Question 1

What types of medical devices does Coltène/Whaledent AG manufacture?

Accepted Answer

Coltène/Whaledent AG specializes in dental devices, including reusable diamond burs for precision cutting, silicone impression materials used to create molds of teeth, and rotary/reciprocating endodontic files for root canal procedures. Their portfolio also covers dental composites, veneers, resin inlays, root canal obturating points, endodontic paper points, and universal adhesive systems for restorative treatments. These products cater to procedures requiring precision, durability, and biocompatibility in dental care.

Question 2

Where is Coltène/Whaledent AG based, and does this affect its devices?

Accepted Answer

Coltène/Whaledent AG has a presence in the United States, which means its devices must comply with FDA regulations. The company’s products are designed and manufactured to meet the standards applicable in the US market, ensuring they align with regulatory requirements for safety, performance, and quality in dental instruments and materials. This includes adherence to classification rules for medical devices.

Question 3

Which regulatory registries list Coltène/Whaledent AG’s devices?

Accepted Answer

Coltène/Whaledent AG’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices throughout their lifecycle, ensuring transparency in regulatory compliance and traceability for healthcare providers. Listing in this database is a requirement for Class I and Class II devices sold in the US.

Question 4

How are Coltène/Whaledent AG’s devices classified under FDA regulations?

Accepted Answer

Coltène/Whaledent AG’s devices are classified as either Class I or Class II under FDA regulations. Class I devices generally pose minimal risk and require general controls for safety and effectiveness, while Class II devices involve a higher risk and may require special controls beyond general regulations. The classification depends on factors like the device’s intended use, potential risks, and the body part it interacts with, such as dental burs or endodontic files.

Question 5

Why do some of Coltène/Whaledent AG’s devices require special controls like those for Class II?

Accepted Answer

Certain devices in Coltène/Whaledent AG’s portfolio, such as rotary endodontic files or dental composites, are classified as Class II because they involve higher risks than general dental instruments. For example, endodontic files used in root canal treatments must ensure precise shaping of root canals to avoid complications like perforations or incomplete cleaning. Special controls—like performance standards or post-market surveillance—are applied to mitigate these risks and ensure patient safety.

Device	Model / Reference	Registries	Class	Status
Brilliant Ng	1201	FDA UDI	Class II	Active
Componeer Brilliant	60014171	FDA UDI	Class II	Active
BRILLIANT Crios	60020097	FDA UDI	Class II	Active
Diatech Diamond Instruments	200402DD	FDA UDI	Class I	Active
HYGENIC® Paper Points	60019136	FDA UDI	Class I	Active
Alpen Diamond Instruments	R856C025FG	FDA UDI	Class I	Active
Diatech Diamond Instruments	200734AA	FDA UDI	Class I	Active
Miris2	8435	FDA UDI	Class II	Active
Diatech Diamond Instruments	200053AA	FDA UDI	Class I	Active
BRILLIANT Crios	60020020	FDA UDI	Class II	Active
HyFlex™ EDM	60022284	FDA UDI	Class I	Active
Diatech Diamond Instruments	200322DD	FDA UDI	Class I	Active
BRILLIANT EverGlow	60024167	FDA UDI	Class II	Active
HyFlex™ Paper Points	60022676	FDA UDI	Class I	Active
HyFlex EDM	60023495	FDA UDI	Class I	Active
BRILLIANT Crios	60020000	FDA UDI	Class II	Active
Cool Temp NATURAL	5820	FDA UDI	Class II	Active
Componeer Brilliant	60014132	FDA UDI	Class II	Active
Alpen Diamond Instruments	R835C008FG	FDA UDI	Class I	Active
Alpen Diamond Instruments	RS847C012FG	FDA UDI	Class I	Active
BRILLIANT Crios	60022889	FDA UDI	Class II	Active
Brilliant Componeer	60023200	FDA UDI	Class II	Active
Diatech Diamond Instruments	200425DD	FDA UDI	Class I	Active
DIATECH Diamond Instruments	60019345	FDA UDI	Class I	Active
Diatech Diamond Instruments	210823DD	FDA UDI	Class I	Active
Diatech Diamond Instruments	200652AA	FDA UDI	Class I	Active
Componeer	60014513	FDA UDI	Class II	Active
Alpen Diamond Instruments	R801F016FG	FDA UDI	Class I	Active
PRESIDENT The Original	60019947	FDA UDI	Class II	Active
Brilliant Componeer	60023157	FDA UDI	Class II	Active
HyFlex™ Guttapercha Points	60022699	FDA UDI	Class I	Active
Diatech Diamond Instruments	200171DD	FDA UDI	Class I	Active
Alpen Diamond Instruments	60018378	FDA UDI	Class I	Active
Diatech Diamond Instruments	200290AA	FDA UDI	Class I	Active
Diatech Diamond Instruments	200141DD	FDA UDI	Class I	Active
Diatech Diamond Instruments	200444AA	FDA UDI	Class I	Active
Alpen Diamond Instruments	R859C021FG	FDA UDI	Class I	Active
Alpen Diamond Instruments	R850TC016FG	FDA UDI	Class I	Active
A.r.t. Bond	7369	FDA UDI	Class II	Active
Componeer	1353	FDA UDI	Class II	Active
TempoSIL 2	3686	FDA UDI	Class II	Active
Synergy D6	8381	FDA UDI	Class II	Active
HyFlex™ EDM	60023573	FDA UDI	Class I	Active
Diatech Diamond Instruments	200122DD	FDA UDI	Class I	Active
Alpen Diamond Instruments	R850TC014FG	FDA UDI	Class I	Active
Brilliant Ng	8983 NG	FDA UDI	Class II	Active
ROEKO GuttaFlow®2	REFILL PACK DUAL-BARREL SYRING	FDA UDI	Class II	Active
Diatech Diamond Instruments	200012DD	FDA UDI	Class I	Active
SwissTEC Universal Activator	5716	FDA UDI	Class II	Unknown
Alpen Diamond Instruments	RS850F012FG	FDA UDI	Class I	Active

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