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FDA 510(k)

ALPHA BOND DENTIN/ENAMEL BONDING AGENT, MODEL 213-000

K-Number: K984503 · 1999-02-26

ApplicantWallace A. Erickson & Co.
Decision Date1999-02-26
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ALPHA BOND DENTIN/ENAMEL BONDING AGENT, MODEL 213-000 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 1999-02-26 under 510(k) number K984503. 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 BOND DENTIN/ENAMEL BONDING AGENT, MODEL 213-000?

ALPHA BOND DENTIN/ENAMEL BONDING AGENT, MODEL 213-000 is a medical device that received FDA 510(k) clearance on 1999-02-26. The listed applicant is Wallace A. Erickson & Co.. The 510(k) number is K984503.

When did ALPHA BOND DENTIN/ENAMEL BONDING AGENT, MODEL 213-000 receive FDA 510(k) clearance?

ALPHA BOND DENTIN/ENAMEL BONDING AGENT, MODEL 213-000 received FDA 510(k) clearance on 1999-02-26, under 510(k) number K984503.

Who is the listed applicant for ALPHA BOND DENTIN/ENAMEL BONDING AGENT, MODEL 213-000?

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 BOND DENTIN/ENAMEL BONDING AGENT, MODEL 213-000?

The FDA product code for ALPHA BOND DENTIN/ENAMEL BONDING AGENT, MODEL 213-000 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.

K963922ALPHA-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 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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