Cleared Traditional

THE AUTOTAC SYSTEM (K993493) - FDA 510(k) Clearance

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

K993493 · BioHorizons Implant Systems, Inc. · Dental device
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Optimized for regulatory review, auditing and printing
Jan 2000
Decision
84d
Days
Class 2
Risk

K993493 is an FDA 510(k) clearance for the THE AUTOTAC SYSTEM. Classified as Screw, Fixation, Intraosseous (product code DZL), Class II - Special Controls.

Submitted by BioHorizons Implant Systems, Inc. (Birmingham, US). The FDA issued a Cleared decision on January 7, 2000 after a review of 84 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 BioHorizons Implant Systems, Inc. devices

Submission Details

510(k) Number K993493 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1999
Decision Date January 07, 2000
Days to Decision 84 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
43d faster than avg
Panel avg: 127d · This submission: 84d
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 K993493.
SYNTHES (USA) IMF SCREWS
K010527 · Synthes (Usa) · Apr 2001
SYNTHES 1.5MM TI BROW LIFT SCREW
K002935 · Synthes (Usa) · Nov 2000
LACTOSORB PUSH SCREW
K002423 · Biomet, Inc. · Oct 2000
SYNTHES 1.3 MM SELF-DRILLING SCREW
K983485 · Synthes (Usa) · Dec 1998
2.5 MM LACTOSORB SCREWS
K981666 · Biomet, Inc. · Nov 1998
MEMBRANE TACK
K981459 · Biomet, Inc. · Jul 1998