Jjgc Industria E Comercio DE Materiais Dentarios S.A.: FDA clearances and approvals
Jjgc Industria E Comercio DE Materiais Dentarios S.A. has 28 FDA 510(k) clearances (first 2016, latest 2023), across 3 product codes in 2 review panels. Median 510(k) review time: 186 days. Since 2017 its median was 189 days, against 188 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2016 | 1 | 163 |
| 2017 | 2 | 268 |
| 2018 | 3 | 183 |
| 2019 | 8 | 166 |
| 2020 | 5 | 127 |
| 2021 | 5 | 170 |
| 2022 | 1 | 218 |
| 2023 | 3 | 200 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Jjgc Industria E Comercio DE Materiais Dentarios S.A.'s cleared 510(k)s took a median 189 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 188 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | 13 | 13 |
| NHA | Abutment, Implant, Dental, Endosseous | 8 | 8 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 7 | 7 |
Review panels
- Dental (21)
- General Hospital (7)
Most recent Jjgc Industria E Comercio DE Materiais Dentarios S.A. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K222026 | Neodent Implant System - Zirconia Implant System | NHA | 2023-07-14 | 368 |
| K223638 | Neodent Implant System - Helix Short Implant System | DZE | 2023-06-23 | 200 |
| K223662 | Neodent Implant System - Helix Short Surgical Kit Cases | KCT | 2023-04-20 | 135 |
| K220251 | Neodent Implant System - GM Narrow Implant System | DZE | 2022-09-06 | 218 |
| K210336 | Neodent Implant System - Zirconia Implant System | DZE | 2021-08-13 | 189 |
| K203542 | Neodent Implant System - Mini Abutment 60° | NHA | 2021-08-02 | 242 |
| K203382 | Neodent Implant System-Easy Pack | DZE | 2021-03-15 | 118 |
| K203618 | Neodent EasyGuide Kit Cases | KCT | 2021-03-09 | 88 |
| K202282 | Neodent Implant System - Zirconia Implant System | NHA | 2021-01-29 | 170 |
| K201491 | Neodent Implant System - Zirconia Implant System | DZE | 2020-12-22 | 201 |
18 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Jjgc Industria E Comercio DE Materiais Dentarios S.A..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Jjgc Industria E Comercio DE Materiais Dentarios S.A. have?
Jjgc Industria E Comercio DE Materiais Dentarios S.A. has 28 FDA 510(k) clearances (first 2016, latest 2023), across 3 product codes in 2 review panels.
How long does FDA take to clear Jjgc Industria E Comercio DE Materiais Dentarios S.A.'s 510(k)s?
The median time from FDA receipt to decision across Jjgc Industria E Comercio DE Materiais Dentarios S.A.'s cleared 510(k)s is 186 days. Since 2017: 189 days, versus 188 days for all cleared 510(k)s in the same product codes.
What devices does Jjgc Industria E Comercio DE Materiais Dentarios S.A. make?
Its most frequent FDA product codes are DZE (Implant, Endosseous, Root-Form, 13); NHA (Abutment, Implant, Dental, Endosseous, 8); KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories, 7).
Has Jjgc Industria E Comercio DE Materiais Dentarios S.A. had device recalls?
openFDA lists no recalls under a recalling firm name matching Jjgc Industria E Comercio DE Materiais Dentarios S.A. Related entities may recall under other names.
Next steps
- See all 28 Jjgc Industria E Comercio DE Materiais Dentarios S.A. clearances with predicates and recalls
- Run predicate analysis for product code DZE, Jjgc Industria E Comercio DE Materiais Dentarios S.A.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.