Cleared Traditional

K983485 - SYNTHES 1.3 MM SELF-DRILLING SCREW

K983485 is an FDA 510(k) clearance for SYNTHES 1.3 MM SELF-DRILLING SCREW, manufactured by Synthes (Usa). The device is a Class 2 Dental device with product code DZL cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K983485 · Synthes (Usa) · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1998
Decision
77d
Days
Class 2
Risk

K983485 is an FDA 510(k) clearance for the SYNTHES 1.3 MM SELF-DRILLING SCREW. Classified as Screw, Fixation, Intraosseous (product code DZL), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on December 21, 1998 after a review of 77 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 Synthes (Usa) devices

FDA 510(k) Submission Details - K983485

510(k) Number K983485 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 1998
Decision Date December 21, 1998
Days to Decision 77 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
50d faster than avg
Panel avg: 127d · This submission: 77d
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 73
Devices cleared under the same product code (DZL) and FDA review panel - the closest regulatory comparables to K983485.
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
DRG SHERLOCK MF BONE SCREW, COCRMO SELF-TAPPING, TI ALLOY SELF-TAPPING/SELF DRILLING, COCRMO SELF-TAPPING/ SELF DRILLING
K981881 · Doctor'S Research Group, Inc. · Dec 1998
2.5 MM LACTOSORB SCREWS
K981666 · Biomet, Inc. · Nov 1998
QUICK TAP SELF DRILLING SCREW
K982927 · Kinamed, Inc. · Sep 1998