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Osteograf/Ar+ Alveolar Rid Hydrox 18-40 Mesh

by Coors Biomedical Co.

510(k) K861083

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 NumberK861083 Date30 Apr 1986ClearedStatusActive

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  • Withdrawn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)

Full name
Osteograf/Ar+(Plus) Alveolar Rid Hydrox 18-40 Mesh
510(k) Number
FDA Product Code
LYC
Device Class
Class II
Regulation
21 CFR Part 872.3930
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 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 Osteograf/Ar+ Alveolar Rid Hydrox 18-40 Mesh is a synthetic bone grafting material used for dental applications. It is composed of hydroxyapatite with a particle size of 18-40 mesh, designed to be placed in alveolar ridges to support bone regeneration.

This device is supplied as a sterile, single-use product and should be stored according to the manufacturer's instructions. It received FDA 510(k) clearance with K number K861083 on April 30, 1986, and is classified under product code LYC for dental use.

Other devices from Coors Biomedical Co.

Questions

AI-generated answers, 26 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 Osteograf/Ar+ Alveolar Rid Hydrox 18-40 Mesh used for?

    This synthetic bone grafting material is specifically designed for dental applications, particularly for placement in alveolar ridges to support bone regeneration procedures. It consists of hydroxyapatite particles sized at 18-40 mesh.

  • How is the Osteograf/Ar+ Alveolar Rid Hydrox supplied and what is its sterility status?

    The device is supplied as a sterile, single-use product. It should be stored according to the manufacturer's instructions to maintain its integrity and sterility until use.

  • What regulatory clearance does this bone grafting material have?

    The Osteograf/Ar+ Alveolar Rid Hydrox 18-40 Mesh received FDA 510(k) clearance with K number K861083 on April 30, 1986. It is classified under product code LYC for dental use.

  • What are the specifications of this bone grafting material?

    This synthetic bone graft is composed of hydroxyapatite with a particle size of 18-40 mesh. It is designed specifically for dental applications to support bone regeneration in alveolar ridges.