FDA 510(k)

ORAL BOND

K-Number: K142130 · 2016-06-06

Decision Date2016-06-06

Product CodeEMA

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

ORAL BOND is the device name listed in this FDA 510(k) record. The listed applicant is Steiner Laboratories. It received FDA 510(k) clearance on 2016-06-06 under 510(k) number K142130. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORAL BOND?

ORAL BOND is a medical device that received FDA 510(k) clearance on 2016-06-06. The listed applicant is Steiner Laboratories. The 510(k) number is K142130.

When did ORAL BOND receive FDA 510(k) clearance?

ORAL BOND received FDA 510(k) clearance on 2016-06-06, under 510(k) number K142130.

Who is the listed applicant for ORAL BOND?

The FDA 510(k) record lists Steiner Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ORAL BOND?

The FDA product code for ORAL BOND is EMA.

Related Devices (Code: EMA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254201Any-CemMediclus Co., Ltd.K261937PacTemp Automix NEThe Belport Company Inc., DBA Gingi-Pak K261166DIA-CEMDiaDent Group International K254109G-CEM UNIVERSALGC America, Inc.K253337REGEN Bioactive CementInter-Med, Inc.K252606Bifix Veneer LC, Bifix Veneer Try-InVoco GmbH

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.