Cleared Special

K093027 - STRAUMANN RC TEMPORARY ABUTMENTS

K093027 is an FDA 510(k) clearance for STRAUMANN RC TEMPORARY ABUTMENTS, manufactured by Straumann USA. The device is a Class 2 Dental device with product code DZE cleared through the Special 510(k) pathway after a 136-day FDA review.

K093027 · Straumann USA · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2010
Decision
136d
Days
Class 2
Risk

K093027 is an FDA 510(k) clearance for the STRAUMANN RC TEMPORARY ABUTMENTS. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Straumann USA (Andover, US). The FDA issued a Cleared decision on February 12, 2010 after a review of 136 days - within the typical 510(k) review window.

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. 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.

FDA 510(k) Submission Details - K093027

510(k) Number K093027 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2009
Decision Date February 12, 2010
Days to Decision 136 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
8d slower than avg
Panel avg: 128d · This submission: 136d
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 1549
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K093027.
SPI DENTAL IMPLANT, ELEMENT
K093615 · Thommen Medical AG · Mar 2010
GS III SYSTEM
K091208 · Osstem Implant Co., Ltd. · Mar 2010
HG II SHORT FIXTURE SYSTEM
K091678 · Osstem Implant Co., Ltd. · Feb 2010
BTI DENTAL IMPLANT 5.5-6.5
K091387 · B.T.I. Biotechnology Institute, Sl. · Jan 2010
ACE SURGICAL SECURE LOCATOR 3.25 IMPLANT SYSTEM
K093518 · Ace Surgical Supply Co., Inc. · Jan 2010
CHAMPIONS IMPLANTS GMBH MIMI 1-PIECE PRECISION IMPLANT, MODEL 1000 UP TO 6000
K091182 · Champions Implants GmbH · Jan 2010
K093027 · STRAUMANN RC TEMPORARY ABUTMENTS
Download PDF FDA Summary Straumann USA