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
President	4632	FDA UDI	Class II	Unknown
ROEKO Guttapercha Points	365125	FDA UDI	Class I	Active
Alpen Diamond Instruments	R6052C018FG	FDA UDI	Class I	Active
Affinis Precious	3851	FDA UDI	Class II	Active
Componeer	1371	FDA UDI	Class II	Active
ROEKO Guttapercha Points	365115	FDA UDI	Class I	Active
Alpen Diamond Instruments	RS862EF012FG	FDA UDI	Class I	Active
Brilliant Componeer	60023168	FDA UDI	Class II	Active
Alpen Diamond Instruments	R392C018FG	FDA UDI	Class I	Active
Alpen Diamond Instruments	R813C018FG	FDA UDI	Class I	Active
Coltex Medium	4220	FDA UDI	Class II	Unknown
Diatech Diamond Instruments	200004AA	FDA UDI	Class I	Active
Diatech Diamond Instruments	200454DD	FDA UDI	Class I	Active
Diatech Diamond Instruments	200732DD	FDA UDI	Class I	Active
Diatech Diamond Instruments	200068DD	FDA UDI	Class I	Active
ParaCore	5887	FDA UDI	Class II	Active
Alpen Diamond Instruments	R379F018FG	FDA UDI	Class I	Active
Componeer Brilliant	60014204	FDA UDI	Class II	Active
Diatech Diamond Instruments	205033DD	FDA UDI	Class I	Active
Diatech Diamond Instruments	200516DD	FDA UDI	Class I	Active
Diatech Diamond Instruments	200435DD	FDA UDI	Class I	Active
Diatech Diamond Instruments	200192DD	FDA UDI	Class I	Active
BRILLIANT EverGlow	60019725	FDA UDI	Class II	Unknown
Diatech Diamond Instruments	200406DD	FDA UDI	Class I	Active
Diatech Diamond Instruments	200329AA	FDA UDI	Class I	Active
Diatech Diamond Instruments	200632DD	FDA UDI	Class I	Active
Coltene Adhesive	4410	FDA UDI	Class II	Unknown
Componeer Brilliant	60014198	FDA UDI	Class II	Active
Diatech Diamond Instruments	200191AA	FDA UDI	Class I	Active
BRILLIANT EverGlow	60021846	FDA UDI	Class II	Active
Componeer Class V	60018056	FDA UDI	Class II	Active
HYGENIC® Paper Points	60019132	FDA UDI	Class I	Active
Diatech Diamond Instruments	210829DD	FDA UDI	Class I	Active
Affinis	6601	FDA UDI	Class II	Active
Brilliant Componeer	60023188	FDA UDI	Class II	Active
Affinis	6582	FDA UDI	Class II	Active
Diatech Diamond Instruments	200113DD	FDA UDI	Class I	Active
ROEKO Calcium Hydroxide PLUS Points	ISO 60	FDA UDI	Class II	Unknown
Diatech Diamond Instruments	210797DD	FDA UDI	Class I	Active
Diatech Diamond Instruments	200668DD	FDA UDI	Class I	Active
Diatech Diamond Instruments	200018AA	FDA UDI	Class I	Active
Diatech Diamond Instruments	200570AA	FDA UDI	Class I	Active
Diatech Diamond Instruments	210828DD	FDA UDI	Class I	Active
Alpen Diamond Instruments	RS392F018FG	FDA UDI	Class I	Active
Alpen Diamond Instruments	R878KC016FG	FDA UDI	Class I	Active
Diatech Diamond Instruments	210782DD	FDA UDI	Class I	Active
Alpen Diamond Instruments	R878KF010FG	FDA UDI	Class I	Active
Diatech Diamond Instruments	200819DD	FDA UDI	Class I	Active
Affinis	6577	FDA UDI	Class II	Unknown
Alpen Diamond Instruments	R801F023FG	FDA UDI	Class I	Active

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