Identity
- Trade Name
- SABLE - STAR Type FDA UDI
- Generic Name
- Dental power tool handpiece motorless component FDA UDI
- Device Name
- SABLE - STAR Type Standard Latch Head with Elbow - 5,000 RPM FDA UDI
- Model / Reference
- 1600406 FDA UDI
- Description
- SABLE - STAR Type Standard Latch Head with Elbow - 5,000 RPM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841359040084 FDA UDI
- 510(k) Number
- K083101 FDA UDI
- FDA Product Code
- EFB FDA UDI
- GMDN Term
- Dental power tool handpiece motorless component FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4200 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental power tool handpiece motorless component
SABLE - STAR Type by Sable Industries Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K083101 also covers:
- Burkhart Dental Supply — BURKHART DENTAL SUPPLY CO., THE
- Burkhart Dental Supply — BURKHART DENTAL SUPPLY CO., THE
- Burkhart Dental Supply — BURKHART DENTAL SUPPLY CO., THE
- Burkhart Dental Supply — BURKHART DENTAL SUPPLY CO., THE
- Burkhart Dental Supply — BURKHART DENTAL SUPPLY CO., THE
- Access Prophy — Sable Industries Inc
- SABLE - Doctor's Package — Sable Industries Inc
- SABLE - Doctor's Package — Sable Industries Inc
- SABLE - Doctor's Package — Sable Industries Inc
- SABLE - Doctor's Package — Sable Industries Inc
- SABLE - Doctor's Package — Sable Industries Inc
- SABLE - Doctor's Package — Sable Industries 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 |
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Manufacturer
- Manufacturer
- Sable Industries Inc
Sources (1)
- FDA UDI bedbd033-45ca-450f-b56a-b7188d62bf14 35 fields · synced May 30, 2026