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FDA 510(k)

HELIOSIT-ORTHODONTIC

K-Number: K823409 · 1983-01-21

ApplicantVivadent (Usa), Inc.
Decision Date1983-01-21
Product CodeDYH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HELIOSIT-ORTHODONTIC is the device name listed in this FDA 510(k) record. The listed applicant is Vivadent (Usa), Inc.. It received FDA 510(k) clearance on 1983-01-21 under 510(k) number K823409. The device is classified under product code DYH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HELIOSIT-ORTHODONTIC?

HELIOSIT-ORTHODONTIC is a medical device that received FDA 510(k) clearance on 1983-01-21. The listed applicant is Vivadent (Usa), Inc.. The 510(k) number is K823409.

When did HELIOSIT-ORTHODONTIC receive FDA 510(k) clearance?

HELIOSIT-ORTHODONTIC received FDA 510(k) clearance on 1983-01-21, under 510(k) number K823409.

Who is the listed applicant for HELIOSIT-ORTHODONTIC?

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

What is the FDA product code for HELIOSIT-ORTHODONTIC?

The FDA product code for HELIOSIT-ORTHODONTIC is DYH.

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Other records listing Vivadent (Usa), 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.

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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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