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
Synergy D6	8383	FDA UDI	Class II	Active
SYNERGY D6 Flow	7654	FDA UDI	Class II	Active
Alpen Diamond Instruments	R856LC018FG	FDA UDI	Class I	Active
BRILLIANT Crios	60020021	FDA UDI	Class II	Active
Miris2	8494	FDA UDI	Class II	Active
Diatech Diamond Instruments	200258DD	FDA UDI	Class I	Active
DIATECH Z-Rex	60022488	FDA UDI	Class I	Active
Diatech Diamond Instruments	200814DD	FDA UDI	Class I	Active
Diatech Diamond Instruments	200652DD	FDA UDI	Class I	Active
Alpen Diamond Instruments	R847TC014FG	FDA UDI	Class I	Active
Alpen Diamond Instruments	RS835C012FG	FDA UDI	Class I	Active
Synergy	7826	FDA UDI	Class II	Unknown
Alpen Diamond Instruments	RS877KC018FG	FDA UDI	Class I	Active
Diatech Diamond Instruments	200605AA	FDA UDI	Class I	Active
Alpen Diamond Instruments	R885C014FG	FDA UDI	Class I	Active
Diatech Diamond Instruments	200408DD	FDA UDI	Class I	Active
HYGENIC® Paper Points	H03348	FDA UDI	Class I	Active
Componeer Class V	60018017	FDA UDI	Class II	Active
HyFlex™ Guttapercha Points	60022705	FDA UDI	Class I	Active
DIATECH Z-Rex	60022570	FDA UDI	Class I	Active
Componeer	60013999	FDA UDI	Class II	Active
HYGENIC® Paper Points	H03191	FDA UDI	Class I	Active
Diatech Diamond Instruments	200546AA	FDA UDI	Class I	Active
Diatech Diamond Instruments	200228DD	FDA UDI	Class I	Active
HyFlex™ Guttapercha Points	60022697	FDA UDI	Class I	Active
BRILLIANT EverGlow	60019733	FDA UDI	Class II	Active
Affinis	6531	FDA UDI	Class II	Active
Alpen Diamond Instruments	R839F012FG	FDA UDI	Class I	Active
Diatech Diamond Instruments	200237AA	FDA UDI	Class I	Active
PRESIDENT The Original	60019949	FDA UDI	Class II	Active
ROEKO Calcium Hydroxide PLUS Points	ISO 80	FDA UDI	Class II	Unknown
Alpen Diamond Instruments	RS858EF014FG	FDA UDI	Class I	Active
PRESIDENT The Original	60019939	FDA UDI	Class II	Active
Alpen Diamond Instruments	R885C012FG	FDA UDI	Class I	Active
ParaCore	5853	FDA UDI	Class II	Active
DIATECH Z-Rex	60022495	FDA UDI	Class I	Active
Synergy D6	8371	FDA UDI	Class II	Active
Alpen Diamond Instruments	R850SC016FG	FDA UDI	Class I	Active
Diatech Diamond Instruments	200134AA	FDA UDI	Class I	Active
HyFlex™ Paper Points	60022672	FDA UDI	Class I	Active
Diatech Diamond Instruments	200697AA	FDA UDI	Class I	Active
Alpen Diamond Instruments	R8567C016FG	FDA UDI	Class I	Active
Brilliant Componeer	60023178	FDA UDI	Class II	Active
Diatech Diamond Instruments	210824DD	FDA UDI	Class I	Active
Diatech Diamond Instruments	200265DD	FDA UDI	Class I	Active
Diatech Diamond Instruments	200543DD	FDA UDI	Class I	Active
Diatech Diamond Instruments	200694AA	FDA UDI	Class I	Active
Brilliant Componeer	60023142	FDA UDI	Class II	Active
Diatech Diamond Instruments	200526DD	FDA UDI	Class I	Active
Diatech Diamond Instruments	200480DD	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