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FDA 510(k)

AMALGAMATOR

K-Number: K880993 · 1988-05-11

ApplicantAcecodent, Inc.
Decision Date1988-05-11
Product CodeEFD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AMALGAMATOR is the device name listed in this FDA 510(k) record. The listed applicant is Acecodent, Inc.. It received FDA 510(k) clearance on 1988-05-11 under 510(k) number K880993. 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 AMALGAMATOR?

AMALGAMATOR is a medical device that received FDA 510(k) clearance on 1988-05-11. The listed applicant is Acecodent, Inc.. The 510(k) number is K880993.

When did AMALGAMATOR receive FDA 510(k) clearance?

AMALGAMATOR received FDA 510(k) clearance on 1988-05-11, under 510(k) number K880993.

Who is the listed applicant for AMALGAMATOR?

The FDA 510(k) record lists Acecodent, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMALGAMATOR?

The FDA product code for AMALGAMATOR is EFD.

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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