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APC™ II Unitek™ Mini Uni-Twin
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 3020-9620
Identity
- Trade Name
- 3M™ Mini Uni-Twin™ APC™ EUDAMEDAPC™ II Unitek™ Mini Uni-Twin FDA UDI
- Generic Name
- Orthodontic bracket, metal FDA UDI
- Device Name
- 3M™ Mini Uni-Twin™ Brackets, .022, LR5, -22T/0A, Hk, Offset, APC™ II, 3020-9620, 5/Pk EUDAMEDMini Uni-Twin(TM) Bracket APC(TM) II LR5 -22T/0A OffsetBase Hk .022 5/Pk FDA UDI
- Model / Reference
- 3020-9620 EUDAMEDFDA UDI
- Description
- Mini Uni-Twin(TM) Bracket APC(TM) II LR5 -22T/0A OffsetBase Hk .022 5/Pk FDA UDI
Identifiers
- Catalog Number
- 3020-9620 FDA UDI
- Primary DI / UDI-DI
- 00652221063519 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00652221063519 EUDAMED
- FDA Product Code
- DYH FDA UDI
- EMDN Code
- Q010403 ORTHODONTIC BRACKETS AND BUTTONS EUDAMED
- GMDN Term
- Orthodontic bracket, metal FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3750 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthodontic bracket, metal
APC™ II Unitek™ Mini Uni-Twin by 3m Unitek Corporation — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Orthodontic bracket, metal.
- Mini-Mono® — Forestadent Bernhard Förster GmbH · Class I
- Intrigue — LANCER ORTHODONTICS, INC. · Class II
- The Orthodontic Store — Young Innovations, Inc. · Class I
- LEGEND — GC Orthodontics America Inc. · Class I
- MIRABAY — MIRABAY ORTHODONTICS CORPORATION · Class I
- RMO — RMO · Class I
- Mini-Mono® — Forestadent Bernhard Förster GmbH · Class I
- Votion — ORTHO TECHNOLOGY, INC. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- 3m Unitek Corporation
Sources (2)
- FDA UDI 79c6579c-72fc-481e-83ba-4a070f1f4cba 35 fields · synced Oct 7, 2026
- EUDAMED ede7a3ed-cd57-42c0-a5b4-834c38f4d38f 61 fields · synced Oct 7, 2026