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FDA 510(k)

OCCLUSIN LIGHT CURED VISIBLE RADIOPAQUE COMPOSITE

K-Number: K844326 · 1984-12-03

ApplicantCoe Laboratories, Inc.
Decision Date1984-12-03
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OCCLUSIN LIGHT CURED VISIBLE RADIOPAQUE 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 1984-12-03 under 510(k) number K844326. 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 OCCLUSIN LIGHT CURED VISIBLE RADIOPAQUE COMPOSITE?

OCCLUSIN LIGHT CURED VISIBLE RADIOPAQUE COMPOSITE is a medical device that received FDA 510(k) clearance on 1984-12-03. The listed applicant is Coe Laboratories, Inc.. The 510(k) number is K844326.

When did OCCLUSIN LIGHT CURED VISIBLE RADIOPAQUE COMPOSITE receive FDA 510(k) clearance?

OCCLUSIN LIGHT CURED VISIBLE RADIOPAQUE COMPOSITE received FDA 510(k) clearance on 1984-12-03, under 510(k) number K844326.

Who is the listed applicant for OCCLUSIN LIGHT CURED VISIBLE RADIOPAQUE 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 OCCLUSIN LIGHT CURED VISIBLE RADIOPAQUE COMPOSITE?

The FDA product code for OCCLUSIN LIGHT CURED VISIBLE RADIOPAQUE 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.

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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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