Cleared Traditional

K093615 - SPI DENTAL IMPLANT

K093615 is an FDA 510(k) clearance for SPI 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 101-day FDA review.

K093615 · Thommen Medical AG · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2010
Decision
101d
Days
Class 2
Risk

K093615 is an FDA 510(k) clearance for the SPI DENTAL IMPLANT, ELEMENT. 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 4, 2010 after a review of 101 days - within the typical 510(k) review window.

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 Thommen Medical AG devices

FDA 510(k) Submission Details - K093615

510(k) Number K093615 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2009
Decision Date March 04, 2010
Days to Decision 101 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
26d faster than avg
Panel avg: 127d · This submission: 101d
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 K093615.
TAPERED SCREW-VENT T IMPLANT
K101977 · Zimmer Dental, Inc. · Sep 2010
MODIFICATION TO: HG III ULTRA WIDE SYSTEM
K093889 · Hiossen, Inc. · Apr 2010
BIOHORIZONS LASER-LOK 3.0 IMPLANT SYSTEM
K093321 · BioHorizons Implant Systems, Inc. · Apr 2010
GS III SYSTEM
K091208 · Osstem Implant Co., Ltd. · Mar 2010
HG II SHORT FIXTURE SYSTEM
K091678 · Osstem Implant Co., Ltd. · Feb 2010
STRAUMANN RC TEMPORARY ABUTMENTS
K093027 · Straumann USA · Feb 2010