Neodent Implant System - GM Line— 510(k) K163194
Substantially EquivalentJjgc Industria E Comercio DE Materiais Dentarios S.A.
FDA 510(k) clearance K163194 for Neodent Implant System - GM Line, Substantially Equivalent on 2017-07-14. Applicant: Jjgc Industria E Comercio DE Materiais Dentarios S.A.. Device class: 2.
Clearance details
- Applicant
- Jjgc Industria E Comercio DE Materiais Dentarios S.A.
- Product code
- Code DZE
- Device class
- Class 2
- Regulation
- 21 CFR 872.3640
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Curitiba, BR
Recent devices under product code DZE
view allMore clearances from Jjgc Industria E Comercio DE Materiais Dentarios S.A.
view all- K222026 — Neodent Implant System - Zirconia Implant System
- K223638 — Neodent Implant System - Helix Short Implant System
- K223662 — Neodent Implant System - Helix Short Surgical Kit Cases
- K220251 — Neodent Implant System - GM Narrow Implant System
- K210336 — Neodent Implant System - Zirconia Implant System
Adverse events under product code DZE
product code DZE- Death
- 28
- Injury
- 3,367,041
- Malfunction
- 19,958
- Other
- 13
- Total
- 3,387,040
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K163194
K-number listed on FDA's recall record- Z-2929-2026 — GM Helix Implant, Endosseous Dental Implant Article No. 109.984
- Z-1862-2025 — GM Helix Acqua Implant, Article Number: 140.984
- Z-1863-2025 — GM Helix Acqua Implant, Article Number: 140.985
- Z-0203-2022 — GM Helix Acqua Implant 3.5x10, Article No. 140.944
- Z-0455-2019 — Neodent¿ GM Mini Conical Abutment - Product Usage: Mini Conical Abutments are intermediary prosthetic components to be installed onto GM implants to support the final prosthesis. They are provided in a rotational shape for the coupling with the prosthesis and in different gingival heights to match the variations in mucosal thickness. The GM Exact Mini Conical abutment is provided angled. They are indicated for screw-retained multiple-unit prostheses onto implants Article Number: 115244
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K163194.
Data sourced from openFDA. This site is unofficial and independent of the FDA.