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FDA 510(k)

CAULK TOOTH CONDITIONER GEL AND SYRINGE

K-Number: K942031 · 1994-06-10

ApplicantDentsply Intl.
Decision Date1994-06-10
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CAULK TOOTH CONDITIONER GEL AND SYRINGE is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 1994-06-10 under 510(k) number K942031. 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 CAULK TOOTH CONDITIONER GEL AND SYRINGE?

CAULK TOOTH CONDITIONER GEL AND SYRINGE is a medical device that received FDA 510(k) clearance on 1994-06-10. The listed applicant is Dentsply Intl.. The 510(k) number is K942031.

When did CAULK TOOTH CONDITIONER GEL AND SYRINGE receive FDA 510(k) clearance?

CAULK TOOTH CONDITIONER GEL AND SYRINGE received FDA 510(k) clearance on 1994-06-10, under 510(k) number K942031.

Who is the listed applicant for CAULK TOOTH CONDITIONER GEL AND SYRINGE?

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 CAULK TOOTH CONDITIONER GEL AND SYRINGE?

The FDA product code for CAULK TOOTH CONDITIONER GEL AND SYRINGE is EBF.

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Related Devices (Code: EBF)

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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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