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D-Fine™ Shape & Shine™ Single Step Diamond Polishers Refill Shape 05
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- D-Fine™ Shape & Shine™ Single Step Diamond Polishers Refill Shape 05 FDA UDI
- Generic Name
- Dental abrasive point, reusable FDA UDI
- Device Name
- Single Step Diamond Polishers FDA UDI
- Model / Reference
- 415505 FDA UDI
- Description
- Single Step Diamond Polishers FDA UDI
Identifiers
- Catalog Number
- 415505 FDA UDI
- Primary DI / UDI-DI
- 00359883005412 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
D-Fine™ Shape & Shine™ Single Step Diamond Polishers Refill Shape 05 by Den-Mat Holdings, LLC — Class I — FDA UDI — listed in FDA GUDID
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 |
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Manufacturer
- Manufacturer
- Den-Mat Holdings, LLC
Sources (1)
- FDA UDI 01dcdae9-09cc-4cbb-b0de-5387cdbc46aa 36 fields · synced Jun 9, 2026