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
ROEKO Calcium Hydroxide PLUS Points	ISO 40	FDA UDI	Class II	Unknown
SwissTEC Composite	5614	FDA UDI	Class II	Unknown
Alpen Diamond Instruments	R898C016FG	FDA UDI	Class I	Active
Diatech Diamond Instruments	200527DD	FDA UDI	Class I	Active
Alpen Diamond Instruments	RS845C012FG	FDA UDI	Class I	Active
HyFlex™ Guttapercha Points	60022692	FDA UDI	Class I	Active
Diatech Diamond Instruments	200819AA	FDA UDI	Class I	Active
Diatech Diamond Instruments	210817DD	FDA UDI	Class I	Active
Alpen Diamond Instruments	R847C010FG	FDA UDI	Class I	Active
Affinis	6501	FDA UDI	Class II	Active
Alpen Diamond Instruments	R85010F018FG	FDA UDI	Class I	Active
Componeer Class V	60018010	FDA UDI	Class II	Active
Diatech Diamond Instruments	200741AA	FDA UDI	Class I	Active
Alpen Diamond Instruments	R848SC023FG	FDA UDI	Class I	Active
HYGENIC® Guttapercha Points	H01486	FDA UDI	Class I	Active
HyFlex™ Paper Points	60022686	FDA UDI	Class I	Active
Alpen Diamond Instruments	R368SC023FG	FDA UDI	Class I	Active
HyFlex™ Guttapercha Points	60022693	FDA UDI	Class I	Active
Diatech Diamond Instruments	210765DD	FDA UDI	Class I	Active
SYSTEM360 Fixing Ring	6163	FDA UDI	Class II	Active
Componeer Class V	60018022	FDA UDI	Class II	Active
Pressure Spot lndicator	4440	FDA UDI	Class II	Active
Alpen Diamond Instruments	R847TC016FG	FDA UDI	Class I	Active
Alpen Diamond Instruments	R850F014FG	FDA UDI	Class I	Active
Diatech Diamond Instruments	200165DD	FDA UDI	Class I	Active
HYGENIC® Paper Points	H02117	FDA UDI	Class I	Active
HyFlex™ EDM	60019629	FDA UDI	Class I	Active
Diatech Diamond Instruments	200443DD	FDA UDI	Class I	Active
Diatech Diamond Instruments	200638DD	FDA UDI	Class I	Active
Diatech Diamond Instruments	200123AA	FDA UDI	Class I	Active
Alpen Diamond Instruments	RS859EF018FG	FDA UDI	Class I	Active
Diatech Diamond Instruments	211784DD	FDA UDI	Class I	Active
Diatech Diamond Instruments	200050DD	FDA UDI	Class I	Active
Alpen Diamond Instruments	R856F014FG	FDA UDI	Class I	Active
Diatech Diamond Instruments	200602AA	FDA UDI	Class I	Active
Affinis Precious	3756	FDA UDI	Class II	Unknown
HYGENIC® Paper Points	H03202	FDA UDI	Class I	Active
Diatech Diamond Instruments	200146DD	FDA UDI	Class I	Active
ROEKO Guttapercha Points	365130	FDA UDI	Class I	Active
Diatech Diamond Instruments	200494DD	FDA UDI	Class I	Active
Diatech Diamond Instruments	200018DD	FDA UDI	Class I	Active
Miris2	8478	FDA UDI	Class II	Active
Alpen Diamond Instruments	RS881F016FG	FDA UDI	Class I	Active
Diatech Diamond Instruments	200328AA	FDA UDI	Class I	Active
Alpen Diamond Instruments	R859C024FG	FDA UDI	Class I	Active
Diatech Diamond Instruments	200371AA	FDA UDI	Class I	Active
ROEKO Calcium Hydroxide PLUS Points	ISO 55	FDA UDI	Class II	Unknown
Margin Bond	7367	FDA UDI	Class II	Unknown
ROEKO Calcium Hydroxide PLUS Points	ISO 15	FDA UDI	Class II	Unknown
Alpen Diamond Instruments	R85010TC018FG	FDA UDI	Class I	Active

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