Cleared Special

K072933 - SPI CONTACT PLATFORM O 4.0 MM

K072933 is an FDA 510(k) clearance for SPI CONTACT PLATFORM O 4.0 MM, manufactured by Thommen Medical AG. The device is a Class 2 Dental device with product code DZE cleared through the Special 510(k) pathway after a 30-day FDA review.

K072933 · Thommen Medical AG · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2007
Decision
30d
Days
Class 2
Risk

K072933 is an FDA 510(k) clearance for the SPI CONTACT PLATFORM O 4.0 MM. 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 November 15, 2007 after a review of 30 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Thommen Medical AG devices

FDA 510(k) Submission Details - K072933

510(k) Number K072933 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 2007
Decision Date November 15, 2007
Days to Decision 30 days
Submission Type Special
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
98d faster than avg
Panel avg: 128d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 1372
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K072933.
SPI SYSTEM DENTAL IMPLANTS
K072649 · Thommen Medical AG · Dec 2007
IMPLUS IMPLANT SYSTEM
K062931 · Leader Italia S.R.L. · Nov 2007
ENDOSSEOUS DENTAL IMPLANT SYSTEM
K071161 · Southern Implants, Inc. · Nov 2007
T.B.R. ZIRCONNECT
K070935 · Sudimplant SA · Nov 2007
SM INTERNAL./EXTERNAL IMPLANT SYSTEM
K070569 · Dio Department Dsi, Inc. · Nov 2007
GS FIXTURE SYSTEM
K072896 · Osstem Implant Co., Ltd. · Nov 2007