Cleared Traditional

K951220 - HEMA-GLU

K951220 is an FDA 510(k) clearance for HEMA-GLU, manufactured by Health-Dent Intl., Inc.. The device is a Class 2 Dental device with product code KLE cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K951220 · Health-Dent Intl., Inc. · Dental device
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May 1995
Decision
53d
Days
Class 2
Risk

K951220 is an FDA 510(k) clearance for the HEMA-GLU. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Health-Dent Intl., Inc. (Northlake, US). The FDA issued a Cleared decision on May 12, 1995 after a review of 53 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 Health-Dent Intl., Inc. devices

FDA 510(k) Submission Details - K951220

510(k) Number K951220 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1995
Decision Date May 12, 1995
Days to Decision 53 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
74d faster than avg
Panel avg: 127d · This submission: 53d
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 322
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K951220.
ABOND
K952124 · Parkell, Inc. · Jun 1995
PRIME & BOND DIRECT COMPOSITE BONDING AGENT
K951864 · Dentsply Intl. · May 1995
PERMAQUIK BONDING PRIMER
K951867 · Ultradent Products, Inc. · May 1995
PERMAQUIK BONDING PRIMER
K951583 · Ultradent Products, Inc. · May 1995
C&B-METABOND RADIOPAQUE POWDER
K950905 · Parkell, Inc. · Apr 1995
PERMALUTE
K950860 · Ultradent Products, Inc. · Mar 1995