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	RS855C010FG	FDA UDI	Class I	Active
Diatech Diamond Instruments	200374AA	FDA UDI	Class I	Active
President	4840	FDA UDI	Class II	Unknown
Diatech Diamond Instruments	200490AA	FDA UDI	Class I	Active
Alpen Diamond Instruments	R379C016FG	FDA UDI	Class I	Active
HYGENIC® Guttapercha Points	H01306	FDA UDI	Class I	Active
SYNERGY D6 Flow	7656	FDA UDI	Class II	Unknown
Diatech Diamond Instruments	200196DD	FDA UDI	Class I	Active
Alpen Diamond Instruments	R847C018SS	FDA UDI	Class I	Active
BRILLIANT EverGlow	60021966	FDA UDI	Class II	Active
Rapid	4541	FDA UDI	Class II	Unknown
Brilliant Componeer	60023174	FDA UDI	Class II	Active
Alpen Diamond Instruments	RS856LC018FG	FDA UDI	Class I	Active
Fill-Up!	60019973	FDA UDI	Class II	Active
Alpen Diamond Instruments	R8467C016FG	FDA UDI	Class I	Active
HYGENIC® Guttapercha Points	H04234	FDA UDI	Class I	Active
Alpen Diamond Instruments	R856LSC016FG	FDA UDI	Class I	Active
Jet Bite	6400	FDA UDI	Class II	Active
Miris2	8409	FDA UDI	Class II	Active
PRESIDENT The Original	60019941	FDA UDI	Class II	Active
Diatech Diamond Instruments	210821DD	FDA UDI	Class I	Active
Brilliant Componeer	60023126	FDA UDI	Class II	Active
Alpen Diamond Instruments	RS368F023FG	FDA UDI	Class I	Active
Diatech Diamond Instruments	200270DD	FDA UDI	Class I	Active
Componeer	1322	FDA UDI	Class II	Active
Alpen Diamond Instruments	R850C014FG	FDA UDI	Class I	Active
Paint On Color	7338	FDA UDI	Class II	Unknown
Synergy D6	8376	FDA UDI	Class II	Active
BRILLIANT EverGlow	60019740	FDA UDI	Class II	Active
Alpen Diamond Instruments	R3926C016FG	FDA UDI	Class I	Active
HyFlex™ Guttapercha Points	60022694	FDA UDI	Class I	Active
Alpen Diamond Instruments	RS880C014FG	FDA UDI	Class I	Active
Affinis	6585	FDA UDI	Class II	Active
Alpen Diamond Instruments	R134EF014FG	FDA UDI	Class I	Active
Diatech Diamond Instruments	200758DD	FDA UDI	Class I	Active
HYGENIC® GuttaFlow®2	REFILL PACK DUAL-BARREL SYRING	FDA UDI	Class II	Active
Diatech Diamond Instruments	200417DD	FDA UDI	Class I	Active
Diatech Diamond Instruments	200502AA	FDA UDI	Class I	Active
HYGENIC® Paper Points	H07688	FDA UDI	Class I	Active
BRILLIANT Bulk Fill Flow	60033280	FDA UDI	Class II	Unknown
BRILLIANT EverGlow	60019708	FDA UDI	Class II	Active
DIATECH Z-Rex	60022029	FDA UDI	Class I	Active
Synergy	7492	FDA UDI	Class II	Unknown
Synergy	7825	FDA UDI	Class II	Unknown
Alpen Diamond Instruments	R8567TC016FG	FDA UDI	Class I	Active
Componeer	1375	FDA UDI	Class II	Active
Componeer	60014514	FDA UDI	Class II	Active
HYGENIC® Guttapercha Points	H01469	FDA UDI	Class I	Active
Alpen Diamond Instruments	RKS4F024FG	FDA UDI	Class I	Active
Diatech Diamond Instruments	200643DD	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