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Coltene/Whaledent Inc.

United States·US-MF-000015761

Last updated September 17, 2026

What Coltene/Whaledent Inc. makes

Coltene/Whaledent Inc. manufactures reusable dental instruments, including carbide burs, rotary and reciprocating endodontic files, abrasive points, and rubber dam clamps. Their portfolio also includes resin artificial teeth, root canal posts, and ultrasonic scaling/debridement systems, as well as latex-based rubber dams for isolation during dental procedures.

The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates from the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Coltene/Whaledent Inc. primarily manufacture?

Coltene/Whaledent Inc. specializes in reusable dental instruments and materials. Their portfolio includes carbide dental burs, rotary and reciprocating endodontic files, abrasive points, rubber dam clamps, resin artificial teeth, root canal posts, and ultrasonic scaling/debridement systems. These devices are designed for use in dental procedures, such as cavity preparation, root canal treatment, tooth isolation, and scaling.

Where is Coltene/Whaledent Inc. based, and does that location impact their device regulations?

Coltene/Whaledent Inc. is based in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations. The FDA classifies their products as either Class I or Class II, depending on the risk level and intended use, which determines the regulatory pathway for authorization.

Are Coltene/Whaledent Inc.’s devices listed in any regulatory registries, and why does this matter?

Yes, Coltene/Whaledent Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This matters because the UDI system ensures traceability, transparency, and better tracking of medical devices in the supply chain. It helps healthcare providers, regulators, and manufacturers identify and monitor devices throughout their lifecycle, reducing risks like counterfeiting or recall issues.

How are Coltene/Whaledent Inc.’s devices classified by the FDA, and what does that classification mean?

Coltene/Whaledent Inc.’s devices are classified under FDA’s Class I and Class II categories. Class I devices generally pose minimal risk and may require general controls (e.g., labeling, manufacturing practices) for authorization. Class II devices involve a higher risk and may require additional controls, such as performance standards or post-market surveillance, to ensure safety and effectiveness before they can be used in clinical settings.

What does it mean for a device to be listed in the FDA’s UDI database, and how does it relate to Coltene/Whaledent Inc.’s products?

Listing in the FDA’s UDI database means the device has been assigned a unique identifier, combining a device identifier and a production identifier. This helps distinguish Coltene/Whaledent Inc.’s products—such as their carbide burs, endodontic files, or ultrasonic scaling systems—from other similar devices in the market. The UDI system improves patient safety, streamlines recalls, and enhances supply chain efficiency by providing clear, standardized information about each device’s specifications and batch details.

AI-generated from registry data and not verified by a human reviewer.

