Cleared Abbreviated

K091424 - OSTA MAXIGRO AND REGIGRO

K091424 is an FDA 510(k) clearance for OSTA MAXIGRO AND REGIGRO, manufactured by Osta Technologies. The device is a Class 2 Dental device with product code NPM cleared through the Abbreviated 510(k) pathway after a 462-day FDA review.

K091424 · Osta Technologies · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2010
Decision
462d
Days
Class 2
Risk

K091424 is an FDA 510(k) clearance for the OSTA MAXIGRO AND REGIGRO. Classified as Bone Grafting Material, Animal Source (product code NPM), Class II - Special Controls.

Submitted by Osta Technologies (Roswell, US). The FDA issued a Cleared decision on August 18, 2010 after a review of 462 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Standards-verified equivalence. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Osta Technologies devices

FDA 510(k) Submission Details - K091424

510(k) Number K091424 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2009
Decision Date August 18, 2010
Days to Decision 462 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
335d slower than avg
Panel avg: 127d · This submission: 462d
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 K091424.
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