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Sign in to claim this brandColtene/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
- —
- —
- [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 47 of 64| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Alpen | R801C018FG | FDA UDI | Class I | Active |
| Alpen | RS41558G | FDA UDI | Class I | Active |
| Alpen | R848C016FG | FDA UDI | Class I | Active |
| Alpen | R850TC016FG | FDA UDI | Class I | Active |
| Alpen | 60021907 | FDA UDI | Class I | Active |
| Alpen | X368SC023 | FDA UDI | Class I | Active |
| Alpen | 60019420 | FDA UDI | Class I | Unknown |
| Alpen | R801C021FG | FDA UDI | Class I | Active |
| Alpen | RLX850C014 | FDA UDI | Class I | Unknown |
| Alpen | R837RC012FG | FDA UDI | Class I | Active |
| Hyflex | HNT8310630 | FDA UDI | Class I | Active |
| Hygenic | H00348 | FDA UDI | Class II | Active |
| Hygenic | H02769C | FDA UDI | Class I | Active |
| Dentronix | DSE201A | FDA UDI | Class I | Unknown |
| Hyflex | H8190825 | FDA UDI | Class I | Active |
| Alpen | R707642 | FDA UDI | Class I | Active |
| Alpen | R909008 | FDA UDI | Class I | Active |
| Alpen | RLX856SC018 | FDA UDI | Class I | Active |
| Alpen | X368EF023 | FDA UDI | Class I | Active |
| Dentronix | DSE104 | FDA UDI | Class I | Unknown |
| Alpen | XU811SC033 | FDA UDI | Class I | Unknown |
| Alpen | 60018657 | FDA UDI | Class I | Unknown |
| Alpen | 60018674 | FDA UDI | Class I | Unknown |
| Alpen | R850C014FG | FDA UDI | Class I | Active |
| ParaPost XP | P74345C | FDA UDI | Class I | Active |
| ParaPost XP | SBP78445 | FDA UDI | Class I | Unknown |
| Hyflex | H08388 | FDA UDI | Class I | Unknown |
| Hygenic | H00415 | FDA UDI | Class II | Active |
| Alpen | RL6055C018 | FDA UDI | Class I | Active |
| Alpen | 60019474 | FDA UDI | Class I | Unknown |
| Hyflex | HGPF8211501 | FDA UDI | Class I | Active |
| Alpen | RS41557GB | FDA UDI | Class I | Unknown |
| Alpen | RL839F012 | FDA UDI | Class I | Active |
| Alpen | R7283-4 | FDA UDI | Class I | Active |
| Alpen | RS100006 | FDA UDI | Class I | Active |
| Alpen | 60018641 | FDA UDI | Class I | Unknown |
| Dentronix | D208 | FDA UDI | Class I | Unknown |
| Alpen | RP230201RA | FDA UDI | Class I | Active |
| Hyflex | 60018455 | FDA UDI | Class I | Active |
| Alpen | X856EF016 | FDA UDI | Class I | Active |
| HyFlex CM | SBHGPF8311501 | FDA UDI | Class I | Active |
| Alpen | RS200004 | FDA UDI | Class I | Active |
| ParaPost | PF18155C | FDA UDI | Class I | Active |
| Alpen | X856LF018 | FDA UDI | Class I | Active |
| BioSonic | 60018763 | FDA UDI | Class II | Unknown |
| Alpen | X850M012 | FDA UDI | Class I | Unknown |
| Hyflex | HNT8210630 | FDA UDI | Class I | Active |
| Hygenic | H00340 | FDA UDI | Class II | Active |
| Alpen | R878KC016FG | FDA UDI | Class I | Active |
| Hyflex | H08387 | FDA UDI | Class I | Unknown |
Related Companies
Authorised Representatives
Importers
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Notified Bodies
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Authorities
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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