Cleared Traditional

K993784 - UNIGRAFT

K993784 is an FDA 510(k) clearance for UNIGRAFT, manufactured by Unicare Biomedical. The device is a Class 2 Dental device with product code LYC cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K993784 · Unicare Biomedical · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2000
Decision
80d
Days
Class 2
Risk

K993784 is an FDA 510(k) clearance for the UNIGRAFT. Classified as Bone Grafting Material, Synthetic (product code LYC), Class II - Special Controls.

Submitted by Unicare Biomedical (Laguna Hills, US). The FDA issued a Cleared decision on January 27, 2000 after a review of 80 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 - K993784

510(k) Number K993784 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1999
Decision Date January 27, 2000
Days to Decision 80 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
48d faster than avg
Panel avg: 128d · This submission: 80d
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 214
Devices cleared under the same product code (LYC) and FDA review panel - the closest regulatory comparables to K993784.
SYNTHETIC GLASS BONE GRAFT MATERIAL
K000633 · Blue Sky Bio · May 2000
CYTOPLAST RESORB, MODELS R-250, RP-250, RU-250, RPS-250, RPL-250
K993610 · Osteogenics Biomedical, Inc. · Mar 2000
NOVABONE-BIOGLASS BONE GRAFT PARTICULATE
K000149 · Usbiomaterials Corp. · Feb 2000
FORTOSS-CEMA
K993238 · Biocomposites, Ltd. · Jan 2000
OSTEO-PIN MEMBRANE FIXATION PIN
K990537 · Luitpold Pharmaceuticals, Inc. · Nov 1999
PERIOGLAS- BIOGLASS BONE GRAFT PARTICULATE
K992416 · Usbiomaterials Corp. · Oct 1999
K993784 · UNIGRAFT
Download PDF FDA Summary Unicare Biomedical