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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 64 of 64

Device	Model / Reference	Registries	Class	Status
10 ParaPost Plus Stainless Steel Posts (.040" / 1.00mm)	P2444	EUDAMEDFDA UDI	Class IIa	Active
TMS LINK PLUS Bulk Kit, Minim Silver, Titanium Alloy, 2in1, 60 pcs	EL84260	EUDAMED	Class IIa	Active
Accu-Trac 12 ATR-12 Kits, Refill Kit Economy Pack	ATR144	EUDAMEDFDA UDI	Class I	Active
Pindex Laser Pinning System, 115V	PX113L	EUDAMEDFDA UDI	Class I	Active
UC50 600ml Beaker with Cover	UC153	EUDAMEDFDA UDI	Class I	Active
25 ParaPost XP Stainless Steel Posts (.036" / 0.90mm)	P7443B	EUDAMEDFDA UDI	Class IIa	Active
TMS LINK SERIES Bulk Kit, Regular Gold, Gold-Plated Stainless Steel, 2in1, 50 pcs	L552	EUDAMEDFDA UDI	Class IIa	Active
HYGENIC Medium Soft, #3 Pink Wax, 2.25 kg	H00812	EUDAMED	Class I	Active
Pindex System 1000 Medium Pins w/ Split Sleeves	PX112S	EUDAMEDFDA UDI	Class I	Active
Accu-Trac 20 Articulation Spacers	ATS20	EUDAMEDFDA UDI	Class I	Active
25 ParaPost XH Titanium Posts (.040" / 1.00mm)	P884B	EUDAMEDFDA UDI	Class IIa	Active
600mL Beaker with cover and Positioning Ring	UC53	EUDAMEDFDA UDI	Class I	Active
UC150 Accessory Kit	60022042	EUDAMEDFDA UDI	Class I	Active
UC300 Two Beaker Holder	UC330	EUDAMEDFDA UDI	Class I	Active
TMS Refill, Minim Silver, Gold-Plated Stainless Steel, 50 pcs	T05	EUDAMEDFDA UDI	Class IIa	Active
TMS LINK SERIES Bulk Kit, Minim Silver, Gold-Plated Stainless Steel, 2in1, 50 pcs	L532	EUDAMEDFDA UDI	Class IIa	Active
25 ParaPost XP Stainless Steel Posts (.070" / 1.75mm)	P7447B	EUDAMEDFDA UDI	Class IIa	Active
SPEC 3 LED EURO Plug Type C	60013942	EUDAMEDFDA UDI	Class I	Active
PerFect TCS 45º Straight Knife Electrode Sheaths, 2 pcs	S6012A	EUDAMEDFDA UDI	Class IIb	Active
25 ParaPost Plus Stainless Steel Posts (.070" / 1.75mm)	P2447B	EUDAMEDFDA UDI	Class IIa	Active
3 TENAX Drills 1.4mm	TEA14	EUDAMED	Class IIa	Active
10 ParaPost Fiber White Posts (.036" / 0.90mm)	60018563	EUDAMED	Class IIa	Active
SPEC 3 Light Shield, 8mm	60013948	EUDAMEDFDA UDI	Class I	Active
PerFect TCS Sterilizable Electrode Sheaths, 8 pcs	S6010A	EUDAMEDFDA UDI	Class IIb	Active
25 ParaPost XP Titanium Posts (.050" / 1.25mm)	P7845B	EUDAMEDFDA UDI	Class IIa	Active
10 ParaPost XH Titanium Posts (.036" / 0.90mm)	P883	EUDAMEDFDA UDI	Class IIa	Active
10 ParaPost Threaded Short Posts - Stainless Steel, 1.25mm	PDM5	EUDAMED	Class IIa	Active
MAX Restorative Pins Bulk Kit Blue, .017 '' / .425 mm, 60 pcs	M63	EUDAMED	Class IIa	Active
10 ParaPost Stainless Steel Posts (.040" / 1.00mm)	P444	EUDAMEDFDA UDI	Class IIa	Active
TMS LINK PLUS Complete-Kit, Minim Silver, Gold-Plated Stainless Steel, 2in1, 20 pcs	L734	EUDAMED	Class IIa	Active
10 ParaPost Stainless Steel Posts (.055" / 1.40mm)	P4455	EUDAMEDFDA UDI	Class IIa	Active
SPEC 3 Battery Module	60013952	EUDAMEDFDA UDI	Class I	Active
10 ParaPost Titanium Posts (.055" / 1.40mm)	P8455	EUDAMEDFDA UDI	Class IIa	Active
TMS LINK PLUS Bulk Kit, Regular Gold, Gold-Plated Stainless Steel, 2in1, 60 pcs	EL75260	EUDAMED	Class IIa	Active
Coltolux LED Screw-On Light Lens, 25 pcs	C7974	EUDAMEDFDA UDI	Class I	Active
PRESIDENT Impression Trays AC - Anterior Universal- Size 9	C6958	EUDAMEDFDA UDI	Class I	Active
10 ParaPost Taper Lux Posts (.045" / 1.14mm)	60018577	EUDAMEDFDA UDI	Class IIa	Active
10 ParaPost Titanium Posts (.060" / 1.50mm)	P846	EUDAMEDFDA UDI	Class IIa	Active
5 ParaPost Taper Lux Posts (.045" / 1.14mm)	PF18145	EUDAMEDFDA UDI	Class IIa	Active
SPEC 3 Clear Light Guide, 8mm Turbo Tip	60013950	EUDAMEDFDA UDI	Class I	Active
30 ParaPost XT Titanium Posts (.040" / 1.00mm)	P6840B	EUDAMEDFDA UDI	Class IIa	Active
SPEC 3 Black Light Guide, 8mm Turbo Tip	60019326	EUDAMEDFDA UDI	Class I	Active
PerFect TCS Straight Long Loop Electrode Sheaths, 2 pcs	S6016A	EUDAMEDFDA UDI	Class IIb	Active
Pindex System 1 Full Arch Mold	PX147	EUDAMEDFDA UDI	Class I	Active
100 Tenax Fiber Trans Posts, 1.1mm	TFT11B	EUDAMEDFDA UDI	Class IIa	Active
20 ParaPost Titanium Temporary Posts (.040" / 1.00mm)	P464	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