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FDA 510(k)

SILAMAT (AMALGAMATOR)

K-Number: K901909 · 1990-06-22

ApplicantIvoclar North America, Inc.
Decision Date1990-06-22
Product CodeEFD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SILAMAT (AMALGAMATOR) is the device name listed in this FDA 510(k) record. The listed applicant is Ivoclar North America, Inc.. It received FDA 510(k) clearance on 1990-06-22 under 510(k) number K901909. 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 SILAMAT (AMALGAMATOR)?

SILAMAT (AMALGAMATOR) is a medical device that received FDA 510(k) clearance on 1990-06-22. The listed applicant is Ivoclar North America, Inc.. The 510(k) number is K901909.

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

SILAMAT (AMALGAMATOR) received FDA 510(k) clearance on 1990-06-22, under 510(k) number K901909.

Who is the listed applicant for SILAMAT (AMALGAMATOR)?

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

What is the FDA product code for SILAMAT (AMALGAMATOR)?

The FDA product code for SILAMAT (AMALGAMATOR) is EFD.

Related Clinical Trials

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Other records listing Ivoclar North America, 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.

K012174ERIS LAYERING MATERIALSK011491HELIOSEAL CLEAR CHROMAK011492IN TEN-SK011490MODIFICATION TO EXCITEK011023D.SIGN 96K011022BIOUNIVERSAL PDF

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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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