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ET IV SA Dental Implants

by Hiossen, Inc.

510(k) K183242

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK183242 Date21 May 2019ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
DZE
Device class
Class II
Regulation
21 CFR Part 872.3640
Advisory committee
Dental
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

ET IV SA Dental Implants are dental implants designed for use in sinus lift, soft bone, and immediate cases. The implants feature a 6° angled taper body design that provides strong initial stability in soft bone conditions.

The ET IV SA Dental Implants are supplied as part of the ET System and are intended for dental implant surgery. They are authorized under FDA 510K clearance with product code DZE and are manufactured by Hiossen, Inc.

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