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FDA 510(k)

R-30 AESTHETIC RESTORATIVE

K-Number: K984387 · 1999-01-13

ApplicantDentsply Intl.
Decision Date1999-01-13
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

R-30 AESTHETIC RESTORATIVE is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 1999-01-13 under 510(k) number K984387. 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 R-30 AESTHETIC RESTORATIVE?

R-30 AESTHETIC RESTORATIVE is a medical device that received FDA 510(k) clearance on 1999-01-13. The listed applicant is Dentsply Intl.. The 510(k) number is K984387.

When did R-30 AESTHETIC RESTORATIVE receive FDA 510(k) clearance?

R-30 AESTHETIC RESTORATIVE received FDA 510(k) clearance on 1999-01-13, under 510(k) number K984387.

Who is the listed applicant for R-30 AESTHETIC RESTORATIVE?

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 R-30 AESTHETIC RESTORATIVE?

The FDA product code for R-30 AESTHETIC RESTORATIVE is EBF.

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Related Devices (Code: EBF)

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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