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FDA 510(k)

ALPHA-DENT GLASS IONOMER CEMENT, SELF CURED

K-Number: K935436 · 1994-06-10

ApplicantWallace A. Erickson & Co.
Decision Date1994-06-10
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ALPHA-DENT GLASS IONOMER CEMENT, SELF CURED is the device name listed in this FDA 510(k) record. The listed applicant is Wallace A. Erickson & Co.. It received FDA 510(k) clearance on 1994-06-10 under 510(k) number K935436. 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 ALPHA-DENT GLASS IONOMER CEMENT, SELF CURED?

ALPHA-DENT GLASS IONOMER CEMENT, SELF CURED is a medical device that received FDA 510(k) clearance on 1994-06-10. The listed applicant is Wallace A. Erickson & Co.. The 510(k) number is K935436.

When did ALPHA-DENT GLASS IONOMER CEMENT, SELF CURED receive FDA 510(k) clearance?

ALPHA-DENT GLASS IONOMER CEMENT, SELF CURED received FDA 510(k) clearance on 1994-06-10, under 510(k) number K935436.

Who is the listed applicant for ALPHA-DENT GLASS IONOMER CEMENT, SELF CURED?

The FDA 510(k) record lists Wallace A. Erickson & Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALPHA-DENT GLASS IONOMER CEMENT, SELF CURED?

The FDA product code for ALPHA-DENT GLASS IONOMER CEMENT, SELF CURED is EMA.

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Other records listing Wallace A. Erickson & Co. 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.

K984503ALPHA BOND DENTIN/ENAMEL BONDING AGENT, MODEL 213-000K963922ALPHA-DENT ROOT CANAL SEALER & FILLERK960667CENTRIX FLOFIL/CENTRIX FLOFIL WITH FLUORIDEK960365ALPHA-DENT HEMA DESENTIZER(748-000)/WITH FLUORIDE(747-000)K960165ALPHA-DENT COMPOSITE SURFACE SEALANTK960122ALPHA-DENT TEMPORARY CROWN AND BRIDGE MATERIAL

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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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