Cleared Traditional

K034014 - SPI CONTACT DENTAL IMPLANT

K034014 is an FDA 510(k) clearance for SPI CONTACT DENTAL IMPLANT, manufactured by Thommen Medical AG. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K034014 · Thommen Medical AG · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2004
Decision
72d
Days
Class 2
Risk

K034014 is an FDA 510(k) clearance for the SPI CONTACT DENTAL IMPLANT. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Thommen Medical AG (San Diego, US). The FDA issued a Cleared decision on March 5, 2004 after a review of 72 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.

View all Thommen Medical AG devices

FDA 510(k) Submission Details - K034014

510(k) Number K034014 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 2003
Decision Date March 05, 2004
Days to Decision 72 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
55d faster than avg
Panel avg: 127d · This submission: 72d
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 758
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K034014.
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
DUAL TOP ANCHOR SYSTEM SCREWS
K033767 · Jeil Medical Corporation · Feb 2004
TEETH IN AN HOUR - ARK IMPLANT CONCEPT
K030685 · Nobel Biocare AB · Feb 2004
3I PATIENT-SPECIFIC DENTAL ABUTMENT AND OVERDENTURE BAR
K032263 · Implant Innovations, Inc. · Jan 2004