Neodent Implant System-Easy Pack— 510(k) K203382
Substantially EquivalentJjgc Industria E Comercio DE Materiais Dentarios S.A.
FDA 510(k) clearance K203382 for Neodent Implant System-Easy Pack, Substantially Equivalent on 2021-03-15. 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 K203382
K-number listed on FDA's recall record- Z-0512-2022 — Neodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 -intended for dental implant Item 138.089
- Z-0513-2022 — Neodent Easypack Helix GM Acqua 3.5X13/Smart 4.5X2.5 Article Number: 138.107
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K203382.
Data sourced from openFDA. This site is unofficial and independent of the FDA.