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Implant Integration Systems Drills And Taps

by Implant Integration Systems, Inc.

510(k) K962394

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 NumberK962394 Date11 Oct 1996ClearedStatusActive

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  • Withdrawn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, 24 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 Implant Integration Systems Drills And Taps are dental drills and taps. They are used in the placement of dental implants.

The device is supplied in various sizes and is intended for single-use. It is classified as a class 2 device and has received FDA 510(k) clearance, with a decision of Substantially Equivalent. The device is stored at the manufacturer's address in Paradise, CA.

Other devices from Implant Integration Systems, Inc.

Questions

AI-generated answers, 24 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 are the Implant Integration Systems Drills And Taps used for?

    The Implant Integration Systems Drills And Taps are used in the placement of dental implants, providing a precise and efficient way to prepare the site for implantation.

  • How are the drills and taps supplied?

    The device is supplied in various sizes and is intended for single-use, reducing the risk of cross-contamination and ensuring a sterile procedure.

  • What is the storage requirement for the device?

    The device is stored at the manufacturer's address in Paradise, CA, ensuring that it is kept in a controlled environment until it is shipped to the end-user.

  • What regulatory clearance has the device received?

    The device has received FDA 510(k) clearance, with a decision of Substantially Equivalent, indicating that it is safe and effective for its intended use.