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FDA 510(k)

DENTAL AMALGAMATOR

K-Number: K780560 · 1978-04-21

ApplicantL.D. Caulk Co.
Decision Date1978-04-21
Product CodeEFD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTAL AMALGAMATOR is the device name listed in this FDA 510(k) record. The listed applicant is L.D. Caulk Co.. It received FDA 510(k) clearance on 1978-04-21 under 510(k) number K780560. The device is classified under product code EFD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DENTAL AMALGAMATOR?

DENTAL AMALGAMATOR is a medical device that received FDA 510(k) clearance on 1978-04-21. The listed applicant is L.D. Caulk Co.. The 510(k) number is K780560.

When did DENTAL AMALGAMATOR receive FDA 510(k) clearance?

DENTAL AMALGAMATOR received FDA 510(k) clearance on 1978-04-21, under 510(k) number K780560.

Who is the listed applicant for DENTAL AMALGAMATOR?

The FDA 510(k) record lists L.D. Caulk Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DENTAL AMALGAMATOR?

The FDA product code for DENTAL AMALGAMATOR is EFD.

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Other records listing L.D. Caulk 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.

K802262COMPOSITE RESTORATIVEK801690VALIANTK790585FINESSEK790586CHEMBONDK780384IMPROVED DYCALK780301CAULK TYLOK

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Related Devices (Code: EFD)

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.

K991913PENTAMIX 2Espe Dental AGK923974SILIMAT PLUSIvoclar North America, Inc.K922203IPT CAPSULE MIXERIpt Technologies, Inc.K915847AUTOMIX DENTAL AMALGAMATORKerr Corporation (Danbury)K914341MIXOMAT AMALGAMATORDegussa AGK914340DUOMAT 3 AMALGAMATORDegussa AG

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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