Cleared Special

K041295 - RN SYNOCTA UCLA GOLD ABUTMENT FOR THE S...

K041295 is the FDA 510(k) clearance for RN SYNOCTA UCLA GOLD ABUTMENT FOR THE S... by Institut Straumann AG. It is a Class 2 Dental device (product code NHA) cleared through the Special 510(k) pathway after a 10-day FDA review.

K041295 · Institut Straumann AG · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2004
Decision
10d
Days
Class 2
Risk

K041295 is an FDA 510(k) clearance for the RN SYNOCTA UCLA GOLD ABUTMENT FOR THE STRAUMANN DENTAL IMPLANT. 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 Institut Straumann AG (Waltham, US). The FDA issued a Cleared decision on May 24, 2004 after a review of 10 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 Institut Straumann AG devices

Submission Details

510(k) Number K041295 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2004
Decision Date May 24, 2004
Days to Decision 10 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
117d faster than avg
Panel avg: 127d · This submission: 10d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 468
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K041295.
ZIMMER DENTAL HEX-LOCK PREPARED ABUTMENT (STRAIGHT & ANGLED)
K052600 · Zimmer Dental, Inc. · Oct 2005
PROCERA IMPLANT BRIDGE, MODELS 15-1001, 15-1002, 15-1051, 15-1052
K043042 · Nobel Biocare AB · Nov 2004
PROCERA IMPLANT BRIDGE, MODELS 15-1001, 15-1002, 15-1051, 15-1052
K041236 · Nobel Biocare AB · May 2004
3I PATIENT-SPECIFIC OVERDENTURE BAR
K034035 · Implant Innovations, Inc. · Mar 2004
ELLIPTIC MATRIX
K040539 · Institut Straumann AG · Mar 2004
ITI SYNOCTA MESO ABUTMENTS
K033243 · Straumann USA · Oct 2003