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SIMDA Abutment

by Simda Co., Ltd. 2 variants

510(k) K223663

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 NumberK223663 Date24 May 2023ClearedStatusActive

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  • Withdrawn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, 19 Sep 2026

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

The SIMDA Abutment is a dental implant abutment designed for use in endosseous dental implant systems. It serves as a critical connector between the implant fixture placed in the jawbone and the prosthetic crown or restoration, ensuring proper alignment and stability for long-term functionality.

This abutment is supplied as a reusable component for dental professionals and is classified under the NHA product code, indicating its role in dental implant prosthetic components. It is intended for use in clinical settings where dental implants are placed and restored, adhering to FDA 510(k) clearance standards for dental implant abutments. No specific sterility or MRI safety information is provided in the available data.

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Questions

AI-generated answers, 19 Sep 2026

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

  • What is the primary purpose of the SIMDA Abutment in dental implant procedures?

    The SIMDA Abutment acts as a crucial connector between the dental implant fixture embedded in the jawbone and the final prosthetic crown or restoration. Its design ensures proper alignment and stability, which are essential for the long-term success and functionality of the implant system.

  • Is the SIMDA Abutment intended for single-use or can it be reused in multiple procedures?

    The SIMDA Abutment is explicitly described as a reusable component for dental professionals. This means it can be used in multiple procedures after proper cleaning and sterilization, making it cost-effective for clinical settings.

  • How is the SIMDA Abutment classified under regulatory standards, and what does that mean for its use?

    The SIMDA Abutment is classified under the NHA product code, which categorizes it as a dental implant prosthetic component. It has received FDA 510(k) clearance with a decision of *Substantially Equivalent* under the *Dental* advisory committee (DE), meaning it meets regulatory requirements for safety and effectiveness as a dental abutment.

  • Does the SIMDA Abutment come with any specific sterility guarantees or MRI safety information?

    The available data does not provide explicit details about sterility guarantees or MRI safety for the SIMDA Abutment. Clinicians should follow standard sterilization protocols for reusable dental components and verify compatibility with MRI systems if needed, as this information is not specified in the provided documentation.