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FDA 510(k)

ULTRATEMP TEMPORARY POLYCARBOXYLATE CEMENT

K-Number: K994261 · 2000-02-02

ApplicantUltradent Products, Inc.
Decision Date2000-02-02
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ULTRATEMP TEMPORARY POLYCARBOXYLATE CEMENT is the device name listed in this FDA 510(k) record. The listed applicant is Ultradent Products, Inc.. It received FDA 510(k) clearance on 2000-02-02 under 510(k) number K994261. 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 ULTRATEMP TEMPORARY POLYCARBOXYLATE CEMENT?

ULTRATEMP TEMPORARY POLYCARBOXYLATE CEMENT is a medical device that received FDA 510(k) clearance on 2000-02-02. The listed applicant is Ultradent Products, Inc.. The 510(k) number is K994261.

When did ULTRATEMP TEMPORARY POLYCARBOXYLATE CEMENT receive FDA 510(k) clearance?

ULTRATEMP TEMPORARY POLYCARBOXYLATE CEMENT received FDA 510(k) clearance on 2000-02-02, under 510(k) number K994261.

Who is the listed applicant for ULTRATEMP TEMPORARY POLYCARBOXYLATE CEMENT?

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

What is the FDA product code for ULTRATEMP TEMPORARY POLYCARBOXYLATE CEMENT?

The FDA product code for ULTRATEMP TEMPORARY POLYCARBOXYLATE CEMENT is EMA.

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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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