510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K945535Substantially Equivalent

Glenroe Ortho-Sil

Glenroe Technologies, Bradenton FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K945535 is the FDA 510(k) clearance record for GLENROE ORTHO-SIL, a class I device, cleared for Glenroe Technologies on under FDA product code EGD (Wax, Dental, Intraoral). FDA records list 9 510(k) clearances for Glenroe Technologies, from to . As of , FDA records show no recalls naming K945535.

Clearance record

Decision date
Received
(74 days to decision)
Product code
EGD Wax, Dental, Intraoral
Regulation
21 CFR 872.6890
Device class
Class I
Review panel
Dental
Applicant
Glenroe Technologies 1912 44th Ave. E, Bradenton FL
510(k) summary
Statement
Third party review
No

Clearances, product code EGD

Trailing 12 months

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

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