The following data is part of a premarket notification filed by Amann Girrbach Ag with the FDA for Ceramill A-splint.
| Device ID | K191836 |
| 510k Number | K191836 |
| Device Name: | Ceramill A-Splint |
| Classification | Mouthguard, Prescription |
| Applicant | Amann Girrbach AG Herrschaftswiesen 1 Koblach, AT 6842 |
| Contact | Debora Engel |
| Correspondent | Rachel Paul Emergo Europe Consulting Prinsessegracht 20 The Hague, NL 2514ap |
| 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 | 2019-07-09 |
| Decision Date | 2019-12-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E4947610861 | K191836 | 000 |
| E4947610851 | K191836 | 000 |
| E4947610841 | K191836 | 000 |
| E4947610821 | K191836 | 000 |
| E4947610811 | K191836 | 000 |
| E4947610801 | K191836 | 000 |
| E4947610891 | K191836 | 000 |
| E4947610881 | K191836 | 000 |
| E4947610871 | K191836 | 000 |