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FDA 510(k)

DIMER DUAL CURE PERMANENT/TEMPORARY RESIN CEMENT

K-Number: K120283 · 2012-07-31

ApplicantNovocol, Inc.
Decision Date2012-07-31
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DIMER DUAL CURE PERMANENT/TEMPORARY RESIN CEMENT is the device name listed in this FDA 510(k) record. The listed applicant is Novocol, Inc.. It received FDA 510(k) clearance on 2012-07-31 under 510(k) number K120283. 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 DIMER DUAL CURE PERMANENT/TEMPORARY RESIN CEMENT?

DIMER DUAL CURE PERMANENT/TEMPORARY RESIN CEMENT is a medical device that received FDA 510(k) clearance on 2012-07-31. The listed applicant is Novocol, Inc.. The 510(k) number is K120283.

When did DIMER DUAL CURE PERMANENT/TEMPORARY RESIN CEMENT receive FDA 510(k) clearance?

DIMER DUAL CURE PERMANENT/TEMPORARY RESIN CEMENT received FDA 510(k) clearance on 2012-07-31, under 510(k) number K120283.

Who is the listed applicant for DIMER DUAL CURE PERMANENT/TEMPORARY RESIN CEMENT?

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

What is the FDA product code for DIMER DUAL CURE PERMANENT/TEMPORARY RESIN CEMENT?

The FDA product code for DIMER DUAL CURE PERMANENT/TEMPORARY RESIN CEMENT is EMA.

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Other records listing Novocol, Inc. 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.

K130601BIOROOT RCSK120237BPA-FREE MICROHYBID COMPOSITEK120619ORTHODONTIC FLOWABLE BRACKET ADHESIVEK110484SELF CURE TEMPORARY CROWN AND BRIDGE MATERIALK092501LIGHT-ACTIVATED LOW-STRESS THIOL-ENE COMPOSITE RESTORATIVE MATERIALK072150DIMER ACID DERIVED NANO-HYBRID COMPOSITE RESTORATIVE MATERIAL

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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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