Cleared Special

K192042 - Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen, Geistlich Perio-System Combi-Pack, Geistlich Mucograft and Geistlich Mucograft Seal

K192042 is an FDA 510(k) clearance for Geistlich Bio-Gide, manufactured by Geistlich Pharma AG. The device is a Class 2 Dental device with product code NPL cleared through the Special 510(k) pathway after a 29-day FDA review.

K192042 · Geistlich Pharma AG · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2019
Decision
29d
Days
Class 2
Risk

K192042 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 August 29, 2019 after a review of 29 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K192042

510(k) Number K192042 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2019
Decision Date August 29, 2019
Days to Decision 29 days
Submission Type Special
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
99d faster than avg
Panel avg: 128d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

NPL Device Classification - Class 2, Special Controls

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 57
Devices cleared under the same product code (NPL) and FDA review panel - the closest regulatory comparables to K192042.
Striate+™
K201241 · Orthocell, Ltd. · Jan 2021
Kerecis Gingiva Graft
K192612 · Kerecis Limited · Nov 2020
OssGuide
K200623 · Sk Bioland Co., Ltd. · Oct 2020
Straumann Jason Membrane
K173562 · Institut Straumann AG · Jul 2018
Geistlich Fibro-Gide
K171050 · Geistlich Pharma AG · Nov 2017
Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed
K171643 · Geistlich Pharma AG · Oct 2017
K192042 · Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen, Geistlich Perio-System Combi-Pack, Geistlich Mucograft and Geistlich Mucograft Seal
Download PDF FDA Summary Geistlich Pharma AG