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FDA 510(k)

ALPHA-DENT HEMA DESENTIZER(748-000)/WITH FLUORIDE(747-000)

K-Number: K960365 · 1996-03-28

ApplicantWallace A. Erickson & Co.
Decision Date1996-03-28
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ALPHA-DENT HEMA DESENTIZER(748-000)/WITH FLUORIDE(747-000) 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 1996-03-28 under 510(k) number K960365. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALPHA-DENT HEMA DESENTIZER(748-000)/WITH FLUORIDE(747-000)?

ALPHA-DENT HEMA DESENTIZER(748-000)/WITH FLUORIDE(747-000) is a medical device that received FDA 510(k) clearance on 1996-03-28. The listed applicant is Wallace A. Erickson & Co.. The 510(k) number is K960365.

When did ALPHA-DENT HEMA DESENTIZER(748-000)/WITH FLUORIDE(747-000) receive FDA 510(k) clearance?

ALPHA-DENT HEMA DESENTIZER(748-000)/WITH FLUORIDE(747-000) received FDA 510(k) clearance on 1996-03-28, under 510(k) number K960365.

Who is the listed applicant for ALPHA-DENT HEMA DESENTIZER(748-000)/WITH FLUORIDE(747-000)?

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 HEMA DESENTIZER(748-000)/WITH FLUORIDE(747-000)?

The FDA product code for ALPHA-DENT HEMA DESENTIZER(748-000)/WITH FLUORIDE(747-000) is KLE.

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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 FLUORIDEK960165ALPHA-DENT COMPOSITE SURFACE SEALANTK960122ALPHA-DENT TEMPORARY CROWN AND BRIDGE MATERIALK955521ALPHA-DENT COPAL CAVITY VARNISH

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Related Devices (Code: KLE)

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.

K262252MPa Max adhesiveDen-Mat Holdings, LLCK260485Any-EtchMediclus Co., Ltd.K260430Porcelain Etch GelBelport Company, Inc., Gingi-PakK252450Adhese 2Ivoclar Vivadent, Inc.K260682Bond-PR™ Universal AdhesivePremier Dental Products CompanyK251587VITA VMLC PrimerVita Zahnfabrik H. Rauter GmbH & Co. Kg.

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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