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Bio-Oss Ceramic

FDA 510(k)

Class II (US FDA 510(k))

510(k) K952619

by Geistlich-Pharma

Identifiers

510(k) Number
K952619 FDA 510(k)
FDA Product Code
LYC FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3930 FDA 510(k)
Regulation Number
872.3930 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Bio-Oss Ceramic is a synthetic bone grafting material used in dental procedures. It is designed to function as a bone substitute to support bone regeneration.

This device is authorized under FDA 510(k) clearance K952619. It is classified as a Class II medical device under regulation number 872.3930.

Frequently asked questions

What is the primary use of Bio-Oss Ceramic?

Bio-Oss Ceramic is a synthetic bone grafting material intended for use in dental procedures to function as a bone substitute and support bone regeneration.

How is this device regulated?

Bio-Oss Ceramic is classified as a Class II medical device under regulation number 872.3930 and is authorized for use under FDA 510(k) clearance K952619.

Who is the manufacturer of this bone graft material?

This device is manufactured by Geistlich-Pharma, which received FDA 510(k) clearance for the product in 1995.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K952619 FDA 510 (k) - BIO-OSS CERAMIC | Geistlich-Pharma, BIO-OSS CERAMIC (K952619) — FDA 510 (k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Geistlich-Pharma

Sources (1)

  • FDA 510(k) K952619 24 fields · synced Sep 21, 2026