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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 61 of 64

Device	Model / Reference	Registries	Class	Status
ParaPost Fiber Lux Intro Kit	PF170	EUDAMEDFDA UDI	Class IIa	Active
10 ParaPost Threaded Short Posts - Titanium, 1.25mm	PDM5T	EUDAMED	Class IIa	Active
Ultrasonic Scaler Insert - #10 OptiMist (30kHz)	US1030KOM	EUDAMEDFDA UDI	Class IIa	Active
PRESIDENT Impression Trays AC - Lower Arch - Large - Size 2	C6951	EUDAMEDFDA UDI	Class I	Active
TMS Complete-Kit, Regular Gold, Gold-Plated Stainless Steel, 20 pcs	T01	EUDAMEDFDA UDI	Class IIa	Active
PerFect TCS 45º Coag Small Ball Electrode Sheaths, 2 pcs	S6011A	EUDAMEDFDA UDI	Class IIb	Active
TMS LINK SERIES Complete-Kit, Regular Gold, Gold-Plated Stainless Steel, 20 pcs	L541	EUDAMEDFDA UDI	Class IIa	Active
Ultrasonic Scaler Insert #10 (25kHz) – SLIM – SuperSoft	USG1025KSP	EUDAMEDFDA UDI	Class IIa	Active
10 ParaPost XH Titanium Posts (.070" / 1.75mm)	P887	EUDAMEDFDA UDI	Class IIa	Active
Pindex System Pindex Laser Retro Fir Kit	PX125	EUDAMEDFDA UDI	Class I	Active
ParaPost Fiber White Intro Kit	PF160	EUDAMEDFDA UDI	Class IIa	Active
5 Max 021 Drills	M92	EUDAMEDFDA UDI	Class IIa	Active
10 ParaPost Titanium Posts (.050" / 1.25mm)	P845	EUDAMEDFDA UDI	Class IIa	Active
25 ParaPost XP Titanium Posts (.045" / 1.14mm)	P78445B	EUDAMEDFDA UDI	Class IIa	Active
6 Kodex Twist Drills Regular Gold, without Depth-Limitation	K97	EUDAMEDFDA UDI	Class IIa	Active
10 ParaPost Taper Lux Posts (.050" / 1.25mm)	60018578	EUDAMEDFDA UDI	Class IIa	Active
Coltolux LED Light Curing System, 100/115V	C7970100115	EUDAMEDFDA UDI	Class I	Active
UC150 Ultrasonic Cleaner Unit Japan Plug Type B	60022047	EUDAMEDFDA UDI	Class I	Active
Ultrasonic Scaler Insert #1000 Triple Bend (25kHz)	US100025K	EUDAMEDFDA UDI	Class IIa	Active
5 ParaPost Fiber White Posts (.036" / 0.90mm)	PF1613	EUDAMEDFDA UDI	Class IIa	Active
UC150 Ultrasonic Cleaner Unit UK Plug Type G	60021989	EUDAMEDFDA UDI	Class I	Active
3 ParaPost Drills - Size 6	P426	EUDAMEDFDA UDI	Class IIa	Active
SPEC 3 Barrier Sleeves, 100 pcs	60013949	EUDAMEDFDA UDI	Class I	Active
10 ParaPost Fiber Lux Posts (.045" / 1.14mm)	60018570	EUDAMEDFDA UDI	Class IIa	Active
TMS LINK SERIES Bulk Kit, Minuta Pink, Gold-Plated Stainless Steel, 50 pcs	L502	EUDAMEDFDA UDI	Class IIa	Active
10 ParaPost Fiber Lux Posts (.050" / 1.25mm)	60018571	EUDAMEDFDA UDI	Class IIa	Active
Ultrasonic Scaler Insert #1000 Triple Bend (30kHz)	US100030K	EUDAMEDFDA UDI	Class IIa	Active
10 ParaPost XT Titanium Posts (.050" / 1.25mm)	P6850	EUDAMEDFDA UDI	Class IIa	Active
10 Tenax Fiber Trans Posts, 1.1mm	60018574	EUDAMEDFDA UDI	Class IIa	Active
PRESIDENT Impression Trays - Assortment Pack (1 each of 9 sizes)	C6910	EUDAMEDFDA UDI	Class I	Active
HYGENIC Extra Tough Wax, 450 g	H00803	EUDAMEDFDA UDI	Class I	Active
BioSonic Ultrasonic Scaler UK	US100R230UK	EUDAMEDFDA UDI	Class IIa	Active
5 ParaPost Fiber White Posts (.045" / 1.14mm)	PF16145	EUDAMEDFDA UDI	Class IIa	Active
Tenax Fiber Trans Intro Kit	TFT1	EUDAMEDFDA UDI	Class IIa	Active
PerFect TCS Sterilizable Electrode Sheaths, 3 pcs	S7010A	EUDAMEDFDA UDI	Class IIb	Active
UC150 Ultrasonic Cleaner Unit China Plug Type I	60021990C	EUDAMED	Class I	Active
TMS LINK PLUS Complete-Kit, Regular Gold, Gold-Plated Stainless Steel, 20 pcs	L741	EUDAMEDFDA UDI	Class IIa	Active
5 ParaPost Fiber Lux Posts (.050" / 1.25mm)	PF1715	EUDAMEDFDA UDI	Class IIa	Active
SPEC 3 Power Supply	60013955	EUDAMEDFDA UDI	Class I	Active
MAX Restorative Pins Complete Kit Blue, .017 '' / .425 mm, 20 pcs	M11	EUDAMEDFDA UDI	Class IIa	Active
5 ParaPost Fiber Lux Posts (.040" / 1.00mm)	PF1714	EUDAMEDFDA UDI	Class IIa	Active
SPEC 3 LED Chinese Plug Type CH	60013946	EUDAMEDFDA UDI	Class I	Active
Coltolux LED Barrier Sleeves, 1000 pcs	C7957	EUDAMEDFDA UDI	Class I	Active
3 ParaPost TaperLux Drills - Size 6	P826	EUDAMEDFDA UDI	Class IIa	Active
10 ParaPost Fiber Lux Posts (.060" / 1.50mm)	60018573	EUDAMEDFDA UDI	Class IIa	Active
PRESIDENT Impression Trays AC - Upper Left/Lower Right - Quadrant - Size 7	C6956	EUDAMEDFDA UDI	Class I	Active
10 ParaPost Threaded Short Posts - Stainless Steel, 1.00mm	PDTA4	EUDAMED	Class IIa	Active
TMS Complete-Kit, Regular Gold, Gold-Plated Stainless Steel, 2in1, 2 x 20 pcs	T07	EUDAMEDFDA UDI	Class IIa	Active
5 ParaPost Fiber Lux Posts (.036" / 0.90mm)	PF1713	EUDAMEDFDA UDI	Class IIa	Active
10 ParaPost Fiber Lux Posts (.040" / 1.00mm)	60018569	EUDAMEDFDA UDI	Class IIa	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