Identity
- Trade Name
- Composite Ninja Comfort Grip FDA UDI
- Generic Name
- Dental restoration carver, amalgam, reusable FDA UDI
- Device Name
- Dental Hand Instrument FDA UDI
- Model / Reference
- 060105 FDA UDI
- Description
- Dental Hand Instrument FDA UDI
Identifiers
- Catalog Number
- 060105 FDA UDI
- Primary DI / UDI-DI
- 00359883006068 FDA UDI
- FDA Product Code
- DZN FDA UDI
- GMDN Term
- Dental restoration carver, amalgam, reusable 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
No
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
Yes
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 restoration carver, amalgam, reusable
Composite Ninja Comfort Grip by Den-Mat Holdings, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental restoration carver, amalgam, reusable.
- Brasseler USA — Peter Brasseler Holdings, LLC · Class I
- Reicodent — devemed GmbH · Class I
- TANAKA DENTAL — NORDENT MANUFACTURING INC · Class I
- NORDENT MANUFACTURING INC — NORDENT MANUFACTURING INC · Class I
- NORDENT MANUFACTURING INC — NORDENT MANUFACTURING INC · Class I
- HU-FRIEDY — HU-FRIEDY MFG CO., LLC · Class I
- NORDENT MANUFACTURING INC — NORDENT MANUFACTURING INC · Class I
- Reicodent — devemed GmbH · 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Den-Mat Holdings, LLC
Sources (1)
- FDA UDI 724d81cb-3250-4d68-ab24-f1e5613a1759 35 fields · synced Jun 9, 2026