Cleared Abbreviated

K111816 - EQUIMATRIX

K111816 is an FDA 510(k) clearance for EQUIMATRIX, manufactured by Luitpold Pharmaceuticals, Inc.. The device is a Class 2 Dental device with product code NPM cleared through the Abbreviated 510(k) pathway after a 94-day FDA review.

K111816 · Luitpold Pharmaceuticals, Inc. · Dental device
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Sep 2011
Decision
94d
Days
Class 2
Risk

K111816 is an FDA 510(k) clearance for the EQUIMATRIX. Classified as Bone Grafting Material, Animal Source (product code NPM), Class II - Special Controls.

Submitted by Luitpold Pharmaceuticals, Inc. (Shirley, US). The FDA issued a Cleared decision on September 29, 2011 after a review of 94 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3930 - the FDA dental device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Luitpold Pharmaceuticals, Inc. devices

FDA 510(k) Submission Details - K111816

510(k) Number K111816 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2011
Decision Date September 29, 2011
Days to Decision 94 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 127d · This submission: 94d
Pathway characteristics
Standards-based clearance path.

NPM Device Classification - Class 2, Special Controls

Product Code NPM Bone Grafting Material, Animal Source
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3930
Definition A Animal-source Bone Grafting Material Is A Naturally-derived Device, Such As Collagen, Intended To Fill, Augment, Or Reconstruct Periodontal Defects And Or Bony Defects Of The Upper Or Lower Jaw.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - NPM Bone Grafting Material, Animal Source

All 27
Devices cleared under the same product code (NPM) and FDA review panel - the closest regulatory comparables to K111816.
GEISTLICH BIO-OSS PEN (0.25 G, 0.25-1.0MM GRANULES), GEISTLICH BIO-OSS PEN (0.5 G, 0.25-1.0MM GRANULES), GEISTLICH BIO-O
K120601 · Geistlich Pharma AG · May 2012
GEISTLICH COMBI-KIT COLLEGEN
K112572 · Geistlich Pharma AG · Dec 2011
GEISTLICH PERIO-SYSTEM COMBI-PACK , GEISTLICH BIO-GIDE PERIO
K112575 · Geistlich Pharma AG · Dec 2011
OSTEOGUIDE ANORGANIC BONE MINERAL PRODUCTS
K043034 · Collagen Matrix, Inc. · Aug 2005
BIO-OSS, BIO-OSS BLOCKS AND BIO-OSS COLLAGEN
K033815 · Geistlich-Pharma · Jan 2004