The following data is part of a premarket notification filed by Implant Direct Llc with the FDA for Legacy Abutment System.
| Device ID | K060063 |
| 510k Number | K060063 |
| Device Name: | LEGACY ABUTMENT SYSTEM |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | IMPLANT DIRECT LLC 27030 MALIBU HILLS RD. Calabasas Hills, CA 91301 |
| Contact | Rosemarie Masteller |
| Correspondent | Rosemarie Masteller IMPLANT DIRECT LLC 27030 MALIBU HILLS RD. Calabasas Hills, CA 91301 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-01-09 |
| Decision Date | 2006-05-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10841307112662 | K060063 | 000 |
| 10841307112471 | K060063 | 000 |
| 10841307112464 | K060063 | 000 |
| 10841307111986 | K060063 | 000 |
| 10841307111979 | K060063 | 000 |
| 10841307111962 | K060063 | 000 |
| 10841307109143 | K060063 | 000 |
| 10841307109136 | K060063 | 000 |
| 10841307109129 | K060063 | 000 |
| 10841307108627 | K060063 | 000 |
| 10841307114239 | K060063 | 000 |
| 00841307114232 | K060063 | 000 |
| 10841307126270 | K060063 | 000 |
| 10841307126263 | K060063 | 000 |
| 10841307126256 | K060063 | 000 |
| 00841307125993 | K060063 | 000 |
| 10841307112488 | K060063 | 000 |
| 10841307112495 | K060063 | 000 |
| 10841307112501 | K060063 | 000 |
| 10841307112655 | K060063 | 000 |
| 10841307112648 | K060063 | 000 |
| 10841307112631 | K060063 | 000 |
| 10841307112624 | K060063 | 000 |
| 10841307112617 | K060063 | 000 |
| 10841307112600 | K060063 | 000 |
| 10841307112594 | K060063 | 000 |
| 10841307112587 | K060063 | 000 |
| 10841307112570 | K060063 | 000 |
| 10841307112563 | K060063 | 000 |
| 10841307112556 | K060063 | 000 |
| 10841307112549 | K060063 | 000 |
| 10841307112532 | K060063 | 000 |
| 10841307112525 | K060063 | 000 |
| 10841307112518 | K060063 | 000 |
| 00841307129496 | K060063 | 000 |