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FDA 510(k)

ORTHOLUX VISIBLE LIGHT CURING UNIT

K-Number: K880392 · 1988-04-07

ApplicantUnitek Corp.
Decision Date1988-04-07
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORTHOLUX VISIBLE LIGHT CURING UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Unitek Corp.. It received FDA 510(k) clearance on 1988-04-07 under 510(k) number K880392. 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 ORTHOLUX VISIBLE LIGHT CURING UNIT?

ORTHOLUX VISIBLE LIGHT CURING UNIT is a medical device that received FDA 510(k) clearance on 1988-04-07. The listed applicant is Unitek Corp.. The 510(k) number is K880392.

When did ORTHOLUX VISIBLE LIGHT CURING UNIT receive FDA 510(k) clearance?

ORTHOLUX VISIBLE LIGHT CURING UNIT received FDA 510(k) clearance on 1988-04-07, under 510(k) number K880392.

Who is the listed applicant for ORTHOLUX VISIBLE LIGHT CURING UNIT?

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

What is the FDA product code for ORTHOLUX VISIBLE LIGHT CURING UNIT?

The FDA product code for ORTHOLUX VISIBLE LIGHT CURING UNIT is EBZ.

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Other records listing Unitek Corp. as applicant

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.

K944286METAL-LINED TRANSCEND CERAMIC BRACKETK933501ALASTIKK940165ALASTIKK923999ALASTIK NSK924645TRANSCEND SERIES 6000 DEBONDING INSTRUMENTSK924295DEBRACKETING INSTRUMENT

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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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