Who is the manufacturer of GLUFLORMA?

Midwest Orthodontic Mfg. submitted the Traditional clearance for GLUFLORMA (K955740).

What is the FDA product code for GLUFLORMA?

KLE. It is classified under 21 CFR 872.3200 as a Class 2 device in the Dental panel.

What is the regulatory pathway for GLUFLORMA?

510(k) clearance (submission type: Traditional).

GLUFLORMA

K955740 · Midwest Orthodontic Mfg. · KLE · Feb 8, 1996 · Dental

Device Facts

Record ID	K955740
Device Name	GLUFLORMA
Applicant	Midwest Orthodontic Mfg.
Product Code	KLE · Dental
Decision Date	Feb 8, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3200
Device Class	Class 2

Regulatory Classification

Identification

A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.