510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K831293Substantially Equivalent

Solarcryl Custom Tray Material

Solar Dental Co., Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K831293 is the FDA 510(k) clearance record for SOLARCRYL CUSTOM TRAY MATERIAL, a class I device, cleared for Solar Dental Co., Inc. on under FDA product code EBH (Material, Impression Tray, Resin). FDA records list 6 510(k) clearances for Solar Dental Co., Inc., from to . As of , FDA records show no recalls naming K831293.

Clearance record

Decision date
Received
(97 days to decision)
Product code
EBH Material, Impression Tray, Resin
Regulation
21 CFR 872.3670
Device class
Class I
Review panel
Dental
Applicant
Solar Dental Co., Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code EBH

Trailing 12 months

FDA records hold no clearances under product code EBH in the trailing twelve months.

FDA records show no clearances under product code EBH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EBH, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260