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
Affinis Precious	6779	FDA UDI	Class II	Unknown
Diatech Diamond Instruments	200081DD	FDA UDI	Class I	Active
Miris2	8487	FDA UDI	Class II	Active
Diatech Diamond Instruments	200440DD	FDA UDI	Class I	Active
Brilliant Ng	1221	FDA UDI	Class II	Active
Alpen Diamond Instruments	RS856C012FG	FDA UDI	Class I	Active
Alpen Diamond Instruments	R856LF016FG	FDA UDI	Class I	Active
Alpen Diamond Instruments	R135EF014FG	FDA UDI	Class I	Active
Alpen Diamond Instruments	R801F021FG	FDA UDI	Class I	Active
Alpen Diamond Instruments	R879KTC014FG	FDA UDI	Class I	Active
Brilliant Ng	8955 NG	FDA UDI	Class II	Active
Diatech Diamond Instruments	200485DD	FDA UDI	Class I	Active
President	4732	FDA UDI	Class II	Unknown
MicroMega Guttapercha Points	60031551	FDA UDI	Class I	Active
ROEKO GuttaFlow®2	REFILL PACK CAPSULES REGULAR	FDA UDI	Class I	Active
Diatech Diamond Instruments	200095DD	FDA UDI	Class I	Active
Diatech Diamond Instruments	200505AA	FDA UDI	Class I	Active
Alpen Diamond Instruments	RS878C010FG	FDA UDI	Class I	Active
Alpen Diamond Instruments	RS856F014FG	FDA UDI	Class I	Active
BRILLIANT Crios	60019998	FDA UDI	Class II	Active
Diatech Diamond Instruments	200462DD	FDA UDI	Class I	Active
Diatech Diamond Instruments	200381DD	FDA UDI	Class I	Active
Alpen Z-Rex	ZREX881C016FG	FDA UDI	Class I	Active
HyFlex EDM	60023493	FDA UDI	Class I	Active
HYGENIC® Paper Points	60019127	FDA UDI	Class I	Active
Diatech Diamond Instruments	210811DD	FDA UDI	Class I	Active
Alpen Diamond Instruments	RS811C048FG	FDA UDI	Class I	Active
HyFlex EDM	60036139	FDA UDI	Class I	Active
President	4617	FDA UDI	Class II	Active
Affinis	6580	FDA UDI	Class II	Active
Diatech Diamond Instruments	200277DD	FDA UDI	Class I	Active
Diatech Diamond Instruments	200006DD	FDA UDI	Class I	Active
HYGENIC® Guttapercha Points	H01485	FDA UDI	Class I	Active
Componeer Brilliant	60014135	FDA UDI	Class II	Active
Brilliant Componeer	60023136	FDA UDI	Class II	Active
Miris2	8436	FDA UDI	Class II	Active
Componeer Brilliant	60014219	FDA UDI	Class II	Active
Componeer	1339	FDA UDI	Class II	Active
Diatech Diamond Instruments	200674AA	FDA UDI	Class I	Active
Diatech Diamond Instruments	200060AA	FDA UDI	Class I	Active
Diatech Diamond Instruments	200002DD	FDA UDI	Class I	Active
HYGENIC® GuttaFlow®2	REFILL PACK CAPSULES FAST	FDA UDI	Class II	Active
Brilliant Componeer	60023175	FDA UDI	Class II	Active
Diatech Diamond Instruments	200526AA	FDA UDI	Class I	Active
Synergy	7841	FDA UDI	Class II	Unknown
Alpen Diamond Instruments	R828C030FG	FDA UDI	Class I	Active
Diatech Diamond Instruments	200050AA	FDA UDI	Class I	Active
BRILLIANT Crios	60020004	FDA UDI	Class II	Active
Miris2	8495	FDA UDI	Class II	Active
MicroMega Guttapercha Points	60031679	FDA UDI	Class I	Active

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