Cleared Traditional

K011521 - ORTHO VLC

Also marketed or referenced as:
ORTHO VLC CAPSULE

K011521 is an FDA 510(k) clearance for ORTHO VLC, manufactured by First Scientific Limited. The device is a Class 2 Dental device with product code DYH cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K011521 · First Scientific Limited · Dental device
Download Printable Device Report (PDF)
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Aug 2001
Decision
76d
Days
Class 2
Risk

K011521 is an FDA 510(k) clearance for the ORTHO VLC. Classified as Adhesive, Bracket And Tooth Conditioner, Resin (product code DYH), Class II - Special Controls.

Submitted by First Scientific Limited (Blaenau Gwent, Wales, GB). The FDA issued a Cleared decision on August 1, 2001 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3750 - 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 - K011521

510(k) Number K011521 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2001
Decision Date August 01, 2001
Days to Decision 76 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 128d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYH Device Classification - Class 2, Special Controls

Product Code DYH Adhesive, Bracket And Tooth Conditioner, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3750
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 - DYH Adhesive, Bracket And Tooth Conditioner, Resin

All 193
Devices cleared under the same product code (DYH) and FDA review panel - the closest regulatory comparables to K011521.
PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEM
K012673 · Prime Dental Manufacturing, Inc. · Oct 2001
FIRST SPEP
K012032 · Bisco, Inc. · Sep 2001
VERTEX L/C ORTHODONTIC DIRECT BONDING PASTE
K010544 · Apex Dental Materials, Inc. · Aug 2001
IMPROVED ENLIGHT LV
K001881 · Sybron Dental Specialties, Inc. · Aug 2000
LIGHT-CURED ORTHODONTIC BAND CEMENT
K001446 · Scientific Pharmaceuticals, Inc. · Jul 2000
LIGHT BOND (QUICK CURE)
K001048 · Reliance Orthodontic Products, Inc. · Apr 2000
K011521 · ORTHO VLC
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