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FDA 510(k)

ADHESIVE HYBRID IONOMER CEMENT

K-Number: K974140 · 1998-01-05

ApplicantDentsply Intl.
Decision Date1998-01-05
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ADHESIVE HYBRID IONOMER CEMENT is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 1998-01-05 under 510(k) number K974140. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADHESIVE HYBRID IONOMER CEMENT?

ADHESIVE HYBRID IONOMER CEMENT is a medical device that received FDA 510(k) clearance on 1998-01-05. The listed applicant is Dentsply Intl.. The 510(k) number is K974140.

When did ADHESIVE HYBRID IONOMER CEMENT receive FDA 510(k) clearance?

ADHESIVE HYBRID IONOMER CEMENT received FDA 510(k) clearance on 1998-01-05, under 510(k) number K974140.

Who is the listed applicant for ADHESIVE HYBRID IONOMER CEMENT?

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 ADHESIVE HYBRID IONOMER CEMENT?

The FDA product code for ADHESIVE HYBRID IONOMER CEMENT is EMA.

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Related Devices (Code: EMA)

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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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