The following data is part of a premarket notification filed by Zest Anchors, Inc. with the FDA for Locator Bar Female, Locator Laser Bar Female, Locator Bar Cast-to Female, Models 08587, 08588, 08586.
| Device ID | K033699 |
| 510k Number | K033699 |
| Device Name: | LOCATOR BAR FEMALE, LOCATOR LASER BAR FEMALE, LOCATOR BAR CAST-TO FEMALE, MODELS 08587, 08588, 08586 |
| Classification | Implant, Endosseous, Root-form |
| Applicant | ZEST ANCHORS, INC. 4329 GRAYDON ROAD San Diego, CA 92130 |
| Contact | Floyd G Larson |
| Correspondent | Floyd G Larson ZEST ANCHORS, INC. 4329 GRAYDON ROAD San Diego, CA 92130 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-25 |
| Decision Date | 2004-04-22 |