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FDA 510(k)

CARBOCEM ZINC POLYCARBOXYLATE CEMENT

K-Number: K993324 · 1999-11-09

ApplicantScientific Pharmaceuticals, Inc.
Decision Date1999-11-09
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CARBOCEM ZINC POLYCARBOXYLATE CEMENT is the device name listed in this FDA 510(k) record. The listed applicant is Scientific Pharmaceuticals, Inc.. It received FDA 510(k) clearance on 1999-11-09 under 510(k) number K993324. 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 CARBOCEM ZINC POLYCARBOXYLATE CEMENT?

CARBOCEM ZINC POLYCARBOXYLATE CEMENT is a medical device that received FDA 510(k) clearance on 1999-11-09. The listed applicant is Scientific Pharmaceuticals, Inc.. The 510(k) number is K993324.

When did CARBOCEM ZINC POLYCARBOXYLATE CEMENT receive FDA 510(k) clearance?

CARBOCEM ZINC POLYCARBOXYLATE CEMENT received FDA 510(k) clearance on 1999-11-09, under 510(k) number K993324.

Who is the listed applicant for CARBOCEM ZINC POLYCARBOXYLATE CEMENT?

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

What is the FDA product code for CARBOCEM ZINC POLYCARBOXYLATE CEMENT?

The FDA product code for CARBOCEM ZINC POLYCARBOXYLATE CEMENT is EMA.

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Other records listing Scientific Pharmaceuticals, 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.

K051952EUGENONEK041886PROVISOK013555SCI-PHARM POST SECUREK001446LIGHT-CURED ORTHODONTIC BAND CEMENTK982915SCI-PHARM DFV VARNISHK983305SCI-PHARM DESENSITIZING VARNISH

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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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