Cleared Traditional

K221808 - InterOss Collagen (FDA 510(k) Clearance)

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

K221808 · Sigmagraft, Inc. · Dental device
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Mar 2023
Decision
269d
Days
Class 2
Risk

K221808 is an FDA 510(k) clearance for the InterOss Collagen. Classified as Bone Grafting Material, Animal Source (product code NPM), Class II - Special Controls.

Submitted by Sigmagraft, Inc. (Fullerton, US). The FDA issued a Cleared decision on March 18, 2023 after a review of 269 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 Sigmagraft, Inc. devices

Submission Details

510(k) Number K221808 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2022
Decision Date March 18, 2023
Days to Decision 269 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
142d slower than avg
Panel avg: 127d · This submission: 269d
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 Consultant

Mtechgroup
Dave Kim

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K221808.
Geistlich Bio-Oss®
K251786 · Geistlich Pharma AG · Jul 2025
SwissGraft X
K251613 · Geistlich Pharma AG · Jun 2025
Geistlich Bio-Flow®
K242510 · Geistlich Pharma AG · Mar 2025
Xenograft Bovine Bone Particulate
K240133 · Collagen Solutions, LLC · Aug 2024
THE Graft Collagen
K230305 · Purgo Biologics, Inc. · Jul 2024
Geistlich Bio-Oss®
K240661 · Geistlich Pharma AG · Jul 2024