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Alveograf Durapatite (18-40 Mesh)

by Sterling Drug, Inc.

510(k) K813257

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 NumberK813257 Date5 Jan 1982ClearedStatusActive

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  • Withdrawn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, 25 Sep 2026

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

Alveograf Durapatite (18-40 Mesh) is an endosseous root-form implant device. It is classified under the dental specialty and is substantially equivalent to a predicate device as determined by FDA 510(k) clearance.

The device is supplied in a non-sterile, reusable format and is intended for use in dental implant procedures. It is manufactured by Sterling Drug, Inc., and its authorization is based on FDA 510(k) K813257 with product code DZE, classified as a Class II medical device under regulation 872.3640.

Other devices from Sterling Drug, Inc.

See all devices from Sterling Drug, Inc. →

Questions

AI-generated answers, 25 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 Alveograf Durapatite (18-40 Mesh) used for?

    It is an endosseous root-form implant device intended for use in dental implant procedures, as indicated by its classification under the dental specialty and its substantial equivalence to a predicate device.

  • Is the Alveograf Durapatite (18-40 Mesh) sterile or non-sterile, and is it single-use or reusable?

    The device is supplied in a non-sterile, reusable format, meaning it must be sterilized by the user prior to each use and can be reused after proper reprocessing.

  • How is the Alveograf Durapatite (18-40 Mesh) supplied and identified?

    It is manufactured by Sterling Drug, Inc., supplied as a non-sterile reusable implant, and identified by the model name ALVEOGRAF DURAPATITE(18-40 MESH) with FDA 510(k) number K813257 and product code DZE.