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FDA 510(k)

BEACH AMALGAM CARVER

K-Number: K821785 · 1982-07-06

Decision Date1982-07-06
Product CodeEKH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BEACH AMALGAM CARVER is the device name listed in this FDA 510(k) record. The listed applicant is Pacific Dental Corp.. It received FDA 510(k) clearance on 1982-07-06 under 510(k) number K821785. The device is classified under product code EKH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BEACH AMALGAM CARVER?

BEACH AMALGAM CARVER is a medical device that received FDA 510(k) clearance on 1982-07-06. The listed applicant is Pacific Dental Corp.. The 510(k) number is K821785.

When did BEACH AMALGAM CARVER receive FDA 510(k) clearance?

BEACH AMALGAM CARVER received FDA 510(k) clearance on 1982-07-06, under 510(k) number K821785.

Who is the listed applicant for BEACH AMALGAM CARVER?

The FDA 510(k) record lists Pacific Dental Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BEACH AMALGAM CARVER?

The FDA product code for BEACH AMALGAM CARVER is EKH.

Related Clinical Trials

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.

Other records listing Pacific Dental Corp. 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.

View all 22 devices →

Related Devices (Code: EKH)

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.

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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