Cleared Traditional

K982699 - UNIGRAFE

K982699 is an FDA 510(k) clearance for UNIGRAFE, 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 78-day FDA review.

K982699 · Unicare Biomedical · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1998
Decision
78d
Days
Class 2
Risk

K982699 is an FDA 510(k) clearance for the UNIGRAFE. 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 October 20, 1998 after a review of 78 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.

View all Unicare Biomedical devices

FDA 510(k) Submission Details - K982699

510(k) Number K982699 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 1998
Decision Date October 20, 1998
Days to Decision 78 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
49d faster than avg
Panel avg: 127d · This submission: 78d
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 127
Devices cleared under the same product code (LYC) and FDA review panel - the closest regulatory comparables to K982699.
FORTOSS-CEMA
K993238 · Biocomposites, Ltd. · Jan 2000
BIOMEND EXTEND ABSORBABLE COLLAGEN MEMBRANE, BIOMEND ABSORBABLE COLLAGEN MENBRANE
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NORIAN PERIODONTAL/DENTAL CEMENT (PDC)
K983104 · Norian Corp. · Feb 1999
BIO-OSS COLLAGEN
K974399 · Geistlich-Pharma · Sep 1998
BIO-OSS ANORGANIC BOVINE BONE
K970321 · Geistlich-Pharma · Sep 1998
RESOR-PIN RESORBABLE MEMBRANE PIN
K972817 · Geistlich-Pharma · Jul 1998