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FDA 510(k)

PRIME-DENT DUAL CURE COMPOSITE LUTING CEMENT

K-Number: K112574 · 2012-01-23

ApplicantPrime Dental Manufacturing, Inc.
Decision Date2012-01-23
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PRIME-DENT DUAL CURE COMPOSITE LUTING CEMENT is the device name listed in this FDA 510(k) record. The listed applicant is Prime Dental Manufacturing, Inc.. It received FDA 510(k) clearance on 2012-01-23 under 510(k) number K112574. 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 PRIME-DENT DUAL CURE COMPOSITE LUTING CEMENT?

PRIME-DENT DUAL CURE COMPOSITE LUTING CEMENT is a medical device that received FDA 510(k) clearance on 2012-01-23. The listed applicant is Prime Dental Manufacturing, Inc.. The 510(k) number is K112574.

When did PRIME-DENT DUAL CURE COMPOSITE LUTING CEMENT receive FDA 510(k) clearance?

PRIME-DENT DUAL CURE COMPOSITE LUTING CEMENT received FDA 510(k) clearance on 2012-01-23, under 510(k) number K112574.

Who is the listed applicant for PRIME-DENT DUAL CURE COMPOSITE LUTING CEMENT?

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

What is the FDA product code for PRIME-DENT DUAL CURE COMPOSITE LUTING CEMENT?

The FDA product code for PRIME-DENT DUAL CURE COMPOSITE LUTING CEMENT is EMA.

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Other records listing Prime Dental Manufacturing, 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.

K022675PRIME-DENT AUTOMIX DUAL CURE CORE BUILD UP MATERIALK021524LIGHT CURE DENTAL DAMK013970PRIME-DENT HEMA DESENSITIZERK012794PRIME-DENT CHEMICAL CURE PIT & FISSURE SEALANTK012761PRIME-DENT VISIBLE LIGHT CURE PIT & FISSURE SEALANTK012673PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEM

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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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