Cleared Traditional

K840260 - PERIOGRAF DURAPATITE 40-60 MESH

K840260 is the FDA 510(k) clearance for PERIOGRAF DURAPATITE 40-60 MESH by Sterling Drug, Inc.. It is a Class 2 Dental device (product code LYC) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K840260 · Sterling Drug, Inc. · Dental device
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Apr 1984
Decision
86d
Days
Class 2
Risk

K840260 is an FDA 510(k) clearance for the PERIOGRAF DURAPATITE 40-60 MESH. Classified as Bone Grafting Material, Synthetic (product code LYC), Class II - Special Controls.

Submitted by Sterling Drug, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 5, 1984 after a review of 86 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 Sterling Drug, Inc. devices

Submission Details

510(k) Number K840260 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1984
Decision Date April 05, 1984
Days to Decision 86 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 127d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.