510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K091852Substantially Equivalent

Bisque Zirconia Blanks, Model R610191, R610210, R610211, R610205

Refractron Technologies Corp., Maineville OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K091852 is the FDA 510(k) clearance record for BISQUE ZIRCONIA BLANKS, MODEL R610191, R610210, R610211, R610205, a class II device, cleared for Refractron Technologies Corp. on under FDA product code EIH (Powder, Porcelain). FDA records list one 510(k) clearance for Refractron Technologies Corp. As of , FDA records show no recalls naming K091852.

Clearance record

Decision date
Received
(79 days to decision)
Product code
EIH Powder, Porcelain
Regulation
21 CFR 872.6660
Device class
Class II
Review panel
Dental
Applicant
Refractron Technologies Corp. 7736 Woodside Ct., Maineville OH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EIH

Trailing 12 months
13 clearances under product code EIH in the twelve months to October 2026, June 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code EIH, trailing twelve months
MonthClearances
November 20250
December 20251
January 20262
February 20260
March 20262
April 20261
May 20261
June 20263
July 20262
August 20261
September 20260
October 20260