Identity
- Trade Name
- DenMat® FDA UDI
- Generic Name
- Dental matrix band retainer FDA UDI
- Device Name
- MTX RFL NEDLS 20GA 100BG FDA UDI
- Model / Reference
- CR0002 FDA UDI
- Description
- MTX RFL NEDLS 20GA 100BG FDA UDI
Identifiers
- Catalog Number
- CR0002 FDA UDI
- Primary DI / UDI-DI
- D813CR00020 FDA UDI
- 510(k) Number
- K772316 FDA UDI
- FDA Product Code
- DZN FDA UDI
- GMDN Term
- Dental matrix band retainer FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 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
No
FDA UDI
Over-the-Counter
Yes
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: Dental matrix band retainer
DenMat® by Den-Mat Holdings, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K772316 also covers:
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 I | Pending data |
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Manufacturer
- Manufacturer
- Den-Mat Holdings, LLC
Sources (1)
- FDA UDI 4992e61b-b91f-45b8-8f7b-c6a56821f947 36 fields · synced Jun 9, 2026