Cleared Special

K101798 - SPI VARIOMULTI ANGLED ABUTMENT

K101798 is an FDA 510(k) clearance for SPI VARIOMULTI ANGLED ABUTMENT, manufactured by Thommen Medical AG. The device is a Class 2 Dental device with product code NHA cleared through the Special 510(k) pathway after a 52-day FDA review.

K101798 · Thommen Medical AG · Dental device
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Aug 2010
Decision
52d
Days
Class 2
Risk

K101798 is an FDA 510(k) clearance for the SPI VARIOMULTI ANGLED ABUTMENT. Classified as Abutment, Implant, Dental, Endosseous within the NHA classification (a category for dental implant abutments and prosthetic components), Class II - Special Controls.

Submitted by Thommen Medical AG (San Diego, US). The FDA issued a Cleared decision on August 19, 2010 after a review of 52 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3630 - 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 - K101798

510(k) Number K101798 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 2010
Decision Date August 19, 2010
Days to Decision 52 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
75d faster than avg
Panel avg: 127d · This submission: 52d
Pathway characteristics
Modification to existing cleared device.

NHA Device Classification - Class 2, Special Controls

Product Code NHA Abutment, Implant, Dental, Endosseous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3630
Definition To Be Used In Conjunction With An Endosseous Dental Implant Fixture To Aid In Prosthetic Rehabilitation.
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 - NHA Abutment, Implant, Dental, Endosseous

All 533
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