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FDA 510(k)

ACCU-MIX AMALGAMATOR

K-Number: K910632 · 1991-03-15

ApplicantWykle Research, Inc.
Decision Date1991-03-15
Product CodeEFD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ACCU-MIX AMALGAMATOR is the device name listed in this FDA 510(k) record. The listed applicant is Wykle Research, Inc.. It received FDA 510(k) clearance on 1991-03-15 under 510(k) number K910632. 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 ACCU-MIX AMALGAMATOR?

ACCU-MIX AMALGAMATOR is a medical device that received FDA 510(k) clearance on 1991-03-15. The listed applicant is Wykle Research, Inc.. The 510(k) number is K910632.

When did ACCU-MIX AMALGAMATOR receive FDA 510(k) clearance?

ACCU-MIX AMALGAMATOR received FDA 510(k) clearance on 1991-03-15, under 510(k) number K910632.

Who is the listed applicant for ACCU-MIX AMALGAMATOR?

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

What is the FDA product code for ACCU-MIX AMALGAMATOR?

The FDA product code for ACCU-MIX AMALGAMATOR is EFD.

Related Clinical Trials

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Other records listing Wykle Research, Inc. 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.

K952670CUPRALLOYK9215711ST IMPRESSION

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)K914340DUOMAT 3 AMALGAMATORDegussa AGK914341MIXOMAT 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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