JJGC Industria e Comercio de Materiais Dentarios SA
Curitiba Parana, BR
JJGC Industria e Comercio de Materiais Dentarios SA appears in FDA device records in Curitiba Parana, BR. FDA records list 40 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to JJGC Industria e Comercio de Materiais Dentarios SA carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Jjgc Industria E Comercio De Materials Dentarios Saenforcement report, recall
510(k) clearance history
FDA records hold 40 510(k) clearances for JJGC Industria e Comercio de Materiais Dentarios SA between 2016 and 2026. The busiest year on record is 2019, with 8. The most recent is 2026, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2016 | 1 |
| 2017 | 2 |
| 2018 | 3 |
| 2019 | 8 |
| 2020 | 5 |
| 2021 | 6 |
| 2022 | 2 |
| 2023 | 6 |
| 2024 | 2 |
| 2025 | 2 |
| 2026 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K261147 | Neodent Implant System - NeoConvert Fit | NHA | Substantially Equivalent | |
| K253922 | Neodent Scannable Healing Abutment | NHA | Substantially Equivalent | |
| K252727 | Neodent InLab Validated Workflow | NHA | Substantially Equivalent | |
| K252090 | Pterygoid Indication for GM Helix Implants | DZE | Substantially Equivalent | |
| K250271 | Neodent Implant System - Zirconia Implant System | DZE | Substantially Equivalent | |
| K241492 | Guided Surgery Kit Cases | KCT | Substantially Equivalent | |
| K233857 | Neodent Implant System – Custom Abutments | NHA | Substantially Equivalent | |
| K231803 | Neodent Implant System - Zirconia Implant System | NHA | Substantially Equivalent | |
| K232099 | Neodent Implant System - GM Zygomatic Implant System | DZE | Substantially Equivalent | |
| K222026 | Neodent Implant System - Zirconia Implant System | NHA | Substantially Equivalent | |
| K230804 | Complement Kit Cases | KCT | Substantially Equivalent | |
| K223638 | Neodent Implant System - Helix Short Implant System | DZE | Substantially Equivalent | |
| K223662 | Neodent Implant System - Helix Short Surgical Kit Cases | KCT | Substantially Equivalent | |
| K220251 | Neodent Implant System - GM Narrow Implant System | DZE | Substantially Equivalent | |
| K214051 | Neodent Implant System-Helix NGM Compact Surgical Kit Cases | KCT | Substantially Equivalent | |
| K210336 | Neodent Implant System - Zirconia Implant System | DZE | Substantially Equivalent | |
| K203542 | Neodent Implant System - Mini Abutment 60° | NHA | Substantially Equivalent | |
| K203309 | NUVO CF Implant System | DZE | Substantially Equivalent | |
| K203382 | Neodent Implant System-Easy Pack | DZE | Substantially Equivalent | |
| K203618 | Neodent EasyGuide Kit Cases | KCT | Substantially Equivalent | |
| K202282 | Neodent Implant System - Zirconia Implant System | NHA | Substantially Equivalent | |
| K201491 | Neodent Implant System - Zirconia Implant System | DZE | Substantially Equivalent | |
| K202515 | NUVO Implant System – NUVO Instrument Kit Cases | KCT | Substantially Equivalent | |
| K201225 | Neodent Implant System - GM Helix Implants 7.0 | DZE | Substantially Equivalent | |
| K193234 | NUVO IF Implant System | DZE | Substantially Equivalent | |
| K193592 | Neodent Implant System - Change in the Shelf Life of Neodent Acqua Implants | DZE | Substantially Equivalent | |
| K190665 | Neodent Instrument Kit Cases | KCT | Substantially Equivalent | |
| K192229 | Neodent Implant System- GM Titanium Base for Bridge | NHA | Substantially Equivalent | |
| K192670 | Neodent Instrument Kit Cases | KCT | Substantially Equivalent | |
| K191191 | Neodent Implant System - Temporary Abutments | NHA | Substantially Equivalent | |
| K190958 | Neodent Implant System | DZE | Substantially Equivalent | |
| K190718 | Zygomatic Implants | DZE | Substantially Equivalent | |
| K182865 | Neodent Instruments Kits | KCT | Substantially Equivalent | |
| K182620 | MRI Compatibility for Existing Neodent Implant System | DZE | Substantially Equivalent | |
| K180536 | Neodent Implant System – GM Line | DZE | Substantially Equivalent | |
| K173902 | Neodent Implant System – GM Line | NHA | Substantially Equivalent | |
| K171713 | Neodent Instrument Kits | KCT | Substantially Equivalent | |
| K170080 | Neodent Implant System - CM Pro PEEK Abutment | NHA | Substantially Equivalent | |
| K163194 | Neodent Implant System - GM Line | DZE | Substantially Equivalent | |
| K160964 | Neodent Implant System - Titanium Base for CEREC | NHA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3008261720 | 3008261720 | JJGC Industria e Comercio de Materiais Dentarios SA | Avenida Juscelino Kubitschek de Olivera, 3291, Curitiba Parana 81270-200 BR | 2026 | and 11 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- NHAAbutment, Implant, Dental, Endosseous
- NDPAccessories, Implant, Dental, Endosseous
- EIFAccessories, Retractor, Dental
- NXCAligner, Sequential
- EGGAttachment, Precision, All
- LYSBone Mill
- EJLBur, Dental
- EMLChisel, Bone, Surgical
- EMMChisel, Osteotome, Surgical
- EMKCurette, Surgical, Dental
- PNPDental Abutment Design Software For Dental Laboratory
- DZADrill, Dental, Intraoral
- EJBHandle, Instrument, Dental
- OATImplant, Endosseous, Orthodontic
- DZEImplant, Endosseous, Root-Form
- QJJIndirect Bonding Tray
- DZNInstruments, Dental Hand
- KMYPositioner, Tooth, Preformed
- DZLScrew, Fixation, Intraosseous
- KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories
- FSMTray, Surgical, Instrument
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0203-2022 | GM Helix Acqua Implant 3.5x10, Article No. 140.944 | 3.5x11.5mm implants were mislabeled as 3.5x10mm implants. In borderline cases where the bone quality is low and the bone ridge has a maximum indication for the implant height (10mm), if the incorrect implant is installed, it could result in damage to the nerve or adjacent bone structures/cavities. | Class II | Terminated | |
| Z-0924-2020 | Neodent Tapered Guided Surgery Drill, Article No. 103.436. UDI 07899878030041. The device is a dental burr. | The laser engraving of the product incorrectly identifies the 4.3 Tapered Guided Surgery Drill as the "4.3+ Tapered Guided Surgery Drill". | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain