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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
158d slower than avg
Panel avg: 128d · 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 1546
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K003045.
ITI DENTAL IMPLANT SYSTEM
K003552 · Institut Straumann SA · 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
MODIFICATION TO: STRAIGHT POST AND CORE II FOR THE BASIC DENTAL IMPLANT SYSTEM
K012299 · Basic Dental Implant Systems, Inc. · Aug 2001
TITANIUM ABUTMENT HEADS FOR IMZ IMPLANTS
K003818 · Titan Implants · Jul 2001
ADVENT IMPLANT SYSTEM, SWISS PLUS IMPLANT SYSTEM
K011245 · Sulzer Dental, Inc. · Jun 2001
SCREW-VENT DENTAL IMPLANT SYSTEM
K011028 · Sulzer Dental, Inc. · May 2001
K003045 · HA-TI (HAND TITANIUM SCREW) IMPLANT
Download PDF FDA Summary Hati Dental Ag.