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FDA 510(k)

PIT AND FISSURE CHEMICAL CURING SEALANT

K-Number: K011822 · 2001-08-07

ApplicantRite-Dent Manufacturing Corp.
Decision Date2001-08-07
Product CodeEBC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PIT AND FISSURE CHEMICAL CURING SEALANT is the device name listed in this FDA 510(k) record. The listed applicant is Rite-Dent Manufacturing Corp.. It received FDA 510(k) clearance on 2001-08-07 under 510(k) number K011822. The device is classified under product code EBC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PIT AND FISSURE CHEMICAL CURING SEALANT?

PIT AND FISSURE CHEMICAL CURING SEALANT is a medical device that received FDA 510(k) clearance on 2001-08-07. The listed applicant is Rite-Dent Manufacturing Corp.. The 510(k) number is K011822.

When did PIT AND FISSURE CHEMICAL CURING SEALANT receive FDA 510(k) clearance?

PIT AND FISSURE CHEMICAL CURING SEALANT received FDA 510(k) clearance on 2001-08-07, under 510(k) number K011822.

Who is the listed applicant for PIT AND FISSURE CHEMICAL CURING SEALANT?

The FDA 510(k) record lists Rite-Dent Manufacturing Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PIT AND FISSURE CHEMICAL CURING SEALANT?

The FDA product code for PIT AND FISSURE CHEMICAL CURING SEALANT is EBC.

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Related Devices (Code: EBC)

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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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