510(k) · Cleared
ClearedATLANTIS ISUS Implant Suprastructures
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply International, Inc. · NHA Abutment, Implant, Dental, Endosseous
Cleared on Sep 21, 2016 as substantially equivalent to K122424 (Dentsply International, Inc., 2013) and 12 other predicates after a 237-day review. Its family tree reaches back 13 generations to 1990. 5 later devices descend from it.
- Decided
- Sep 21, 2016
- Review
- 237 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 13
Its longest line of descent runs back 13 generations to K894595 (1990). 233 ancestors in all, the oldest K781060 (1978). 5 later devices descend from it, 1 citing it directly.
- Root · 13 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 9 generations between
- 3 generations backK112138 Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus ImplantAstra Tech, Inc. · 2011
- 2 generations backK120414 Osseospeed PlusAstra Tech AB · 2012
- 1 generation backK130999 Osseospeed Profile EVDentsply Implants Manufacturing GmbH · 2013
- This deviceK160207 ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc. · 2016
- Descendant · cites it directly · 4 of its ownK163350 Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona · 2017
- Descendant · 2 generations on · 2 of its ownK213449 DS Implants abutments provided with the EV connectionDentsply Sirona · 2021
- Descendant · 3 generations on · 0 of its ownK220841 PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV…Dentsply Sirona · 2022
- Descendant · 3 generations on · 0 of its ownK221094 OmniTaper EV Dental Implants, DS Implants abutments with EV connectionDentsply Sirona · 2022
- Descendant · 2 generations on · 0 of its ownK193064 Atlantis suprastructuresDentsply Sirona, Inc. · 2020
Show all 13 generations
- Root · 13 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 12 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 11 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 10 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 9 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- 8 generations backK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
- 7 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 6 generations backK071370 Nobelactive Internal Connection ImplantNobel Biocare AB · 2007 · Recalled
- 5 generations backK101732 Astra Tech Implant SystemAstra Tech AB · 2011
- 4 generations backK111287 Astra Tech Implant SystemAstra Tech AB · 2011
- 3 generations backK112138 Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus ImplantAstra Tech, Inc. · 2011
- 2 generations backK120414 Osseospeed PlusAstra Tech AB · 2012
- 1 generation backK130999 Osseospeed Profile EVDentsply Implants Manufacturing GmbH · 2013
- This deviceK160207 ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc. · 2016
Most influential descendants
Showing 5 of 5 · See all- K163350Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona · 2017 · cites it directly4descendants
- K213449DS Implants abutments provided with the EV connectionDentsply Sirona · 2021 · 2 generations on2descendants
- K220841PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)Dentsply Sirona · 2022 · 3 generations on0descendants
- K221094OmniTaper EV Dental Implants, DS Implants abutments with EV connectionDentsply Sirona · 2022 · 3 generations on0descendants
- K193064Atlantis suprastructuresDentsply Sirona, Inc. · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −12 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −11 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −10 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −9 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| −8 | K050258 | Groovy Implants | Nobel Biocare AB | 2005 | 28 |
| −7 | K061003 | SFB & CFB Implants | Nobel Biocare AB | 2006 | — |
| −6 | K071370 | Nobelactive Internal Connection Implant | Nobel Biocare AB | 2007 | 4 |
| −5 | K101732 | Astra Tech Implant System | Astra Tech AB | 2011 | — |
| −4 | K111287 | Astra Tech Implant System | Astra Tech AB | 2011 | — |
| −3 | K112138 | Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus Implant | Astra Tech, Inc. | 2011 | — |
| −2 | K120414 | Osseospeed Plus | Astra Tech AB | 2012 | — |
| −1 | K130999 | Osseospeed Profile EV | Dentsply Implants Manufacturing GmbH | 2013 | — |
