The following data is part of a premarket notification filed by Ivory Super Holdco Inc. / Zest Anchors Llc with the FDA for Locator Overdenture Implant System.
| Device ID | K203701 |
| 510k Number | K203701 |
| Device Name: | Locator Overdenture Implant System |
| Classification | Implant, Endosseous, Root-form |
| Applicant | Ivory Super Holdco Inc. / Zest Anchors LLC 2875 Loker Avenue East Carlsbad, CA 92010 |
| Contact | Marysa Loustalot |
| Correspondent | Marysa Loustalot Ivory Super Holdco Inc. / Zest Anchors LLC 2875 Loker Avenue East Carlsbad, CA 92010 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-18 |
| Decision Date | 2021-04-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840481130618 | K203701 | 000 |
| 00840481130601 | K203701 | 000 |