Identity
- Trade Name
- PRO3DURE GR-17 temporary FDA UDI
- Generic Name
- Temporary dental crown/bridge resin FDA UDI
- Model / Reference
- 500g - bleach FDA UDI
Identifiers
- Primary DI / UDI-DI
- EPRCD1001630 FDA UDI
- 510(k) Number
- K201827 FDA UDI
- FDA Product Code
- EBG FDA UDI
- GMDN Term
- Temporary dental crown/bridge resin FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3770 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Temporary dental crown/bridge resin
PRO3DURE GR-17 temporary by Pro3Dure Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Temporary dental crown/bridge resin.
- Alpha-Crown® — Dental Technologies, Inc. · Class II
- JET TOOTH SHADE POWDER — Lang Dental Manufacturing Company, Inc. · Class II
- UNIFAST™ — Gc America Inc. · Class II
- MODIFYING STAIN — AMERICAN TOOTH INDUSTRIES · Class II
- DENTURE BASE — AMERICAN TOOTH INDUSTRIES · Class II
- PORTUX CAD/CAM Disc. 98.5X 25mm C2. MN — PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A · Class II
- tempofit premium BL — DETAX GmbH · Class II
- YAMAHACHI PMMA DISK — YAMAHACHI DENTAL MFG., CO. · Class II
Cleared under the same submission
K201827 also covers:
- ACRY PRINT RU-001 Temporary — Pro3Dure Medical
- ACRY PRINT RU-001 Temporary — Pro3Dure Medical
- PRO3DURE GR-17 temporary — Pro3Dure Medical
- PRO3DURE GR-17 temporary — Pro3Dure Medical
- PRO3DURE GR-17 temporary — Pro3Dure Medical
- PRO3DURE GR-17 temporary — Pro3Dure Medical
- PRO3DURE GR-17 temporary — Pro3Dure Medical
- PRO3DURE GR-17 temporary — Pro3Dure Medical
- PRO3DURE GR-17 temporary — Pro3Dure Medical
- PRO3DURE GR-17 temporary — Pro3Dure Medical
- PRO3DURE GR-17 temporary — Pro3Dure Medical
- PRO3DURE GR-17 temporary — Pro3Dure Medical
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Pro3Dure Medical
Sources (1)
- FDA UDI 6f753c50-fa1d-40d7-9d3d-bfacdd388909 35 fields · synced Jun 1, 2026