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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 59 of 64

Device	Model / Reference	Registries	Class	Status
MAX Restorative Pins Bulk Kit Blue, .017 '' / .425 mm, 50 pcs	M13	EUDAMEDFDA UDI	Class IIa	Active
6 Kodex Twist Drills Minim Silver, Depth-Limiting	K92	EUDAMEDFDA UDI	Class IIa	Active
Ultrasonic Scaler Insert #10 Slim OptiMist (25 kHz) SuperSoft	USG1025KOS	EUDAMEDFDA UDI	Class IIa	Active
3 TENAX Fiber Trans Drills 1.5mm	TED15	EUDAMED	Class IIa	Active
TMS Bulk Kit, Minim Silver, Gold-Plated Stainless Steel, 2in1, 2 x 100 pcs	T12	EUDAMEDFDA UDI	Class IIa	Active
20 ParaPost XP Titanium Temporary Posts (.045" / 1.14mm)	P74645	EUDAMEDFDA UDI	Class IIa	Active
TMS LINK SERIES Complete-Kit, Minim Silver, Gold-Plated Stainless Steel, 20 pcs	L521	EUDAMEDFDA UDI	Class IIa	Active
Pindex System 1000 Short Pins and Sleeves	PX115	EUDAMEDFDA UDI	Class I	Active
25 ParaPost XP Titanium Posts (.040" / 1.00mm)	P7844B	EUDAMEDFDA UDI	Class IIa	Active
SPEC 3 Eye Shield	60014444	EUDAMEDFDA UDI	Class I	Active
TMS LINK SERIES Complete-Kit, Regular Gold, Gold-Plated Stainless Steel, 2in1, 20 pcs	L551	EUDAMEDFDA UDI	Class IIa	Active
HYGENIC Bite-Wafers, Yellow, Soft, 50 pcs	H00839	EUDAMEDFDA UDI	Class I	Active
10 ParaPost Plus Titanium Posts (.070" / 1.75mm)	P2847	EUDAMEDFDA UDI	Class IIa	Active
Coltolux LED Light Curing System, 100/115V Pink	C7970100115P	EUDAMEDFDA UDI	Class I	Active
25 ParaPost XP Stainless Steel Posts (.050" / 1.25mm)	P7445B	EUDAMEDFDA UDI	Class IIa	Active
10 ParaPost XP Titanium Posts (.050" / 1.25mm)	P7845	EUDAMEDFDA UDI	Class IIa	Active
10 ParaPost Threaded Short Posts - Stainless Steel, 0.90mm	PDL3	EUDAMED	Class IIa	Active
10 ParaPost Fiber White Posts (.060" / 1.50mm)	60018567	EUDAMED	Class IIa	Active
10 ParaPost Taper Lux Posts (.060" / 1.50mm)	60018580	EUDAMEDFDA UDI	Class IIa	Active
UC150 Ultrasonic Cleaner Unit Australian Plug Type I	60021990	EUDAMEDFDA UDI	Class I	Active
SPEC 3 LED USA Plug Type A	60013941	EUDAMEDFDA UDI	Class I	Active
Accu-Trac 25 Articulation Keepers	ATK25	EUDAMEDFDA UDI	Class I	Active
3 ParaPost XT Drills - Size 4	P6240	EUDAMEDFDA UDI	Class IIa	Active
3 ParaPost XT Drills - Size 3	P6230	EUDAMEDFDA UDI	Class IIa	Active
20 ParaPost XP Titanium Temporary Posts (.040" / 1.00mm)	P7464	EUDAMEDFDA UDI	Class IIa	Active
25 ParaPost XP Stainless Steel Posts (.040" / 1.00mm)	P7444B	EUDAMEDFDA UDI	Class IIa	Active
10 ParaPost XP Titanium Posts (.036" / 0.90mm)	P7843	EUDAMEDFDA UDI	Class IIa	Active
10 ParaPost XP Stainless Steel Posts (.040" / 1.00mm)	P7444	EUDAMEDFDA UDI	Class IIa	Active
HYGENIC Square Wax Ropes, White	H00820	EUDAMEDFDA UDI	Class I	Active
25 ParaPost Plus Titanium Posts (.040" / 1.00mm)	P2844B	EUDAMEDFDA UDI	Class IIa	Active
PerFect TCS 45º Diamond Loop Electrode Sheaths, 2 pcs	S6017A	EUDAMEDFDA UDI	Class IIb	Active
10 ParaPost Threaded Short Posts - Titanium, 1.50mm	PDM6T	EUDAMED	Class IIa	Active
UC150 Sealing Gasket	60022046	EUDAMEDFDA UDI	Class I	Active
Bondent Bulk Kit, Gold-Plated Stainless Steel, Long Pins, 50 pcs	DB50L	EUDAMEDFDA UDI	Class IIa	Active
Accu-Trac 12 Model Ejectors	ATE12	EUDAMED	Class I	Active
TMS Complete-Kit, Minuta Pink, Gold-Plated Stainless Steel, 20 pcs	T111	EUDAMEDFDA UDI	Class IIa	Active
ParaPost Threaded Short - One-Office-Visit Introductory Kit - Stainless Steel	PDL	EUDAMED	Class IIa	Active
UC150 Ultrasonic Cleaner Unit North American-No Heater	60035062	EUDAMEDFDA UDI	Class I	Active
UC50 240V Ultrasonic Cleaner	UC50DB240	EUDAMED	Class I	Active
TMS LINK PLUS Complete-Kit, Minim Silver, Gold-Plated Stainless Steel, 2in1, 24 pcs	EL73124	EUDAMED	Class IIa	Active
10 ParaPost Threaded Short Posts - Stainless Steel, 1.50mm	PDM6	EUDAMED	Class IIa	Active
10 ParaPost Threaded Short Posts - Titanium, 0.90mm	PDM3T	EUDAMED	Class IIa	Active
HYGENIC Yellow Bite Wax, 450 g	H00807	EUDAMEDFDA UDI	Class I	Active
Coltolux LED Charger Base w/ Power Supply, International Units	C7970RK2	EUDAMEDFDA UDI	Class I	Active
25 ParaPost Plus Stainless Steel Posts (.045" / 1.14mm)	P24445B	EUDAMEDFDA UDI	Class IIa	Active
10 ParaPost Plus Titanium Posts (.050" / 1.25mm)	P2845	EUDAMEDFDA UDI	Class IIa	Active
5 ParaPost Fiber Lux Posts (.060" / 1.50mm)	PF1716	EUDAMEDFDA UDI	Class IIa	Active
Pindex System 100 Long Pins and Sleeves	PX116	EUDAMED	Class I	Active
HYGENIC Medium Soft, #3 Pink Wax, 450 g	H00806	EUDAMED	Class I	Active
UC50 Instrument Basket	UC58	EUDAMED	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