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FDA 510(k)

FOUNDATION INDIRECT COMPOSITE RESIN

K-Number: K970495 · 1997-04-16

ApplicantSybron Dental Specialties, Inc.
Decision Date1997-04-16
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FOUNDATION INDIRECT COMPOSITE RESIN is the device name listed in this FDA 510(k) record. The listed applicant is Sybron Dental Specialties, Inc.. It received FDA 510(k) clearance on 1997-04-16 under 510(k) number K970495. 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 FOUNDATION INDIRECT COMPOSITE RESIN?

FOUNDATION INDIRECT COMPOSITE RESIN is a medical device that received FDA 510(k) clearance on 1997-04-16. The listed applicant is Sybron Dental Specialties, Inc.. The 510(k) number is K970495.

When did FOUNDATION INDIRECT COMPOSITE RESIN receive FDA 510(k) clearance?

FOUNDATION INDIRECT COMPOSITE RESIN received FDA 510(k) clearance on 1997-04-16, under 510(k) number K970495.

Who is the listed applicant for FOUNDATION INDIRECT COMPOSITE RESIN?

The FDA 510(k) record lists Sybron Dental Specialties, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FOUNDATION INDIRECT COMPOSITE RESIN?

The FDA product code for FOUNDATION INDIRECT COMPOSITE RESIN is 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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