Jjgc Industria E Comercio DE Materiais Dentarios S: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Jjgc Industria E Comercio DE Materiais Dentarios S” (first 2010, latest 2016), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 137 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Straumann Group, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 231 |
| 2014 | 1 | 84 |
| 2015 | 4 | 144 |
| 2016 | 1 | 119 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | 6 | 6 |
| NHA | Abutment, Implant, Dental, Endosseous | 3 | 3 |
| DZL | Screw, Fixation, Intraosseous | 1 | 1 |
| OAT | Implant, Endosseous, Orthodontic | 1 | 1 |
Review panels
- Dental (11)
Most recent Jjgc Industria E Comercio DE Materiais Dentarios S 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K153624 | Neodent Implant System | NHA | 2016-04-15 | 119 |
| K141777 | NEODENT IMPLANT SYSTEM | DZE | 2015-07-20 | 383 |
| K150367 | Neodent Implant System | NHA | 2015-07-13 | 151 |
| K150199 | Neodent Implant System | DZE | 2015-06-15 | 137 |
| K150182 | Neodent Implant System- CM Drive Implants | DZE | 2015-04-23 | 86 |
| K133696 | NEODENT IMPLANT SYSTEM | NHA | 2014-02-25 | 84 |
| K123022 | NEODENT IMPLANT SYSTEM | DZE | 2013-05-17 | 231 |
| K102769 | NEODENT IMPLANT FOR ORTHODONTIC ANCHORAGE | OAT | 2011-02-23 | 152 |
| K103084 | NEODENT GRAFT SCREW | DZL | 2011-02-14 | 118 |
| K101945 | NEODENT IMPLANT SYSTEM | DZE | 2011-01-26 | 198 |
1 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.
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.
- Jjgc Industria E Comercio DE Materiais Dentarios S.A. (28 510(k)s)
- JJGC Indústria e Comércio de Materiais Dentários S.A. (12 510(k)s)
- Jjgc Indústria E Comércia DE Materiais Dentários S.A. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Jjgc Industria E Comercio DE Materiais Dentarios S?
FDA lists 11 510(k) clearances under the applicant name “Jjgc Industria E Comercio DE Materiais Dentarios S” (first 2010, latest 2016), across 4 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 Jjgc Industria E Comercio DE Materiais Dentarios S?
The median time from FDA receipt to decision across 510(k)s cleared under the name Jjgc Industria E Comercio DE Materiais Dentarios S is 137 days.
Which FDA product codes appear under Jjgc Industria E Comercio DE Materiais Dentarios S?
The most frequent FDA product codes under this applicant name are DZE (Implant, Endosseous, Root-Form, 6); NHA (Abutment, Implant, Dental, Endosseous, 3); DZL (Screw, Fixation, Intraosseous, 1).
Next steps
- See all 11 Jjgc Industria E Comercio DE Materiais Dentarios S clearances with predicates and recalls
- Run predicate analysis for product code DZE, Jjgc Industria E Comercio DE Materiais Dentarios S'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.