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FDA 510(k)

GRANITEC IONOMER RESIN CEMENT

K-Number: K940546 · 1994-04-29

ApplicantConfi-Dental Products Co.
Decision Date1994-04-29
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GRANITEC IONOMER RESIN CEMENT is the device name listed in this FDA 510(k) record. The listed applicant is Confi-Dental Products Co.. It received FDA 510(k) clearance on 1994-04-29 under 510(k) number K940546. 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 GRANITEC IONOMER RESIN CEMENT?

GRANITEC IONOMER RESIN CEMENT is a medical device that received FDA 510(k) clearance on 1994-04-29. The listed applicant is Confi-Dental Products Co.. The 510(k) number is K940546.

When did GRANITEC IONOMER RESIN CEMENT receive FDA 510(k) clearance?

GRANITEC IONOMER RESIN CEMENT received FDA 510(k) clearance on 1994-04-29, under 510(k) number K940546.

Who is the listed applicant for GRANITEC IONOMER RESIN CEMENT?

The FDA 510(k) record lists Confi-Dental Products Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GRANITEC IONOMER RESIN CEMENT?

The FDA product code for GRANITEC IONOMER RESIN CEMENT is EMA.

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Related Devices (Code: EMA)

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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