Cleared Traditional

K033815 - BIO-OSS, BIO-OSS BLOCKS AND BIO-OSS COLLAGEN (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K033815 · Geistlich-Pharma · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2004
Decision
37d
Days
Class 2
Risk

K033815 is an FDA 510(k) clearance for the BIO-OSS, BIO-OSS BLOCKS AND BIO-OSS COLLAGEN. Classified as Bone Grafting Material, Animal Source (product code NPM), Class II - Special Controls.

Submitted by Geistlich-Pharma (Washington, US). The FDA issued a Cleared decision on January 15, 2004 after a review of 37 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Geistlich-Pharma devices

Submission Details

510(k) Number K033815 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 2003
Decision Date January 15, 2004
Days to Decision 37 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
90d faster than avg
Panel avg: 127d · This submission: 37d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 38
Devices cleared under the same product code (NPM) and FDA review panel - the closest regulatory comparables to K033815.
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