The following data is part of a premarket notification filed by Astron Dental Corporation with the FDA for Clearsplint Es.
| Device ID | K111828 |
| 510k Number | K111828 |
| Device Name: | CLEARSPLINT ES |
| Classification | Mouthguard, Prescription |
| Applicant | ASTRON DENTAL CORPORATION 815 OAKWOOD RD. UNIT G Lake Zurich, IL 60047 |
| Contact | Douglas S Muller |
| Correspondent | Douglas S Muller ASTRON DENTAL CORPORATION 815 OAKWOOD RD. UNIT G Lake Zurich, IL 60047 |
| Product Code | MQC |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-28 |
| Decision Date | 2011-10-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D810PCSRSEK11 | K111828 | 000 |
| D810PCSD2095Z111 | K111828 | 000 |
| D810PCSD2098NS111 | K111828 | 000 |
| D810PCSD985111 | K111828 | 000 |
| D810PCSFEK11 | K111828 | 000 |
| D810PCSFLK11 | K111828 | 000 |
| D810PCSFSEK11 | K111828 | 000 |
| D810PCSREK11 | K111828 | 000 |
| D810PCSRLK11 | K111828 | 000 |
| D810PCSD1698111 | K111828 | 000 |