Neodent Implant System - Titanium Base for CEREC— 510(k) K160964
Substantially EquivalentJjgc Industria E Comercio DE Materiais Dentarios S.A.
FDA 510(k) clearance K160964 for Neodent Implant System - Titanium Base for CEREC, Substantially Equivalent on 2016-09-16. 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 NHA
- Device class
- Class 2
- Regulation
- 21 CFR 872.3630
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Curitiba, BR
Recent devices under product code NHA
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 NHA
product code NHA- Injury
- 1,270
- Malfunction
- 2,860
- Total
- 4,130
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.