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Equimatrix

FDA 510(k)

Class II (US FDA 510(k))

510(k) K111816

by Luitpold Pharmaceuticals, Inc.

Identifiers

510(k) Number
K111816 FDA 510(k)
FDA Product Code
NPM 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)

Equimatrix is a bone grafting material of animal source. It is indicated for use in dental procedures.

This device is classified as a Class 2 medical device under regulation 872.3930. It received FDA 510(k) clearance on September 29, 2011, under K111816.

Frequently asked questions

What is the primary use of Equimatrix?

Equimatrix is a bone grafting material derived from an animal source that is specifically indicated for use in dental procedures.

What is the regulatory classification of this device?

Equimatrix is classified as a Class 2 medical device under regulation 872.3930. It received FDA 510(k) clearance on September 29, 2011, under the submission number K111816.

Who is the manufacturer of Equimatrix?

Equimatrix is manufactured by Luitpold Pharmaceuticals, Inc., located in Shirley, New York.

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: EQUIMATRIX 510 (k) K111816 - FDA.report, PDF One Luitpold Drive, P0 Box 9001SE29Q1 - Food and Drug Administration, LUITPOLD PHARMACEUTICALS, INC. FDA Filings - FDA.report, EQUIMATRIX (K111816) — FDA 510(k) | Innolitics, Luitpold Pharmaceuticals, Inc. Company Information - Drugs.com

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Luitpold Pharmaceuticals, Inc.

Sources (1)

  • FDA 510(k) K111816 24 fields · synced Sep 24, 2026