Cleared Traditional

K011028 - SCREW-VENT DENTAL IMPLANT SYSTEM

K011028 is an FDA 510(k) clearance for SCREW-VENT DENTAL IMPLANT SYSTEM, manufactured by Sulzer Dental, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K011028 · Sulzer Dental, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2001
Decision
46d
Days
Class 2
Risk

K011028 is an FDA 510(k) clearance for the SCREW-VENT DENTAL IMPLANT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Sulzer Dental, Inc. (Carlsbad, US). The FDA issued a Cleared decision on May 21, 2001 after a review of 46 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K011028

510(k) Number K011028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2001
Decision Date May 21, 2001
Days to Decision 46 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
82d faster than avg
Panel avg: 128d · This submission: 46d
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 K011028.
HA-TI (HAND TITANIUM SCREW) IMPLANT
K003045 · Hati Dental Ag. · Jul 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
LIFECORE BIOMEDICAL DENTAL IMPLANT SYSTEMS
K002037 · Lifecore Biomedical, Inc. · May 2001
TAPER-LOCK DENTAL IMPLANT SYSTEM
K011038 · Sulzer Dental, Inc. · May 2001
ITI DENTAL IMPLANT SYSTEM
K010291 · Straumann USA · May 2001
K011028 · SCREW-VENT DENTAL IMPLANT SYSTEM
Download PDF FDA Summary Sulzer Dental, Inc.