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GUIDOSS

FDA 510(k)

Class II (US FDA 510(k))

510(k) K133507

by Nibec Co., Ltd.

Identifiers

510(k) Number
K133507 FDA 510(k)
FDA Product Code
NPL 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)

GUIDOSS is a barrier device of animal source intended for intraoral use. It is classified as a Class II medical device under FDA regulation number 872.3930 and product code NPL.

The device received FDA 510(k) clearance (K133507) on November 5, 2014, following a traditional submission process. It is manufactured by Nibec Co., Ltd. and is supplied in versions such as GDS 1-3025 and GDS 2-3025, with one specified size of 30mm X 25mm.

Frequently asked questions

What is the GUIDOSS device used for?

GUIDOSS is a barrier device made from animal source material intended for intraoral use, designed to provide a protective barrier during dental procedures as indicated by its classification under FDA regulation 872.3930 and product code NPL.

How is the GUIDOSS device supplied and what sizes are available?

GUIDOSS is supplied in specific versions including GDS 1-3025 and GDS 2-3025, with one specified size of 30mm X 25mm, as noted in the device description under specifications.

Is the GUIDOSS device sterile and intended for single use or reuse?

The device data does not specify sterility or single-use/reuse status; therefore, no claim can be made about its sterility or reusability based solely on the provided information.

What regulatory pathway was used for GUIDOSS FDA clearance?

GUIDOSS received FDA 510(k) clearance through a traditional submission process, as indicated by the clearance_type field stating 'Traditional' and the K-number K133507 with decision date November 5, 2014.

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. Sources consulted: GuidOss - BEUDAMED, Nibec Co., Ltd. GDS 2-3025 GuidOss - RevMed

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Nibec Co., Ltd.

Sources (1)

  • FDA 510(k) K133507 24 fields · synced Sep 22, 2026