| 0 (this device) | K160207 | ATLANTIS ISUS Implant Suprastructures | Dentsply International, Inc. | 2016 | — |
| +1 | K163350 | Multibase Abutments EV and ATLANTIS Suprastructures | Dentsply Sirona | 2017 | — |
| +2 | K213449 | DS Implants abutments provided with the EV connection | Dentsply Sirona | 2021 | — |
| +3 | K220841 | PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection… | Dentsply Sirona | 2022 | — |
| +3 | K221094 | OmniTaper EV Dental Implants, DS Implants abutments with EV connection | Dentsply Sirona | 2022 | — |
| +2 | 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 | 4 | 0 |
| 2007 | 9 | 0 |
| 2008 | 6 | 0 |
| 2009 | 4 | 0 |
| 2010 | 8 | 0 |
| 2011 | 5 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 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? (13)
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 |
|---|---|---|---|
| * | K122424 | Isus Implant SuprastructuresSummary page 5…Primary Predicate Device: Predicate Device Name 510(k) Company Name ISUS Implant Suprastructures K122424 DENTSPLY International, Inc. Reference Predicate Devices: Predicate Device Name… | 2013 |
| * | K121810 | Osseospeed Angled Abutment EVSummary page 5…Company Name DENTSPLY International, Inc. Astra Tech OsseoSpeed Angled Abutment EV K121810 (former: ASTRA TECH AB)… | 2013 |
| * | K931767 | Astra Tech Implants-Dental SystemSummary page 5…ASTRA TECH AB) DENTSPLY International, Inc. Astra Tech Implants-Dental System K931767 (former: ASTRA TECH AB)… | 1994 |
| * | K101732 | Astra Tech Implant SystemSummary page 5…ASTRA TECH AB) DENTSPLY International, Inc. Astra Tech Implant System K101732 (former: ASTRA TECH AB)… | 2011 |
| * | K120414 | Osseospeed PlusSummary page 5…ASTRA TECH AB) DENTSPLY International, Inc. Astra Tech OsseoSpeed Plus K120414 (former: ASTRA TECH AB)… | 2012 |
| * | K080156 | Osseospeed TM Profile SystemSummary page 5…ASTRA TECH AB) DENTSPLY International, Inc. Astra Tech OsseoSpeed Profile System K080156 (former: ASTRA TECH AB) Astra Tech OsseoSpeed Profil… | 2008 |
| * | K130999 | Osseospeed Profile EVSummary page 5…m K080156 (former: ASTRA TECH AB) Astra Tech OsseoSpeed Profile EV K130999 DENTSPLY International, Inc. BioHorizons Tapered Internal Implant System K071638 BioHorizons Implant Syste… | 2013 |
| * | K071638 | Biohorizons Tapered Internal Implant SystemSummary page 5…ASTRA TECH AB) Astra Tech OsseoSpeed Profile EV K130999 DENTSPLY International, Inc. BioHorizons Tapered Internal Implant System K071638 BioHorizons Implant Systems, Inc. Camlog Screw Implant System K000099 Altatec Biotechnolog… | 2007 |
| * | K000099 | Camlog Screw Implant SystemSummary page 5…l, Inc. BioHorizons Tapered Internal Implant System K071638 BioHorizons Implant Systems, Inc. Camlog Screw Implant System K000099 Altatec Biotechnologies ATLANTIS™ ISUS Implant Suprastructures DENTSPLY International Inc.… | 2000 |
| * | K000100 | Camlog Rootform Implant SystemSummary page 6…International Inc. Predicate Device Name 510(k) Company Name Camlog Rootform Implant System K000100 Altatec Biotechnologies Lifecore PrimaConnex Internal Connection Keystone Dental, Inc.… | 2000 |
| * | K051614 | Primaconnex Internal Connection Implant System, Primaconnex Internal Connection…Summary page 6…Altatec Biotechnologies Lifecore PrimaConnex Internal Connection Keystone Dental, Inc. K051614 Implant System (former: Lifecore Biomedical, Inc.) Genesis Implant Sys… | 2005 |
| * | K101545 | Genesis Implant SystemSummary page 6…K051614 Implant System (former: Lifecore Biomedical, Inc.) Genesis Implant System K101545 Keystone Dental, Inc. Straumann Magellan Screw-Retained K133421… | 2010 |
| * | K133421 | Straumann Magellan (TM) Abutment,Protective Cap,Titanium Copings,Gold Chopings,Basal ScrewSummary page 6…s Implant System K101545 Keystone Dental, Inc. Straumann Magellan Screw-Retained K133421 Institut Straumann AG Abutment System 4. Description of Device: The ATLANTIS™ ISUS Implant Suprastructures i… | 2014 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K163350 | Multibase Abutments EV and ATLANTIS Suprastructures | 2017 | 4 |
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 26 years and passes through 8 companies; a new generation was cleared every 1.2 years on median.
