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
SwissTEC Composite	5606	FDA UDI	Class II	Unknown
Componeer	1357	FDA UDI	Class II	Active
Coltosol F	5930	FDA UDI	Class II	Active
Alpen Diamond Instruments	R801C018FG	FDA UDI	Class I	Active
Alpen Diamond Instruments	R836RC012FG	FDA UDI	Class I	Active
Diatech Diamond Instruments	200744AA	FDA UDI	Class I	Active
Componeer Brilliant	60014203	FDA UDI	Class II	Active
HYGENIC® Paper Points	H07686	FDA UDI	Class I	Active
Diatech Diamond Instruments	200670AA	FDA UDI	Class I	Active
HYGENIC® Guttapercha Points	H01470	FDA UDI	Class I	Active
BRILLIANT EverGlow	Univ. Comp B-EA2	FDA UDI	Class II	Active
Diatech Diamond Instruments	200641DD	FDA UDI	Class I	Active
Brilliant Ng	8968 NG	FDA UDI	Class II	Active
Componeer	C1305	FDA UDI	Class II	Active
Alpen Diamond Instruments	R834C016FG	FDA UDI	Class I	Active
Rapid	4530	FDA UDI	Class II	Unknown
PRESIDENT The Original	60019944	FDA UDI	Class II	Active
Diatech Diamond Instruments	200822DD	FDA UDI	Class I	Active
Diatech Diamond Instruments	210757DD	FDA UDI	Class I	Active
Diatech Diamond Instruments	200141AA	FDA UDI	Class I	Active
DIATECH Z-Rex	60022024	FDA UDI	Class I	Active
Componeer	1349	FDA UDI	Class II	Active
Diatech Diamond Instruments	200275DD	FDA UDI	Class I	Active
Diatech Diamond Instruments	200030AA	FDA UDI	Class I	Active
Affinis Black	60019638	FDA UDI	Class II	Unknown
Diatech Diamond Instruments	250007AA	FDA UDI	Class I	Active
Diatech Diamond Instruments	200187AA	FDA UDI	Class I	Active
Diatech Diamond Instruments	200049DD	FDA UDI	Class I	Active
Diatech Diamond Instruments	200721DD	FDA UDI	Class I	Active
Diatech Diamond Instruments	200079AA	FDA UDI	Class I	Active
HYGENIC® Paper Points	H07680	FDA UDI	Class I	Active
Alpen Diamond Instruments	RS379EF016FG	FDA UDI	Class I	Active
Diatech Diamond Instruments	200013DD	FDA UDI	Class I	Active
Alpen Diamond Instruments	RS368EF023FG	FDA UDI	Class I	Active
Diatech Diamond Instruments	200448DD	FDA UDI	Class I	Active
ROEKO GuttaFlow®2	INTROKIT	FDA UDI	Class II	Active
DIATECH Z-Rex	60022028	FDA UDI	Class I	Active
Brilliant Componeer	60023133	FDA UDI	Class II	Active
Diatech Diamond Instruments	200390DD	FDA UDI	Class I	Active
Diatech Diamond Instruments	200165AA	FDA UDI	Class I	Active
BRILLIANT Crios	60019993	FDA UDI	Class II	Active
HYGENIC® Paper Points	H02114	FDA UDI	Class I	Active
Diatech Diamond Instruments	200446AA	FDA UDI	Class I	Active
Componeer Brilliant	60014157	FDA UDI	Class II	Active
BRILLIANT EverGlow	60019745	FDA UDI	Class II	Active
Componeer Brilliant	60014191	FDA UDI	Class II	Active
Diatech Diamond Instruments	200390AA	FDA UDI	Class I	Active
Diatech Diamond Instruments	200162DD	FDA UDI	Class I	Active
Diatech Diamond Instruments	200705AA	FDA UDI	Class I	Active
Diatech Diamond Instruments	200462AA	FDA UDI	Class I	Active

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