Cleared Traditional

K951690 - TITANIUM MINIPLATE SYSTEM

K951690 is an FDA 510(k) clearance for TITANIUM MINIPLATE SYSTEM, manufactured by Medicon EG. The device is a Class 2 Dental device with product code JEY cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K951690 · Medicon EG · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 1995
Decision
112d
Days
Class 2
Risk

K951690 is an FDA 510(k) clearance for the TITANIUM MINIPLATE SYSTEM. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Medicon EG (Black Diamond, US). The FDA issued a Cleared decision on July 26, 1995 after a review of 112 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K951690

510(k) Number K951690 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 1995
Decision Date July 26, 1995
Days to Decision 112 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
16d faster than avg
Panel avg: 128d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JEY Device Classification - Class 2, Special Controls

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 283
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K951690.
MESH TITANIUM IMPLANT SYSTEM
K951687 · Medicon EG · Jul 1995
TITANIUM MANDIBULAT RECONSTRUCTION SYSTEM
K951689 · Medicon EG · Jul 1995
MICRO TITANIUM PLATE SYSTEM
K951688 · Medicon EG · Jul 1995
CMS CRANIO MAXILLO FACIAL TITANIUM IMPLANT SYSTEM
K951691 · Medicon EG · Jul 1995
LUHR MANDIBULAR/SMALL FIXATION IMPLANTS
K950595 · Howmedica Corp. · Jul 1995
MINIBONEPLATE SYSTEM
K951392 · Ace Surgical Supply Co., Inc. · May 1995