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FDA 510(k)

SULTAN SENSITEMP RESIN TEMPORARY CEMENT, MODEL 70010

K-Number: K002843 · 2000-11-15

ApplicantSultan Chemists, Inc.
Decision Date2000-11-15
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SULTAN SENSITEMP RESIN TEMPORARY CEMENT, MODEL 70010 is the device name listed in this FDA 510(k) record. The listed applicant is Sultan Chemists, Inc.. It received FDA 510(k) clearance on 2000-11-15 under 510(k) number K002843. 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 SULTAN SENSITEMP RESIN TEMPORARY CEMENT, MODEL 70010?

SULTAN SENSITEMP RESIN TEMPORARY CEMENT, MODEL 70010 is a medical device that received FDA 510(k) clearance on 2000-11-15. The listed applicant is Sultan Chemists, Inc.. The 510(k) number is K002843.

When did SULTAN SENSITEMP RESIN TEMPORARY CEMENT, MODEL 70010 receive FDA 510(k) clearance?

SULTAN SENSITEMP RESIN TEMPORARY CEMENT, MODEL 70010 received FDA 510(k) clearance on 2000-11-15, under 510(k) number K002843.

Who is the listed applicant for SULTAN SENSITEMP RESIN TEMPORARY CEMENT, MODEL 70010?

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

What is the FDA product code for SULTAN SENSITEMP RESIN TEMPORARY CEMENT, MODEL 70010?

The FDA product code for SULTAN SENSITEMP RESIN TEMPORARY CEMENT, MODEL 70010 is EMA.

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Other records listing Sultan Chemists, 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.

K052699VERSA-LINK PORCELAIN BONDING SYSTEMK052409SILGIMIX ALGINATE REPLACEMENT IMPRESSION MATERIALK043054GENIE MAGIC MIX ULTRA HYDROPHILIC IMPRESSION MATERIALK030414GENIE ULTRA HYDROPHILIC IMPRESSION MATERIALK020612SULTAN SPOROX TEST VIAL, MODEL 75195K991509PRO-PORTION CLEANER/DISINFECTANT

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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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