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FDA 510(k)

AMDENT 2030, POLISHER/SCALER

K-Number: K920328 · 1993-10-20

ApplicantAmdent AB
Decision Date1993-10-20
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AMDENT 2030, POLISHER/SCALER is the device name listed in this FDA 510(k) record. The listed applicant is Amdent AB. It received FDA 510(k) clearance on 1993-10-20 under 510(k) number K920328. The device is classified under product code ELC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMDENT 2030, POLISHER/SCALER?

AMDENT 2030, POLISHER/SCALER is a medical device that received FDA 510(k) clearance on 1993-10-20. The listed applicant is Amdent AB. The 510(k) number is K920328.

When did AMDENT 2030, POLISHER/SCALER receive FDA 510(k) clearance?

AMDENT 2030, POLISHER/SCALER received FDA 510(k) clearance on 1993-10-20, under 510(k) number K920328.

Who is the listed applicant for AMDENT 2030, POLISHER/SCALER?

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

What is the FDA product code for AMDENT 2030, POLISHER/SCALER?

The FDA product code for AMDENT 2030, POLISHER/SCALER is ELC.

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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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