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
BRILLIANT Crios	60020007	FDA UDI	Class II	Active
Alpen Diamond Instruments	RS3928F016FG	FDA UDI	Class I	Active
Diatech Diamond Instruments	200975AA	FDA UDI	Class I	Active
Diatech Diamond Instruments	200745DD	FDA UDI	Class I	Active
Alpen Diamond Instruments	R881SC014FG	FDA UDI	Class I	Active
Componeer	60014515	FDA UDI	Class II	Active
BRILLIANT EverGlow Flow	60019757	FDA UDI	Class II	Active
Diatech Diamond Instruments	200138AA	FDA UDI	Class I	Active
BRILLIANT EverGlow	60021920	FDA UDI	Class II	Unknown
Diatech Diamond Instruments	200353DD	FDA UDI	Class I	Active
Diatech Diamond Instruments	200272DD	FDA UDI	Class I	Active
Alpen Diamond Instruments	RS801C016FG	FDA UDI	Class I	Active
HYGENIC® Paper Points	H02115	FDA UDI	Class I	Active
Alpen Diamond Instruments	R856LSC018FG	FDA UDI	Class I	Active
Diatech Diamond Instruments	200014AA	FDA UDI	Class I	Active
Diatech Diamond Instruments	200056DD	FDA UDI	Class I	Active
Alpen Z-Rex	ZREX850M016FG	FDA UDI	Class I	Active
Affinis	6520	FDA UDI	Class II	Active
Brilliant Componeer	60023172	FDA UDI	Class II	Active
ROEKO Guttapercha Points	365196	FDA UDI	Class I	Active
One Coat Bond SL	7630	FDA UDI	Class II	Unknown
Diatech Diamond Instruments	200548DD	FDA UDI	Class I	Active
Alpen Diamond Instruments	R879KC023FG	FDA UDI	Class I	Active
Diatech Diamond Instruments	200180DD	FDA UDI	Class I	Active
PRESIDENT The Original	60019945	FDA UDI	Class II	Active
Diatech Diamond Instruments	200048DD	FDA UDI	Class I	Active
Diatech Diamond Instruments	200291AA	FDA UDI	Class I	Active
Diatech Diamond Instruments	200083DD	FDA UDI	Class I	Active
Alpen Diamond Instruments	RS878KF018FG	FDA UDI	Class I	Active
Alpen Diamond Instruments	RS858UF012FG	FDA UDI	Class I	Active
Alpen Diamond Instruments	R878KF018FG	FDA UDI	Class I	Active
PRESIDENT microSystem	6012	FDA UDI	Class II	Unknown
BRILLIANT Crios	60022899	FDA UDI	Class II	Active
Diatech Diamond Instruments	200266AA	FDA UDI	Class I	Active
Speedex	4990	FDA UDI	Class II	Active
Diatech Diamond Instruments	200323DD	FDA UDI	Class I	Active
Affinis	6680	FDA UDI	Class II	Active
HyFlex EDM	60036138	FDA UDI	Class I	Active
Diatech Diamond Instruments	200180AA	FDA UDI	Class I	Active
Diatech Diamond Instruments	200620AA	FDA UDI	Class I	Active
Cool Temp NATURAL	5825	FDA UDI	Class II	Active
BRILLIANT Flow	7115	FDA UDI	Class II	Active
Alpen Diamond Instruments	R855C014FG	FDA UDI	Class I	Active
Alpen Diamond Instruments	RKS2SC014FG	FDA UDI	Class I	Active
Diatech Diamond Instruments	200530AA	FDA UDI	Class I	Active
Affinis	6537	FDA UDI	Class II	Active
Diatech Diamond Instruments	205095DD	FDA UDI	Class I	Active
Alpen Diamond Instruments	RS806C014FG	FDA UDI	Class I	Active
SYNERGY D6 Flow	7660	FDA UDI	Class II	Active
Componeer Class V	60018018	FDA UDI	Class II	Active

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