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Perioglas Bioglass Bone Graft Particulate

by Usbiomaterials Corp.

510(k) K992416

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 NumberK992416 Date15 Oct 1999ClearedStatusActive

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  • Withdrawn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
LYC
Device Class
Class II
Regulation
21 CFR Part 872.3930
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

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

Perioglas Bioglass Bone Graft Particulate is a synthetic, absorbable, osteoconductive bone graft substitute composed of a calcium phospho‑silicate bioactive glass (Bioglass®). It is provided in a particulate form with particle sizes ranging from 90 µm to 710 µm and is classified as a bone grafting material for dental, intra‑osseous, oral, and cranio‑maxillofacial bony defects.

The product is supplied sterile in a Tyvek‑sealed PET‑G cup and is intended for single‑use application in the indicated dental and maxillofacial procedures. It received FDA 510(k) clearance (K992416) as a Class II device under the traditional clearance pathway.

Other devices from Usbiomaterials Corp.

Questions

AI-generated answers, 22 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 Perioglas Bioglass Bone Graft Particulate used for?

    Perioglas Bioglass Bone Graft Particulate is a synthetic, absorbable, osteoconductive bone graft substitute designed for use in dental, intra-osseous, oral, and cranio-maxillofacial bony defects to promote bone regeneration.

  • How is Perioglas Bioglass Bone Graft Particulate supplied and is it sterile?

    The product is supplied sterile in a Tyvek-sealed PET-G cup and is intended for single-use application in the indicated dental and maxillofacial procedures to ensure patient safety and prevent contamination.

  • What are the particle sizes available for Perioglas Bioglass Bone Graft Particulate?

    Perioglas Bioglass Bone Graft Particulate is provided in a particulate form with particle sizes ranging from 90µm to 710µm, allowing for versatility in different surgical applications and defect sizes.

  • What is the regulatory status of Perioglas Bioglass Bone Graft Particulate?

    Perioglas Bioglass Bone Graft Particulate received FDA 510(k) clearance (K992416) as a Class II device under the traditional clearance pathway for use as a bone grafting material in dental and maxillofacial procedures.