Cleared Traditional

K151540 - MC BIO Supertack Tack 3mm

K151540 is an FDA 510(k) clearance for MC BIO Supertack Tack 3mm, manufactured by Eli-Ka Technologies. The device is a Class 2 Dental device with product code DZL cleared through the Traditional 510(k) pathway after a 353-day FDA review.

K151540 · Eli-Ka Technologies · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2016
Decision
353d
Days
Class 2
Risk

K151540 is an FDA 510(k) clearance for the MC BIO Supertack Tack 3mm, 4mm and 5mm. Classified as Screw, Fixation, Intraosseous (product code DZL), Class II - Special Controls.

Submitted by Eli-Ka Technologies (Monrovia, US). The FDA issued a Cleared decision on May 26, 2016 after a review of 353 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Eli-Ka Technologies devices

FDA 510(k) Submission Details - K151540

510(k) Number K151540 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2015
Decision Date May 26, 2016
Days to Decision 353 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
226d slower than avg
Panel avg: 127d · This submission: 353d
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 57
Devices cleared under the same product code (DZL) and FDA review panel - the closest regulatory comparables to K151540.
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
J TAC MODEL JT-MD-035, JT-MD-040, JT-MD-045, JT-CL-030
K101902 · Jeil Medical Corporation · Feb 2011
RAPIDSORB PLUS SCREW SYSTEM
K093464 · Synthes (Usa) · Jan 2010
MILTEX MEMBRANE TACK KIT
K092855 · Miltex, Inc. · Dec 2009