Cleared Traditional

K021511 - CYTOFLEX MESH

K021511 is an FDA 510(k) clearance for CYTOFLEX MESH, manufactured by Unicare Biomedical, Inc.. The device is a Class 2 Dental device with product code JEY cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K021511 · Unicare Biomedical, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2002
Decision
89d
Days
Class 2
Risk

K021511 is an FDA 510(k) clearance for the CYTOFLEX MESH. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Unicare Biomedical, Inc. (Laguna Hills, US). The FDA issued a Cleared decision on August 6, 2002 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4760 - 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 Unicare Biomedical, Inc. devices

FDA 510(k) Submission Details - K021511

510(k) Number K021511 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2002
Decision Date August 06, 2002
Days to Decision 89 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
38d faster than avg
Panel avg: 127d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JEY Device Classification - Class 2, Special Controls

Product Code JEY Plate, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4760
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 - JEY Plate, Bone

All 206
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K021511.
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K022033 · Bioplate, Inc. · Jul 2002
THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY
K021684 · Bioplate, Inc. · Jun 2002
SYNTHES (USA) AUTOMATED TACK DRIVER
K021382 · Synthes (Usa) · May 2002