Cleared Traditional

K193529 - ATLANTIS Abutment for MIS Conical Conne...

K193529 is the FDA 510(k) clearance for ATLANTIS Abutment for MIS Conical Conne... by Dentsply Sirona. It is a Class 2 Dental device (product code NHA) cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K193529 · Dentsply Sirona · Dental device
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Optimized for regulatory review, auditing and printing
Mar 2020
Decision
76d
Days
Class 2
Risk

K193529 is an FDA 510(k) clearance for the ATLANTIS Abutment for MIS Conical Connection Implants. 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 Sirona (York, US). The FDA issued a Cleared decision on March 5, 2020 after a review of 76 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dentsply Sirona devices

Submission Details

510(k) Number K193529 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2019
Decision Date March 05, 2020
Days to Decision 76 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
51d faster than avg
Panel avg: 127d · This submission: 76d
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 463
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K193529.
MIS CONNECT Conical Connection System
K193078 · Dentsply Sirona · Mar 2020
Sherlock
K193335 · Open Implants, LLC · Mar 2020
Pre-Milled Blank
K193425 · Arum Dentistry Co., Ltd. · Mar 2020
Atlantis suprastructures
K193064 · Dentsply Sirona, Inc. · Mar 2020
Rodo Abutment System
K193274 · Rodo Medical, Inc. · Feb 2020
Luna Dental Implant System- Healing Abutment
K200189 · Shinhung Mst Co., Ltd. · Feb 2020