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FDA 510(k)

HYDROXYLATE DENTAL COMPOSITE RESTROATIVE

K-Number: K802535 · 1980-12-18

ApplicantWallace A. Erickson & Co.
Decision Date1980-12-18
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HYDROXYLATE DENTAL COMPOSITE RESTROATIVE 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 1980-12-18 under 510(k) number K802535. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYDROXYLATE DENTAL COMPOSITE RESTROATIVE?

HYDROXYLATE DENTAL COMPOSITE RESTROATIVE is a medical device that received FDA 510(k) clearance on 1980-12-18. The listed applicant is Wallace A. Erickson & Co.. The 510(k) number is K802535.

When did HYDROXYLATE DENTAL COMPOSITE RESTROATIVE receive FDA 510(k) clearance?

HYDROXYLATE DENTAL COMPOSITE RESTROATIVE received FDA 510(k) clearance on 1980-12-18, under 510(k) number K802535.

Who is the listed applicant for HYDROXYLATE DENTAL COMPOSITE RESTROATIVE?

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 DENTAL COMPOSITE RESTROATIVE?

The FDA product code for HYDROXYLATE DENTAL COMPOSITE RESTROATIVE is EBF.

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Other records listing Wallace A. Erickson & Co. as applicant

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Related Devices (Code: EBF)

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.

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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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