Data / Medical devices / United States / Astron Dental Corporation
Astron Dental Corporation: FDA-registered device maker in Lake Zurich, IL, United States, 3 510(k) clearances
Astron Dental Corporation is registered with the FDA (registration 1483306) in Lake Zurich, IL, United States. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated October 26, 2011. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1483306
- Address
- 815 Oakwood Rd Ste G, Lake Zurich, IL, United States, 60047
- Owner or operator
- Astron Dental Corporation (1483306)
- Roles
- Repackager or relabeler
- First device listed
- March 19, 2008
- Registered through
- 2027
- Brand names listed
- Astron LC Light Cure Base Plate, Astron LC Light Cure Custom Tray, Astron LC Light Cure Reline, Clearsplint, Clearsplint Disc, Clearsplint ES, Duraclean Denture Cleaner, Duraclean II Denture Cleaner and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cleaner, Denture, Mechanical | JER | 1 | Repackager or relabeler | accessdata.fda.gov |
| Mouthguard, Prescription | MQC | U | Repackager or relabeler | accessdata.fda.gov |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | 2 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 26, 2011 | K111828 | CLEARSPLINT ES | MQC | Substantially Equivalent | Astron Dental Corporation | accessdata.fda.gov |
| February 10, 1987 | K864757 | MODIFIED VINYLAC PRESS PACK DENTURE RESIN | EBI | Substantially Equivalent | Astron Dental Corp. | accessdata.fda.gov |
| July 31, 1985 | K852906 | DURACLEAN DENTURE CLEANER | JER | Substantially Equivalent | Astron Dental Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Mouthguard, Prescription
- All makers of Resin, Denture, Relining, Repairing, Rebasing
- All makers of Cleaner, Denture, Mechanical
Updated October 26, 2011. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.