Cleared Traditional

K033984 - STRAUMANN DENTAL IMPLANT SYSTEM

K033984 is an FDA 510(k) clearance for STRAUMANN DENTAL IMPLANT SYSTEM, manufactured by Institut Straumann AG. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 190-day FDA review.

K033984 · Institut Straumann AG · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2004
Decision
190d
Days
Class 2
Risk

K033984 is an FDA 510(k) clearance for the STRAUMANN DENTAL IMPLANT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Institut Straumann AG (Waltham, US). The FDA issued a Cleared decision on June 30, 2004 after a review of 190 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 Institut Straumann AG devices

FDA 510(k) Submission Details - K033984

510(k) Number K033984 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2003
Decision Date June 30, 2004
Days to Decision 190 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
63d slower than avg
Panel avg: 127d · This submission: 190d
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 1189
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K033984.
ACE CONNECT INTERNAL CONNECTION
K041759 · Ace Surgical Supply Co., Inc. · Jul 2004
MAXIMUS OS (OVERDENTURE SYSTEM)
K041938 · BioHorizons Implant Systems, Inc. · Jul 2004
ANKYLOS DENTAL IMPLANT SYSTEM
K040946 · Friadent GmbH · Jul 2004
MODIFICATION TO OSSEOTITE NT CERTAIN IMPLANTS
K041402 · Implant Innovations, Inc. · Jun 2004
KLS MARTIN ORTHO ANCHORAGE SYSTEM (PLATES)
K040891 · KLS-Martin L.P. · May 2004
LORENZ SELF-DRILLING IMF SCREW
K040983 · Walter Lorenz Surgical, Inc. · May 2004