510(k) · Cleared
ClearedAtlantis suprastructures
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply Sirona, Inc. · NHA Abutment, Implant, Dental, Endosseous
Cleared on Mar 3, 2020 as substantially equivalent to K163350 (Dentsply Sirona, 2017) and 1 other predicate after a 120-day review. Its family tree reaches back 15 generations to 1990.
- Decided
- Mar 3, 2020
- Review
- 120 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 15 generations to K894595 (1990). 238 ancestors in all, the oldest K781060 (1978). No later device cites it as a predicate yet.
- Root · 15 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 11 generations between
- 3 generations backK130999 Osseospeed Profile EVDentsply Implants Manufacturing GmbH · 2013
- 2 generations backK160207 ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc. · 2016
- 1 generation backK163350 Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona · 2017
- This deviceK193064 Atlantis suprastructuresDentsply Sirona, Inc. · 2020
Show all 15 generations
- Root · 15 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 14 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 13 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 12 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 11 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- 10 generations backK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
- 9 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 8 generations backK071370 Nobelactive Internal Connection ImplantNobel Biocare AB · 2007 · Recalled
- 7 generations backK101732 Astra Tech Implant SystemAstra Tech AB · 2011
- 6 generations backK111287 Astra Tech Implant SystemAstra Tech AB · 2011
- 5 generations backK112138 Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus ImplantAstra Tech, Inc. · 2011
- 4 generations backK120414 Osseospeed PlusAstra Tech AB · 2012
- 3 generations backK130999 Osseospeed Profile EVDentsply Implants Manufacturing GmbH · 2013
- 2 generations backK160207 ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc. · 2016
- 1 generation backK163350 Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona · 2017
- This deviceK193064 Atlantis suprastructuresDentsply Sirona, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −14 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −13 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −12 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −11 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| −10 | K050258 | Groovy Implants | Nobel Biocare AB | 2005 | 28 |
| −9 | K061003 | SFB & CFB Implants | Nobel Biocare AB | 2006 | — |
| −8 | K071370 | Nobelactive Internal Connection Implant | Nobel Biocare AB | 2007 | 4 |
| −7 | K101732 | Astra Tech Implant System | Astra Tech AB | 2011 | — |
| −6 | K111287 | Astra Tech Implant System | Astra Tech AB | 2011 | — |
| −5 | K112138 | Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus Implant | Astra Tech, Inc. | 2011 | — |
| −4 | K120414 | Osseospeed Plus | Astra Tech AB | 2012 | — |
| −3 | K130999 | Osseospeed Profile EV | Dentsply Implants Manufacturing GmbH | 2013 | — |
| −2 | K160207 | ATLANTIS ISUS Implant Suprastructures | Dentsply International, Inc. | 2016 | — |
| −1 | K163350 | Multibase Abutments EV and ATLANTIS Suprastructures | Dentsply Sirona | 2017 | — |
| 0 (this device) | K193064 | Atlantis suprastructures | Dentsply Sirona, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 5 | 0 |
| 1990 | 6 | 0 |
| 1991 | 1 | 0 |
| 1992 | 4 | 0 |
| 1993 | 12 | 0 |
| 1994 | 11 | 0 |
| 1995 | 14 | 0 |
| 1996 | 16 | 0 |
| 1997 | 8 | 0 |
| 1998 | 8 | 0 |
| 1999 | 10 | 0 |
| 2000 | 7 | 0 |
| 2001 | 15 | 0 |
| 2002 | 17 | 0 |
| 2003 | 18 | 0 |
| 2004 | 11 | 0 |
| 2005 | 9 | 0 |
| 2006 | 5 | 0 |
| 2007 | 10 | 0 |
| 2008 | 6 | 0 |
| 2009 | 4 | 0 |
| 2010 | 8 | 0 |
| 2011 | 5 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NHA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NHA device
- #1 K222288 DESS Dental Smart Solutionsscore 30.6 · 19 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K163350 | Multibase Abutments EV and ATLANTIS SuprastructuresSummary page 6…vice Name 510(k) Company Name Multibase Abutments EV and ATLANTIS™ Suprastructures K163350 Dentsply Sirona Predicate Device for subject Atlantis suprastructures made by additive manufacturing: Predicate Device Name… | 2017 |
| * | K163398 | ATLANTIS suprastructuresSummary page 6…additive manufacturing: Predicate Device Name 510(k) Company Name ATLANTIS™ Suprastructures K163398 Dentsply Sirona Traditional 510(k)-Atlantis suprastructures Section 5-1 Dentsply Sirona… | 2017 |
| † | K160207 | ATLANTIS ISUS Implant Suprastructures | 2016 |
| † | K071638 | Biohorizons Tapered Internal Implant System | 2007 |
| † | K100985 | Biohorizons Simple Solutions with Laser-Lok | 2010 |
| † | K180282 | MIS Internal Hex Dental Implant System | 2018 |
| † | K172505 | MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical… | 2017 |
| † | K163349 | MIS V3 Conical Connection Dental Implant System | 2017 |
| † | K112162 | Conical Connection Implants | 2012 |
| † | K133731 | Nobelactive Wide Platform (WP) | 2014 |
| † | K022562 | Various Branemark System Implants-Immediate Function Indication | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 30 years and passes through 10 companies; a new generation was cleared every 1.2 years on median.
- 23 of the 238 ancestors have a recall of any class.
