Identity
- Trade Name
- Renew FDA UDI
- Generic Name
- Carbide dental bur, reusable FDA UDI
- Device Name
- The Renew® Finishing System is intended for use in the removal of composite paste after debonding and polishing of the surface of enamel, porcelain, metal or composite. The Renew Finishing System Points #383 will remove small residual amounts of adhesive from the tooth surface and will polish the enamel without damage. It's rubberized tapered shape facilitates removal of adhesive close to the gingiva. The #383 Point is the second step in the Renew Finishing System Points. This is the Friction Grip Finishing Point. FDA UDI
- Model / Reference
- GRSPFG FDA UDI
- Description
- The Renew® Finishing System is intended for use in the removal of composite paste after debonding and polishing of the surface of enamel, porcelain, metal or composite. The Renew Finishing System Points #383 will remove small residual amounts of adhesive from the tooth surface and will polish the enamel without damage. It's rubberized tapered shape facilitates removal of adhesive close to the gingiva. The #383 Point is the second step in the Renew Finishing System Points. This is the Friction Grip Finishing Point. FDA UDI
Identifiers
- Catalog Number
- GRSPFG FDA UDI
- Primary DI / UDI-DI
- D798GRSPFG1 FDA UDI
- FDA Product Code
- EJL FDA UDI
- GMDN Term
- Carbide dental bur, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3240 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
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: Carbide dental bur, reusable
Renew by Reliance Orthodontic Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Carbide dental bur, reusable.
- EDENTA — EDENTA ETABLISSEMENT · Class I
- Alpen — Coltene/Whaledent Inc. · Class I
- Henry Schein — HENRY SCHEIN, INC. · Class I
- Brasseler USA — Peter Brasseler Holdings, LLC · Class I
- ACE — ACE SURGICAL SUPPLY CO., INC. · Class I
- Brasseler USA — Peter Brasseler Holdings, LLC · Class I
- Alpen — Coltene/Whaledent Inc. · Class I
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · 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
- Reliance Orthodontic Products, Inc.
Sources (1)
- FDA UDI 487740fb-752d-46cf-9b11-31cdeded655e 35 fields · synced May 30, 2026