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Sendax MDI (Mini Dental Implant)

by Sendax Mdic Management, Inc.

510(k) K972351

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 NumberK972351 Date24 Nov 1997ClearedStatusActive

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  • Withdrawn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
DZE
Device Class
Class II
Regulation
21 CFR Part 872.3640
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 Sendax MDI (Mini Dental Implant) is a dental implant. It is substantially equivalent and has a product code of DZE.

The Sendax MDI is supplied by Sendax Mdic Management, Inc. and has been given an FDA 510K authorization. The device has a k number of K972351 and is reviewed by the Dental advisory committee.

Questions

AI-generated answers, 23 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 Sendax MDI used for?

    The Sendax MDI is used for dental applications as a mini dental implant.

  • Is the Sendax MDI supplied sterile?

    The description does not specify if the Sendax MDI is supplied sterile, it is recommended to check the packaging or manufacturer's instructions.

  • What is the regulatory status of the Sendax MDI?

    The Sendax MDI has been given an FDA 510K authorization, with a k number of K972351, and is reviewed by the Dental advisory committee.

  • Who is the manufacturer of the Sendax MDI?

    The Sendax MDI is manufactured by Sendax Mdic Management, Inc.