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FDA 510(k)

NUVA-LITE II PHOTO-CURE UNIT

K-Number: K770599 · 1977-04-05

ApplicantDentsply Intl.
Decision Date1977-04-05
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NUVA-LITE II PHOTO-CURE UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 1977-04-05 under 510(k) number K770599. The device is classified under product code EBZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NUVA-LITE II PHOTO-CURE UNIT?

NUVA-LITE II PHOTO-CURE UNIT is a medical device that received FDA 510(k) clearance on 1977-04-05. The listed applicant is Dentsply Intl.. The 510(k) number is K770599.

When did NUVA-LITE II PHOTO-CURE UNIT receive FDA 510(k) clearance?

NUVA-LITE II PHOTO-CURE UNIT received FDA 510(k) clearance on 1977-04-05, under 510(k) number K770599.

Who is the listed applicant for NUVA-LITE II PHOTO-CURE UNIT?

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 NUVA-LITE II PHOTO-CURE UNIT?

The FDA product code for NUVA-LITE II PHOTO-CURE UNIT is EBZ.

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Related Devices (Code: EBZ)

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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