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Sign in to claim this brandAstron Dental
United States·US-MF-000034006
Last updated September 18, 2026
About
Astron has been providing innovations to help make smiles since 1967. We sell our products worldwide and maintain a reputation for quality products, guaranteed performance, outstanding patient comfort, and reasonable prices. And all of our materials are made in the U.S.A., and ISO and CE certified.
From the manufacturer's own website. Source
What Astron Dental makes
Astron Dental manufactures custom-made and single-use mouthguards, including thermoformed splints like CLEARSPLINT, as well as preformed models such as ULTRAFLEX and LABTEC. Their portfolio also includes the ASTRON LC, a specialized mouthguard variant. These products are designed for dental protection and stabilization, catering to both athletic and clinical applications.
The company’s devices are classified as Class II, Class IIa, or unclassified (U) under regulatory frameworks, with listings in the EU’s eudamed database and the FDA’s Unique Device Identifier (UDI) system. Astron Dental operates from the United States, where its products are developed and manufactured.
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 Astron Dental manufacture?
Astron Dental specializes in mouthguards, which are primarily used for dental protection and stabilization. Their portfolio includes both custom-made mouthguards, such as thermoformed splints like CLEARSPLINT, and single-use preformed models like ULTRAFLEX and LABTEC. They also produce a specialized variant called the ASTRON LC. These devices are designed for applications ranging from athletic protection to clinical use, ensuring patient comfort and performance.
Where is Astron Dental based, and where are their devices manufactured?
Astron Dental is based in the United States, and their devices are developed and manufactured there. The company emphasizes domestic production, ensuring quality control and compliance with U.S. manufacturing standards.
Which regulatory registries list Astron Dental’s devices?
Astron Dental’s devices are listed in two key regulatory databases: the EU’s eudamed system, which tracks medical devices authorized in the European Economic Area, and the FDA’s Unique Device Identifier (UDI) system, which catalogs devices cleared or approved for use in the United States. These listings help ensure traceability and compliance with global regulatory requirements.
How are Astron Dental’s devices classified under regulatory frameworks?
Astron Dental’s devices fall into three primary regulatory classifications: Class II, which typically includes devices with moderate risk requiring special controls; Class IIa, a subset of Class II with slightly lower risk; and unclassified (U), indicating devices that do not meet the criteria for Class I or higher risk categories. These classifications determine the regulatory scrutiny and authorization pathways required for each product.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 815, Oakwood Road, Lake Zurich, United States
- Website
- www.astrondental.com
- —
- —
- [email protected]
- Phone
- +001847726-8787
- PRRC Contact
- Doug Muller
- EUDAMED SRN
- US-MF-000034006
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (73)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Ultraflex | PUFMCLK1 | FDA UDI | Class II | Active |
| Ultraflex | PUFELEK1 | FDA UDI | Class II | Active |
| Ultraflex | PUFELSEK1 | FDA UDI | Class II | Active |
| CLEARsplint Disc | 98x20 No Shoulder | EUDAMED | Class IIa | Active |
| CLEARsplint Super Economy Kit | PCSRSEK11 | EUDAMED | Class IIa | Active |
| CLEARsplint Disc | 98x20 Shoulder | EUDAMED | Class IIa | Active |
| CLEARsplint Disc BES | BES 95x25 Clover Edge Blue | EUDAMEDFDA UDI | Class IIa | Active |
| 2nd Modified Vinylac Press Pack Denture Resin | K874025 | FDA 510(k) | Class II | Active |
| Duraclean Denture Cleaner | K852906 | FDA 510(k) | Class I | Active |
| Vinylac Press-Pack Denture Resin | K831269 | FDA 510(k) | Class II | Active |
| Clearsplint Es | K111828 | FDA 510(k) | U | Active |
| Modified Vinylac Press Pack Denture Resin | K864757 | FDA 510(k) | Class II | Active |
| Astron 77 Injection Denture Resin | K833270 | FDA 510(k) | Class II | Active |
| CLEARsplint CAD/CAM Pro Economy Kit | PCSREK11 | EUDAMED | Class IIa | Active |
| CLEARsplint Disc BES | BES 98x16 Shoulder Clear | EUDAMED | Class IIa | Active |
| CLEARsplint Disc BES | BES 98x20 Shoulder Magenta | EUDAMED | Class IIa | Active |
| CLEARsplint Disc BES | BES 95x25 Clover Edge Magenta | EUDAMED | Class IIa | Active |
| CLEARsplint Disc | 95x16 Clover Edge | EUDAMED | Class IIa | Active |
| CLEARsplint CAD/CAM Pro Super Economy Kit | PCSRSEK11CAD/CAM | EUDAMED | Class IIa | Active |
| Labtec Pro | Labtec Pro Economy Kit | EUDAMED | Class IIa | Active |
| CLEARsplint | BES 98x25 Shoulder Magenta | EUDAMED | Class IIa | Active |
| CLEARsplint Disc BES | BES 98x25 Shoulder Blue | EUDAMED | Class IIa | Active |
| CLEARsplint Disc BES | BES 95x20 Clover Edge Magenta | EUDAMED | Class IIa | Active |
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