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Dia Healing Cap

by Dental Imaging Assoc., Inc. 510(k)

Active United States

510(k) K902434

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK902434 Date27 Feb 1991ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

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 Dia Healing Cap is a dental device designed for use in implantology and dentistry. It functions as a component to support the healing process following the placement of a dental implant.

This device is supplied by Dental Imaging Assoc., Inc. and has received FDA 510(k) clearance. It is available in various configurations, including options with a 3mm height and internal hex design.

Other devices from Dental Imaging Assoc., Inc.

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 primary function of the Dia Healing Cap?

    The Dia Healing Cap is designed for use in implantology to support the healing process following the placement of a dental implant.

  • What configurations are available for this device?

    The device is available in various configurations to suit clinical needs, including options featuring a 3mm height and an internal hex design.

  • What is the regulatory status of the Dia Healing Cap?

    The Dia Healing Cap has received FDA 510(k) clearance, which indicates that the device has been found to be substantially equivalent to legally marketed predicate devices.