Cleared Traditional

K810265 - VISIO-BAND

K810265 is an FDA 510(k) clearance for VISIO-BAND, manufactured by Espe-Premier Sales Co.. The device is a Class 2 Dental device with product code KLE cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K810265 · Espe-Premier Sales Co. · Dental device
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Feb 1981
Decision
21d
Days
Class 2
Risk

K810265 is an FDA 510(k) clearance for the VISIO-BAND. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Espe-Premier Sales Co. (Mchenry, US). The FDA issued a Cleared decision on February 23, 1981 after a review of 21 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 Espe-Premier Sales Co. devices

FDA 510(k) Submission Details - K810265

510(k) Number K810265 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 1981
Decision Date February 23, 1981
Days to Decision 21 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
107d faster than avg
Panel avg: 128d · This submission: 21d
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 386
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K810265.
AURAFILL* DENTAL RESTORATIVE BONDING AG.
K822451 · Johnson & Johnson Professionals, Inc. · Sep 1982
SCOTCHBOND DENTAL ADHESIVE
K813180 · 3M Company · Jan 1982
HYDROXYLATE ENAMEL BOND SYSTEM
K810407 · Wallace A. Erickson & Co. · Mar 1981
HELIOBOND
K802681 · Vivadent (Usa), Inc. · Nov 1980
INSTANT BRIDGE
K802333 · Scientific Pharmaceuticals, Inc. · Nov 1980
DEN-MAT DENTIN BONDING AGENT
K801216 · Den-Mat Corp. · May 1980