Implant Center of the Palm Beaches: FDA filings under this applicant name
FDA lists 20 510(k) clearances under the applicant name “Implant Center of the Palm Beaches” (first 1994, latest 1995), across 1 product code in 1 review panel. Median 510(k) review time under this name: 130 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 | 20 | 20 |
Review panels
- Dental (20)
Most recent Implant Center of the Palm Beaches 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K953001 | TP-4K SCREW IMPLANT 3.3, 3.75, 4.0 | DZE | 1995-10-31 | 130 |
| K953000 | WIDE SYSTEM SCREW B5 UNCOATED 5MM, 6MM | DZE | 1995-10-31 | 130 |
| K952999 | UNCOATED SCREW IMPLANT 3.75, 4.0-B5 | DZE | 1995-10-31 | 130 |
| K952998 | TP SCREW IMPLANT 3.75, 4.0-B5 | DZE | 1995-10-31 | 130 |
| K952997 | PRE ANGULATED PROSTH: 15 DEG ANGLED, 25,& 25 CONE ANGLED | DZE | 1995-10-31 | 130 |
| K952996 | HA/TP COATED CYLINDER IMPLANT 3.3,4.0 | DZE | 1995-10-31 | 130 |
| K952994 | TP-4 WIDE CYLINDER IMPLANTS | DZE | 1995-10-31 | 130 |
| K952992 | PROSTHETICS 4MM | DZE | 1995-10-31 | 130 |
| K952991 | WIDE SCREW HA-5B, CYL-HA-5 | DZE | 1995-10-31 | 130 |
| K952985 | WIDE SCREWS TP-5B. PROS G5, TOOLS G5 OR 17-4 SS | DZE | 1995-10-31 | 130 |
10 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named 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.
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.
- Implant Innovations, Inc. (51 510(k)s)
- Implant Innovations International, Inc. (18 510(k)s)
- Implant Direct Sybron Manufacturing, LLC (17 510(k)s)
- Implant Technology, Inc. (13 510(k)s)
- Implant Direct, LLC (10 510(k)s)
- Implant Support Systems, Inc. (10 510(k)s)
- Implant Protesis Dental 2004, S.L. (6 510(k)s)
- Implant Sciences Corp. (6 510(k)s)
- Implant Integration Systems, Inc. (4 510(k)s)
- Implant Corp. of America (3 510(k)s)
- Implant Logistics, Inc. (3 510(k)s)
- Implant Resource, Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Implant Center of the Palm Beaches?
FDA lists 20 510(k) clearances under the applicant name “Implant Center of the Palm Beaches” (first 1994, latest 1995), 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 Implant Center of the Palm Beaches?
The median time from FDA receipt to decision across 510(k)s cleared under the name Implant Center of the Palm Beaches is 130 days.
Which FDA product codes appear under Implant Center of the Palm Beaches?
The most frequent FDA product codes under this applicant name are DZE (Implant, Endosseous, Root-Form, 20).
Next steps
- See all 20 Implant Center of the Palm Beaches clearances with predicates and recalls
- Run predicate analysis for product code DZE, 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.