Cleared Traditional

K923419 - TISMESH SYSTEM

K923419 is an FDA 510(k) clearance for TISMESH SYSTEM, manufactured by Ti-Mesh, Inc.. The device is a Class 2 Dental device with product code JEY cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K923419 · Ti-Mesh, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1993
Decision
269d
Days
Class 2
Risk

K923419 is an FDA 510(k) clearance for the TISMESH SYSTEM. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Ti-Mesh, Inc. (Las Vegas, US). The FDA issued a Cleared decision on April 8, 1993 after a review of 269 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 Ti-Mesh, Inc. devices

FDA 510(k) Submission Details - K923419

510(k) Number K923419 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 1992
Decision Date April 08, 1993
Days to Decision 269 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
142d slower than avg
Panel avg: 127d · This submission: 269d
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 258
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K923419.
MICRO OSTEOSYNTHESIS SYSTEM (1.0)
K944561 · KLS-Martin L.P. · Oct 1994
KLS-MARTIN MICRO OSTEOSYTHESIS SYSTEM(1.5MM)
K944565 · KLS-Martin L.P. · Oct 1994
AESCULAP CRANIOFACIAL TITANIUM PLATES AND SCREWS
K923705 · Aesculap, Inc. · Feb 1994
OSTEOMED M3 SYSTEM (SBF SYSTEM)
K924138 · Osteomed Corp. · Feb 1993
LORENZ 1.0 MM SYSTEM
K922741 · Walter Lorenz Surgical, Inc. · Dec 1992
MODIFICATION TECHMEDICA MP (MINIPLATING) SYSTEM
K921801 · Techmedica, Inc. · Jul 1992