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
Componeer Brilliant	60014163	FDA UDI	Class II	Active
Alpen Diamond Instruments	R878KC014FG	FDA UDI	Class I	Active
Componeer	60014010	FDA UDI	Class II	Active
ROEKO Double adapter	463000	FDA UDI	Class II	Active
Alpen Diamond Instruments	60018468	FDA UDI	Class I	Active
Diatech Diamond Instruments	200288DD	FDA UDI	Class I	Active
Alpen Diamond Instruments	RS855C012FG	FDA UDI	Class I	Active
Alpen Diamond Instruments	R850C016FG	FDA UDI	Class I	Active
DIATECH Z-Rex	60022160	FDA UDI	Class I	Active
Componeer	60014222	FDA UDI	Class II	Active
Alpen Diamond Instruments	R879KC012FG	FDA UDI	Class I	Active
BRILLIANT EverGlow	Univ. Comp B-EB1	FDA UDI	Class II	Active
Diatech Diamond Instruments	200273DD	FDA UDI	Class I	Active
SYNERGY D6 Flow	7655	FDA UDI	Class II	Active
Alpen Diamond Instruments	R878KC012FG	FDA UDI	Class I	Active
HYGENIC® Paper Points	H02131	FDA UDI	Class I	Active
HyFlex EDM	60022270	FDA UDI	Class I	Active
Diatech Diamond Instruments	200693AA	FDA UDI	Class I	Active
Alpen Diamond Instruments	R801F018FG	FDA UDI	Class I	Active
Diatech Diamond Instruments	210858DD	FDA UDI	Class I	Active
Alpen Diamond Instruments	R878KF014FG	FDA UDI	Class I	Active
Diatech Diamond Instruments	200250DD	FDA UDI	Class I	Active
Alpen Diamond Instruments	R801C029FG	FDA UDI	Class I	Active
Diatech Diamond Instruments	200604AA	FDA UDI	Class I	Active
Miris2	8486	FDA UDI	Class II	Active
Diatech Diamond Instruments	200467AA	FDA UDI	Class I	Active
Coltoflax	4046	FDA UDI	Class II	Unknown
HYGENIC® Guttapercha Points	60026844	FDA UDI	Class I	Active
Diatech Diamond Instruments	200719DD	FDA UDI	Class I	Active
Componeer	C1304	FDA UDI	Class II	Active
Diatech Diamond Instruments	210833DD	FDA UDI	Class I	Active
Diatech Diamond Instruments	210752DD	FDA UDI	Class I	Active
Alpen Diamond Instruments	R133EF010FG	FDA UDI	Class I	Active
Affinis	6620	FDA UDI	Class II	Active
Diatech Diamond Instruments	200191DD	FDA UDI	Class I	Active
Componeer	1343	FDA UDI	Class II	Active
BRILLIANT Bulk Fill Flow	60036824	FDA UDI	Class II	Active
Diatech Diamond Instruments	200413AA	FDA UDI	Class I	Active
BRILLIANT Flow	7101	FDA UDI	Class II	Active
Diatech Diamond Instruments	200623DD	FDA UDI	Class I	Active
Diatech Diamond Instruments	200504DD	FDA UDI	Class I	Active
Alpen Diamond Instruments	R379SC023FG	FDA UDI	Class I	Active
Diatech Diamond Instruments	200572AA	FDA UDI	Class I	Active
Diatech Diamond Instruments	200491AA	FDA UDI	Class I	Active
Alpen Diamond Instruments	R878KSC014FG	FDA UDI	Class I	Active
Componeer	60014394	FDA UDI	Class II	Active
Alpen Diamond Instruments	R889MF007FG	FDA UDI	Class I	Active
Diatech Diamond Instruments	200434AA	FDA UDI	Class I	Active
Diatech Diamond Instruments	200272AA	FDA UDI	Class I	Active
Diatech Diamond Instruments	200631AA	FDA UDI	Class I	Active

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