Atlantis Isus
FDA 510(k) K151439 · Dentsply International, Inc.
510(k) numberK151439
Submission
- Device name
- Atlantis Isus
- Applicant
- Dentsply International, Inc.
York, PA, US - Received
- May 29, 2015
- Decision date
- February 19, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code NHA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253999 | Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC…NHA · Traditional | Nobel Biocare AB | 08/06/2026SE |
| K261147 | Neodent Implant System - NeoConvert FitNHA · Traditional | JJGC Indústria e Comércio de Materiais Dentários… | 07/01/2026SE |
| K261122 | Mist IcNHA · Traditional | Imagine Milling Technologies, LLC | 06/27/2026SE |
| K260061 | BioHorizons CEREC Compatible Ti-BasesNHA · Traditional | BioHorizons Implant Systems, Inc. | 06/26/2026SE |
| K253922 | Neodent Scannable Healing AbutmentNHA · Traditional | JJGC Indústria e Comércio de Materiais Dentários… | 06/15/2026SE |
| K254145 | Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut)NHA · Abbreviated | Smart Denture Conversions, LLC | 06/11/2026SE |
| K260564 | DESS Dental Smart SolutionsNHA · Traditional | Terrats Medical SL | 06/09/2026SE |
| K252904 | SIC Abutments including CAD/CAM SolutionsNHA · Traditional | Sic Invent AG | 06/03/2026SE |
| K253774 | Elos Accurate® Denture Fixation SystemNHA · Traditional | Elos Medtech Pinol A/S | 05/20/2026SE |
| K253372 | ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsNHA · Traditional | Hiossen, Inc. | 05/14/2026SE |
More from Hiossen, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K160207 | ATLANTIS ISUS Implant SuprastructuresNHA · Traditional | 09/21/2016SE |
| K160232 | Disposable Barrier Sleeves and CoversPEM · Traditional | 06/07/2016SE |
| K152247 | ATLANTIS CrownEIH · Traditional | 01/29/2016SE |
| K151039 | ATLANTIS Abutment for NobelActive 3.0NHA · Traditional | 01/14/2016SE |
| K151619 | Prime&Bond Elect Universal Dental AdhesiveKLE · Traditional | 10/30/2015SE |
| K150535 | Cavitron Touch Ultrasonic Scaling SystemELC · Traditional | 06/16/2015SE |
| K142178 | Proroot Mta White, Proroot Mta GrayKIF · Traditional | 02/26/2015SE |
| K131907 | Raypex 6LQY · Traditional | 01/31/2014SE |
| K131644 | Ankylos Syncone Abutment 5(DEGREE)NHA · Traditional | 01/22/2014SE |
| K132145 | Mtm(R) Clear AlignerNXC · Traditional | 10/11/2013SE |
Questions and answers
When was Atlantis Isus cleared by the FDA?
Atlantis Isus (K151439) received a 510(k) decision of Substantially Equivalent on February 19, 2016, 266 days after the submission was received.
What is the product code of K151439?
The FDA product code is NHA – Abutment, Implant, Dental, Endosseous, a Class II (moderate risk) device regulated under 21 CFR 872.3630.