Cleared Traditional

ENHANCE (K861041) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K861041 · Packaging Technologies, Inc. · Dental device
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May 1986
Decision
73d
Days
Class 2
Risk

K861041 is an FDA 510(k) clearance for the ENHANCE. Classified as Bone Grafting Material, Synthetic (product code LYC), Class II - Special Controls.

Submitted by Packaging Technologies, Inc. (Brea, US). The FDA issued a Cleared decision on May 30, 1986 after a review of 73 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 Packaging Technologies, Inc. devices

Submission Details

510(k) Number K861041 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1986
Decision Date May 30, 1986
Days to Decision 73 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 127d · This submission: 73d
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.

Regulatory Peers - LYC Bone Grafting Material, Synthetic

All 25
Devices cleared under the same product code (LYC) and FDA review panel - the closest regulatory comparables to K861041.
RESOLUT REGENERATIVE MATERIAL
K970884 · W.L. Gore & Associates, Inc. · May 1997
RESOLUT REGENERATIVE MATERIAL
K962624 · W.L. Gore & Associates, Inc. · Oct 1996
RESOLUT REGENERATIVE MATERIAL
K932866 · W.L. Gore & Associates, Inc. · Mar 1995
HYDROXYAPATITE
K842718 · Depuy, Inc. · Nov 1984
SYNTHOGRAFT LG-AUGMENTATION & BONE FILL
K821752 · Depuy, Inc. · Aug 1982