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FDA 510(k)

DESENS-IONOMER

K-Number: K032175 · 2003-10-09

ApplicantMilton Hodosh, M.D.
Decision Date2003-10-09
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DESENS-IONOMER is the device name listed in this FDA 510(k) record. The listed applicant is Milton Hodosh, M.D.. It received FDA 510(k) clearance on 2003-10-09 under 510(k) number K032175. 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 DESENS-IONOMER?

DESENS-IONOMER is a medical device that received FDA 510(k) clearance on 2003-10-09. The listed applicant is Milton Hodosh, M.D.. The 510(k) number is K032175.

When did DESENS-IONOMER receive FDA 510(k) clearance?

DESENS-IONOMER received FDA 510(k) clearance on 2003-10-09, under 510(k) number K032175.

Who is the listed applicant for DESENS-IONOMER?

The FDA 510(k) record lists Milton Hodosh, M.D. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DESENS-IONOMER?

The FDA product code for DESENS-IONOMER is EMA.

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Other records listing Milton Hodosh, M.D. 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.

K031721COMPOSITE RESTORATION MATERIALK022025MODIFICATION TO POTASSIUM NITRATE-POLYCARBOXYLATE DENTAL CEMENTK925207GLASS IONOMER CEMENTK905582POTASSIUM NITRATE COMPOSITE RESTORATION PIT ANDK895988POTASSIUM NITRATE-ZINC OXIDE EUGENOL TEMP. DENTALK882417POTASSIUM NITRATE POLYCARBOXYLATE DENTAL CEMENT

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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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