The following data is part of a premarket notification filed by Gc America, Inc. with the FDA for Acron Mc Modification.
| Device ID | K991774 |
| 510k Number | K991774 |
| Device Name: | ACRON MC MODIFICATION |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | GC AMERICA, INC. 3737 WEST 127TH ST. Alsip, IL 60803 |
| Contact | Terry L Joritz |
| Correspondent | Terry L Joritz GC AMERICA, INC. 3737 WEST 127TH ST. Alsip, IL 60803 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-25 |
| Decision Date | 1999-07-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D6583496571 | K991774 | 000 |
| 10386040007290 | K991774 | 000 |
| 10386040007283 | K991774 | 000 |
| 10386040007276 | K991774 | 000 |
| 10386040007269 | K991774 | 000 |
| 10386040007252 | K991774 | 000 |
| 10386040007245 | K991774 | 000 |
| 10386040007238 | K991774 | 000 |
| 10386040007221 | K991774 | 000 |
| 10386040007214 | K991774 | 000 |
| 10386040007207 | K991774 | 000 |
| 10386040007191 | K991774 | 000 |
| 10386040007306 | K991774 | 000 |
| 10386040007313 | K991774 | 000 |
| D6583496561 | K991774 | 000 |
| D6583496551 | K991774 | 000 |
| D6583496541 | K991774 | 000 |
| D6583496531 | K991774 | 000 |
| D6583496521 | K991774 | 000 |
| D6583496511 | K991774 | 000 |
| D6583496501 | K991774 | 000 |
| 10386040007351 | K991774 | 000 |
| 10386040007344 | K991774 | 000 |
| 10386040007337 | K991774 | 000 |
| 10386040007320 | K991774 | 000 |
| 10386040007184 | K991774 | 000 |