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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 58 of 64

Device	Model / Reference	Registries	Class	Status
PRESIDENT Impression Trays - Lower Arch - Large - Size 2	C6902	EUDAMEDFDA UDI	Class I	Active
Ultrasonic Scaler Insert #10 Slim OptiMist (30kHz)	US1030KOS	EUDAMEDFDA UDI	Class IIa	Active
Ultrasonic Scaler Insert #10 (30kHz) - SLIM	US1030KSP	EUDAMEDFDA UDI	Class IIa	Active
UC300 Cassette Basket for IMS Cassettes	UC325	EUDAMEDFDA UDI	Class I	Active
30 ParaPost XT Titanium Posts (.050" / 1.25mm)	P6850B	EUDAMEDFDA UDI	Class IIa	Active
MAX Restorative Pins Bulk Kit Purple, .021 '' / .525 mm, 60 pcs	M73	EUDAMED	Class IIa	Active
Ultrasonic Scaler Insert, #10 Universal, 25 kHz	US1025K	EUDAMEDFDA UDI	Class IIa	Active
Pindex System 3 Flexible Molds	PX146	EUDAMEDFDA UDI	Class I	Active
25 ParaPost Plus Titanium Posts (.036" / 0.90mm)	P2843B	EUDAMEDFDA UDI	Class IIa	Active
PerFect TCS 90º AP 1 1/2 Electrode Sheaths, 2 pcs	S6018A	EUDAMEDFDA UDI	Class IIb	Active
UC300 Drain Hose	UC355	EUDAMED	Class I	Active
3 ParaPost Drills - Size 4	P424	EUDAMEDFDA UDI	Class IIa	Active
HYGENIC Yellow Bite Wax Form #19	H02626	EUDAMED	Class I	Active
10 ParaPost Threaded Short Posts - Stainless Steel, 0.90mm	PDK3	EUDAMED	Class IIa	Active
TMS Complete-Kit, Minim Silver, Gold-Plated Stainless Steel, 20 pcs	T04	EUDAMEDFDA UDI	Class IIa	Active
10 ParaPost Plus Stainless Steel Posts (.050" / 1.25mm)	P2445	EUDAMEDFDA UDI	Class IIa	Active
TMS LINK SERIES Bulk Kit, Minikin Red, Titanium Alloy, 50 pcs	L812	EUDAMEDFDA UDI	Class IIa	Active
TMS LINK SERIES Complete-Kit, Minim Silver, Gold-Plated Stainless Steel, 2in1, 20 pcs	L531	EUDAMEDFDA UDI	Class IIa	Active
10 ParaPost Stainless Steel Posts (.036" / 0.90mm)	P443	EUDAMEDFDA UDI	Class IIa	Active
ParaPost XH Stainless Steel - One-Office-Visit Introductory Kit	P880	EUDAMEDFDA UDI	Class IIa	Active
3 TENAX Drills 1.1mm	TEA11	EUDAMED	Class IIa	Active
10 ParaPost Threaded Short Posts - Stainless Steel, 1.00mm	PDM4	EUDAMED	Class IIa	Active
10 Tenax Fiber Trans Posts, 1.5mm	60018576	EUDAMEDFDA UDI	Class IIa	Active
25 ParaPost XH Titanium Posts (.045" / 1.14mm)	P8845B	EUDAMEDFDA UDI	Class IIa	Active
10 ParaPost XH Titanium Posts (.045" / 1.14mm)	P8845	EUDAMEDFDA UDI	Class IIa	Active
25 ParaPost Plus Stainless Steel Posts (.055" / 1.40mm)	P24455B	EUDAMEDFDA UDI	Class IIa	Active
ParaPost XP Stainless Steel - One-Office-Visit Introductory Kit	P780	EUDAMEDFDA UDI	Class IIa	Active
5 Tenax Fiber Trans Posts, 1.3mm	TFT13	EUDAMEDFDA UDI	Class IIa	Active
ParaPost Taper Lux Intro Kit	PF180	EUDAMEDFDA UDI	Class IIa	Active
SPEC 3 Black Light Guide, 11mm Straight Tip	60019327	EUDAMEDFDA UDI	Class I	Active
MAX Restorative Pins Bulk Kit Purple, .021 '' / .525 mm, 50 pcs	M23	EUDAMEDFDA UDI	Class IIa	Active
10 ParaPost Plus Titanium Posts (.045" / 1.14mm)	P28445	EUDAMEDFDA UDI	Class IIa	Active
UC300 Basket Section Inserts	UC335	EUDAMEDFDA UDI	Class I	Active
UC300 Small Parts Basket	UCB2	EUDAMEDFDA UDI	Class I	Active
10 ParaPost Plus Stainless Steel Posts (.045" / 1.14mm)	P24445	EUDAMEDFDA UDI	Class IIa	Active
10 ParaPost XP Titanium Posts (.045" / 1.14mm)	P78445	EUDAMEDFDA UDI	Class IIa	Active
25 ParaPost Plus Stainless Steel Posts (.050" / 1.25mm)	P2445B	EUDAMEDFDA UDI	Class IIa	Active
10 ParaPost Fiber White Posts (.045" / 1.14mm)	60018564	EUDAMED	Class IIa	Active
3 ParaPost XT Drills - Size 5	P6250	EUDAMEDFDA UDI	Class IIa	Active
SPEC 3 Charger Base	60013953	EUDAMEDFDA UDI	Class I	Active
TMS Refill, Minuta Pink, Gold-Plated Stainless Steel, 50 pcs	T112	EUDAMEDFDA UDI	Class IIa	Active
HYGENIC Round Wax Strips, White, 80 pcs	H00818	EUDAMED	Class I	Active
5 Max 017 Drills	M91	EUDAMEDFDA UDI	Class IIa	Active
Pindex System 2 Flexible Molds, Quadrant Left and Right	PX148	EUDAMEDFDA UDI	Class I	Active
BioSonic Ultrasonic Scaler CE	US100R230CE	EUDAMEDFDA UDI	Class IIa	Active
3 ParaPost Drills - Size 5.5	P4255	EUDAMEDFDA UDI	Class IIa	Active
PerFect TCS Footswitch	S8FSRK	EUDAMEDFDA UDI	Class IIb	Active
BioSonic Enzymatic Ultrasonic Cleaning Solution Concentrate	UC32	EUDAMEDFDA UDI	Class I	Active
10 ParaPost Fiber Lux Posts (.036" / 0.90mm)	60018568	EUDAMEDFDA UDI	Class IIa	Active
25 ParaPost Plus Stainless Steel Posts (.060" / 1.50mm)	P2446B	EUDAMEDFDA UDI	Class IIa	Active

Related Companies

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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