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FDA 510(k)

GLASS IONOMER BASE

K-Number: K882751 · 1988-11-29

ApplicantDentsply Intl.
Decision Date1988-11-29
Product CodeEJK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GLASS IONOMER BASE is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 1988-11-29 under 510(k) number K882751. The device is classified under product code EJK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GLASS IONOMER BASE?

GLASS IONOMER BASE is a medical device that received FDA 510(k) clearance on 1988-11-29. The listed applicant is Dentsply Intl.. The 510(k) number is K882751.

When did GLASS IONOMER BASE receive FDA 510(k) clearance?

GLASS IONOMER BASE received FDA 510(k) clearance on 1988-11-29, under 510(k) number K882751.

Who is the listed applicant for GLASS IONOMER BASE?

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 GLASS IONOMER BASE?

The FDA product code for GLASS IONOMER BASE is EJK.

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Related Devices (Code: EJK)

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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