DeviceClearance

ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments— 510(k) K253372

Substantially Equivalent

Hiossen, Inc.

FDA 510(k) clearance K253372 for ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments, Substantially Equivalent on 2026-05-14. Applicant: Hiossen, Inc.. Device class: 2.

Summary

Hiossen's record covers three abutment names: ET Healing Abutments, ET Scan Healing Abutments and EK Scan Healing Abutments. The product code is NHA, endosseous dental implant abutments.

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 spells the city Fariless Hills, Pennsylvania. The decision came 226 calendar days after receipt (September 30, 2025 to May 14, 2026).

Clearance details

Applicant
Hiossen, Inc.
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
Fariless Hills, PA, US
Download summary PDFView on FDA.gov ↗

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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.