Cleared Traditional

K896404 - TITAMED ANTWERP SYSTEM

K896404 is an FDA 510(k) clearance for TITAMED ANTWERP SYSTEM, manufactured by Optik. The device is a Class 2 Dental device with product code JEY cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K896404 · Optik · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1990
Decision
160d
Days
Class 2
Risk

K896404 is an FDA 510(k) clearance for the TITAMED ANTWERP SYSTEM. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Optik (Criftib, US). The FDA issued a Cleared decision on April 16, 1990 after a review of 160 days - an extended review 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: 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.

View all Optik devices

FDA 510(k) Submission Details - K896404

510(k) Number K896404 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1989
Decision Date April 16, 1990
Days to Decision 160 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 127d · This submission: 160d
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 255
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K896404.
LORENZ ULTRA-MICRO TITANIUM OSTEOSYNTHESIS SYSTEM
K910038 · Walter Lorenz Surgical, Inc. · Feb 1991
LUHR MICRO MESH
K901940 · Howmedica Corp. · Sep 1990
LUHR MANDIBULAR COMPRESSION/RECONSTRUCTION PLATES
K901941 · Howmedica Corp. · Sep 1990
STORZ CONTOURED ANATOMICAL PLATING INSTRUMENT
K873926 · Storz Instrument Co. · Feb 1988
DUMBACH TITANIUM MESH IMPLANT SYSTEM
K862532 · Walter Lorenz Surgical, Inc. · Sep 1986
MANUAL SURG. INSTRU. FOR PAULUS TITANIUM SYSTEM
K862505 · Walter Lorenz Surgical, Inc. · Aug 1986