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FDA 510(k)

DUAL-CURE RADIOPAQUE

K-Number: K874189 · 1988-02-11

ApplicantPentron Corp.
Decision Date1988-02-11
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DUAL-CURE RADIOPAQUE is the device name listed in this FDA 510(k) record. The listed applicant is Pentron Corp.. It received FDA 510(k) clearance on 1988-02-11 under 510(k) number K874189. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DUAL-CURE RADIOPAQUE?

DUAL-CURE RADIOPAQUE is a medical device that received FDA 510(k) clearance on 1988-02-11. The listed applicant is Pentron Corp.. The 510(k) number is K874189.

When did DUAL-CURE RADIOPAQUE receive FDA 510(k) clearance?

DUAL-CURE RADIOPAQUE received FDA 510(k) clearance on 1988-02-11, under 510(k) number K874189.

Who is the listed applicant for DUAL-CURE RADIOPAQUE?

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

What is the FDA product code for DUAL-CURE RADIOPAQUE?

The FDA product code for DUAL-CURE RADIOPAQUE is EBF.

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Other records listing Pentron Corp. 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.

K021457FLEX SPAN TEMPORARY CROWN & BRIDGE MATERIALK874275OPTEC SUPPLEMENTARY KITK874162OPTEC STAIN CHARACTERIZATION AND MODIFICATION KITK873683CODE #23 R SYSTEM (DENTIN ADHESIVE MATERIAL)K873878#24L SYSTEMK864404PENTRON HIGH STRENGTH PORCELAIN

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Related Devices (Code: EBF)

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K262982Core·it DualSpident Co., Ltd.K262202Cerasmart ForteGC America, Inc.K261695Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)Guilin Kevin Peter Technology Co., Ltd.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261246SRGC-06GC America, 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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