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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 2 of 64

Device	Model / Reference	Registries	Class	Status
Alpen	R879KC023FG	FDA UDI	Class I	Active
HyFlex CM	SBH8210640	FDA UDI	Class I	Active
Alpen	60019457	FDA UDI	Class I	Unknown
Alpen	RCB8470148	FDA UDI	Class I	Active
Alpen	RZ862F014FG	FDA UDI	Class I	Active
Alpen	R41557G	FDA UDI	Class I	Active
Hygenic	H05694	FDA UDI	Class II	Active
Alpen	60019424	FDA UDI	Class I	Unknown
Dentronix	DE200S	FDA UDI	Class I	Unknown
Hygenic	H02800C	FDA UDI	Class I	Active
Alpen	60019395	FDA UDI	Class I	Unknown
Alpen	60018590	FDA UDI	Class I	Unknown
Alpen	R8567F016FG	FDA UDI	Class I	Active
ParaPost XP	P781C	FDA UDI	Class I	Active
Alpen	R830LC012FG	FDA UDI	Class I	Active
HyFlex CM	SBHNT8250440	FDA UDI	Class I	Active
Alpen	R500003	FDA UDI	Class I	Active
Alpen	R830C016FG	FDA UDI	Class I	Active
ParaPost XT	SBP6850	FDA UDI	Class I	Unknown
Alpen	X830M012	FDA UDI	Class I	Active
Alpen	RS40558G	FDA UDI	Class I	Active
ParaPost XH	SBP884B	FDA UDI	Class I	Unknown
Alpen	60018602	FDA UDI	Class I	Unknown
Hygenic	H04644	FDA UDI	Class I	Active
BioSonic	60014267	FDA UDI	Class II	Unknown
Alpen	60019105	FDA UDI	Class I	Active
Alpen	R847RF016FG	FDA UDI	Class I	Active
Alpen	RL856L9C014	FDA UDI	Class I	Active
Dentronix	DSE230N	FDA UDI	Class I	Unknown
Alpen	R850F014FG	FDA UDI	Class I	Active
Alpen	R879KSC021FG	FDA UDI	Class I	Active
Hyflex	HNT8310635	FDA UDI	Class I	Active
Alpen	R600701	FDA UDI	Class I	Active
Hygenic	H04239	FDA UDI	Class I	Unknown
BioSonic	60014281	FDA UDI	Class II	Unknown
Alpen	RS100558	FDA UDI	Class I	Active
Hygenic	H09963C	FDA UDI	Class I	Active
ParaPost XH	SBP8845	FDA UDI	Class I	Unknown
Alpen	X847M018	FDA UDI	Class I	Unknown
Hygenic	H01440	FDA UDI	Class I	Active
Alpen	R858C016FG	FDA UDI	Class I	Active
Hygenic	H02142	FDA UDI	Class I	Active
Hygenic	H09961	FDA UDI	Class I	Active
Hyflex	HNT8210430	FDA UDI	Class I	Active
Alpen	X837RC014	FDA UDI	Class I	Active
Alpen	X859C012	FDA UDI	Class I	Active
Alpen	R856C018B	FDA UDI	Class I	Active
Hyflex	H08396	FDA UDI	Class I	Unknown
Alpen	R40004GC	FDA UDI	Class I	Active
Alpen	60018591	FDA UDI	Class I	Active

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Authorities

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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