Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
JJGC Indústria e Comércio de Materiais Dentários S.A. · Predicate Candidate Screening
40 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
170 daysmedian FDA review time
283 days90th percentile
40clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261147 | Neodent Implant System - NeoConvert Fit | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2026-07-01 | 85 | 0 |
| K253922 | Neodent Scannable Healing Abutment | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2026-06-15 | 189 | 0 |
| K252727 | Neodent InLab Validated Workflow | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2026-01-07 | 132 | 0 |
| K252090 | Pterygoid Indication for GM Helix Implants | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2025-12-12 | 163 | 0 |
| K250271 | Neodent Implant System - Zirconia Implant System | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2025-08-18 | 200 | 0 |
| K241492 | Guided Surgery Kit Cases | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2024-08-23 | 87 | 0 |
| K233857 | Neodent Implant System – Custom Abutments | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2024-05-02 | 149 | 0 |
| K231803 | Neodent Implant System - Zirconia Implant System | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2023-12-13 | 176 | 0 |
| K232099 | Neodent Implant System - GM Zygomatic Implant System | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2023-10-31 | 110 | 0 |
| K222026 | Neodent Implant System - Zirconia Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2023-07-14 | 368 | 0 |
| K230804 | Complement Kit Cases | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2023-07-07 | 106 | 0 |
| K223638 | Neodent Implant System - Helix Short Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2023-06-23 | 200 | 0 |
| K223662 | Neodent Implant System - Helix Short Surgical Kit Cases | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2023-04-20 | 135 | 0 |
| K220251 | Neodent Implant System - GM Narrow Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2022-09-06 | 218 | 0 |
| K214051 | Neodent Implant System-Helix NGM Compact Surgical Kit Cases | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2022-04-13 | 107 | 0 |
| K210336 | Neodent Implant System - Zirconia Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2021-08-13 | 189 | 0 |
| K203542 | Neodent Implant System - Mini Abutment 60° | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2021-08-02 | 242 | 0 |
| K203309 | NUVO CF Implant System | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2021-07-06 | 238 | 0 |
| K203382 | Neodent Implant System-Easy Pack | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2021-03-15 | 118 | 0 |
| K203618 | Neodent EasyGuide Kit Cases | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2021-03-09 | 88 | 0 |
| K202282 | Neodent Implant System - Zirconia Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2021-01-29 | 170 | 0 |
| K201491 | Neodent Implant System - Zirconia Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2020-12-22 | 201 | 0 |
| K202515 | NUVO Implant System – NUVO Instrument Kit Cases | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2020-11-24 | 84 | 0 |
| K201225 | Neodent Implant System - GM Helix Implants 7.0 | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2020-09-04 | 121 | 0 |
| K193234 | NUVO IF Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2020-06-18 | 206 | 0 |
| K193592 | Neodent Implant System - Change in the Shelf Life of Neodent | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2020-04-28 | 127 | 0 |
| K190665 | Neodent Instrument Kit Cases | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2019-12-23 | 283 | 0 |
| K192229 | Neodent Implant System- GM Titanium Base for Bridge | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2019-12-19 | 125 | 0 |
| K192670 | Neodent Instrument Kit Cases | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2019-12-18 | 84 | 0 |
| K191191 | Neodent Implant System - Temporary Abutments | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2019-12-05 | 216 | 0 |
| K190958 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2019-11-09 | 211 | 0 |
| K190718 | Zygomatic Implants | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2019-07-11 | 113 | 0 |
| K182865 | Neodent Instruments Kits | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2019-05-07 | 208 | 0 |
| K182620 | MRI Compatibility for Existing Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2019-01-18 | 116 | 0 |
| K180536 | Neodent Implant System – GM Line | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2018-08-30 | 183 | 0 |
| K173902 | Neodent Implant System – GM Line | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2018-04-20 | 119 | 0 |
| K171713 | Neodent Instrument Kits | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2018-04-05 | 300 | 0 |
| K170080 | Neodent Implant System - CM Pro PEEK Abutment | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2017-11-02 | 296 | 0 |
| K163194 | Neodent Implant System - GM Line | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2017-07-14 | 241 | 3 |
| K160964 | Neodent Implant System - Titanium Base for CEREC | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2016-09-16 | 163 | 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