Cleared Traditional

K141764 - TRISTAR BONE GRAFT FIXATION SYSTEM

K141764 is an FDA 510(k) clearance for TRISTAR BONE GRAFT FIXATION SYSTEM, manufactured by Impladent , Ltd.. The device is a Class 2 Dental device with product code JEY cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K141764 · Impladent , Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2014
Decision
170d
Days
Class 2
Risk

K141764 is an FDA 510(k) clearance for the TRISTAR BONE GRAFT FIXATION SYSTEM. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Impladent , Ltd. (Hollis, US). The FDA issued a Cleared decision on December 18, 2014 after a review of 170 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 Impladent , Ltd. devices

FDA 510(k) Submission Details - K141764

510(k) Number K141764 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2014
Decision Date December 18, 2014
Days to Decision 170 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d slower than avg
Panel avg: 127d · This submission: 170d
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 230
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