- 22 of the 233 ancestors have a recall of any class.
- Of its descendants, K163350 (Dentsply Sirona, 2017) has gone furthest, with 4 descendants of its own.
- 3 other devices also cite its predicate K122424.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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™ ISUS Implant 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™ ISUS Implant Suprastructures are intended for attachment to a minimum of two (2) implants and are indicated for compatibility with the following implant and abutment systems: Implants: Manufacturer Name of Implant Size Biomet 3i Certain 3.25…
Read the full statement (300 words)
ATLANTIS™ ISUS Implant 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™ ISUS Implant Suprastructures are intended for attachment to a minimum of two (2) implants and are indicated for compatibility with the following implant and abutment systems:
Implants:
Manufacturer Name of Implant Size
Biomet 3i Certain 3.25, 4/3 – Prevail 3/4/3, 4/3
Certain 4.0, 5/4 – Prevail 4/5/4. 5/4
Certain 5.0, XP 4/5 – Prevail 5/6/5, 6/5
Certain 6.0, XP 5/6
BioHorizons Internal/Tapered 3.5, 4.5, 5.7
Camlog Screw-line Implant 3.3
Screw-line / Root-line Implant 3.8, 4.3, 5.0, 6.0
DENTSPLY Implants XiVE S 3.0, S 3.4, S 3.8, S 4.5, S 5.5
OsseoSpeed™ TX 3.0, 3.5/4.0, 4.5/5.0
Osseospeed™ Profile TX 4.5/5.0
Osseospeed™ EV 3.0, 3.6, 4.2, 4.8, 5.4
Osseospeed™ Profile EV 4.2, 4.8
Keystone Dental 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
Nobel Biocare NobelActive NP 3.5 – RP 4.3, 5.0
NobelReplace NP-3.5 – RP 4.3 – WP 5.0 – 6.0
Straumann Bone Level 3.3 NC – 4.1, 4.8 NC
Standard Plus 3.5 NN
Standard / Standard Plus 4.8 RN – 4.8 WN
Zimmer Dental Tapered Screw Vent S-V 3.5/S-V 3.3, 3.7 / S-V 4.5/ S-V 4.5
Tapered Screw Vent 5.7
Abutments:
Manufacturer Name of Abutment
Biomet 3i Low Profile Abutment
DENTSPLY Implants ATIS Uni Abutment EV
ATIS UniAbutment 20°, ATIS UniAbutment 45°
ATIS Angled Abutment EV
ATIS Angled Abutment 20°
ANKYLOS Balance Base Narrow D4.2, Balance Base D5.5
XiVE MP 3.4, MP 3.8, MP 4.5, MP 5.5
XiVE TG 3.4, TG 3.8, TG 4.5
Nobel Biocare Multi-Unit Abutment RP
Straumann Bone Level Multi-Base Angled Abutment
Bone Level Multi-Base Abutment D3.5, D4.5
RN Abutment Level, WN Abutment Level
Screw-Retained Abutment 3.5, 4.6
Zimmer Dental Tapered Abument
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160207 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160207: ATLANTIS ISUS Implant Suprastructures.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160207
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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