The following data is part of a premarket notification filed by Southern Implants (pty) Ltd. with the FDA for Piccolo Implants And Accessories.
| Device ID | K173706 |
| 510k Number | K173706 |
| Device Name: | Piccolo Implants And Accessories |
| Classification | Implant, Endosseous, Root-form |
| Applicant | Southern Implants (Pty) Ltd. 1 Albert Road Irene, ZA 0062 |
| Contact | Lauranda Breytenbach |
| Correspondent | Lauranda Breytenbach Southern Implants (Pty) Ltd. 1 Albert Road Irene, ZA 0062 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-04 |
| Decision Date | 2018-06-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06009544027171 | K173706 | 000 |
| 06009544019879 | K173706 | 000 |
| 06009544007548 | K173706 | 000 |
| 06009544007418 | K173706 | 000 |
| 06009544000907 | K173706 | 000 |
| 06009544000891 | K173706 | 000 |
| 06009544000884 | K173706 | 000 |
| 06009544000877 | K173706 | 000 |
| 06009544022862 | K173706 | 000 |
| 06009544038481 | K173706 | 000 |
| 06009544038474 | K173706 | 000 |
| 06009544038467 | K173706 | 000 |
| 06009544038450 | K173706 | 000 |
| 06009544038436 | K173706 | 000 |
| 06009544038429 | K173706 | 000 |
| 06009544038412 | K173706 | 000 |
| 06009544043553 | K173706 | 000 |
| 06009544020561 | K173706 | 000 |
| 06009544020578 | K173706 | 000 |
| 06009544027164 | K173706 | 000 |
| 06009544027157 | K173706 | 000 |
| 06009544026679 | K173706 | 000 |
| 06009544026662 | K173706 | 000 |
| 06009544026655 | K173706 | 000 |
| 06009544026648 | K173706 | 000 |
| 06009544026631 | K173706 | 000 |
| 06009544022435 | K173706 | 000 |
| 06009544022428 | K173706 | 000 |
| 06009544022411 | K173706 | 000 |
| 06009544022404 | K173706 | 000 |
| 06009544022398 | K173706 | 000 |
| 06009544022381 | K173706 | 000 |
| 06009544022022 | K173706 | 000 |
| 06009544022015 | K173706 | 000 |
| 06009544020585 | K173706 | 000 |
| 06009544043348 | K173706 | 000 |