FDA 510(k)

CHEW-DENT

K-Number: K843406 · 1984-12-11

Decision Date1984-12-11

Product CodeJEW

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

CHEW-DENT is the device name listed in this FDA 510(k) record. The listed applicant is Senair-Mot. It received FDA 510(k) clearance on 1984-12-11 under 510(k) number K843406. The device is classified under product code JEW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHEW-DENT?

CHEW-DENT is a medical device that received FDA 510(k) clearance on 1984-12-11. The listed applicant is Senair-Mot. The 510(k) number is K843406.

When did CHEW-DENT receive FDA 510(k) clearance?

CHEW-DENT received FDA 510(k) clearance on 1984-12-11, under 510(k) number K843406.

Who is the listed applicant for CHEW-DENT?

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

What is the FDA product code for CHEW-DENT?

The FDA product code for CHEW-DENT is JEW.

Other records listing Senair-Mot 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.

K904527KAPPER

Related Devices (Code: JEW)

K862635RABINOWITZ GUM MASSAGERArnell, Inc.K790588ASSAY REAGENTS, LSA 290Kallestad Laboratories, Inc.

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.