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
Diatech Diamond Instruments	200427DD	FDA UDI	Class I	Active
Diatech Diamond Instruments	200705DD	FDA UDI	Class I	Active
BRILLIANT Flow	7112	FDA UDI	Class II	Active
Alpen Diamond Instruments	RS859F014FG	FDA UDI	Class I	Active
Componeer Class V	60018422	FDA UDI	Class II	Active
Diatech Diamond Instruments	200038AA	FDA UDI	Class I	Active
Alpen Diamond Instruments	RS878C016FG	FDA UDI	Class I	Active
MicroMega Guttapercha Points	60031552	FDA UDI	Class I	Active
Diatech Diamond Instruments	200046AA	FDA UDI	Class I	Active
Brilliant Ng	8954 NG	FDA UDI	Class II	Active
HYGENIC® Paper Points	60019143	FDA UDI	Class I	Active
Diatech Diamond Instruments	200217DD	FDA UDI	Class I	Active
Alpen Diamond Instruments	R392EF018FG	FDA UDI	Class I	Active
Alpen Diamond Instruments	R807C016FG	FDA UDI	Class I	Active
Alpen Diamond Instruments	R864F014FG	FDA UDI	Class I	Active
HYGENIC® Paper Points	60019134	FDA UDI	Class I	Active
HyFlex™ Guttapercha Points	60022690	FDA UDI	Class I	Active
Affinis	6471	FDA UDI	Class II	Active
Alpen Diamond Instruments	R847TC018FG	FDA UDI	Class I	Active
Componeer Brilliant	60014212	FDA UDI	Class II	Active
Miris2	8403	FDA UDI	Class II	Active
BRILLIANT Crios	60022902	FDA UDI	Class II	Active
HYGENIC® Guttapercha Points	H01484	FDA UDI	Class I	Active
Diatech Diamond Instruments	200348DD	FDA UDI	Class I	Active
Alpen Diamond Instruments	R879KTC016FG	FDA UDI	Class I	Active
Diatech Diamond Instruments	211704DD	FDA UDI	Class I	Active
Diatech Diamond Instruments	200206DD	FDA UDI	Class I	Active
Diatech Diamond Instruments	200044DD	FDA UDI	Class I	Active
Componeer	1331	FDA UDI	Class II	Active
Alpen Diamond Instruments	R879KF012FG	FDA UDI	Class I	Active
Diatech Diamond Instruments	200514AA	FDA UDI	Class I	Active
Universal Mixing Tip	60019663	FDA UDI	Class II	Active
SoloCem	60014061	FDA UDI	Class II	Active
Componeer	60014500	FDA UDI	Class II	Active
SYNERGY D6 Flow	7652	FDA UDI	Class II	Active
Affinis	6680	FDA UDI	Class II	Active
Diatech Diamond Instruments	210739DD	FDA UDI	Class I	Active
Diatech Diamond Instruments	210785DD	FDA UDI	Class I	Active
BRILLIANT Crios	60022888	FDA UDI	Class II	Active
Diatech Diamond Instruments	210793DD	FDA UDI	Class I	Active
BRILLIANT EverGlow	60019701	FDA UDI	Class II	Active
Affinis	6511	FDA UDI	Class II	Active
Diatech Diamond Instruments	200701AA	FDA UDI	Class I	Active
One Coat 7 Universal	60019691	FDA UDI	Class II	Unknown
ROEKO Surgitip-micro	462013	FDA UDI	Class II	Active
Alpen Diamond Instruments	R856C014FG	FDA UDI	Class I	Active
Componeer Brilliant	60014159	FDA UDI	Class II	Active
Diatech Diamond Instruments	200387DD	FDA UDI	Class I	Active
SwissTEC Etchant	5630 L	FDA UDI	Class II	Unknown
ParaCore	1500	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