510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K810538Substantially Equivalent

Plasticeph

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

K810538 is the FDA 510(k) clearance record for PLASTICEPH, a class II device, cleared for Morningstar Dental Co. on under FDA product code EAG (Cephalometer). FDA records list one 510(k) clearance for Morningstar Dental Co. As of , FDA records show no recalls naming K810538.

Clearance record

Decision date
Received
(62 days to decision)
Product code
EAG Cephalometer
Regulation
21 CFR 872.1830
Device class
Class II
Review panel
Dental
Applicant
Morningstar Dental Co. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code EAG

Trailing 12 months

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

FDA records show no clearances under product code EAG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EAG, 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