Cleared Special

K092814 - STRAUMANN DENTAL ABUTMENTS

K092814 is an FDA 510(k) clearance for STRAUMANN DENTAL ABUTMENTS, manufactured by Straumann Manufacturing, Inc.. The device is a Class 2 Dental device with product code NHA cleared through the Special 510(k) pathway after a 92-day FDA review.

K092814 · Straumann Manufacturing, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2009
Decision
92d
Days
Class 2
Risk

K092814 is an FDA 510(k) clearance for the STRAUMANN DENTAL ABUTMENTS. 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 Straumann Manufacturing, Inc. (Andover, US). The FDA issued a Cleared decision on December 15, 2009 after a review of 92 days - within the typical 510(k) review window.

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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Straumann Manufacturing, Inc. devices

FDA 510(k) Submission Details - K092814

510(k) Number K092814 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2009
Decision Date December 15, 2009
Days to Decision 92 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 127d · This submission: 92d
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 567
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K092814.
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