Cleared Traditional

K840260 - PERIOGRAF DURAPATITE 40-60 MESH

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

K840260 · Sterling Drug, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K840260

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.

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 170
Devices cleared under the same product code (LYC) and FDA review panel - the closest regulatory comparables to K840260.
TOOTH ROOT SOCKET GAUGE
K843154 · Interpore Intl. · Oct 1984
ANTERIOR ALVEOLAR RIDGE SIZER
K843153 · Interpore Intl. · Sep 1984
POROUS HYDROXYAPATITE BG200
K841201 · Interpore Intl. · Aug 1984
SYNTHOGRAFT LG-AUGMENTATION & BONE FILL
K821752 · Depuy, Inc. · Aug 1982
HYDROXYLAPATITE
K811101 · Carbomedics, Inc. · Nov 1981
HYDROXYLAPATITE ALVEOLAR RIDGE MAIN
K810382 · Carbomedics, Inc. · Mar 1981