Cleared Traditional

K993327 - TALON ANCHOR SNAP-PAK

K993327 is an FDA 510(k) clearance for TALON ANCHOR SNAP-PAK, manufactured by Mitek Products. The device is a Class 2 Dental device with product code DZL cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K993327 · Mitek Products · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1999
Decision
73d
Days
Class 2
Risk

K993327 is an FDA 510(k) clearance for the TALON ANCHOR SNAP-PAK. Classified as Screw, Fixation, Intraosseous (product code DZL), Class II - Special Controls.

Submitted by Mitek Products (Westwood, US). The FDA issued a Cleared decision on December 16, 1999 after a review of 73 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Mitek Products devices

FDA 510(k) Submission Details - K993327

510(k) Number K993327 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1999
Decision Date December 16, 1999
Days to Decision 73 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
54d faster than avg
Panel avg: 127d · This submission: 73d
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 76
Devices cleared under the same product code (DZL) and FDA review panel - the closest regulatory comparables to K993327.
THE AUTOTAC SYSTEM
K993493 · BioHorizons Implant Systems, Inc. · Jan 2000
RESOLVE QUICKANCHOR
K993575 · Mitek Products · Dec 1999
KLS-MARTIN MMF SCREW
K980760 · KLS-Martin L.P. · Dec 1999
MITEK MINI ANCHOR
K992623 · Mitek Products · Nov 1999
IMTEC BIOPIN
K982951 · Imtec Corp. · Jun 1999
LORENZ IMF SCREW
K983728 · Walter Lorenz Surgical, Inc. · May 1999