Cleared Abbreviated

K132325 - GUIDOR BIORESORBABLE MATRIX BARRIER (FDA 510(k) Clearance)

Class II Dental device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K132325 · Sunstar Americas, Inc. · Dental device
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Oct 2013
Decision
95d
Days
Class 2
Risk

K132325 is an FDA 510(k) clearance for the GUIDOR BIORESORBABLE MATRIX BARRIER. Classified as Barrier, Synthetic, Intraoral (product code NPK), Class II - Special Controls.

Submitted by Sunstar Americas, Inc. (New York, US). The FDA issued a Cleared decision on October 29, 2013 after a review of 95 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3930 - the FDA dental device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Sunstar Americas, Inc. devices

Submission Details

510(k) Number K132325 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 2013
Decision Date October 29, 2013
Days to Decision 95 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 127d · This submission: 95d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code NPK Barrier, Synthetic, Intraoral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3930
Definition A Synthetic Dental Barrier Is A Synthetic Material Device, Such As Ptfe, Intended To Aid In Guided Tissue And/or Bone Regeneration Procedures And To Act As A Stable Barrier For The Containment Of Bone Graft Materials.
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 - NPK Barrier, Synthetic, Intraoral

All 30
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