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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 4 of 64

Device	Model / Reference	Registries	Class	Status
Alpen	60018614	FDA UDI	Class I	Unknown
Alpen	RLX85010SC016	FDA UDI	Class I	Active
BioSonic	60014276	FDA UDI	Class II	Active
Dentronix	DSE270-1	FDA UDI	Class I	Unknown
Alpen	60019526	FDA UDI	Class I	Unknown
Alpen	60019445	FDA UDI	Class I	Unknown
ParaPost XH	P886B	FDA UDI	Class I	Active
Alpen	R707006	FDA UDI	Class I	Active
Alpen	R878C010FG	FDA UDI	Class I	Active
Hyflex	H8250425	FDA UDI	Class I	Active
Hygenic	H00209	FDA UDI	Class II	Active
Alpen	XU856SC021	FDA UDI	Class I	Unknown
Alpen	R879C012FG	FDA UDI	Class I	Active
Hyflex	H08407	FDA UDI	Class I	Unknown
Hygenic	H09960	FDA UDI	Class I	Active
BioSonic	60014277	FDA UDI	Class II	Active
Alpen	RS100245B	FDA UDI	Class I	Active
HyFlex CM	SBH8210625	FDA UDI	Class I	Active
Alpen	R885F012FG	FDA UDI	Class I	Active
Hygenic	H09962C	FDA UDI	Class I	Active
Dentronix	DE502	FDA UDI	Class I	Unknown
ParaPost	P423C	FDA UDI	Class I	Active
Alpen	X801M016	FDA UDI	Class I	Active
Alpen	XU862C012	FDA UDI	Class I	Unknown
Alpen	X805M012	FDA UDI	Class I	Active
Alpen	R879KTC014FG	FDA UDI	Class I	Active
Alpen	60018637	FDA UDI	Class I	Unknown
ParaPost	P847	FDA UDI	Class I	Active
Alpen	X855SC016S	FDA UDI	Class I	Active
Hygenic	H02764	FDA UDI	Class I	Active
BioSonic	US100RXF	FDA UDI	Class II	Active
Alpen	RP230389HP	FDA UDI	Class I	Active
Alpen	RL100169	FDA UDI	Class I	Active
Dentronix	DE201	FDA UDI	Class I	Unknown
Alpen	X862F010	FDA UDI	Class I	Active
Hyflex	60018442	FDA UDI	Class I	Active
Hyflex	H8210425	FDA UDI	Class I	Active
Dentronix	DSE139	FDA UDI	Class I	Unknown
ParaPost	P4345	FDA UDI	Class I	Active
Alpen	R877C012FG	FDA UDI	Class I	Active
Alpen	RKS5SC031FG	FDA UDI	Class I	Active
Alpen	R884F012FG	FDA UDI	Class I	Active
Hygenic	H00098	FDA UDI	Class II	Active
Alpen	R856TC014FG	FDA UDI	Class I	Active
Wedjets	H08040	FDA UDI	Class I	Active
Hygenic	H00833	FDA UDI	Class I	Active
Alpen	XL392M016	FDA UDI	Class I	Active
Hygenic	H00345	FDA UDI	Class II	Active
Hygenic	H00335	FDA UDI	Class II	Active
Alpen	60019584	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