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FDA 510(k)

SPECTRUM 800 CURING UNIT

K-Number: K982318 · 1998-09-15

ApplicantDentsply Intl.
Decision Date1998-09-15
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SPECTRUM 800 CURING 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 1998-09-15 under 510(k) number K982318. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPECTRUM 800 CURING UNIT?

SPECTRUM 800 CURING UNIT is a medical device that received FDA 510(k) clearance on 1998-09-15. The listed applicant is Dentsply Intl.. The 510(k) number is K982318.

When did SPECTRUM 800 CURING UNIT receive FDA 510(k) clearance?

SPECTRUM 800 CURING UNIT received FDA 510(k) clearance on 1998-09-15, under 510(k) number K982318.

Who is the listed applicant for SPECTRUM 800 CURING 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 SPECTRUM 800 CURING UNIT?

The FDA product code for SPECTRUM 800 CURING UNIT is EBF.

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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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