510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K973495Substantially Equivalent

Glenroe Glow in Dark Elastomeric Ligatures

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

K973495 is the FDA 510(k) clearance record for GLENROE GLOW IN DARK ELASTOMERIC LIGATURES, a class I device, cleared for Glenroe on under FDA product code ECI (Band, Elastic, Orthodontic). FDA records list 2 510(k) clearances for Glenroe, from to . As of , FDA records show no recalls naming K973495.

Clearance record

Decision date
Received
(76 days to decision)
Product code
ECI Band, Elastic, Orthodontic
Regulation
21 CFR 872.5410
Device class
Class I
Review panel
Dental
Applicant
Glenroe 1912 44th Ave. E, Bradenton FL
510(k) summary
Statement
Third party review
No

Clearances, product code ECI

Trailing 12 months

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

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