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FDA 510(k)

DEOX, OXYGEN BARRIER VISCOUS SOLUTION

K-Number: K941065 · 1994-06-16

ApplicantUltradent Products, Inc.
Decision Date1994-06-16
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DEOX, OXYGEN BARRIER VISCOUS SOLUTION is the device name listed in this FDA 510(k) record. The listed applicant is Ultradent Products, Inc.. It received FDA 510(k) clearance on 1994-06-16 under 510(k) number K941065. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEOX, OXYGEN BARRIER VISCOUS SOLUTION?

DEOX, OXYGEN BARRIER VISCOUS SOLUTION is a medical device that received FDA 510(k) clearance on 1994-06-16. The listed applicant is Ultradent Products, Inc.. The 510(k) number is K941065.

When did DEOX, OXYGEN BARRIER VISCOUS SOLUTION receive FDA 510(k) clearance?

DEOX, OXYGEN BARRIER VISCOUS SOLUTION received FDA 510(k) clearance on 1994-06-16, under 510(k) number K941065.

Who is the listed applicant for DEOX, OXYGEN BARRIER VISCOUS SOLUTION?

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

What is the FDA product code for DEOX, OXYGEN BARRIER VISCOUS SOLUTION?

The FDA product code for DEOX, OXYGEN BARRIER VISCOUS SOLUTION is EMA.

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Related Devices (Code: EMA)

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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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