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FDA 510(k)

OCCLU-SEAL(TM) VISIBLE LIGHT-CURED FISSURE SEALANT

K-Number: K891140 · 1989-05-01

ApplicantCoe Laboratories, Inc.
Decision Date1989-05-01
Product CodeEBC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OCCLU-SEAL(TM) VISIBLE LIGHT-CURED FISSURE SEALANT 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 1989-05-01 under 510(k) number K891140. The device is classified under product code EBC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OCCLU-SEAL(TM) VISIBLE LIGHT-CURED FISSURE SEALANT?

OCCLU-SEAL(TM) VISIBLE LIGHT-CURED FISSURE SEALANT is a medical device that received FDA 510(k) clearance on 1989-05-01. The listed applicant is Coe Laboratories, Inc.. The 510(k) number is K891140.

When did OCCLU-SEAL(TM) VISIBLE LIGHT-CURED FISSURE SEALANT receive FDA 510(k) clearance?

OCCLU-SEAL(TM) VISIBLE LIGHT-CURED FISSURE SEALANT received FDA 510(k) clearance on 1989-05-01, under 510(k) number K891140.

Who is the listed applicant for OCCLU-SEAL(TM) VISIBLE LIGHT-CURED FISSURE SEALANT?

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 OCCLU-SEAL(TM) VISIBLE LIGHT-CURED FISSURE SEALANT?

The FDA product code for OCCLU-SEAL(TM) VISIBLE LIGHT-CURED FISSURE SEALANT is EBC.

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Other records listing Coe Laboratories, Inc. as applicant

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K903292ACCUFLEX/ACCUMIX VINYL POLY IMPRESSION MATERIALSK894282FIRST IMPRESSION TMK894281FIRST IMPRESSION WITH CHLORHEXIDINEK885010TRIPTON(TM) VISIBLE LIGHT-CURED UNIV. BONDINGK881422COE PAK AUTO MIX, REGULAR OR HARD SETK881091OMNISIL, VINYL POLYSILOXANE IMPRESSION MATERIAL

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Related Devices (Code: EBC)

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.

K260819Any-Com SealMediclus Co., Ltd.K243254Parkell Pit and Fissure SealantParkell, Inc.K232498UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by NobioUltradent Product, Inc.K230455Enamel Coating ResinRizhao Huge Biomaterials Company, Ltd.K190998BA Pit & Fissure SealantApex Dental Materials, Inc.K190339Helioseal F PlusIvoclar Vivadent, AG

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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