Implant Protesis Dental 2004, S.L.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Implant Protesis Dental 2004, S.L.” (first 2022, latest 2026), across 1 product code in 1 review panel. Median 510(k) review time under this name: 99 days. Since 2017 the median was 99 days, against 165 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2022 | 1 | 88 |
| 2023 | 1 | 147 |
| 2024 | 2 | 96 |
| 2025 | 1 | 99 |
| 2026 | 1 | 115 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Implant Protesis Dental 2004, S.L. took a median 99 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 165 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NHA | Abutment, Implant, Dental, Endosseous | 6 | 6 |
Review panels
- Dental (6)
Most recent Implant Protesis Dental 2004, S.L. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253253 | IPDmilled Blanks | NHA | 2026-01-22 | 115 |
| K251471 | IPD Dental Implant Abutments | NHA | 2025-08-20 | 99 |
| K242819 | IPD Dental Implant Abutments | NHA | 2024-12-19 | 92 |
| K240570 | IPD Dental Implant Abutments | NHA | 2024-06-07 | 99 |
| K231413 | IPD Dental Implant Abutments | NHA | 2023-10-10 | 147 |
| K222215 | IPD Dental Implant Abutments | NHA | 2022-10-21 | 88 |
Recalls
openFDA lists no recalls under a recalling firm named Implant Protesis Dental 2004, S.L..
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 Center of the Palm Beaches (20 510(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 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 Protesis Dental 2004, S.L.?
FDA lists 6 510(k) clearances under the applicant name “Implant Protesis Dental 2004, S.L.” (first 2022, latest 2026), 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 Protesis Dental 2004, S.L.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Implant Protesis Dental 2004, S.L. is 99 days. Since 2017: 99 days, versus 165 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Implant Protesis Dental 2004, S.L.?
The most frequent FDA product codes under this applicant name are NHA (Abutment, Implant, Dental, Endosseous, 6).
Next steps
- See all 6 Implant Protesis Dental 2004, S.L. clearances with predicates and recalls
- Run predicate analysis for product code NHA, Implant Protesis Dental 2004, S.L.'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.