The following data is part of a premarket notification filed by Discus Dental, Inc. with the FDA for Mega Bite Registration - Dental Bite Registration Material.
| Device ID | K030776 |
| 510k Number | K030776 |
| Device Name: | MEGA BITE REGISTRATION - DENTAL BITE REGISTRATION MATERIAL |
| Classification | Material, Impression |
| Applicant | DISCUS DENTAL, INC. 8550 HIGUERA ST. Culver City, CA 90232 -2522 |
| Contact | Yogi Shah |
| Correspondent | Yogi Shah DISCUS DENTAL, INC. 8550 HIGUERA ST. Culver City, CA 90232 -2522 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-11 |
| Decision Date | 2003-05-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D813SPD13700 | K030776 | 000 |
| D813SPD11860 | K030776 | 000 |
| D813SPD11050 | K030776 | 000 |
| D813SPD11040 | K030776 | 000 |
| D813J002561 | K030776 | 000 |