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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 5 of 64

Device	Model / Reference	Registries	Class	Status
BioSonic	UC125LCD	FDA UDI	Class I	Active
Alpen	60019459	FDA UDI	Class I	Unknown
Hygenic	H00343	FDA UDI	Class II	Active
Alpen	X830M012S	FDA UDI	Class I	Unknown
Hyflex	HNT8310625	FDA UDI	Class I	Active
Hygenic	H00323	FDA UDI	Class II	Active
ParaPost XT	SBP6230	FDA UDI	Class I	Unknown
HyFlex CM	SBHNT8250450	FDA UDI	Class I	Active
Hygenic	H01516	FDA UDI	Class II	Active
Dentronix	DE261A	FDA UDI	Class I	Unknown
Alpen	60019401	FDA UDI	Class I	Unknown
Hygenic	H01048	FDA UDI	Class I	Active
Hyflex	H8210630	FDA UDI	Class I	Active
Alpen	RL300056	FDA UDI	Class I	Active
Dentronix	D216I	FDA UDI	Class I	Unknown
Alpen	X878F012	FDA UDI	Class I	Active
Alpen	X848M016	FDA UDI	Class I	Active
Hyflex	HNT8310430	FDA UDI	Class I	Active
BioSonic	USE3S	FDA UDI	Class II	Active
Alpen	RP230375HP	FDA UDI	Class I	Active
Alpen	R801F018FG	FDA UDI	Class I	Active
Hygenic	H03343	FDA UDI	Class II	Active
Alpen	RS100702	FDA UDI	Class I	Active
Hyflex	HNT8210420	FDA UDI	Class I	Active
Alpen	60019394	FDA UDI	Class I	Unknown
Hygenic	H00307	FDA UDI	Class II	Active
Hyflex	H8310425	FDA UDI	Class I	Active
Alpen	RP230291RA	FDA UDI	Class I	Active
Alpen	R601703	FDA UDI	Class I	Active
Alpen	RLX368F023	FDA UDI	Class I	Active
Alpen	X858M008	FDA UDI	Class I	Unknown
Dentronix	DSE208	FDA UDI	Class I	Unknown
Hygenic	H02706C	FDA UDI	Class I	Active
Alpen	60019441	FDA UDI	Class I	Unknown
Alpen	60018631	FDA UDI	Class I	Unknown
Alpen	R100557C	FDA UDI	Class I	Active
Alpen	60018634	FDA UDI	Class I	Unknown
Alpen	RLX878KC014	FDA UDI	Class I	Unknown
Alpen	R806C016FG	FDA UDI	Class I	Active
BioSonic	60019569	FDA UDI	Class II	Active
Alpen	R859F014FG	FDA UDI	Class I	Active
HyFlex CM	SBHGPF8211502	FDA UDI	Class I	Unknown
Alpen	60018620	FDA UDI	Class I	Unknown
Hyflex	HNT8250625	FDA UDI	Class I	Active
Alpen	RS100035	FDA UDI	Class I	Active
Hygenic	H02762C	FDA UDI	Class I	Active
Alpen	RS101157	FDA UDI	Class I	Active
Hygenic	H02794C	FDA UDI	Class I	Active
Dentronix	DE104	FDA UDI	Class I	Unknown
Hyflex	H8210625	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