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FDA 510(k)

ALPHA-DENT TISSUE CONDITIONER AND TEMPORARY RELINER

K-Number: K934248 · 1993-12-08

ApplicantWallace A. Erickson & Co.
Decision Date1993-12-08
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ALPHA-DENT TISSUE CONDITIONER AND TEMPORARY RELINER 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 1993-12-08 under 510(k) number K934248. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALPHA-DENT TISSUE CONDITIONER AND TEMPORARY RELINER?

ALPHA-DENT TISSUE CONDITIONER AND TEMPORARY RELINER is a medical device that received FDA 510(k) clearance on 1993-12-08. The listed applicant is Wallace A. Erickson & Co.. The 510(k) number is K934248.

When did ALPHA-DENT TISSUE CONDITIONER AND TEMPORARY RELINER receive FDA 510(k) clearance?

ALPHA-DENT TISSUE CONDITIONER AND TEMPORARY RELINER received FDA 510(k) clearance on 1993-12-08, under 510(k) number K934248.

Who is the listed applicant for ALPHA-DENT TISSUE CONDITIONER AND TEMPORARY RELINER?

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 TISSUE CONDITIONER AND TEMPORARY RELINER?

The FDA product code for ALPHA-DENT TISSUE CONDITIONER AND TEMPORARY RELINER is EBI.

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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: EBI)

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.

K261802Glidewell™ Denture Base ResinPrismatik Dentalcraft, Inc.K261626UltraPrint Flexible Denture UVGuangzhou Heygears IMC., Inc.K262681NanoCeram Resin3BFAB TEKNOLOJI A.S.K262300Denture Base Resin V2Formlabs Ohio, Inc.K261474DENTCA Tru FlexibleDentca, Inc.K260569DB 4000 High Impact Denture BaseCarbon, 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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