Zest Anchors, Inc.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Zest Anchors, Inc.” (first 1980, latest 2015), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 97 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 1 | 168 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | 6 | 6 |
| NHA | Abutment, Implant, Dental, Endosseous | 4 | 4 |
| EGG | Attachment, Precision, All | 3 | 3 |
| ELS | Splint, Endodontic Stabilizing | 1 | 1 |
Review panels
- Dental (14)
Most recent Zest Anchors, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K150295 | LOCATOR RTx | NHA | 2015-07-24 | 168 |
| K083324 | LOCATOR IMPLANT ANCHOR ATTACHMENT SYSTEM | NHA | 2009-02-25 | 105 |
| K072878 | MODIFICATION TO: LOCATOR IMPLANT ANCHOR | NHA | 2007-12-03 | 55 |
| K042466 | X-2 IMPLANT ABUTMENT; BAR MALE; DISTAL EXTENSION MALE | NHA | 2004-11-24 | 72 |
| K033699 | LOCATOR BAR FEMALE, LOCATOR LASER BAR FEMALE, LOCATOR BAR CAST-TO FEMALE, MODELS 08587, 08588, 08586 | DZE | 2004-04-22 | 149 |
| K994257 | LOCATOR IMPLANT ANCHOR | DZE | 2000-03-17 | 92 |
| K925849 | ZEST IMPLANT ANCHOR | DZE | 1994-11-18 | 730 |
| K934668 | ZEST IMPLANT ANCHOR ADVANCED GENERATION (DENTAL) | DZE | 1994-06-22 | 266 |
| K925700 | ZEST ANCHOR ADVANCED GENERATION | EGG | 1994-04-07 | 511 |
| K882063 | MAGNE-DENT MAGNET/ZEST RETROFIT KEEPER | EGG | 1988-06-13 | 28 |
4 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2008-04-09.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Zest Anchors, LLC (12 510(k)s)
- Zest Mark Industrial Co., Ltd. (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Zest Anchors, Inc.?
FDA lists 14 510(k) clearances under the applicant name “Zest Anchors, Inc.” (first 1980, latest 2015), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Zest Anchors, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Zest Anchors, Inc. is 97 days.
Which FDA product codes appear under Zest Anchors, Inc.?
The most frequent FDA product codes under this applicant name are DZE (Implant, Endosseous, Root-Form, 6); NHA (Abutment, Implant, Dental, Endosseous, 4); EGG (Attachment, Precision, All, 3).
Next steps
- See all 14 Zest Anchors, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DZE, Zest Anchors, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.