The Implant Center of the Palm Beaches: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “The Implant Center of the Palm Beaches” (first 1995, latest 1998), across 1 product code in 1 review panel. Median 510(k) review time under this name: 68 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 | 0 | — |
| 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 | 12 | 12 |
Review panels
- Dental (12)
Most recent The Implant Center of the Palm Beaches 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K974280 | ABUTMENT - COMPLETE | DZE | 1998-02-20 | 107 |
| K960111 | KIS MT4 | DZE | 1996-03-27 | 76 |
| K960110 | KIS MT3 | DZE | 1996-03-20 | 69 |
| K960112 | KIS MT5 | DZE | 1996-03-15 | 64 |
| K955048 | KIS MED THREAD IMPLANT & PROSTHESIS SYSTEM | DZE | 1996-01-11 | 69 |
| K953558 | KIS II LG HEX SCREW & CYLINDER IMPLANTS | DZE | 1995-12-19 | 154 |
| K953234 | SCREW IMPLANTS, GRADE 3; UNCOATED, HA, TP-B3 | DZE | 1995-11-08 | 120 |
| K954539 | LG HEX PROSTHETICS | DZE | 1995-10-30 | 52 |
| K953237 | PROSTHETICS & INSTRUMENTATION A. PROSTHETIC ABUTMENTS 4, 5, 6 DIAMETER, GRADE 3, B. IRRIGATION DRILLS, TOOLING & PREANG' | DZE | 1995-09-15 | 66 |
| K953236 | CYLINDER IMPLANTS HA, TP, GRADE 3 | DZE | 1995-09-13 | 64 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named The Implant Center of the Palm Beaches.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under The Implant Center of the Palm Beaches?
FDA lists 12 510(k) clearances under the applicant name “The Implant Center of the Palm Beaches” (first 1995, latest 1998), across 1 product code 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 The Implant Center of the Palm Beaches?
The median time from FDA receipt to decision across 510(k)s cleared under the name The Implant Center of the Palm Beaches is 68 days.
Which FDA product codes appear under The Implant Center of the Palm Beaches?
The most frequent FDA product codes under this applicant name are DZE (Implant, Endosseous, Root-Form, 12).
Next steps
- See all 12 The Implant Center of the Palm Beaches clearances with predicates and recalls
- Run predicate analysis for product code DZE, The Implant Center of the Palm Beaches'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.