Cleared Traditional

K955740 - GLUFLORMA

K955740 is an FDA 510(k) clearance for GLUFLORMA, manufactured by Midwest Orthodontic Mfg.. The device is a Class 2 Dental device with product code KLE cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K955740 · Midwest Orthodontic Mfg. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1996
Decision
55d
Days
Class 2
Risk

K955740 is an FDA 510(k) clearance for the GLUFLORMA. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Midwest Orthodontic Mfg. (Columbus, US). The FDA issued a Cleared decision on February 8, 1996 after a review of 55 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3200 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Midwest Orthodontic Mfg. devices

FDA 510(k) Submission Details - K955740

510(k) Number K955740 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 1995
Decision Date February 08, 1996
Days to Decision 55 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 127d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KLE Device Classification - Class 2, Special Controls

Product Code KLE Agent, Tooth Bonding, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3200
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - KLE Agent, Tooth Bonding, Resin

All 347
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K955740.
CONFI-BOND
K955328 · Confi-Dental Products Co. · Mar 1996
ALPHA-DENT HEMA DESENTIZER(748-000)/WITH FLUORIDE(747-000)
K960365 · Wallace A. Erickson & Co. · Mar 1996
AMALGAMIBOND PLUS
K960879 · Parkell, Inc. · Mar 1996
D-SENSE
K955279 · Centrix, Inc. · Dec 1995
AMERICAN DENTAL PRODUCTS WETTING AGENT & DESENSITIZER
K954133 · American Dental Products, Inc. · Oct 1995
SILANE PRIMER
K954708 · Sybron Dental Specialties, Inc. · Oct 1995