Cleared Traditional

K033632 - VARIFLEX

K033632 is an FDA 510(k) clearance for VARIFLEX, 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 63-day FDA review.

K033632 · Great Lakes Orthodontics, Ltd. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2004
Decision
63d
Days
Class 2
Risk

K033632 is an FDA 510(k) clearance for the VARIFLEX. 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 January 21, 2004 after a review of 63 days - a notably fast clearance cycle.

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

FDA 510(k) Submission Details - K033632

510(k) Number K033632 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2003
Decision Date January 21, 2004
Days to Decision 63 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 128d · This submission: 63d
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 303
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K033632.
TUF LINK SILICONE RELINER
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K040881 · Great Lakes Orthodontics, Ltd. · May 2004
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K034024 · Bisco, Inc. · Mar 2004
TESCERA U-BAR AND BARRELS
K033472 · Bisco, Inc. · Jan 2004
VERSYO.BOND
K033629 · Heraeus Kulzer, Inc. · Dec 2003
IMPAK ACRYLIC REPAIR RESIN LIQUID
K033020 · Cmp Industries, LLC · Dec 2003
K033632 · VARIFLEX
Download PDF FDA Summary Great Lakes Orthodont…