Identity
- Trade Name
- Contours™ Coarse Anatomy Trimmers Shape 08 FDA UDI
- Generic Name
- Dental abrasive point, reusable FDA UDI
- Device Name
- Dental Mandrel FDA UDI
- Model / Reference
- 078208 FDA UDI
- Description
- Dental Mandrel FDA UDI
Identifiers
- Catalog Number
- 078208 FDA UDI
- Primary DI / UDI-DI
- 00359883003104 FDA UDI
- FDA Product Code
- EJR FDA UDI
- GMDN Term
- Dental abrasive point, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6030 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental abrasive point, reusable
Contours™ Coarse Anatomy Trimmers Shape 08 by Den-Mat Holdings, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental abrasive point, reusable.
- MALIBU SEPARATORS — AMERICAN TOOTH INDUSTRIES · Class I
- HORICO — Hopf, Ringleb & Co. GmbH & Cie. · Class I
- Brasseler USA — Peter Brasseler Holdings, LLC · Class I
- KOMET Abrasive Instruments — Gebr. Brasseler GmbH & Co. KG · Class I
- EDENTA — EDENTA ETABLISSEMENT · Class I
- EDENTA — EDENTA ETABLISSEMENT · Class I
- Alpen — Coltene/Whaledent Inc. · Class I
- Strauss Diamond — Diamond Strauss Instruments Inc · 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 decf976d-2e4c-4d91-9367-ee5236c827b6 36 fields · synced Jun 9, 2026