Identity
- Trade Name
- 3M™ FDA UDI
- Generic Name
- Orthodontic appliance relief material FDA UDI
- Device Name
- Unitek(TM) TAD Cap Elastic Ring Ea FDA UDI
- Model / Reference
- 504-202 FDA UDI
- Description
- Unitek(TM) TAD Cap Elastic Ring Ea FDA UDI
Identifiers
- Catalog Number
- 504-202 FDA UDI
- Primary DI / UDI-DI
- 00652221153593 FDA UDI
- FDA Product Code
- DZE FDA UDI
- GMDN Term
- Orthodontic appliance relief material FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3640 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthodontic appliance relief material
3m™ by 3m Unitek Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthodontic appliance relief material.
- Utility Wax — Ortho Organizers, Inc. · Class I
- The Orthodontic Store — Young Innovations, Inc. · Class I
- Ortho Organizers — Ortho Organizers, Inc. · Class I
- ReliaWax — RELIANCE ORTHODONTIC PRODUCTS, INC. · Class I
- Gishy Goo — ULTRADENT PRODUCTS, INC. · Class I
- PATIENT RELIEF WAX — Ortho Organizers, Inc. · Class I
- JMU — JMU DENTAL, INC · Class I
- Ortho Pro — Ortho Pro Dent LLC · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- 3m Unitek Corporation
Sources (1)
- FDA UDI 7a58a5d2-2112-4e44-ad18-5891eb57b489 35 fields · synced Jun 6, 2026