Cleared Traditional

K090794 - OSTEOTAPE

K090794 is an FDA 510(k) clearance for OSTEOTAPE, manufactured by Impladent , Ltd.. The device is a Class 2 Dental device with product code NPM cleared through the Traditional 510(k) pathway after a 261-day FDA review.

K090794 · Impladent , Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2009
Decision
261d
Days
Class 2
Risk

K090794 is an FDA 510(k) clearance for the OSTEOTAPE. Classified as Bone Grafting Material, Animal Source (product code NPM), Class II - Special Controls.

Submitted by Impladent , Ltd. (Hollis, US). The FDA issued a Cleared decision on December 10, 2009 after a review of 261 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3930 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Impladent , Ltd. devices

FDA 510(k) Submission Details - K090794

510(k) Number K090794 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 2009
Decision Date December 10, 2009
Days to Decision 261 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
134d slower than avg
Panel avg: 127d · This submission: 261d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K090794.
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