Cleared Traditional

K083479 - BIOCRYL X

K083479 is an FDA 510(k) clearance for BIOCRYL X, manufactured by Great Lakes Orthodontics, Ltd.. The device is a Class 2 Dental device with product code EBI cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K083479 · Great Lakes Orthodontics, Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2009
Decision
95d
Days
Class 2
Risk

K083479 is an FDA 510(k) clearance for the BIOCRYL X. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Great Lakes Orthodontics, Ltd. (Tonawanda, US). The FDA issued a Cleared decision on February 27, 2009 after a review of 95 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3760 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Great Lakes Orthodontics, Ltd. devices

FDA 510(k) Submission Details - K083479

510(k) Number K083479 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 2008
Decision Date February 27, 2009
Days to Decision 95 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 127d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBI Device Classification - Class 2, Special Controls

Product Code EBI Resin, Denture, Relining, Repairing, Rebasing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3760
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 - EBI Resin, Denture, Relining, Repairing, Rebasing

All 189
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K083479.
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ION DENTAL RESIN SYSTEM
K072713 · Dentsply International, Inc. · Oct 2007
COE SOFT
K070697 · GC America, Inc. · Mar 2007
COE COMFORT
K070698 · GC America, Inc. · Mar 2007