Cleared Traditional

K093643 - MULTI- UNIT ABUTMENTS FOR STRAUMANN AND...

K093643 is the FDA 510(k) clearance for MULTI- UNIT ABUTMENTS FOR STRAUMANN AND... by Nobel Biocare AB. It is a Class 2 Dental device (product code NHA) cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K093643 · Nobel Biocare AB · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2010
Decision
211d
Days
Class 2
Risk

K093643 is an FDA 510(k) clearance for the MULTI- UNIT ABUTMENTS FOR STRAUMANN AND ASTRA TECH IMPLANT SYSTEMS. 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 Nobel Biocare AB (Yorba Linda,, US). The FDA issued a Cleared decision on June 24, 2010 after a review of 211 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3630 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Nobel Biocare AB devices

Submission Details

510(k) Number K093643 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2009
Decision Date June 24, 2010
Days to Decision 211 days
Submission Type Traditional
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
84d slower than avg
Panel avg: 127d · This submission: 211d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 408
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K093643.
STRAUMANN CARES BRIDGE
K101465 · Institut Straumann AG · Dec 2010
NOBELPROCERA TI ABUTMENT THOMMEN PLATFORMS
K101714 · Nobel Biocare AB · Aug 2010
HS/HG PROSTHETIC SYSTEM
K100245 · Osstem Implant Co., Ltd. · Aug 2010
STRAUMANN MODIFIED DENTAL ABUTMENT
K091701 · Institut Straumann AG · Dec 2009
ETKON ES1, MODEL 019.0001, ETKON VISUAL, STRAUMANN CADCAM ABUTMENT
K093113 · Institut Straumann AG · Dec 2009
NOBEL/PROCERA IMPLANT BRIDGE
K091848 · Nobel Biocare AB · Oct 2009