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FDA 510(k)

FLUROSHIELD(TM) VISIBLE LIGHT CURE PIT & FISSURE

K-Number: K896341 · 1990-04-23

ApplicantDentsply Intl.
Decision Date1990-04-23
Product CodeEBC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FLUROSHIELD(TM) VISIBLE LIGHT CURE PIT & FISSURE is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 1990-04-23 under 510(k) number K896341. The device is classified under product code EBC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLUROSHIELD(TM) VISIBLE LIGHT CURE PIT & FISSURE?

FLUROSHIELD(TM) VISIBLE LIGHT CURE PIT & FISSURE is a medical device that received FDA 510(k) clearance on 1990-04-23. The listed applicant is Dentsply Intl.. The 510(k) number is K896341.

When did FLUROSHIELD(TM) VISIBLE LIGHT CURE PIT & FISSURE receive FDA 510(k) clearance?

FLUROSHIELD(TM) VISIBLE LIGHT CURE PIT & FISSURE received FDA 510(k) clearance on 1990-04-23, under 510(k) number K896341.

Who is the listed applicant for FLUROSHIELD(TM) VISIBLE LIGHT CURE PIT & FISSURE?

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

What is the FDA product code for FLUROSHIELD(TM) VISIBLE LIGHT CURE PIT & FISSURE?

The FDA product code for FLUROSHIELD(TM) VISIBLE LIGHT CURE PIT & FISSURE is EBC.

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Related Devices (Code: EBC)

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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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