Cleared Traditional

K895401 - NORTHERNLIGHTS ORTHODONTIC BONDING SYSTEM

K895401 is the FDA 510(k) clearance for NORTHERNLIGHTS ORTHODONTIC BONDING SYSTEM by Rocky Mountain Orthodontics, Inc.. It is a Class 2 Dental device (product code EBF) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K895401 · Rocky Mountain Orthodontics, Inc. · Dental device
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Dec 1989
Decision
88d
Days
Class 2
Risk

K895401 is an FDA 510(k) clearance for the NORTHERNLIGHTS ORTHODONTIC BONDING SYSTEM. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Rocky Mountain Orthodontics, Inc. (Denver, US). The FDA issued a Cleared decision on December 4, 1989 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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 Rocky Mountain Orthodontics, Inc. devices

Submission Details

510(k) Number K895401 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 1989
Decision Date December 04, 1989
Days to Decision 88 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 127d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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 - EBF Material, Tooth Shade, Resin

All 613
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K895401.
AIR BLOCK
K896662 · Pulpdent Corp. · Feb 1990
DENTAL CORE MATERIAL
K896564 · Dentsply Intl. · Feb 1990
ENAMEL PREP ENAMEL ETCHANT (EMAIL-PREPARATOR GS)
K896132 · Ivoclar North America, Inc. · Jan 1990
CRYSTALLINE C2 AND CRYSTALLINE L3
K894890 · Confi-Dental Products Co. · Oct 1989
CROWN AND BRIDGE DENTAL RESTORATIVE COMPOSITE SYST
K894644 · Jeneric/Pentron, Inc. · Oct 1989
KULZER ADHESIVE CEMENT
K892455 · Kulzer, Inc. · Jun 1989