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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 3 of 64

Device	Model / Reference	Registries	Class	Status
BioSonic	USE1S	FDA UDI	Class II	Active
Alpen	RL847F014	FDA UDI	Class I	Active
ParaPost XT	SBP6830	FDA UDI	Class I	Unknown
Alpen	RL858C012	FDA UDI	Class I	Active
Alpen	RS707714	FDA UDI	Class I	Active
Alpen	R836SC014FG	FDA UDI	Class I	Active
HyFlex CM	SBH8210445	FDA UDI	Class I	Active
Alpen	R801SC021FG	FDA UDI	Class I	Active
Alpen	X805C016	FDA UDI	Class I	Active
Hygenic	H02703	FDA UDI	Class I	Active
Dentronix	D105G	FDA UDI	Class I	Unknown
Alpen	R805C016FG	FDA UDI	Class I	Active
Alpen	R846RC016FG	FDA UDI	Class I	Active
Hygenic	H02141	FDA UDI	Class I	Active
Alpen	R801F010FG	FDA UDI	Class I	Active
Alpen	X856F018	FDA UDI	Class I	Active
Hygenic	H02099	FDA UDI	Class II	Active
BioSonic	USE4S	FDA UDI	Class II	Active
Tenax	60018575C	FDA UDI	Class I	Active
Alpen	R909803	FDA UDI	Class I	Active
Hyflex	HNT8250630	FDA UDI	Class I	Active
Alpen	RP230379RA	FDA UDI	Class I	Active
HyFlex CM	SBH8250450	FDA UDI	Class I	Active
Alpen	60019483	FDA UDI	Class I	Unknown
Alpen	R859C024FG	FDA UDI	Class I	Active
Alpen	RU100330	FDA UDI	Class I	Active
HyFlex CM	SBHNT8210415	FDA UDI	Class I	Active
ParaPost XP	P7465C	FDA UDI	Class I	Active
Alpen	R40331GSS	FDA UDI	Class I	Active
Alpen	R880C014FG	FDA UDI	Class I	Active
Alpen	R601558	FDA UDI	Class I	Active
Hygenic	H02766C	FDA UDI	Class I	Active
ParaPost XP	PCMC	FDA UDI	Class I	Active
CanalPro	60011175	FDA UDI	Class I	Active
Alpen	R863C016FG	FDA UDI	Class I	Active
Hygenic	H01506	FDA UDI	Class II	Active
Hygenic	H02148C	FDA UDI	Class I	Active
Hygenic	H01441	FDA UDI	Class I	Active
HyFlex CM	SBH8310625	FDA UDI	Class I	Active
Alpen	60019477	FDA UDI	Class I	Unknown
Hygenic	H02252	FDA UDI	Class II	Active
Alpen	R85010C018FG	FDA UDI	Class I	Active
Alpen	60019575	FDA UDI	Class I	Unknown
Hygenic	H00405	FDA UDI	Class II	Active
Alpen	RP230369HP	FDA UDI	Class I	Active
Hygenic	H00136	FDA UDI	Class II	Active
Alpen	R700EF9	FDA UDI	Class I	Active
Alpen	R856LSC021FG	FDA UDI	Class I	Active
Hygenic	H02100	FDA UDI	Class II	Active
Alpen	60019505	FDA UDI	Class I	Unknown

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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