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W Zirconia Implants

by Tav Medical, Ltd. 2 variants

510(k) K192053

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 NumberK192053 Date29 Oct 2019ClearedStatusActive

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  • Withdrawn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
FDA applicant
Tav Medical , Ltd.
Device Class
Class II
Regulation
21 CFR Part 872.3640
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 W Zirconia Implants are dental implants classified under the product code DZE, designed for osseointegration in the oral cavity. These implants are manufactured from zirconia, a ceramic material known for its biocompatibility, mechanical strength, and resistance to plaque accumulation, making them suitable for single-tooth or multi-tooth replacement procedures.

These implants are supplied as single-use, sterile devices intended for surgical placement by dental professionals. They are regulated under the FDA’s 510(k) clearance (K192053) and are manufactured using Ceramic Injection Molding (CIM) technology. Storage and handling must comply with dental implant protocols to maintain sterility and integrity prior to use.

Other devices from Tav Medical, Ltd.

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 types of dental procedures are these zirconia implants designed for, and why is zirconia preferred in these cases?

    The W Zirconia Implants by Tav Medical are specifically designed for osseointegration in the oral cavity, suitable for replacing single-tooth or multi-tooth restorations. Zirconia is preferred because it offers excellent biocompatibility, high mechanical strength, and resistance to plaque buildup, reducing the risk of peri-implant disease and improving long-term success rates.

  • Are these implants single-use or reusable, and how should they be stored to maintain sterility?

    The W Zirconia Implants are single-use devices, intended for one-time surgical placement only. To preserve sterility and integrity before use, they must be stored according to standard dental implant protocols—typically in a sealed, sterile packaging until the moment of surgery, away from direct sunlight or extreme temperatures.

  • How are these implants manufactured, and what does that process imply about their quality and precision?

    These implants are produced using Ceramic Injection Molding (CIM) technology, a method known for achieving high precision and consistent quality in ceramic components. This process ensures tight tolerances and uniform structural integrity, which are critical for proper osseointegration and long-term stability in dental applications.

  • What regulatory pathway did these implants follow to gain market authorization, and what does that mean for clinicians?

    The W Zirconia Implants received FDA clearance through a 510(k) submission (K192053), classified as substantially equivalent to a predicate device under product code DZE. This means the FDA determined they meet the same performance standards as existing dental implants, providing clinicians with confidence in their safety and effectiveness for osseointegration procedures.