Cleared Traditional

K130216 - ATLANTIS STRAUMANN BONE LEVEL ABUTMENT (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K130216 · Dentsply Implant · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2013
Decision
92d
Days
Class 2
Risk

K130216 is an FDA 510(k) clearance for the ATLANTIS STRAUMANN BONE LEVEL ABUTMENT. 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 Dentsply Implant (San Diego, US). The FDA issued a Cleared decision on May 1, 2013 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. 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 Dentsply Implant devices

Submission Details

510(k) Number K130216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 2013
Decision Date May 01, 2013
Days to Decision 92 days
Submission Type Traditional
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
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 705
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K130216.
SIC Abutments including CAD/CAM Solutions
K252904 · Sic Invent AG · Jun 2026
Elos Accurate® Denture Fixation System
K253774 · Elos Medtech Pinol A/S · May 2026
ET Healing Abutments
K253372 · Hiossen, Inc. · May 2026
Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue
K260460 · Institut Straumann AG · May 2026
DESS Dental Smart Solutions
K253804 · Terrats Medical SL · Apr 2026
LOCATOR® Angled Abutment
K260555 · Zest Anchors, LLC · Apr 2026