Identity
- Trade Name
- Renew FDA UDI
- Generic Name
- Polymeric dental bur 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. This is the Handpiece Renew Finishing System Point. FDA UDI
- Model / Reference
- RSPHP 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. This is the Handpiece Renew Finishing System Point. FDA UDI
Identifiers
- Catalog Number
- RSPHP FDA UDI
- Primary DI / UDI-DI
- D798RSPHP1 FDA UDI
- FDA Product Code
- EHL FDA UDI
- GMDN Term
- Polymeric dental bur FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6010 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: Polymeric dental bur
Renew by Reliance Orthodontic Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 20b3354a-519d-4a51-b439-dc61bfa3bfe8 35 fields · synced May 30, 2026