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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 1 of 64

Device	Model / Reference	Registries	Class	Status
BioSonic	USEK40	FDA UDI	Class II	Active
Dentronix	D230W	FDA UDI	Class I	Unknown
Alpen	R601158	FDA UDI	Class I	Active
CanalPro	60019323	FDA UDI	Class I	Active
ParaPost XP	P7513BC	FDA UDI	Class I	Active
ParaPost XH	SBP884	FDA UDI	Class I	Unknown
BioSonic	USS5S	FDA UDI	Class II	Active
Hygenic	H01440C	FDA UDI	Class I	Active
Alpen	R40557G	FDA UDI	Class I	Active
Hyflex	H08409	FDA UDI	Class I	Unknown
BioSonic	USEFW	FDA UDI	Class II	Active
Hygenic	H02802	FDA UDI	Class I	Active
Hygenic	H00048	FDA UDI	Class II	Active
Alpen	60019501	FDA UDI	Class I	Unknown
Hygenic	H07082C	FDA UDI	Class I	Active
Alpen	RL368C016	FDA UDI	Class I	Active
Alpen	R909802	FDA UDI	Class I	Active
Hygenic	H02177	FDA UDI	Class I	Unknown
Alpen	RL859EF014	FDA UDI	Class I	Active
Alpen	RKS6C025FG	FDA UDI	Class I	Active
Hygenic	H00409	FDA UDI	Class II	Active
Hygenic	H02703C	FDA UDI	Class I	Active
Hygenic	H07315	FDA UDI	Class I	Active
Alpen	X858EF014	FDA UDI	Class I	Active
Hygenic	H01051	FDA UDI	Class I	Active
Hygenic	H00403	FDA UDI	Class II	Active
Dentronix	DSE211P	FDA UDI	Class I	Unknown
Alpen	RLX379SC023	FDA UDI	Class I	Active
Alpen	X837C016	FDA UDI	Class I	Active
Alpen	60019435	FDA UDI	Class I	Unknown
Alpen	60018615	FDA UDI	Class I	Unknown
Alpen	RS300245	FDA UDI	Class I	Active
Alpen	R839C014FG	FDA UDI	Class I	Active
Hygenic	H01501	FDA UDI	Class II	Active
Alpen	60019408	FDA UDI	Class I	Unknown
Alpen	RU300002	FDA UDI	Class I	Active
Dentronix	DE208	FDA UDI	Class I	Unknown
ParaPost XP	P75145E	FDA UDI	Class I	Active
Alpen	X392F016	FDA UDI	Class I	Active
Hyflex	HNT8250420	FDA UDI	Class I	Active
Alpen	R8568F016FG	FDA UDI	Class I	Active
Hygenic	H00023	FDA UDI	Class II	Active
Hyflex	H08400	FDA UDI	Class I	Unknown
BioSonic	60014324	FDA UDI	Class II	Active
Alpen	R856SC018FG	FDA UDI	Class I	Active
Alpen	60019103	FDA UDI	Class I	Active
BioSonic	60014255	FDA UDI	Class II	Active
Alpen	R500557C	FDA UDI	Class I	Active
Hygenic	H00355	FDA UDI	Class II	Active
Hyflex	HNT8210440	FDA UDI	Class I	Active

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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