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FDA 510(k)

SELF-ADHESIVE RESIN CEMENT

K-Number: K073173 · 2008-01-23

ApplicantDentsply Interntional
Decision Date2008-01-23
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SELF-ADHESIVE RESIN CEMENT is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Interntional. It received FDA 510(k) clearance on 2008-01-23 under 510(k) number K073173. 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 SELF-ADHESIVE RESIN CEMENT?

SELF-ADHESIVE RESIN CEMENT is a medical device that received FDA 510(k) clearance on 2008-01-23. The listed applicant is Dentsply Interntional. The 510(k) number is K073173.

When did SELF-ADHESIVE RESIN CEMENT receive FDA 510(k) clearance?

SELF-ADHESIVE RESIN CEMENT received FDA 510(k) clearance on 2008-01-23, under 510(k) number K073173.

Who is the listed applicant for SELF-ADHESIVE RESIN CEMENT?

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

What is the FDA product code for SELF-ADHESIVE RESIN CEMENT?

The FDA product code for SELF-ADHESIVE RESIN CEMENT is EMA.

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Other records listing Dentsply Interntional as applicant

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.

K092614X-SMART EASYK092030ELATION MB METAL REINFORCED PLASTIC BRACKETK090454ALLURE MB CERAMIC BRACKETSK082973STER-MATE STERILE LAVAGE KITK082974MYSTIQUE MB CERAMIC BRACKETSK081291PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION

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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.

K262983EsTemp ImplantSpident Co., Ltd.K254201Any-CemMediclus Co., Ltd.K261937PacTemp Automix NEThe Belport Company Inc., DBA Gingi-PakK261166DIA-CEMDiaDent Group InternationalK254109G-CEM UNIVERSALGC America, Inc.K253337REGEN Bioactive CementInter-Med, Inc.

Official Source

View on FDA Database →

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

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