510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K955740Substantially Equivalent

Gluflorma

Midwest Orthodontic Mfg., Columbus IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K955740 is the FDA 510(k) clearance record for GLUFLORMA, a class II device, cleared for Midwest Orthodontic Mfg. on under FDA product code KLE (Agent, Tooth Bonding, Resin). FDA records list 7 510(k) clearances for Midwest Orthodontic Mfg., from to . As of , FDA records show no recalls naming K955740.

Clearance record

Decision date
Received
(55 days to decision)
Product code
KLE Agent, Tooth Bonding, Resin
Regulation
21 CFR 872.3200
Device class
Class II
Review panel
Dental
Applicant
Midwest Orthodontic Mfg. 4570 Progress Dr., Columbus IN
510(k) summary
Statement
Third party review
No

Clearances, product code KLE

Trailing 12 months
8 clearances under product code KLE in the twelve months to October 2026, March 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code KLE, trailing twelve months
MonthClearances
November 20251
December 20251
January 20260
February 20261
March 20262
April 20261
May 20261
June 20260
July 20260
August 20260
September 20261
October 20260