Cleared Traditional

K002619 - NEWGEN SYSTEM

K002619 is the FDA 510(k) clearance for NEWGEN SYSTEM by Stryker Instruments. It is a Class 2 Dental device (product code JEY) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K002619 · Stryker Instruments · Dental device
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Nov 2000
Decision
85d
Days
Class 2
Risk

K002619 is an FDA 510(k) clearance for the NEWGEN SYSTEM. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Stryker Instruments (Kalamazoo, US). The FDA issued a Cleared decision on November 16, 2000 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4760 - 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 Stryker Instruments devices

Submission Details

510(k) Number K002619 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2000
Decision Date November 16, 2000
Days to Decision 85 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
42d faster than avg
Panel avg: 127d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JEY Plate, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4760
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 - JEY Plate, Bone

All 156
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K002619.
SYNTHES (USA) RESORBABLE TACK SYSTEM
K000560 · Synthes (Usa) · Jan 2001
LEIBINGER NEURO CLIP SYSTEM
K003660 · Stryker Instruments · Dec 2000
CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM DRILL BITS
K002798 · Codman & Shurtleff, Inc. · Dec 2000
CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM
K992905 · Codman & Shurtleff, Inc. · Aug 2000
LORENZ TITANIUM FRACTURE / RECONSTRUCTION PLATING SYSTEM
K001238 · Walter Lorenz Surgical, Inc. · May 2000
MOD LINE OF MOLINA DISTRACTORS, 51-600 SERIES
K994154 · KLS-Martin L.P. · Feb 2000