Identity
- Trade Name
- Stage-1 FDA UDI
- Generic Name
- Fixture/appliance dental drill bit, reusable FDA UDI
- Device Name
- Drill FDA UDI
- Model / Reference
- S1401-33-01K FDA UDI
- Description
- Drill FDA UDI
Identifiers
- Primary DI / UDI-DI
- D768S14013301K0 FDA UDI
- 510(k) Number
- K072768 FDA UDI
- FDA Product Code
- DZA FDA UDI
- GMDN Term
- Fixture/appliance dental drill bit, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4130 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: Fixture/appliance dental drill bit, reusable
Stage-1 by Keystone Dental Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Fixture/appliance dental drill bit, reusable.
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Cleared under the same submission
K072768 also covers:
- Prima Implant System — Keystone Dental Inc.
- Prima Implant System — Keystone Dental Inc.
- Prima Implant System — Keystone Dental Inc.
- Prima Implant System — Keystone Dental Inc.
- Prima Implant System — Keystone Dental Inc.
- Prima Implant System — Keystone Dental Inc.
- Prima Implant System — Keystone Dental Inc.
- Prima Implant System — Keystone Dental Inc.
- Prima Implant System — Keystone Dental Inc.
- Prima Implant System — Keystone Dental Inc.
- Prima Implant System — Keystone Dental Inc.
- Prima Implant System — Keystone Dental Inc.
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
- Keystone Dental Inc.
Sources (1)
- FDA UDI 30d33f55-f95c-41f5-b1d5-fbf27f2882cd 35 fields · synced Jun 1, 2026