Question 1

What types of medical devices does Sable Industries Inc manufacture?

Accepted Answer

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.

Question 2

Where is Sable Industries Inc based, and what is the primary market for its devices?

Accepted Answer

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.

Question 3

Which regulatory registries list Sable Industries Inc’s devices, and why?

Accepted Answer

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.

Question 4

How are Sable Industries Inc’s devices classified under US regulations?

Accepted Answer

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.

Device	Model / Reference	Registries	Class	Status
SABLE - STAR Type	1600408	FDA UDI	Class I	Active
SABLE M-Style	1600504	FDA UDI	Class I	Active
SABLE M-Style	1600501	FDA UDI	Class I	Active
SABLE - STAR Type	1600410	FDA UDI	Class I	Active
SABLE Rotamax II	2000004	FDA UDI	Class I	Active
SABLE M-Style	1600302	FDA UDI	Class I	Active
SABLE E-Type 4:1	1600216	FDA UDI	Class I	Active
SABLE 20K Air Motor	1600110	FDA UDI	Class I	Active
SABLE Kavo Type 1:1	1610310	FDA UDI	Class I	Active
SABLE - STAR Type	1600409	FDA UDI	Class I	Active
SABLE - KAVO Type	1610820	FDA UDI	Class I	Active
SABLE NSK Type 4:1	1600202	FDA UDI	Class I	Active
SABLE U-Type	1300103	FDA UDI	Class I	Active
SABLE - Doctor's Package	1600024	FDA UDI	Class I	Active
SABLE - KAVO Type	1610810	FDA UDI	Class I	Active
SABLE - STAR Type	1600412	FDA UDI	Class I	Active
Access Prophy	1600305	FDA UDI	Class I	Active
SABLE - Hygienist Package	1600018	FDA UDI	Class I	Active
SABLE - STAR Type	1600406	FDA UDI	Class I	Active
SABLE U-Type	1300303	FDA UDI	Class I	Active
SABLE Access PRO KL	2000021	FDA UDI	Class I	Active
SABLE E-Type 1:1	1600211	FDA UDI	Class I	Active
SABLE NSK Type 16:1	1600203	FDA UDI	Class I	Active
SABLE - Doctor's Package	1600009	FDA UDI	Class I	Active
SABLE 5K Air Motor	1600102	FDA UDI	Class I	Active
Sable Blades	K863885	FDA 510(k)	Class I	Active
Access And Rotamax Fiber Optic High Speed Dental Handpieces	K072554	FDA 510(k)	Class I	Active
Premium Slow Speed; 20k Air Motor, Heads, Contra-Angles, Straight Nosecones	K083101	FDA 510(k)	Class I	Active

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