Paragon Implant Mfg., LLC: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Paragon Implant Mfg., LLC” (first 2025, latest 2026), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 158 days. Since 2017 the median was 158 days, against 210 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 |
|---|---|---|
| 2025 | 4 | 162 |
| 2026 | 1 | 141 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Paragon Implant Mfg., LLC took a median 158 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 210 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | 4 | 4 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 1 | 1 |
Review panels
- Dental (4)
- General Hospital (1)
Most recent Paragon Implant Mfg., LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261392 | TriActive Dental Implant System | DZE | 2026-09-17 | 141 |
| K252145 | GEN5 and GEN5+ 3.3mmD Dental Implants | DZE | 2025-12-23 | 167 |
| K250476 | NizPlant Dental Implant System | DZE | 2025-12-23 | 307 |
| K251756 | Sterilization Trays | KCT | 2025-11-14 | 158 |
| K251938 | GEN5 and GEN5+ Dental Implant System | DZE | 2025-10-30 | 128 |
Recalls
openFDA lists no recalls under a recalling firm named Paragon Implant Mfg., LLC.
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.
- Paragon 28, Inc. (60 510(k)s)
- Paragon Vision Sciences (16 510(k)s)
- Paragon Trade Brands, Inc. (14 510(k)s)
- Paragon Diagnostics, Inc. (7 510(k)s)
- Paragon Medical (5 510(k)s)
- Paragon Optical Co. (1 510(k)s)
- Paragon Bioteck, Inc. (1 510(k)s)
- Paragon Medical and Scientific, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Paragon Implant Mfg., LLC?
FDA lists 5 510(k) clearances under the applicant name “Paragon Implant Mfg., LLC” (first 2025, latest 2026), across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Paragon Implant Mfg., LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Paragon Implant Mfg., LLC is 158 days. Since 2017: 158 days, versus 210 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Paragon Implant Mfg., LLC?
The most frequent FDA product codes under this applicant name are DZE (Implant, Endosseous, Root-Form, 4); KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories, 1).
Next steps
- See all 5 Paragon Implant Mfg., LLC clearances with predicates and recalls
- Run predicate analysis for product code DZE, Paragon Implant Mfg., LLC'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.