Is this your brand? Sign in to claim ownership.

Coltene/Whaledent Inc.

United States·US-MF-000015761

Last updated September 17, 2026

Information

Country: United States
Address: 235, Ascot Parkway, Cuyahoga Falls, United States
Website: www.coltene.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1 330 916 8800
PRRC Contact: Tricia Cregger
EUDAMED SRN: US-MF-000015761
FDA FEI Number: 2416455
DUNS Number: —

Catalogue (3196)

Page 6 of 64

Device	Model / Reference	Registries	Class	Status
Alpen	R8496C012FG	FDA UDI	Class I	Active
Alpen	R909004	FDA UDI	Class I	Active
Dentronix	DE201A	FDA UDI	Class I	Unknown
HyFlex CM	SBH8310620	FDA UDI	Class I	Active
Alpen	60019587	FDA UDI	Class I	Unknown
Alpen	R848C018FG	FDA UDI	Class I	Active
Alpen	RCB8560148	FDA UDI	Class I	Active
CanalPro	60011170	FDA UDI	Class I	Active
Hygenic	H00533	FDA UDI	Class I	Active
Alpen	RP230188UM	FDA UDI	Class I	Active
Alpen	60019433	FDA UDI	Class I	Unknown
Alpen	R878KSC016FG	FDA UDI	Class I	Active
Alpen	R847C025FG	FDA UDI	Class I	Active
Alpen	R835RC012FG	FDA UDI	Class I	Active
Hyflex	HNT8310425	FDA UDI	Class I	Active
Alpen	R850RC014FG	FDA UDI	Class I	Active
ParaPost XP	SBP7846	FDA UDI	Class I	Unknown
Hygenic	H00099	FDA UDI	Class II	Active
Alpen	RS300557	FDA UDI	Class I	Active
Alpen	RP230211RA	FDA UDI	Class I	Active
ParaPost XP	P7513E	FDA UDI	Class I	Active
Hygenic	H00534C	FDA UDI	Class I	Active
Alpen	R500001	FDA UDI	Class I	Active
Dentronix	DS243	FDA UDI	Class I	Unknown
Alpen	60018626	FDA UDI	Class I	Unknown
Alpen	R801C027FG	FDA UDI	Class I	Active
Alpen	60019419	FDA UDI	Class I	Unknown
Spec 3	60019249	FDA UDI	Class II	Active
Alpen	60018616	FDA UDI	Class I	Unknown
Hyflex	60018444	FDA UDI	Class I	Active
Dentronix	DS344Q	FDA UDI	Class I	Unknown
BioSonic	USEK30	FDA UDI	Class II	Active
Alpen	RP230305RA	FDA UDI	Class I	Active
Hygenic	H00526	FDA UDI	Class I	Unknown
Hygenic	H09956	FDA UDI	Class I	Active
Alpen	R859C018FG	FDA UDI	Class I	Active
Alpen	RP230321RA	FDA UDI	Class I	Active
Alpen	R40245GC	FDA UDI	Class I	Active
Alpen	RS707408	FDA UDI	Class I	Active
Strauss	100057XXV	FDA UDI	Class I	Active
Alpen	R8378C012FG	FDA UDI	Class I	Active
Alpen	R885C014FG	FDA UDI	Class I	Active
Alpen	60019481	FDA UDI	Class I	Unknown
HyFlex CM	SBH8310415	FDA UDI	Class I	Active
Hygenic	H00338	FDA UDI	Class II	Active
Alpen	X837RF014	FDA UDI	Class I	Active
BioSonic	60014303	FDA UDI	Class II	Unknown
Alpen	RZ889F010FG	FDA UDI	Class I	Active
Wedjets	H06523	FDA UDI	Class I	Active
Alpen	X392M016	FDA UDI	Class I	Active

Related Companies

Authorised Representatives

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (14)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Jan 20, 2023	Z-1208-2023	—	open, classified	Screw connection between the turbine head and the push button may loosen and fall off during the treatment, and increase the risk of swallowing or inhaling part of the turbines head or the push button
Mar 18, 2021	Z-1494-2021	—	open, classified	The incorrect dental pins were packaged and subsequently distributed.
Oct 20, 2020	Z-0464-2021	—	open, classified	The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs.
Oct 20, 2020	Z-0465-2021	—	open, classified	The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs.
Oct 20, 2020	Z-0468-2021	—	open, classified	The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs.
Oct 20, 2020	Z-0466-2021	—	open, classified	The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs.
Oct 20, 2020	Z-0467-2021	—	open, classified	The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs.
Jun 3, 2020	Z-2420-2020	—	open, classified	Multiple Coltene batches of the product have a pin size larger than acceptable, which may make it difficult for the forceps to fit appropriately with dental dam clamps.
Jun 3, 2020	Z-2419-2020	—	open, classified	Multiple Coltene batches of the product have a pin size larger than acceptable, which may make it difficult for the forceps to fit appropriately with dental dam clamps.
Jun 3, 2020	Z-2422-2020	—	open, classified	Multiple Coltene batches of the product have a pin size larger than acceptable, which may make it difficult for the forceps to fit appropriately with dental dam clamps.
Jun 3, 2020	Z-2421-2020	—	open, classified	Multiple Coltene batches of the product have a pin size larger than acceptable, which may make it difficult for the forceps to fit appropriately with dental dam clamps.
Aug 21, 2018	Z-0376-2019	—	terminated	ParaPost Plus Titanium Posts contain stainless steel post that are a size 4
Apr 13, 2018	Z-1883-2018	—	terminated	The products are labeled with an incorrect product number.
Dec 11, 2013	Z-2151-2014	—	terminated	Coltne/Whaledent Inc. received a complaint about the dental dams being the incorrect color. During an internal investigation, the firm found that Latex dental dams had been packaged in Non-Latex packaging.

FDA Establishments (2)

Establishments registered with the FDA under this company group, matched by name.

Coltene/Whaledent Ag ALTSTAETTEN Sankt Gallen · CH FEI 3002806620
Coltene/Whaledent Gmbh & Co. Kg LANGENAU Baden-Wurttemberg · DE FEI 3001180585