Cleared Traditional

K090083 - CYTOFLEX RESORB, MODEL C03-0010 THROUGH C03-090

K090083 is an FDA 510(k) clearance for CYTOFLEX RESORB, manufactured by Unicare Biomedical, Inc.. The device is a Class 2 Dental device with product code LYC cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K090083 · Unicare Biomedical, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2009
Decision
70d
Days
Class 2
Risk

K090083 is an FDA 510(k) clearance for the CYTOFLEX RESORB, MODEL C03-0010 THROUGH C03-090. Classified as Bone Grafting Material, Synthetic (product code LYC), Class II - Special Controls.

Submitted by Unicare Biomedical, Inc. (Laguna Hills, US). The FDA issued a Cleared decision on March 23, 2009 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3930 - 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 - K090083

510(k) Number K090083 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 2009
Decision Date March 23, 2009
Days to Decision 70 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
58d faster than avg
Panel avg: 128d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LYC Device Classification - Class 2, Special Controls

Product Code LYC Bone Grafting Material, Synthetic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3930
Definition A Synthetic Bone Grafting Material Is Synthetically-derived Device, Such As Hydroxylapatite, Intended To Fill, Augment, Or Reconstruct Periodontal And Or Bony Defects Of The Upper Or Lower Jaw.
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 - LYC Bone Grafting Material, Synthetic

All 202
Devices cleared under the same product code (LYC) and FDA review panel - the closest regulatory comparables to K090083.
ACTIFUSE BONE GRAFT SUBSTITUTE, ACTIFUSE MICROGRANULES BONE GRAFT SUBSTITUTE
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BONGROS HA
K090793 · Bioalpha, Inc. · May 2009
BOND BONE
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NANGEL
K083005 · Teknimed, S.A. · Mar 2009
BIOACTYS
K082286 · Graftys · Feb 2009