The following data is part of a premarket notification filed by Goldsmith & Revere, Inc. with the FDA for Ultra Spherical Amalgam Alloy.
| Device ID | K951865 |
| 510k Number | K951865 |
| Device Name: | ULTRA SPHERICAL AMALGAM ALLOY |
| Classification | Alloy, Amalgam |
| Applicant | GOLDSMITH & REVERE, INC. 242 SOUTH DEAN ST. Englewood, NJ 07631 |
| Contact | D. T Wolf |
| Correspondent | D. T Wolf GOLDSMITH & REVERE, INC. 242 SOUTH DEAN ST. Englewood, NJ 07631 |
| Product Code | EJJ |
| CFR Regulation Number | 872.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-21 |
| Decision Date | 1995-05-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H65810092461 | K951865 | 000 |
| D033099610391 | K951865 | 000 |
| D033099610371 | K951865 | 000 |
| D033099610361 | K951865 | 000 |
| D033099610351 | K951865 | 000 |
| D033099610061 | K951865 | 000 |
| D033099610021 | K951865 | 000 |
| D033099550671 | K951865 | 000 |
| D033099550661 | K951865 | 000 |
| D033099550651 | K951865 | 000 |
| D033099550471 | K951865 | 000 |
| D033099550461 | K951865 | 000 |
| D033099550451 | K951865 | 000 |
| 20889813001527 | K951865 | 000 |
| 20889813001510 | K951865 | 000 |
| 20889813001503 | K951865 | 000 |
| 10889813001520 | K951865 | 000 |
| 10889813001513 | K951865 | 000 |
| D033099610401 | K951865 | 000 |
| D033099610411 | K951865 | 000 |
| D033099610471 | K951865 | 000 |
| H65810075321 | K951865 | 000 |
| H65810040171 | K951865 | 000 |
| H65810037771 | K951865 | 000 |
| H65810015281 | K951865 | 000 |
| H65810012351 | K951865 | 000 |
| H65810011851 | K951865 | 000 |
| H65810011811 | K951865 | 000 |
| H65810001171 | K951865 | 000 |
| H65810000371 | K951865 | 000 |
| D773100UTT3501 | K951865 | 000 |
| D773100UTT35001 | K951865 | 000 |
| D773100UTT2501 | K951865 | 000 |
| D773100UTT25001 | K951865 | 000 |
| D773100UTT1501 | K951865 | 000 |
| D773100UTT15001 | K951865 | 000 |
| D033099610491 | K951865 | 000 |
| D033099610481 | K951865 | 000 |
| 10889813001506 | K951865 | 000 |