The following data is part of a premarket notification filed by Amann Girrbach Ag with the FDA for Ceramill A-temp.
| Device ID | K191843 |
| 510k Number | K191843 |
| Device Name: | Ceramill A-Temp |
| Classification | Crown And Bridge, Temporary, Resin |
| 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 | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-09 |
| Decision Date | 2019-10-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E4947612631 | K191843 | 000 |
| E4947610641 | K191843 | 000 |
| E4947610631 | K191843 | 000 |
| E4947610621 | K191843 | 000 |
| E4947610611 | K191843 | 000 |
| E4947610601 | K191843 | 000 |
| E4947610591 | K191843 | 000 |
| E4947610581 | K191843 | 000 |
| E4947610571 | K191843 | 000 |
| E4947610561 | K191843 | 000 |
| E4947610651 | K191843 | 000 |
| E4947610661 | K191843 | 000 |
| E4947612481 | K191843 | 000 |
| E4947612621 | K191843 | 000 |
| E4947612611 | K191843 | 000 |
| E4947612601 | K191843 | 000 |
| E4947612591 | K191843 | 000 |
| E4947612531 | K191843 | 000 |
| E4947612521 | K191843 | 000 |
| E4947612511 | K191843 | 000 |
| E4947612501 | K191843 | 000 |
| E4947612491 | K191843 | 000 |
| E4947610551 | K191843 | 000 |
| E4947610511 | K191843 | 000 |
| E4947610501 | K191843 | 000 |
| E4947681331 | K191843 | 000 |
| E4947681321 | K191843 | 000 |
| E4947681311 | K191843 | 000 |
| E4947681301 | K191843 | 000 |
| E4947681291 | K191843 | 000 |
| E4947681281 | K191843 | 000 |
| E4947681271 | K191843 | 000 |
| E4947681261 | K191843 | 000 |
| E4947681251 | K191843 | 000 |
| E4947681341 | K191843 | 000 |
| E4947681351 | K191843 | 000 |
| E4947610401 | K191843 | 000 |
| E4947610491 | K191843 | 000 |
| E4947610481 | K191843 | 000 |
| E4947610471 | K191843 | 000 |
| E4947610461 | K191843 | 000 |
| E4947610451 | K191843 | 000 |
| E4947610441 | K191843 | 000 |
| E4947610431 | K191843 | 000 |
| E4947610421 | K191843 | 000 |
| E4947610411 | K191843 | 000 |
| E4947681241 | K191843 | 000 |
| E4947612641 | K191843 | 000 |
| E4947613831 | K191843 | 000 |
| E4947613661 | K191843 | 000 |
| E4947613651 | K191843 | 000 |
| E4947613641 | K191843 | 000 |
| E4947613631 | K191843 | 000 |
| E4947613621 | K191843 | 000 |
| E4947613611 | K191843 | 000 |
| E4947613601 | K191843 | 000 |
| E4947613591 | K191843 | 000 |
| E4947613581 | K191843 | 000 |
| E4947613671 | K191843 | 000 |
| E4947613701 | K191843 | 000 |
| E4947613711 | K191843 | 000 |
| E4947613821 | K191843 | 000 |
| E4947613811 | K191843 | 000 |
| E4947613801 | K191843 | 000 |
| E4947613791 | K191843 | 000 |
| E4947613781 | K191843 | 000 |
| E4947613751 | K191843 | 000 |
| E4947613741 | K191843 | 000 |
| E4947613731 | K191843 | 000 |
| E4947613721 | K191843 | 000 |
| E4947613571 | K191843 | 000 |
| E4947613561 | K191843 | 000 |
| E4947613551 | K191843 | 000 |
| E4947613391 | K191843 | 000 |
| E4947613381 | K191843 | 000 |
| E4947613371 | K191843 | 000 |
| E4947613361 | K191843 | 000 |
| E4947613351 | K191843 | 000 |
| E4947613341 | K191843 | 000 |
| E4947613331 | K191843 | 000 |
| E4947613321 | K191843 | 000 |
| E4947613311 | K191843 | 000 |
| E4947613401 | K191843 | 000 |
| E4947613411 | K191843 | 000 |
| E4947613431 | K191843 | 000 |
| E4947613541 | K191843 | 000 |
| E4947613531 | K191843 | 000 |
| E4947613521 | K191843 | 000 |
| E4947613511 | K191843 | 000 |
| E4947613501 | K191843 | 000 |
| E4947613471 | K191843 | 000 |
| E4947613461 | K191843 | 000 |
| E4947613451 | K191843 | 000 |
| E4947613441 | K191843 | 000 |
| E4947613301 | K191843 | 000 |