- 1 other device also cites its predicate K163350.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · NHA
40in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NHA
147in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NHA
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NHA
838in 2025
MAUDE reports naming product code NHA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 38 | 91 | 1 | 1 |
| 2008 | 31 | 90 | 2 | 8 |
| 2009 | 30 | 95 | 0 | 30 |
| 2010 | 19 | 162 | 0 | 61 |
| 2011 | 31 | 130 | 5 | 56 |
| 2012 | 25 | 171 | 1 | 5 |
| 2013 | 22 | 184 | 1 | 143 |
| 2014 | 27 | 160 | 0 | 146 |
| 2015 | 29 | 151 | 1 | 858 |
| 2016 | 38 | 202 | 36 | 314 |
| 2017 | 31 | 188 | 2 | 577 |
| 2018 | 31 | 200 | 1 | 591 |
| 2019 | 28 | 160 | 0 | 530 |
| 2020 | 38 | 153 | 7 | 458 |
| 2021 | 29 | 211 | 0 | 546 |
| 2022 | 33 | 142 | 0 | 497 |
| 2023 | 51 | 147 | 3 | 618 |
| 2024 | 43 | 158 | 0 | 635 |
| 2025 | 40 | 147 | 1 | 838 |
| 2026 | 23 | 169 | 3 | — |
What is it indicated for?
Atlantis® suprastructures are indicated for attachment to dental implants or abutments in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function. Atlantis® suprastructures are intended for attachment to a minimum of two (2) implants. Atlantis® suprastructures are compatible with following implants and abutments: Manufacturer/ Implant system C BioHorizons Implant Level Internal/ Tapered 3.5, 4.5, 5.7 Abutment…
Read the full statement (405 words)
Atlantis® suprastructures are indicated for attachment to dental implants or abutments in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function.
Atlantis® suprastructures are intended for attachment to a minimum of two (2) implants. Atlantis® suprastructures are compatible with following implants and abutments:
Manufacturer/ Implant system
C
BioHorizons Implant Level
Internal/ Tapered 3.5, 4.5, 5.7
Abutment Level
Multi-unit abutment
Biomet 3i Implant Level
Certain™ 3.25, 4.0, 4/3, 5.0, 5/4, 6.0
Certain™ Prevail™ 3/4/3 (3.4), 4/5/4, 5/6/5, 4/3, 5/4, 6/5
Certain™ XP 4/5, 5/6
Abutment Level
Low Profile Abutment
Camlog Implant Level
Screw-line Implant 3.3
Screw-line/Root-line Implant 3.8, 4.3
Screw-line/Root-line Implant 5.0, 6.0
Dentsply Implant Level
Sirona Astra Tech Implant System®
Astra Tech Implant EV 3.0 – Green
Astra Tech Implant EV 3.6 – Purple
Astra Tech Implant EV 4.2 – Yellow
Astra Tech Implant EV 4.8 – Blue
Astra Tech Implant EV 5.4 – Brown
Astra Tech Implant EV Profile 4.2
Astra Tech Implant EV Profile 4.8
OsseoSpeed® TX 3.0 – Yellow
OsseoSpeed® TX 3.5, 4.0 – Aqua
OsseoSpeed® TX 4.5, 5.0 – Lilac
OsseoSpeed® TX Profile 4.5/5.0
Xive®
Xive® S 3.0
Xive® S 3.4, 3.8, 4.5, 5.5
Abutment Level
Astra Tech Implant System®
UniAbutment EV
Angled Abutment EV
Multibase Abutment EV
20° UniAbutment
45° UniAbutment
Angled Abutment 20°
Ankylos®
Ankylos® Balance Base Narrow D4.2
Ankylos® Balance Base D5.5
Xive®
Xive® TG 3.4, 3.8, 4.5
Xive® MP 3.4, 3.8, 4.5
Xive® MP 5.5
Keystone Implant Level
PrimaConnex SD 3.3, 3.5
PrimaConnex RD 4.0, 4.1
PrimaConnex WD 5.0
Genesis 3.8, 4.5, 5.5, 6.5
MIS Implant Level
Internal Hex Narrow SEVEN – M4
Internal Hex Standard SEVEN – M4
Internal Hex Wide SEVEN – M4
Conical Connection Narrow C1 – V3
Conical Connection Standard C1 – V3
Conical Connection Wide C1
Abutment Level
Multi-Unit Abutment
Nobel Biocare Implant Level
NobelActive NP 3.5
NobelActive RP 4.3, 5.0
NobelActive WP 5.5
NobelReplace NP 3.5
NobelReplace RP 4.3
NobelReplace WP 5.0
NobelReplace 6.0
Branemark System NP 3.3
Branemark System RP 3.75, 4.0
Abutment Level
Multi-Unit Abutment RP
Straumann Implant Level
Bone Level 3.3 NC
Bone Level 4.1, 4.8 RC
Standard/Standard Plus 4.8 RN (Regular Neck)
Standard/Standard Plus 4.8 WN (Wide Neck)
Abutment Level
RN Abutment Level
WN Abutment Level
Bone Level Multi-Base Abutment D3.5, 4.5
Bone Level Multi-Base Angled Abutment
Screw-Retained Abutment 3.5
Screw-Retained Abutment 4.6
Zimmer Dental Implant Level
Tapered Screw-Vent™ 3.5, 4.5, 5.7
Screw Vent™ 3.3, 3.7, 4.5
Abutment Level
Tapered Abutment
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193064 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193064: Atlantis suprastructures.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193064
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026