Belport Company, Inc., Gingi-Pak: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Belport Company, Inc., Gingi-Pak” (first 2020, latest 2026), across 9 product codes in 1 review panel. Median 510(k) review time under this name: 152 days. Since 2017 the median was 152 days, against 144 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 |
|---|---|---|
| 2020 | 1 | 190 |
| 2021 | 0 | — |
| 2022 | 2 | 280 |
| 2023 | 1 | 144 |
| 2024 | 3 | 280 |
| 2025 | 3 | 100 |
| 2026 | 1 | 59 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Belport Company, Inc., Gingi-Pak took a median 152 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 144 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KLE | Agent, Tooth Bonding, Resin | 2 | 2 |
| MVL | Cord, Retraction | 2 | 2 |
| EBD | Coating, Filling Material, Resin | 1 | 1 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 1 | 1 |
| EMA | Cement, Dental | 1 | 1 |
| KJJ | Cleanser, Root Canal | 1 | 1 |
| LBH | Varnish, Cavity | 1 | 1 |
| MQC | Mouthguard, Prescription | 1 | 1 |
| PHR | Diammine Silver Fluoride Dental Hypersensitivity Varnish | 1 | 1 |
Review panels
- Dental (11)
Most recent Belport Company, Inc., Gingi-Pak 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260430 | Porcelain Etch Gel | KLE | 2026-04-10 | 59 |
| K251775 | RODIN Cement | EMA | 2025-09-02 | 84 |
| K250279 | RC-SwiftPrep | KJJ | 2025-07-02 | 152 |
| K250222 | SDF Pro | PHR | 2025-05-07 | 100 |
| K240688 | RODIN Titan 3D Resin | EBI | 2024-06-20 | 99 |
| K231060 | ProMin Dental Desensitizing Gel | LBH | 2024-06-13 | 427 |
| K231793 | RODIN 3D Resin SPLINT, Hard/Flex | MQC | 2024-03-26 | 280 |
| K223365 | RODIN Palette Naturalizing Kit | EBD | 2023-03-27 | 144 |
| K211420 | Stasis Gel | MVL | 2022-03-14 | 311 |
| K211419 | Gingi-Aid Gel | MVL | 2022-01-10 | 248 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Belport Company, Inc., Gingi-Pak.
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.
- Belport Co., Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Belport Company, Inc., Gingi-Pak?
FDA lists 11 510(k) clearances under the applicant name “Belport Company, Inc., Gingi-Pak” (first 2020, latest 2026), across 9 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 Belport Company, Inc., Gingi-Pak?
The median time from FDA receipt to decision across 510(k)s cleared under the name Belport Company, Inc., Gingi-Pak is 152 days. Since 2017: 152 days, versus 144 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Belport Company, Inc., Gingi-Pak?
The most frequent FDA product codes under this applicant name are KLE (Agent, Tooth Bonding, Resin, 2); MVL (Cord, Retraction, 2); EBD (Coating, Filling Material, Resin, 1).
Next steps
- See all 11 Belport Company, Inc., Gingi-Pak clearances with predicates and recalls
- Run predicate analysis for product code KLE, Belport Company, Inc., Gingi-Pak'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.