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
Alpen Diamond Instruments	RS878KC018FG	FDA UDI	Class I	Active
Diatech Diamond Instruments	200404DD	FDA UDI	Class I	Active
Alpen Diamond Instruments	RS852C012FG	FDA UDI	Class I	Active
SwissTEC Composite	60019107	FDA UDI	Class II	Active
Diatech Diamond Instruments	200457DD	FDA UDI	Class I	Active
Alpen Diamond Instruments	R801MF009FG	FDA UDI	Class I	Active
Diatech Diamond Instruments	200698DD	FDA UDI	Class I	Active
Diatech Diamond Instruments	200568AA	FDA UDI	Class I	Active
SwissTEC Composite	5604	FDA UDI	Class II	Unknown
Alpen Diamond Instruments	R878KSC018FG	FDA UDI	Class I	Active
Alpen Diamond Instruments	R368SC020FG	FDA UDI	Class I	Active
Diatech Diamond Instruments	200414AA	FDA UDI	Class I	Active
Alpen Diamond Instruments	R379C018FG	FDA UDI	Class I	Active
Componeer Brilliant	60014189	FDA UDI	Class II	Active
HyFlex™ EDM	60022287	FDA UDI	Class I	Active
Alpen Diamond Instruments	R862C012FG	FDA UDI	Class I	Active
Brilliant Componeer	60023204	FDA UDI	Class II	Active
Diatech Diamond Instruments	200291DD	FDA UDI	Class I	Active
Componeer Brilliant	60014151	FDA UDI	Class II	Active
Diatech Diamond Instruments	205021DD	FDA UDI	Class I	Active
Diatech Diamond Instruments	200086AA	FDA UDI	Class I	Active
One Coat 7 Universal	60019538	FDA UDI	Class II	Active
Cool Temp NATURAL	5824	FDA UDI	Class II	Active
Alpen Diamond Instruments	R853EF008FG	FDA UDI	Class I	Active
Alpen Diamond Instruments	RS8508SC018FG	FDA UDI	Class I	Active
Alpen Diamond Instruments	R845RC016FG	FDA UDI	Class I	Active
HYGENIC® Paper Points	H03185	FDA UDI	Class I	Active
Diatech Diamond Instruments	200420DD	FDA UDI	Class I	Active
Alpen Diamond Instruments	R837C014FG	FDA UDI	Class I	Active
Alpen Diamond Instruments	R855C025FG	FDA UDI	Class I	Active
SwissTEC HydroXtreme	4762	FDA UDI	Class II	Unknown
Componeer Brilliant	60014208	FDA UDI	Class II	Active
Componeer Brilliant	60014225	FDA UDI	Class II	Active
Diatech Diamond Instruments	200378AA	FDA UDI	Class I	Active
Componeer	60014502	FDA UDI	Class II	Active
Alpen Diamond Instruments	RS8568F016FG	FDA UDI	Class I	Active
Diatech Diamond Instruments	200089AA	FDA UDI	Class I	Active
Alpen Diamond Instruments	R836TC016FG	FDA UDI	Class I	Active
Diatech Diamond Instruments	210857DD	FDA UDI	Class I	Active
Alpen Diamond Instruments	R368EF023FG	FDA UDI	Class I	Active
MicroMega Guttapercha Points	60037026	FDA UDI	Class I	Active
Alpen Diamond Instruments	R878KSC023FG	FDA UDI	Class I	Active
HYGENIC® Paper Points	H07690	FDA UDI	Class I	Active
Diatech Diamond Instruments	210796DD	FDA UDI	Class I	Active
BRILLIANT EverGlow Flow	60019756	FDA UDI	Class II	Active
BRILLIANT EverGlow	60019734	FDA UDI	Class II	Active
Diatech Diamond Instruments	205099DD	FDA UDI	Class I	Active
Diatech Diamond Instruments	200097DD	FDA UDI	Class I	Active
HYGENIC® Guttapercha Points	H01475	FDA UDI	Class I	Active
Affinis	6585	FDA UDI	Class II	Active

Coltène/Whaledent AG

What Coltène/Whaledent AG makes

Frequently asked questions

Information

Catalogue (2822)

Related Companies

Authorised Representatives

Importers

Notified Bodies

Authorities