Guidor Bioresorbable Matrix Barrier

FDA 510(k)

Class II (US FDA 510(k))

510(k) K132325

Identifiers

510(k) Number: K132325 FDA 510(k)
FDA Product Code: NPK FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 872.3930 FDA 510(k)
Regulation Number: 872.3930 FDA 510(k)
Advisory Committee: Dental FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

This device is a synthetic intraoral barrier. It is a bioresorbable matrix barrier intended for use in dental applications.

It is supplied as a sterile, single-use device. The device is classified as Class II and has received FDA 510(k) clearance under product code NPK and regulation number 872.3930.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K132325	Class II	Active

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Manufacturer

Manufacturer: Sunstar Americas, Inc.

Sources (1)

FDA 510(k) K132325 24 fields · synced Sep 21, 2026