Cleared Special

K070007 - SPI ELEMENT PLATFORM O 4.0 MM

K070007 is an FDA 510(k) clearance for SPI ELEMENT 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 7-day FDA review.

K070007 · Thommen Medical AG · Dental device
Download Printable Device Report (PDF)
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Jan 2007
Decision
7d
Days
Class 2
Risk

K070007 is an FDA 510(k) clearance for the SPI ELEMENT 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 January 10, 2007 after a review of 7 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 - K070007

510(k) Number K070007 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2007
Decision Date January 10, 2007
Days to Decision 7 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
120d faster than avg
Panel avg: 127d · This submission: 7d
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 758
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K070007.
CERTAIN PREVAIL DENTAL IMPLANT
K061629 · Implant Innovations, Inc. · Feb 2007
NANOTITE DENTAL IMPLANTS
K062432 · Implant Innovations, Inc. · Feb 2007
ZIMMER ONE PIECE IMPLANT, 3.7MM AND 4.7MM, MODELS ZOP37S10, 11, 13, 16
K063523 · Zimmer Dental, Inc. · Feb 2007
SFB AND CFB IMPLANTS - 5.0 PLATFORM
K063718 · Nobel Biocare AB · Jan 2007
NOBELPERFECT CONICAL CONNECTION
K062936 · Nobel Biocare AB · Dec 2006
US SYSTEM
K062030 · Osstem Implant Co., Ltd. · Nov 2006