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Sign in to claim this brandSable Industries Inc
US
Last updated May 24, 2026
What Sable Industries Inc makes
Sable Industries Inc manufactures dental power tools, including motorless handpiece components, pneumatic surgical motors, and pneumatic couplers for dental handpieces. Their portfolio also includes motorized handpiece sets designed for dental procedures, such as the Hygienist Package, Kavo Multiflex, and various NSK/STAR and U-Type models. These devices are engineered for use in dental offices and clinics, supporting tasks like cleaning, polishing, and precision cutting.
The company’s dental power tools are classified as Class I medical devices under US regulations and are listed in the FDA’s 510(k) and UDI registries. These devices comply with US regulatory requirements and are intended for distribution within the United States. The manufacturer is based in the US.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Sable Industries Inc manufacture?
Sable Industries Inc specializes in dental power tools, focusing on components and systems used in dental procedures. Their portfolio includes motorless handpiece components, pneumatic surgical motors, pneumatic couplers, and motorized handpiece sets. Examples include the Hygienist Package, Kavo Multiflex, and various NSK/STAR and U-Type models, which are designed for tasks like cleaning, polishing, and precision cutting in dental offices and clinics.
Where is Sable Industries Inc based, and what is the primary market for its devices?
Sable Industries Inc is based in the United States. Their devices are engineered specifically for the US market, adhering to regulatory requirements applicable in that region. The company’s dental power tools are intended for use in US dental offices and clinics.
Which regulatory registries list Sable Industries Inc’s devices, and why?
Sable Industries Inc’s devices are listed in the FDA’s 510(k) and UDI registries. These registries are used to track and verify the compliance of medical devices with US regulatory standards. The 510(k) process ensures that devices meet safety and effectiveness requirements, while the UDI system provides a unique identifier for each device to improve tracking and traceability.
How are Sable Industries Inc’s devices classified under US regulations?
Sable Industries Inc’s dental power tools are classified as Class I medical devices under US regulations. This classification is typically assigned to devices posing minimal risk to patients, such as dental handpieces and their components. Class I devices often require general controls (like good manufacturing practices) but may not need pre-market approval, depending on their specific design and intended use.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- sableindustriesinc.com
- —
- —
- [email protected]
- Phone
- 1-800-368-8106
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 255407272
Catalogue (78)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| SABLE - Hygienist Package | 1600013 | FDA UDI | Class I | Active |
| SABLE - Kavo Multiflex | 2000116 | FDA UDI | Class I | Active |
| SABLE - Hygienist Package | 1600011 | FDA UDI | Class I | Active |
| SABLE U-Type | 1300302 | FDA UDI | Class I | Active |
| SABLE NSK Type 1:1 | 1600304 | FDA UDI | Class I | Active |
| SABLE - Doctor's Package | 1600023 | FDA UDI | Class I | Active |
| SABLE - NSK/STAR Type | 1600407 | FDA UDI | Class I | Active |
| SABLE Kavo Type 1:1 | 1610210 | FDA UDI | Class I | Active |
| SABLE - NSK/STAR Type | 1600402 | FDA UDI | Class I | Active |
| SABLE M-Style | 1600502 | FDA UDI | Class I | Active |
| SABLE U-Type | 1300301 | FDA UDI | Class I | Active |
| SABLE Access II | 2000003 | FDA UDI | Class I | Active |
| SABLE Rotamax PRO 45KL | 2000023 | FDA UDI | Class I | Active |
| SABLE - Doctor's Package | 1600010 | FDA UDI | Class I | Active |
| SABLE - Hygienist Package | 1600014 | FDA UDI | Class I | Active |
| SABLE Rotamax PRO KL | 2000022 | FDA UDI | Class I | Active |
| SABLE 20K Air Motor | 1610110 | FDA UDI | Class I | Active |
| SABLE - Kavo Multiflex | 2000119 | FDA UDI | Class I | Active |
| SABLE Quick Connect | 2000101 | FDA UDI | Class I | Active |
| SABLE - Hygienist Package | 1600026 | FDA UDI | Class I | Active |
| SABLE - STAR Type | 1604004 | FDA UDI | Class I | Active |
| SABLE - NSK/STAR Type | 1600401 | FDA UDI | Class I | Active |
| SABLE Quick Connect | 2000107 | FDA UDI | Class I | Active |
| SABLE - Hygienist Package | 1600025 | FDA UDI | Class I | Active |
| SABLE NSK Type 4:1 | 1600303 | FDA UDI | Class I | Active |
| SABLE 20K Air Motor | 1600111 | FDA UDI | Class I | Active |
| SABLE Rotamax PRO 45 | 2000024 | FDA UDI | Class I | Active |
| SABLE - Kavo Multiflex | 2000114 | FDA UDI | Class I | Active |
| SABLE - Hygienist Package | 1600012 | FDA UDI | Class I | Active |
| SABLE 5K Prophy | 1600005 | FDA UDI | Class I | Active |
| SABLE E-Type 1:1 | 1600214 | FDA UDI | Class I | Active |
| SABLE NSK Type 1:1 | 1600310 | FDA UDI | Class I | Active |
| SABLE - Doctor's Package | 1600016 | FDA UDI | Class I | Active |
| SABLE U-Type | 1300104 | FDA UDI | Class I | Active |
| SABLE Quick Connect | 2000108 | FDA UDI | Class I | Active |
| SABLE E-Type 1:1 | 1600215 | FDA UDI | Class I | Active |
| SABLE M-Style | 1600503 | FDA UDI | Class I | Active |
| SABLE - NSK/STAR Type | 1600403 | FDA UDI | Class I | Active |
| SABLE NSK Type 1:1 | 1600210 | FDA UDI | Class I | Active |
| SABLE M-Style | 1600204 | FDA UDI | Class I | Active |
| SABLE - NSK/STAR Type | 1600405 | FDA UDI | Class I | Active |
| SABLE E-Type 4:1 | 1600217 | FDA UDI | Class I | Active |
| SABLE U-Type | 1300304 | FDA UDI | Class I | Active |
| SABLE M-Style | 1600507 | FDA UDI | Class I | Active |
| SABLE E-Type 4:1 | 1600218 | FDA UDI | Class I | Active |
| SABLE E-Type 4:1 | 1600212 | FDA UDI | Class I | Active |
| SABLE - Kavo Multiflex | 2000105 | FDA UDI | Class I | Active |
| SABLE - NSK/STAR Type | 1600421 | FDA UDI | Class I | Active |
| SABLE - Doctor's Package | 1600008 | FDA UDI | Class I | Active |
| SABLE - NSK/STAR Type | 1600404 | FDA UDI | Class I | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Sable Industries, Inc. Kitchener Ontario · CA FEI 3002105090