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FDA 510(k)

COLTOSOL TEMPORARY ENDODONTIC FILLING MATERIAL

K-Number: K902392 · 1990-08-28

ApplicantColtene, Inc.
Decision Date1990-08-28
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

COLTOSOL TEMPORARY ENDODONTIC FILLING MATERIAL is the device name listed in this FDA 510(k) record. The listed applicant is Coltene, Inc.. It received FDA 510(k) clearance on 1990-08-28 under 510(k) number K902392. 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 COLTOSOL TEMPORARY ENDODONTIC FILLING MATERIAL?

COLTOSOL TEMPORARY ENDODONTIC FILLING MATERIAL is a medical device that received FDA 510(k) clearance on 1990-08-28. The listed applicant is Coltene, Inc.. The 510(k) number is K902392.

When did COLTOSOL TEMPORARY ENDODONTIC FILLING MATERIAL receive FDA 510(k) clearance?

COLTOSOL TEMPORARY ENDODONTIC FILLING MATERIAL received FDA 510(k) clearance on 1990-08-28, under 510(k) number K902392.

Who is the listed applicant for COLTOSOL TEMPORARY ENDODONTIC FILLING MATERIAL?

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

What is the FDA product code for COLTOSOL TEMPORARY ENDODONTIC FILLING MATERIAL?

The FDA product code for COLTOSOL TEMPORARY ENDODONTIC FILLING MATERIAL is EMA.

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Other records listing Coltene, 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.

K882800COLTENE PRESIDENT JET REGULAR BODYK873671COLTENE PRESIDENT JET IMPRESSION MATERIALS SYSTEMK870266COLTENE BRILLIANT D.I. DIRECT INLAY SYSTEMK870047COLTENE RAPIDK863998COLTENE JET-MIXERK850036COLTENE PRECISE

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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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