Cleared Traditional

K003045 - HA-TI (HAND TITANIUM SCREW) IMPLANT

K003045 is an FDA 510(k) clearance for HA-TI (HAND TITANIUM SCREW) IMPLANT, manufactured by Hati Dental Ag.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 286-day FDA review.

K003045 · Hati Dental Ag. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2001
Decision
286d
Days
Class 2
Risk

K003045 is an FDA 510(k) clearance for the HA-TI (HAND TITANIUM SCREW) IMPLANT. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Hati Dental Ag. (Ridley Park, US). The FDA issued a Cleared decision on July 12, 2001 after a review of 286 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - 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 Hati Dental Ag. devices

FDA 510(k) Submission Details - K003045

510(k) Number K003045 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2000
Decision Date July 12, 2001
Days to Decision 286 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
159d slower than avg
Panel avg: 127d · This submission: 286d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DZE Device Classification - Class 2, Special Controls

Product Code DZE Implant, Endosseous, Root-form
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3640
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 - DZE Implant, Endosseous, Root-form

All 1164
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K003045.
QUANTUM VERSATILITY IMPLANT SYSTEM
K991250 · Quantum Bioengineering, Ltd. · Sep 2001
ITI DENTAL IMPLANT SYSTEM
K012757 · Straumann USA · Aug 2001
ALLFIT IMPLANT SYSTEM, SHORT NECK, MODEL STI RT LENGTH, ALLFIT IMPLANT SYSTEM, LONG NECK, MODEL STI RT LN LENGTH
K991822 · Dr. Ihde Dental AG Switzerland · Aug 2001
LIFECORE BIOMEDICAL DENTAL IMPLANT SYSTEMS
K002037 · Lifecore Biomedical, Inc. · May 2001
ITI DENTAL IMPLANT SYSTEM
K010291 · Straumann USA · May 2001
THE MAESTRO SYSTEM
K010458 · BioHorizons Implant Systems, Inc. · May 2001