow Short Facebow Short Facebow Long Sz 3 045 Facebow Short Sz 3 045 S5 BOW 15 LG #3 045 Facebow Short Sz 3 045 Facebow Short Facebow Long Sz 4 045 Facebow Short Sz 4 045 S5 BOW 15 LG #4 045 Facebow Short Facebow Short Facebow Long Sz 5 045 Facebow Short Sz 5 045 S5 BOW 15 LG #5 045 Facebow Short Facebow Short Facebow Short Sz 1 051 Facebow Short Facebow Short Sz 2 051 Facebow Short Sz 2 051 Facebow Short Sz 3 051 Facebow Short Facebow Short #4 051 Facebow Short Facebow Short Sz 5 051 Facebow Short S5 BOW LG W/H #1 045 Facebow Short Sz 1 045 Hk S5 BOW 15 LG W/H #1 045 Facebow Short S5 BOW LG W/H #2 045 Facebow Short Sz 2 045 Hk S5 BOW 15 LG W/H #2 045 Facebow Short S5 BOW LG W/H #3 045 Facebow Short Sz 3 045 Hk S5 BOW 15 LG W/H #3 045 Facebow Short S5 BOW LG W/H #4 045 Facebow Short Sz 4 045 Hk S5 BOW 15 LG W/H #4 045 Facebow Short S5 BOW LG W/H #5 045 Facebow Short Sz 5 045 Hk S5 BOW 15 LG W/H #5 045 Facebow Short Traction Release Headgear Traction Release Headgear Traction Release Headgear Traction Release Headgear Traction Release Headgear Traction Release Headgear Traction Release Headgear Traction Release Headgear Traction Release Headgear Traction Release Headgear Traction Release Headgear Traction Release Headgear Traction Release Headgear Traction Release Headgear Traction Release Headgear Traction Release Headgear Traction Release Headgear Traction Release Headgear Traction Release Headgear Traction Release Headgear Traction Release Headgear Traction Release Headgear Traction Release Headgear Traction Release Headgear Traction Release Headgear Traction Release Headgear Traction Release Headgear Traction Release Headgear Traction Release Headgear Traction Release Headgear Traction Release Headgear Traction Release Headgear Traction Release Headgear Traction Release Headgear Traction Release Headgear Traction Release Headgear Traction Release Headgear Traction Release Headgear Traction Release Headgear Traction Release Headgear NorthWest Headgear NorthWest Headgear NorthWest Headgear NorthWest Headgear NorthWest Headgear Northwest Headgear NorthWest Headgear NorthWest Headgear NorthWest Headgear NorthWest Headgear NorthWest Headgear NorthWest HeadGear NorthWest Headgear Northwest Headgear NorthWest Headgear NorthWest Headgear NorthWest Headgear NorthWest Headgear NorthWest Headgear Northwest Headgear NorthWest HeadGear Northwest Headgear NorthWest Headgear NorthWest Headgear NorthWest Headgear NorthWest Headgear NorthWest Headgear NorthWest Headgear NorthWest Headgear NorthWest Headgear NorthWest Headgear Friction Stops 045
Model Identifier(s)
320-215 320-225 320-235 320-245 320-255 320-401 320-402 320-450 320-451 320-452 320-511 320-512 320-621 321-215 321-225 321-235 321-245 321-255 321-451 321-452 322-402 322-451 322-452 322-511 322-512 323-451 323-452 324-451 324-452 325-301 325-302 325-410 325-411 325-412 325-413 326-400 326-450 327-400 327-450 328-112 328-122 328-132 328-142 328-152 328-211 328-212 328-213 328-214 328-215 328-221 328-222 328-223 328-224 328-225 328-231 328-232 328-233 328-234 328-235 328-241 328-242 328-243 328-244 328-245 328-251 328-252 328-253 328-254 328-255 328-312 328-314 328-322 328-324 328-332 328-334 328-342 328-344 328-352 328-354 329-211 329-212 329-213 329-214 329-221 329-222 329-223 329-224 329-231 329-232 329-233 329-234 329-241 329-242 329-243 329-244 329-251 329-252 329-253 329-254 414-069 414-070 414-071 414-072 414-073 414-074 414-075 414-076 414-077 414-078 414-079 414-080 414-081 414-082 415-007 415-008 415-009 415-017 415-018 415-019 415-035 415-036 415-037 415-038 415-039 415-040 415-041 415-042 415-049 415-050 415-051 415-058 415-059 415-060 415-061 415-064 415-067 415-068 415-069 415-072 444-001 444-002 444-007 444-008 444-014 444-020 444-026 444-032 444-080 444-086 444-092 444-098 444-103 444-174 444-218 444-290 444-319 444-320 444-800 444-801 444-806 444-807 444-808 444-809 444-814 444-816 444-817 444-818 444-822 444-823 444-828 519-562