Neodent Scannable Healing Abutment— 510(k) K253922
Substantially EquivalentJJGC Indústria e Comércio de Materiais Dentários S.A.
FDA 510(k) clearance K253922 for Neodent Scannable Healing Abutment, Substantially Equivalent on 2026-06-15. Applicant: JJGC Indústria e Comércio de Materiais Dentários S.A.. Device class: 2.
Summary
The Neodent Scannable Healing Abutment is from JJGC Indústria e Comércio de Materiais Dentários S.A. and is filed under NHA, endosseous dental implant abutments. The record gives no sizes or model numbers.
Class II, 21 CFR 872.3630. Dental is both the classification panel and the review panel, and it came in as a Traditional 510(k).
The record gives the applicant's location as Curitiba, PR, US. The decision came 189 calendar days after receipt (December 8, 2025 to June 15, 2026).
Clearance details
- Applicant
- JJGC Indústria e Comércio de Materiais Dentários S.A.
- Product code
- Product 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, PR, US
Recent devices under product code NHA
view allMore clearances from JJGC Indústria e Comércio de Materiais Dentários S.A.
view allAdverse 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.