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SIMDA Abutments

by Simda Co., Ltd.

510(k) K252320

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

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK252320 Date18 Dec 2025ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
NHA
Device Class
Class II
Regulation
21 CFR Part 872.3630
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

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

SIMDA Abutments are endosseous dental implant abutments used to support prosthetic restorations. The system includes Pre-Milled Blanks, Ti-Base abutments, Multi-unit Abutments, and Multi-unit Bases. Pre-Milled Blanks are patient-specific components designed by clinicians or labs and manufactured at a SIMDA-validated milling center.

SIMDA Abutments received FDA 510(k) clearance (K252320) on December 18, 2025, and are substantially equivalent to a predicate device. The device is supplied by Simda Co., Ltd., located in Busan, South Korea. It is intended for use in dental implant procedures to connect the implant to the prosthetic restoration.

Other devices from Simda Co., Ltd.

See all devices from Simda Co., Ltd. →

Questions

AI-generated answers, 6 Oct 2026

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

  • What are SIMDA Abutments used for?

    SIMDA Abutments are endosseous dental implant abutments used to support prosthetic restorations, connecting the implant to the prosthetic restoration in dental implant procedures.

  • What components are included in the SIMDA Abutments system?

    The SIMDA Abutments system includes Pre-Milled Blanks, Ti-Base abutments, Multi-unit Abutments, and Multi-unit Bases, with Pre-Milled Blanks being patient-specific components designed by clinicians or labs and manufactured at a SIMDA-validated milling center.

  • Who manufactures SIMDA Abutments and where are they located?

    SIMDA Abutments are supplied by Simda Co., Ltd., located at 233, Hakgam Dea-Ro, Sasang-Gu, Busan, South Korea, with postal code 46986.