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FDA 510(k)

AUTOMIX DENTAL AMALGAMATOR

K-Number: K915847 · 1992-03-02

ApplicantKerr Corporation (Danbury)
Decision Date1992-03-02
Product CodeEFD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AUTOMIX DENTAL AMALGAMATOR is the device name listed in this FDA 510(k) record. The listed applicant is Kerr Corporation (Danbury). It received FDA 510(k) clearance on 1992-03-02 under 510(k) number K915847. 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 AUTOMIX DENTAL AMALGAMATOR?

AUTOMIX DENTAL AMALGAMATOR is a medical device that received FDA 510(k) clearance on 1992-03-02. The listed applicant is Kerr Corporation (Danbury). The 510(k) number is K915847.

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

AUTOMIX DENTAL AMALGAMATOR received FDA 510(k) clearance on 1992-03-02, under 510(k) number K915847.

Who is the listed applicant for AUTOMIX DENTAL AMALGAMATOR?

The FDA 510(k) record lists Kerr Corporation (Danbury) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AUTOMIX DENTAL AMALGAMATOR?

The FDA product code for AUTOMIX DENTAL AMALGAMATOR is EFD.

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Other records listing Kerr Corporation (Danbury) 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.

K051545L.E. DEMETRON IIK020091OPTILUX 501K951663TYTIN RK951511TYTIN ADMIXK942480M4 CONTRA-ANGLE HANDPIECEK940513OPTIBOND

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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.K914340DUOMAT 3 AMALGAMATORDegussa AGK914341MIXOMAT AMALGAMATORDegussa AGK914339DENTOMAT 3 AMALGAMATORSDegussa 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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