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FDA 510(k)

HYDROXYLATE ENAMEL BOND SYSTEM

K-Number: K810407 · 1981-03-17

ApplicantWallace A. Erickson & Co.
Decision Date1981-03-17
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HYDROXYLATE ENAMEL BOND SYSTEM 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 1981-03-17 under 510(k) number K810407. 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 HYDROXYLATE ENAMEL BOND SYSTEM?

HYDROXYLATE ENAMEL BOND SYSTEM is a medical device that received FDA 510(k) clearance on 1981-03-17. The listed applicant is Wallace A. Erickson & Co.. The 510(k) number is K810407.

When did HYDROXYLATE ENAMEL BOND SYSTEM receive FDA 510(k) clearance?

HYDROXYLATE ENAMEL BOND SYSTEM received FDA 510(k) clearance on 1981-03-17, under 510(k) number K810407.

Who is the listed applicant for HYDROXYLATE ENAMEL BOND SYSTEM?

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 HYDROXYLATE ENAMEL BOND SYSTEM?

The FDA product code for HYDROXYLATE ENAMEL BOND SYSTEM 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 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: 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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