Cleared Traditional

K212463 - Geistlich Bio-Gide

K212463 is the FDA 510(k) clearance for Geistlich Bio-Gide by Geistlich Pharma AG. It is a Class 2 Dental device (product code NPL) cleared through the Traditional 510(k) pathway after a 242-day FDA review.

K212463 · Geistlich Pharma AG · Dental device
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Optimized for regulatory review, auditing and printing
Apr 2022
Decision
242d
Days
Class 2
Risk

K212463 is an FDA 510(k) clearance for the Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, .... Classified as Barrier, Animal Source, Intraoral (product code NPL), Class II - Special Controls.

Submitted by Geistlich Pharma AG (Wolhusen, CH). The FDA issued a Cleared decision on April 5, 2022 after a review of 242 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 Geistlich Pharma AG devices

Submission Details

510(k) Number K212463 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2021
Decision Date April 05, 2022
Days to Decision 242 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
115d slower than avg
Panel avg: 127d · This submission: 242d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NPL Barrier, Animal Source, Intraoral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3930
Definition An Animal Source Dental Barrier Is An Animal-derived Material Device, Such As Collagen, Intended To Aid In Guided Tissue/bone Regeneration Procedures And To Act As A Stable Barrier For The Containment Of Bone Graft Materials When Placed Around Implants.
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

Telos Partners, LLC
Roshana Ahmed

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 - NPL Barrier, Animal Source, Intraoral

All 27
Devices cleared under the same product code (NPL) and FDA review panel - the closest regulatory comparables to K212463.
InterCollagen® Guide
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OSSIX Breeze
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K210280 · Geistlich Pharma AG · Mar 2021
Striate+™
K201241 · Orthocell, Ltd. · Jan 2021
Kerecis Gingiva Graft
K192612 · Kerecis Limited · Nov 2020