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FDA 510(k)

COE PAK AUTO MIX, REGULAR OR HARD SET

K-Number: K881422 · 1988-10-31

ApplicantCoe Laboratories, Inc.
Decision Date1988-10-31
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

COE PAK AUTO MIX, REGULAR OR HARD SET 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 1988-10-31 under 510(k) number K881422. 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 COE PAK AUTO MIX, REGULAR OR HARD SET?

COE PAK AUTO MIX, REGULAR OR HARD SET is a medical device that received FDA 510(k) clearance on 1988-10-31. The listed applicant is Coe Laboratories, Inc.. The 510(k) number is K881422.

When did COE PAK AUTO MIX, REGULAR OR HARD SET receive FDA 510(k) clearance?

COE PAK AUTO MIX, REGULAR OR HARD SET received FDA 510(k) clearance on 1988-10-31, under 510(k) number K881422.

Who is the listed applicant for COE PAK AUTO MIX, REGULAR OR HARD SET?

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 COE PAK AUTO MIX, REGULAR OR HARD SET?

The FDA product code for COE PAK AUTO MIX, REGULAR OR HARD SET is EMA.

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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. BONDINGK881091OMNISIL, VINYL POLYSILOXANE IMPRESSION MATERIAL

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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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