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FDA 510(k)

OPALUX VISIBLE LIGHT CURED ANTERIOR COMPOSITE

K-Number: K863882 · 1986-11-18

ApplicantCoe Laboratories, Inc.
Decision Date1986-11-18
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OPALUX VISIBLE LIGHT CURED ANTERIOR COMPOSITE is the device name listed in this FDA 510(k) record. The listed applicant is Coe Laboratories, Inc.. It received FDA 510(k) clearance on 1986-11-18 under 510(k) number K863882. 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 OPALUX VISIBLE LIGHT CURED ANTERIOR COMPOSITE?

OPALUX VISIBLE LIGHT CURED ANTERIOR COMPOSITE is a medical device that received FDA 510(k) clearance on 1986-11-18. The listed applicant is Coe Laboratories, Inc.. The 510(k) number is K863882.

When did OPALUX VISIBLE LIGHT CURED ANTERIOR COMPOSITE receive FDA 510(k) clearance?

OPALUX VISIBLE LIGHT CURED ANTERIOR COMPOSITE received FDA 510(k) clearance on 1986-11-18, under 510(k) number K863882.

Who is the listed applicant for OPALUX VISIBLE LIGHT CURED ANTERIOR COMPOSITE?

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

What is the FDA product code for OPALUX VISIBLE LIGHT CURED ANTERIOR COMPOSITE?

The FDA product code for OPALUX VISIBLE LIGHT CURED ANTERIOR COMPOSITE is EBF.

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Other records listing Coe Laboratories, 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.

K903292ACCUFLEX/ACCUMIX VINYL POLY IMPRESSION MATERIALSK894282FIRST IMPRESSION TMK894281FIRST IMPRESSION WITH CHLORHEXIDINEK891140OCCLU-SEAL(TM) VISIBLE LIGHT-CURED FISSURE SEALANTK885010TRIPTON(TM) VISIBLE LIGHT-CURED UNIV. BONDINGK881422COE PAK AUTO MIX, REGULAR OR HARD SET

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Related Devices (Code: EBF)

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.

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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