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FDA 510(k)

SPECTRUM

K-Number: K880774 · 1988-05-18

ApplicantDentsply Intl.
Decision Date1988-05-18
Product CodeELL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SPECTRUM is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 1988-05-18 under 510(k) number K880774. The device is classified under product code ELL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPECTRUM?

SPECTRUM is a medical device that received FDA 510(k) clearance on 1988-05-18. The listed applicant is Dentsply Intl.. The 510(k) number is K880774.

When did SPECTRUM receive FDA 510(k) clearance?

SPECTRUM received FDA 510(k) clearance on 1988-05-18, under 510(k) number K880774.

Who is the listed applicant for SPECTRUM?

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?

The FDA product code for SPECTRUM is ELL.

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Related PubMed Literature

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PMID: 28005723Light-Driven Contact Hearing Aid for Broad-Spectrum Amplification: Safety and Effectiveness Pivotal Study.Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology ()

Other records listing Dentsply Intl. as applicant

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Related Devices (Code: ELL)

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.

K240586Additive Manufacturing Zirconia Customized RestorationHangzhou Thales Medtech Co., Ltd.K203072Franz Zirconia Dental CrownFranz Biotech, Inc.K162043NobelProcera HT ML FCZ BridgeNobel Biocare ABK153534NobelProcera HT ML Full Contour Zirconia CrownNobel Biocare ABK071182PROCERA BRIDGE ZIRCONIA 9 UNITS-14 UNITS, MODELS 30-4004 TO 30-4013Nobel Biocare ABK060530SD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING. MODEL 45301. RD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING, MODEL 45302.Lifecore Biomedical, Inc.

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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