Cleared Traditional

K140908 - JUGGERKNOT MINI SOFT ANCHOR

K140908 is an FDA 510(k) clearance for JUGGERKNOT MINI SOFT ANCHOR, manufactured by Biomet Sports Medicine. The device is a Class 2 Dental device with product code DZL cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K140908 · Biomet Sports Medicine · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2014
Decision
176d
Days
Class 2
Risk

K140908 is an FDA 510(k) clearance for the JUGGERKNOT MINI SOFT ANCHOR. Classified as Screw, Fixation, Intraosseous (product code DZL), Class II - Special Controls.

Submitted by Biomet Sports Medicine (Warsaw, US). The FDA issued a Cleared decision on October 2, 2014 after a review of 176 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 Biomet Sports Medicine devices

FDA 510(k) Submission Details - K140908

510(k) Number K140908 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 2014
Decision Date October 02, 2014
Days to Decision 176 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
49d slower than avg
Panel avg: 127d · This submission: 176d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DZL Device Classification - Class 2, Special Controls

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 72
Devices cleared under the same product code (DZL) and FDA review panel - the closest regulatory comparables to K140908.
Neo GBR System
K160991 · Neobiotech Co., Ltd. · Jan 2017
MC BIO Supertack Tack 3mm, 4mm and 5mm
K151540 · Eli-Ka Technologies · May 2016
OsteoMed IMF Screw
K151195 · Osteomed · Sep 2015
DENTAL BONE SCREWS
K132212 · Hager& Meisinger GmbH · Feb 2014
MEISINGER TACS (MEISINGER MEITAC-KIT), MEISINGER PINS (MEISINGER MASTER-PIN-CONTROL-KIT, BASIC-KIT
K130682 · Hager& Meisinger GmbH · Aug 2013
J TAC MODEL JT-MD-035, JT-MD-040, JT-MD-045, JT-CL-030
K101902 · Jeil Medical Corporation · Feb 2011