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. Size 815, Lingual Bur FDA UDI
- Model / Reference
- RSB815 FDA UDI
- Description
- The Renew® Finishing System is intended for use in the removal of composite paste after debonding. Size 815, Lingual Bur FDA UDI
Identifiers
- Catalog Number
- RSB815 FDA UDI
- Primary DI / UDI-DI
- D798RSB8150 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
- Not 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
Renew by Reliance Orthodontic Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Reliance Orthodontic Products, Inc.
Sources (1)
- FDA UDI 88d6e6a8-7e3c-43a2-9096-192a60b7241a 37 fields · synced May 30, 2026