Identity
- Trade Name
- SABLE - Doctor's Package FDA UDI
- Generic Name
- Dental power tool handpiece motorless component FDA UDI
- Device Name
- SABLE E-Type Doctor's Package. Package contains: Air Motor(1600110), 1:1 Contra Angle(1600211), 1:1 Nosecone(1600310) FDA UDI
- Model / Reference
- 1600016 FDA UDI
- Description
- SABLE E-Type Doctor's Package. Package contains: Air Motor(1600110), 1:1 Contra Angle(1600211), 1:1 Nosecone(1600310) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841359060082 FDA UDI
- 510(k) Number
- K083101 FDA UDI
- FDA Product Code
- EGS FDA UDIEFB 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
Yes
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 componentDental surgical power tool motor, pneumatic
SABLE - Doctor's Package by Sable Industries Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental surgical power tool motor, pneumatic.
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- AM-20 E RM — W & H Dentalwerk Bürmoos GmbH · Class I
- Brasseler USA — Peter Brasseler Holdings, LLC · Class I
- TA Bulb — NAKANISHI INC. · Class I
- AM-25 LT Air Motor — W & H Dentalwerk Bürmoos GmbH · Class I
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 - Hygienist 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sable Industries Inc
Sources (1)
- FDA UDI 8f3a752b-8bd7-4b06-95fe-2839b35ec8da 35 fields · synced Jun 6, 2026