Identity
- Trade Name
- Prima FDA UDI
- Generic Name
- Dental osteotome FDA UDI
- Device Name
- Osteotome FDA UDI
- Model / Reference
- 15069K FDA UDI
- Description
- Osteotome FDA UDI
Identifiers
- Primary DI / UDI-DI
- D76815069K0 FDA UDI
- FDA Product Code
- KDG FDA UDI
- GMDN Term
- Dental osteotome FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4820 FDA UDI
- Commercial Distribution
- 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
No
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
No
FDA UDI
Category: Dental osteotome
Prima by Keystone Dental Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental osteotome.
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- devemed — devemed GmbH · Class I
- Avalign — AVALIGN TECHNOLOGIES, Inc. · Class I
- Tatum Surgical-Osteotome — SUNCOAST DENTAL, INC. · Class I
- OSTEOTOME — KLS-Martin L.P. · Class I
- OSTEOTOME REPLACE - 6.0mm - RADIUS HF MARKINGS 7-10-13-16 — W.H. Holden, Inc. · Class I
- KOHDENT — Kohler Medizintechnik GmbH & Co. KG · 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 |
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Manufacturer
- Manufacturer
- Keystone Dental Inc.
Sources (1)
- FDA UDI 86f4b4ab-c1cd-48ed-8aac-1eadcd3dbd6a 34 fields · synced Jun 1, 2026