Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Jjgc Industria E Comercio DE Materiais Dentarios S · Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
137 daysmedian FDA review time
231 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K153624 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2016-04-15 | 119 | 0 |
| K141777 | NEODENT IMPLANT SYSTEM | Jjgc Industria E Comercio DE Materiais Dentarios S | 2015-07-20 | 383 | 0 |
| K150367 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2015-07-13 | 151 | 0 |
| K150199 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2015-06-15 | 137 | 0 |
| K150182 | Neodent Implant System- CM Drive Implants | Jjgc Industria E Comercio DE Materiais Dentarios S | 2015-04-23 | 86 | 0 |
| K133696 | NEODENT IMPLANT SYSTEM | Jjgc Industria E Comercio DE Materiais Dentarios S | 2014-02-25 | 84 | 0 |
| K123022 | NEODENT IMPLANT SYSTEM | Jjgc Industria E Comercio DE Materiais Dentarios S | 2013-05-17 | 231 | 0 |
| K102769 | NEODENT IMPLANT FOR ORTHODONTIC ANCHORAGE | Jjgc Industria E Comercio DE Materiais Dentarios S | 2011-02-23 | 152 | 0 |
| K103084 | NEODENT GRAFT SCREW | Jjgc Industria E Comercio DE Materiais Dentarios S | 2011-02-14 | 118 | 0 |
| K101945 | NEODENT IMPLANT SYSTEM | Jjgc Industria E Comercio DE Materiais Dentarios S | 2011-01-26 | 198 | 0 |
| K101207 | NEODENT IMPLANT SYSTEM | Jjgc Industria E Comercio DE Materiais Dentarios S | 2010-08-02 | 94 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda