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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 7 of 64

Device	Model / Reference	Registries	Class	Status
Alpen	R862TC016FG	FDA UDI	Class I	Active
Alpen	R40701G	FDA UDI	Class I	Active
Alpen	RL905F031	FDA UDI	Class I	Active
Alpen	RL101171	FDA UDI	Class I	Active
Alpen	RKS7SC054FG	FDA UDI	Class I	Active
Hyflex	HNT8210640	FDA UDI	Class I	Active
Alpen	R847TC018FG	FDA UDI	Class I	Active
Alpen	R880C012FG	FDA UDI	Class I	Active
BioSonic	60014321	FDA UDI	Class II	Active
Hygenic	H02774C	FDA UDI	Class I	Active
Dentronix	DE138	FDA UDI	Class I	Unknown
Alpen	60019398	FDA UDI	Class I	Unknown
Alpen	X850TC016	FDA UDI	Class I	Active
Alpen	R856LC018FG	FDA UDI	Class I	Active
Alpen	R850C023FG	FDA UDI	Class I	Active
Alpen	RP230080RA	FDA UDI	Class I	Active
Alpen	RLX878C012	FDA UDI	Class I	Unknown
Alpen	RL200006	FDA UDI	Class I	Active
Hyflex	H08402	FDA UDI	Class I	Unknown
Alpen	R811SC033FG	FDA UDI	Class I	Active
Hygenic	H02175	FDA UDI	Class I	Unknown
Alpen	RLX848SC016	FDA UDI	Class I	Active
BioSonic	60014254	FDA UDI	Class II	Active
Alpen	R41558GSS	FDA UDI	Class I	Active
Alpen	RS40331GB	FDA UDI	Class I	Unknown
Hygenic	H00277	FDA UDI	Class II	Active
Alpen	R600007	FDA UDI	Class I	Active
HyFlex CM	SBH8250435	FDA UDI	Class I	Active
Dentronix	DSE242	FDA UDI	Class I	Unknown
Alpen	R8377C012FG	FDA UDI	Class I	Active
Hygenic	H00347	FDA UDI	Class II	Active
BioSonic	60014305	FDA UDI	Class II	Active
Hyflex	HNT8210425	FDA UDI	Class I	Active
Alpen	60019411	FDA UDI	Class I	Unknown
BioSonic	60014269	FDA UDI	Class II	Unknown
Alpen	RZ856F025FG	FDA UDI	Class I	Active
Dentronix	DSE242N	FDA UDI	Class I	Unknown
Alpen	60019502	FDA UDI	Class I	Unknown
Alpen	60018611	FDA UDI	Class I	Unknown
BioSonic	US100R115T	FDA UDI	Class II	Active
BioSonic	60014286	FDA UDI	Class II	Unknown
Alpen	X862F016	FDA UDI	Class I	Active
ParaPost XT	SBP6860	FDA UDI	Class I	Unknown
Hyflex	H08413	FDA UDI	Class I	Unknown
HyFlex CM	SBHGPF8312002	FDA UDI	Class I	Unknown
Alpen	60019104	FDA UDI	Class I	Active
Alpen	X847M014	FDA UDI	Class I	Active
Alpen	RLX858C014	FDA UDI	Class I	Unknown
Alpen	XL801C023	FDA UDI	Class I	Active
Alpen	RP230387HP	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