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FDA 510(k)

VISIBLE LIGHT-CURE COMPOSITE -POLISHABLE

K-Number: K844471 · 1985-02-08

ApplicantDentsply Intl.
Decision Date1985-02-08
Product CodeEBH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

VISIBLE LIGHT-CURE COMPOSITE -POLISHABLE is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 1985-02-08 under 510(k) number K844471. The device is classified under product code EBH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VISIBLE LIGHT-CURE COMPOSITE -POLISHABLE?

VISIBLE LIGHT-CURE COMPOSITE -POLISHABLE is a medical device that received FDA 510(k) clearance on 1985-02-08. The listed applicant is Dentsply Intl.. The 510(k) number is K844471.

When did VISIBLE LIGHT-CURE COMPOSITE -POLISHABLE receive FDA 510(k) clearance?

VISIBLE LIGHT-CURE COMPOSITE -POLISHABLE received FDA 510(k) clearance on 1985-02-08, under 510(k) number K844471.

Who is the listed applicant for VISIBLE LIGHT-CURE COMPOSITE -POLISHABLE?

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 VISIBLE LIGHT-CURE COMPOSITE -POLISHABLE?

The FDA product code for VISIBLE LIGHT-CURE COMPOSITE -POLISHABLE is EBH.

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Related Devices (Code: EBH)

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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