Cleared Traditional

K101902 - J TAC MODEL JT-MD-035

K101902 is the FDA 510(k) clearance for J TAC MODEL JT-MD-035 by Jeil Medical Corporation. It is a Class 2 Dental device (product code DZL) cleared through the Traditional 510(k) pathway after a 215-day FDA review.

K101902 · Jeil Medical Corporation · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2011
Decision
215d
Days
Class 2
Risk

K101902 is an FDA 510(k) clearance for the J TAC MODEL JT-MD-035, JT-MD-040, JT-MD-045, JT-CL-030. Classified as Screw, Fixation, Intraosseous (product code DZL), Class II - Special Controls.

Submitted by Jeil Medical Corporation (Marietta, US). The FDA issued a Cleared decision on February 8, 2011 after a review of 215 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4880 - 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 Jeil Medical Corporation devices

Submission Details

510(k) Number K101902 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 2010
Decision Date February 08, 2011
Days to Decision 215 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
88d slower than avg
Panel avg: 127d · This submission: 215d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DZL Screw, Fixation, Intraosseous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4880
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 - DZL Screw, Fixation, Intraosseous

All 41
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