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FDA 510(k)

VISTADENT OC - VERSION 4

K-Number: K060836 · 2006-10-27

ApplicantDentsply Intl., Inc.
Decision Date2006-10-27
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VISTADENT OC - VERSION 4 is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl., Inc.. It received FDA 510(k) clearance on 2006-10-27 under 510(k) number K060836. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VISTADENT OC - VERSION 4?

VISTADENT OC - VERSION 4 is a medical device that received FDA 510(k) clearance on 2006-10-27. The listed applicant is Dentsply Intl., Inc.. The 510(k) number is K060836.

When did VISTADENT OC - VERSION 4 receive FDA 510(k) clearance?

VISTADENT OC - VERSION 4 received FDA 510(k) clearance on 2006-10-27, under 510(k) number K060836.

Who is the listed applicant for VISTADENT OC - VERSION 4?

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

What is the FDA product code for VISTADENT OC - VERSION 4?

The FDA product code for VISTADENT OC - VERSION 4 is LLZ.

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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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