Identity
- Trade Name
- Stern Root Anchor® Mini RA Diamond Bur FDA UDI
- Generic Name
- Diamond dental bur, reusable FDA UDI
- Device Name
- The Stern Root AnchorSystem includes the Stern Anchor Female (Standard, Mini and casting), The Stern Anchor Male (Standard, short, oversize, extra oversize), the Stern Anchor Denture Cap. Intended to be used in attachment dentistry for stabilization and retention of removable appliances in the mouth. Stern Root Anchor®, Latch (RA) diamond bur for mini female. FDA UDI
- Model / Reference
- 833115 FDA UDI
- Description
- The Stern Root AnchorSystem includes the Stern Anchor Female (Standard, Mini and casting), The Stern Anchor Male (Standard, short, oversize, extra oversize), the Stern Anchor Denture Cap. Intended to be used in attachment dentistry for stabilization and retention of removable appliances in the mouth. Stern Root Anchor®, Latch (RA) diamond bur for mini female. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841549106781 FDA UDI
- 510(k) Number
- K950213 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Diamond dental bur, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3630 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Diamond dental bur, reusable
Stern Root Anchor® Mini RA Diamond Bur by Sterngold Dental LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K950213 also covers:
- Stern Root Anchor® 10 Root Mini Refill Kit Ti — Sterngold Dental LLC
- Stern Root Anchor® 10 Root Std Refill Kit Ti — Sterngold Dental LLC
- Stern Root Anchor® 5 Root Mini Refill Kit Ti — Sterngold Dental LLC
- Stern Root Anchor® 5 Root Std Refill Kit Ti — Sterngold Dental LLC
- Stern Root Anchor® Caps, 5 — Sterngold Dental LLC
- Stern Root Anchor® Female Replicas, 5 — Sterngold Dental LLC
- Stern Root Anchor® Mini 1-Step RA Bur — Sterngold Dental LLC
- Stern Root Anchor® Mini Blue Transfer Males, 5 — Sterngold Dental LLC
- Stern Root Anchor® Mini FG Diamond Bur — Sterngold Dental LLC
- Stern Root Anchor® Mini Female Ti — Sterngold Dental LLC
- Stern Root Anchor® Mini Oversized Orange Males, 5 — Sterngold Dental LLC
- Stern Root Anchor® Mini White Males, 5 — Sterngold Dental LLC
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 |
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Manufacturer
- Manufacturer
- Sterngold Dental LLC
Sources (1)
- FDA UDI 8df16aae-5717-48c6-be44-4bbf269794d8 35 fields · synced May 30, 2026