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FDA 510(k)

AMDENT MODEL 830 ULTRASONIC SCALER

K-Number: K880940 · 1988-07-15

ApplicantPathway Products, Inc.
Decision Date1988-07-15
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AMDENT MODEL 830 ULTRASONIC SCALER is the device name listed in this FDA 510(k) record. The listed applicant is Pathway Products, Inc.. It received FDA 510(k) clearance on 1988-07-15 under 510(k) number K880940. 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 MODEL 830 ULTRASONIC SCALER?

AMDENT MODEL 830 ULTRASONIC SCALER is a medical device that received FDA 510(k) clearance on 1988-07-15. The listed applicant is Pathway Products, Inc.. The 510(k) number is K880940.

When did AMDENT MODEL 830 ULTRASONIC SCALER receive FDA 510(k) clearance?

AMDENT MODEL 830 ULTRASONIC SCALER received FDA 510(k) clearance on 1988-07-15, under 510(k) number K880940.

Who is the listed applicant for AMDENT MODEL 830 ULTRASONIC SCALER?

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

What is the FDA product code for AMDENT MODEL 830 ULTRASONIC SCALER?

The FDA product code for AMDENT MODEL 830 ULTRASONIC SCALER is ELC.

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Related Devices (Code: ELC)

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.

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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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