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 Z-Rex	60022490	FDA UDI	Class I	Active
BRILLIANT EverGlow	60021842	FDA UDI	Class II	Active
Componeer	1364	FDA UDI	Class II	Active
ROEKO Guttapercha Points	364010	FDA UDI	Class I	Active
Diatech Diamond Instruments	200089DD	FDA UDI	Class I	Active
CanalPro™ Color Syringes	60019324	FDA UDI	Class I	Active
HyFlex™ Paper Points	60022677	FDA UDI	Class I	Active
HYGENIC® Guttapercha Points	H01473	FDA UDI	Class I	Active
Componeer Brilliant	60014405	FDA UDI	Class II	Active
Diatech Diamond Instruments	210753DD	FDA UDI	Class I	Active
Diatech Diamond Instruments	200096AA	FDA UDI	Class I	Active
Diatech Diamond Instruments	200442DD	FDA UDI	Class I	Active
Componeer Brilliant	60014192	FDA UDI	Class II	Active
Alpen Diamond Instruments	R846TC016FG	FDA UDI	Class I	Active
Brilliant Componeer	60023160	FDA UDI	Class II	Active
Alpen Diamond Instruments	RS845F016FG	FDA UDI	Class I	Active
PRESIDENT microSystem	6005	FDA UDI	Class II	Unknown
Coltex Extrafine	4142	FDA UDI	Class II	Unknown
Componeer	60018758	FDA UDI	Class II	Active
Synergy D6	3241	FDA UDI	Class II	Unknown
HYGENIC® Paper Points	H02116	FDA UDI	Class I	Active
Diatech Diamond Instruments	200058DD	FDA UDI	Class I	Active
Diatech Diamond Instruments	200010DD	FDA UDI	Class I	Active
Miris2	8490	FDA UDI	Class II	Active
Diatech Diamond Instruments	211788DD	FDA UDI	Class I	Active
Alpen Diamond Instruments	R862C010FG	FDA UDI	Class I	Active
Alpen Diamond Instruments	R6051SC018FG	FDA UDI	Class I	Active
Alpen Diamond Instruments	R3928C016FG	FDA UDI	Class I	Active
Diatech Diamond Instruments	200183AA	FDA UDI	Class I	Active
SoloCem	60013986	FDA UDI	Class II	Active
HyFlex™ Paper Points	60022687	FDA UDI	Class I	Active
Diatech Diamond Instruments	200029AA	FDA UDI	Class I	Active
Diatech Diamond Instruments	200145AA	FDA UDI	Class I	Active
Diatech Diamond Instruments	200038DD	FDA UDI	Class I	Active
BRILLIANT EverGlow	60019732	FDA UDI	Class II	Active
Diatech Diamond Instruments	200569DD	FDA UDI	Class I	Active
Affinis Black	60019776	FDA UDI	Class II	Active
HyFlex Guttapercha Points	60036504	FDA UDI	Class I	Active
Diatech Diamond Instruments	200311DD	FDA UDI	Class I	Active
Brilliant Ng	8971 NG	FDA UDI	Class II	Active
Diatech Diamond Instruments	200306AA	FDA UDI	Class I	Active
HYGENIC® Paper Points	H03199	FDA UDI	Class I	Active
Alpen Diamond Instruments	R879KSC018FG	FDA UDI	Class I	Active
BRILLIANT Crios	60020012	FDA UDI	Class II	Active
Diatech Diamond Instruments	210808DD	FDA UDI	Class I	Active
One Coat 7 Universal	60019690	FDA UDI	Class II	Unknown
Componeer Brilliant	60014197	FDA UDI	Class II	Active
Alpen Diamond Instruments	R368EF020FG	FDA UDI	Class I	Active
Componeer	60014393	FDA UDI	Class II	Active
Diatech Diamond Instruments	210746DD	FDA UDI	Class I	Active

Coltène/Whaledent AG

What Coltène/Whaledent AG makes

Frequently asked questions

Information

Catalogue (2822)

Related Companies

Authorised Representatives

Importers

Notified Bodies

Authorities