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FDA 510(k)

BISQUE ZIRCONIA BLANKS, MODEL R610191, R610210, R610211, R610205

K-Number: K091852 · 2009-09-10

ApplicantRefractron Technologies Corp.
Decision Date2009-09-10
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BISQUE ZIRCONIA BLANKS, MODEL R610191, R610210, R610211, R610205 is the device name listed in this FDA 510(k) record. The listed applicant is Refractron Technologies Corp.. It received FDA 510(k) clearance on 2009-09-10 under 510(k) number K091852. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BISQUE ZIRCONIA BLANKS, MODEL R610191, R610210, R610211, R610205?

BISQUE ZIRCONIA BLANKS, MODEL R610191, R610210, R610211, R610205 is a medical device that received FDA 510(k) clearance on 2009-09-10. The listed applicant is Refractron Technologies Corp.. The 510(k) number is K091852.

When did BISQUE ZIRCONIA BLANKS, MODEL R610191, R610210, R610211, R610205 receive FDA 510(k) clearance?

BISQUE ZIRCONIA BLANKS, MODEL R610191, R610210, R610211, R610205 received FDA 510(k) clearance on 2009-09-10, under 510(k) number K091852.

Who is the listed applicant for BISQUE ZIRCONIA BLANKS, MODEL R610191, R610210, R610211, R610205?

The FDA 510(k) record lists Refractron Technologies Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BISQUE ZIRCONIA BLANKS, MODEL R610191, R610210, R610211, R610205?

The FDA product code for BISQUE ZIRCONIA BLANKS, MODEL R610191, R610210, R610211, R610205 is EIH.

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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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