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 57 of 64

Device	Model / Reference	Registries	Class	Status
PerFect TCS Cord Assembly	S6008CE	EUDAMEDFDA UDI	Class IIb	Active
HYGENIC Red Wax, 450 g	H00805	EUDAMED	Class I	Active
20 ParaPost Titanium Temporary Posts (.060" / 1.50mm)	P466	EUDAMEDFDA UDI	Class IIa	Active
TMS LINK PLUS Bulk Kit, Minim Silver, Gold-Plated Stainless Steel, 50 pcs	L722	EUDAMEDFDA UDI	Class IIa	Active
3 ParaPost XT Drills - Size 4.5	P6245	EUDAMED	Class IIa	Active
HYGENIC Boxing Wax, Regular 2.25 kg	H00837	EUDAMEDFDA UDI	Class I	Active
20 ParaPost Titanium Temporary Posts (.036" / 0.90mm)	P463	EUDAMEDFDA UDI	Class IIa	Active
TMS LINK PLUS Complete-Kit, Minim Silver, Gold-Plated Stainless Steel, 2in1, 20 pcs	L731	EUDAMEDFDA UDI	Class IIa	Active
25 ParaPost Stainless Steel Posts (.045" / 1.14mm)	P4445B	EUDAMEDFDA UDI	Class IIa	Active
Pindex System 1 Reamer	PX120	EUDAMEDFDA UDI	Class I	Active
Ultrasonic Scaler Insert #10 Slim OptiMist (30kHz) SuperSoft	USG1030KOS	EUDAMEDFDA UDI	Class IIa	Active
Ultrasonic Scaler Insert #10 (25kHz) - SLIM	US1025KSP	EUDAMEDFDA UDI	Class IIa	Active
Accu-Trac 40 Locking Arms	ATA20	EUDAMEDFDA UDI	Class I	Active
Pindex System 12 Proxima Replacement Saw Blades	P38	EUDAMED	Class I	Active
TMS Bulk Kit, Regular Gold, Gold-Plated Stainless Steel, 100 pcs	T03	EUDAMEDFDA UDI	Class IIa	Active
MAX Restorative Pins Complete Kit Purple, .021 '' / .525 mm, 25 pcs	M71	EUDAMED	Class IIa	Active
3 TENAX Drills 1.2mm	TEA12	EUDAMED	Class IIa	Active
10 ParaPost Threaded Short Posts - Stainless Steel, 1.50mm	PDTA6	EUDAMED	Class IIa	Active
TMS LINK PLUS Complete-Kit, Regular Gold, Gold-Plated Stainless Steel, 2in1, 24 pcs	EL75124	EUDAMED	Class IIa	Active
TMS LINK PLUS Complete-Kit, Minim Silver, Titanium Alloy, 20 pcs	L821	EUDAMEDFDA UDI	Class IIa	Active
HYGENIC Orthodontic Tray Wax, White, 48 pcs	H00827	EUDAMEDFDA UDI	Class I	Active
PRESIDENT Impression Trays - Upper Arch - Small - Size 5	C6905	EUDAMEDFDA UDI	Class I	Active
HYGENIC Red Wax, 2.25 kg	H00811	EUDAMEDFDA UDI	Class I	Active
TMS Complete-Kit, Minim Silver, Gold-Plated Stainless Steel, 2in1, 2 x 20 pcs	T10	EUDAMEDFDA UDI	Class IIa	Active
10 ParaPost Stainless Steel Posts (.050" / 1.25mm)	P445	EUDAMEDFDA UDI	Class IIa	Active
PerFect TCS 45º Tapered Knife Electrode Sheaths, 2pcs	S6013A	EUDAMEDFDA UDI	Class IIb	Active
PRESIDENT Impression Trays - Upper Right/Lower Left - Quadrant - Size 8	C6908	EUDAMEDFDA UDI	Class I	Active
TMS LINK PLUS Complete-Kit, Minim Silver, Titanium Alloy, 2in1, 24 pcs	EL84124	EUDAMED	Class IIa	Active
10 ParaPost Stainless Steel Posts (.045" / 1.14mm)	P4445	EUDAMEDFDA UDI	Class IIa	Active
10 ParaPost Plus Stainless Steel Posts (.060" / 1.50mm)	P2446	EUDAMEDFDA UDI	Class IIa	Active
20 ParaPost XP Titanium Temporary Posts (.055" / 1.40mm)	P74655	EUDAMEDFDA UDI	Class IIa	Active
Modification Of Parapost Cement	K993710	FDA 510(k)	Class II	Active
Coltene President Jet Light/Reg Body Hydrophilic	K912485	FDA 510(k)	Class II	Active
One Coat Se Bond	K033760	FDA 510(k)	Class II	Active
One Coat Bond Dentin/Enamel Adhesive System	K974906	FDA 510(k)	Class II	Active
Coltolux Light Meter	K950106	FDA 510(k)	Class II	Active
Biosonic Suvi Piezeoelectric Scaler And Polisher	K130137	FDA 510(k)	Class II	Active
Perfect Tissue Contouring System Ii	K071632	FDA 510(k)	Class II	Active
Biosonic Ultrasonic Scaler System	K983727	FDA 510(k)	Class II	Active
Dentronix Dds 7000 Rapid Dry Heat Sterilizer Sterilization System	K051660	FDA 510(k)	Class II	Active
Biosonic Uc-70 Sterilizable Instrument Cassette	K993255	FDA 510(k)	Class II	Active
Coltene A.r.t. Bond	K922615	FDA 510(k)	Class II	Active
Synergy	K974465	FDA 510(k)	Class II	Active
Tenax White Post	K993545	FDA 510(k)	Class I	Active
Parapost Cement	K945366	FDA 510(k)	Class II	Active
Parapost Xt System	K934192	FDA 510(k)	Class I	Active
Parapost System Sterilizable Organizer	K993835	FDA 510(k)	Class II	Active
Coltene Aura Compomer Restorative System	K003034	FDA 510(k)	Class II	Active
Coltosol F	K031752	FDA 510(k)	Class II	Active
Synergy Flow	K013400	FDA 510(k)	Class II	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.

Coltene/Whaledent Inc. has 14 recall records initiated between December 11, 2013, and January 20, 2023, with statuses recorded as open, classified, or terminated. The reasons cited include mispackaging—such as latex dental dams shipped in non-latex packaging, incorrect bur labeling (FG 557 mislabeled as FG 57), and wrong-sized dental posts or pins—and labeling errors, including incorrect product numbers. One record notes a potential mechanical issue with a turbine head connection that may loosen during use, while others involve deviations in product dimensions affecting compatibility with dental tools.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

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