JJGC Indústria e Comércio de Materiais Dentários S.A.: FDA clearances and approvals
JJGC Indústria e Comércio de Materiais Dentários S.A. has 12 FDA 510(k) clearances (first 2021, latest 2026), across 3 product codes in 2 review panels. Median 510(k) review time: 140 days. Since 2017 its median was 140 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 |
|---|---|---|
| 2021 | 1 | 238 |
| 2022 | 1 | 107 |
| 2023 | 3 | 110 |
| 2024 | 2 | 118 |
| 2025 | 2 | 182 |
| 2026 | 3 | 132 |
Review time against the same product codes
Since 2017, JJGC Indústria e Comércio de Materiais Dentários S.A.'s cleared 510(k)s took a median 140 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 |
|---|---|---|---|
| NHA | Abutment, Implant, Dental, Endosseous | 5 | 5 |
| DZE | Implant, Endosseous, Root-Form | 4 | 4 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 3 | 3 |
Review panels
- Dental (9)
- General Hospital (3)
Most recent JJGC Indústria e Comércio de Materiais Dentários S.A. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261147 | Neodent Implant System - NeoConvert Fit | NHA | 2026-07-01 | 85 |
| K253922 | Neodent Scannable Healing Abutment | NHA | 2026-06-15 | 189 |
| K252727 | Neodent InLab Validated Workflow | NHA | 2026-01-07 | 132 |
| K252090 | Pterygoid Indication for GM Helix Implants | DZE | 2025-12-12 | 163 |
| K250271 | Neodent Implant System - Zirconia Implant System | DZE | 2025-08-18 | 200 |
| K241492 | Guided Surgery Kit Cases | KCT | 2024-08-23 | 87 |
| K233857 | Neodent Implant System Custom Abutments | NHA | 2024-05-02 | 149 |
| K231803 | Neodent Implant System - Zirconia Implant System | NHA | 2023-12-13 | 176 |
| K232099 | Neodent Implant System - GM Zygomatic Implant System | DZE | 2023-10-31 | 110 |
| K230804 | Complement Kit Cases | KCT | 2023-07-07 | 106 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named JJGC Indústria e Comércio de Materiais Dentários 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 Indústria e Comércio de Materiais Dentários S.A. have?
JJGC Indústria e Comércio de Materiais Dentários S.A. has 12 FDA 510(k) clearances (first 2021, latest 2026), across 3 product codes in 2 review panels.
How long does FDA take to clear JJGC Indústria e Comércio de Materiais Dentários S.A.'s 510(k)s?
The median time from FDA receipt to decision across JJGC Indústria e Comércio de Materiais Dentários S.A.'s cleared 510(k)s is 140 days. Since 2017: 140 days, versus 188 days for all cleared 510(k)s in the same product codes.
What devices does JJGC Indústria e Comércio de Materiais Dentários S.A. make?
Its most frequent FDA product codes are NHA (Abutment, Implant, Dental, Endosseous, 5); DZE (Implant, Endosseous, Root-Form, 4); KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories, 3).
Has JJGC Indústria e Comércio de Materiais Dentários S.A. had device recalls?
openFDA lists no recalls under a recalling firm name matching JJGC Indústria e Comércio de Materiais Dentários S.A. Related entities may recall under other names.
Next steps
- See all 12 JJGC Indústria e Comércio de Materiais Dentários S.A. clearances with predicates and recalls
- Run predicate analysis for product code NHA, JJGC Indústria e Comércio de Materiais Dentários 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.