Cleared Special

K092248 - SPI CUSTOMIZABLE GINGIVA FORMER

K092248 is an FDA 510(k) clearance for SPI CUSTOMIZABLE GINGIVA FORMER, 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 59-day FDA review.

K092248 · Thommen Medical AG · Dental device
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Sep 2009
Decision
59d
Days
Class 2
Risk

K092248 is an FDA 510(k) clearance for the SPI CUSTOMIZABLE GINGIVA FORMER. 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 September 25, 2009 after a review of 59 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 - K092248

510(k) Number K092248 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 2009
Decision Date September 25, 2009
Days to Decision 59 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
68d faster than avg
Panel avg: 127d · This submission: 59d
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
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K092248.
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