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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 63 of 64

Device	Model / Reference	Registries	Class	Status
10 ParaPost Fiber White Posts (.050" / 1.25mm)	60018565	EUDAMED	Class IIa	Active
SPEC 3 LED Japan Plug Type AJ	60013945	EUDAMEDFDA UDI	Class I	Active
Coltolux LED Light Curing System, 230/240V	C7970230240	EUDAMEDFDA UDI	Class I	Active
HYGENIC U-shaped Occlusal Rim Wax, 100 pcs	H00822	EUDAMEDFDA UDI	Class I	Active
SPEC 3 LED UK Plug Type G	60013943	EUDAMEDFDA UDI	Class I	Active
BioSonic Super Concentrate General Purpose Cleaning	UC30	EUDAMEDFDA UDI	Class I	Active
3 TENAX Drills 1.3mm	TEA13	EUDAMED	Class IIa	Active
ParaPost XP Titanium - One-Office-Visit Introductory Kit	P780T	EUDAMEDFDA UDI	Class IIa	Active
TMS LINK PLUS Complete-Kit, Minim Silver, Gold-Plated Stainless Steel, 24 pcs	EL72124	EUDAMED	Class IIa	Active
10 ParaPost XP Stainless Steel Posts (.050" / 1.25mm)	P7445	EUDAMEDFDA UDI	Class IIa	Active
10 ParaPost Threaded Short Posts - Stainless Steel, 1.75mm	PDM7	EUDAMED	Class IIa	Active
MAX Restorative Pins Complete Kit Purple, .021 '' / .525 mm, US, 20 pcs	M21	EUDAMEDFDA UDI	Class IIa	Active
6 Bondent Drills	DB91	EUDAMED	Class IIa	Active
10 ParaPost XT Titanium Posts (.036" / 0.90mm)	P6830	EUDAMEDFDA UDI	Class IIa	Active
25 ParaPost Plus Stainless Steel Posts (.036" / 0.90mm)	P2443B	EUDAMEDFDA UDI	Class IIa	Active
10 ParaPost Plus Titanium Posts (.055" / 1.40mm)	P28455	EUDAMEDFDA UDI	Class IIa	Active
UC300-230V Ultrasonic Cleaner	UC300230CE	EUDAMED	Class I	Active
10 ParaPost XT Titanium Posts (.055" / 1.40mm)	P6855	EUDAMEDFDA UDI	Class IIa	Active
HYGENIC Round Wax Strips, Red, 80 pcs	H00817	EUDAMEDFDA UDI	Class I	Active
Ultrasonic Scaler Insert #10 Slim OptiMist (25kHz)	US1025KOS	EUDAMEDFDA UDI	Class IIa	Active
Pindex System 100 Pindex Replacement Blades - 0.010	PX302	EUDAMED	Class I	Active
Accu-Trac 50 Disposable Carrying Cases	ATN50	EUDAMED	Class I	Active
3 ParaPost Drills - Size 5	P425	EUDAMEDFDA UDI	Class IIa	Active
Pindex System 12 Pindex Replacement Blades - 0.007	PX201	EUDAMEDFDA UDI	Class I	Active
TMS LINK PLUS Bulk Kit, Minim Silver, Titanium Alloy, 50 pcs	L822	EUDAMEDFDA UDI	Class IIa	Active
10 ParaPost XP Titanium Posts (.055" / 1.40mm)	P78455	EUDAMEDFDA UDI	Class IIa	Active
TMS LINK PLUS Bulk Kit, Minim Silver, Titanium Alloy, 2in1, 50 pcs	L842	EUDAMEDFDA UDI	Class IIa	Active
TMS LINK PLUS Bulk Kit, Minim Silver, Titanium Alloy, 60 pcs	EL82260	EUDAMED	Class IIa	Active
SPEC 3 Clear Light Guide, 11mm Straight Tip	60013951	EUDAMEDFDA UDI	Class I	Active
3 ParaPost XT Drills - Size 6	P6260	EUDAMEDFDA UDI	Class IIa	Active
PRESIDENT Impression Trays - Upper Arch - Medium - Size 3	C6903	EUDAMEDFDA UDI	Class I	Active
Pindex System 12 Pindex Replacement Blades - 0.010	PX202	EUDAMEDFDA UDI	Class I	Active
TMS LINK SERIES Bulk Kit, Regular Gold, Gold-Plated Stainless Steel, 50 pcs	L542	EUDAMEDFDA UDI	Class IIa	Active
HYGENIC Extra Tough Wax, 2.25 kg	H00809	EUDAMED	Class I	Active
Ultrasonic Scaler Insert #10 (30kHz) – SLIM – SuperSoft	USG1030KSP	EUDAMEDFDA UDI	Class IIa	Active
HYGENIC Bite-Wafers, Green, Hard, 50 pcs	H03365	EUDAMEDFDA UDI	Class I	Active
10 ParaPost Titanium Posts (.040" / 1.00mm)	P844	EUDAMEDFDA UDI	Class IIa	Active
TMS Bulk Kit, Minim Silver, Gold-Plated Stainless Steel, 100 pcs	T06	EUDAMEDFDA UDI	Class IIa	Active
6 ParaPost Drills - 1 of each size, except 7	P42A	EUDAMEDFDA UDI	Class IIa	Active
3 TEANX Fiber Trans Drills 1.1mm	TED11	EUDAMED	Class IIa	Active
PRESIDENT Impression Trays AC - Upper Arch - Large - Size 1	C6950	EUDAMEDFDA UDI	Class I	Active
TMS LINK PLUS Bulk Kit, Minim Silver, Gold-Plated Stainless Steel, 2in1, 50 pcs	L732	EUDAMEDFDA UDI	Class IIa	Active
Pindex System 3 Carbide Drills	PX119	EUDAMEDFDA UDI	Class I	Active
Ultrasonic Scaler Insert #10 (25kHz) - SuperSoft	USG1025K	EUDAMEDFDA UDI	Class IIa	Active
5 ParaPost Fiber White Posts (.055" / 1.40mm)	PF16155	EUDAMEDFDA UDI	Class IIa	Active
UC50 230V Ultrasonic Cleaner with UK Line Cord	UC50DB230UK	EUDAMED	Class I	Active
10 ParaPost XP Titanium Posts (.070" / 1.75mm)	P7847	EUDAMEDFDA UDI	Class IIa	Active
25 ParaPost Stainless Steel Posts (.036" / 0.90mm)	P443B	EUDAMEDFDA UDI	Class IIa	Active
25 ParaPost Plus Stainless Steel Posts (.040" / 1.00mm)	P2444B	EUDAMEDFDA UDI	Class IIa	Active
25 ParaPost XH Titanium Posts (.050" / 1.25mm)	P885B	EUDAMEDFDA UDI	Class IIa	Active

Related Companies

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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