Cleared Traditional

Intra-Lock Bone Fixation System (K171831) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K171831 · Intra-Lock International, Inc. · Dental device
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Oct 2017
Decision
128d
Days
Class 2
Risk

K171831 is an FDA 510(k) clearance for the Intra-Lock Bone Fixation System. Classified as Screw, Fixation, Intraosseous (product code DZL), Class II - Special Controls.

Submitted by Intra-Lock International, Inc. (Boca Raton, US). The FDA issued a Cleared decision on October 26, 2017 after a review of 128 days - within the typical 510(k) review window.

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 Intra-Lock International, Inc. devices

Submission Details

510(k) Number K171831 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2017
Decision Date October 26, 2017
Days to Decision 128 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
1d slower than avg
Panel avg: 127d · This submission: 128d
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 31
Devices cleared under the same product code (DZL) and FDA review panel - the closest regulatory comparables to K171831.
Membrane Screws and Membrane Tacks
K201561 · Neoss Limited · Oct 2020
Bone Screw, Bone Tack
K182881 · Osstem Implant Co., Ltd. · Aug 2019
OssBuilder System
K181854 · Osstem Implant Co., Ltd. · May 2019
RAPIDSORB PLUS SCREW SYSTEM
K093464 · Synthes (Usa) · Jan 2010
SYNTHES 1.0MM TI. CORTEX, SELF-DRILLING SCREWS (CARNIOFACIAL)
K050606 · Synthes (Usa) · Apr 2005
SYNTHES (USA) 1.0/1.22 MM CRANIOFACIAL SCREWS
K041887 · Synthes (Usa) · Aug 2004