510(k) · Cleared
ClearedMultibase Abutments EV and ATLANTIS Suprastructures
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply Sirona · NHA Abutment, Implant, Dental, Endosseous
Cleared on Mar 31, 2017 as substantially equivalent to K121810 (Astra Tech AB, 2013) and 4 other predicates after a 121-day review. Its family tree reaches back 14 generations to 1990. 4 later devices descend from it.
- Decided
- Mar 31, 2017
- Review
- 121 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 14 generations to K894595 (1990). 236 ancestors in all, the oldest K781060 (1978). 4 later devices descend from it, 2 citing it directly.
- Root · 14 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 10 generations between
- 3 generations backK120414 Osseospeed PlusAstra Tech AB · 2012
- 2 generations backK130999 Osseospeed Profile EVDentsply Implants Manufacturing GmbH · 2013
- 1 generation backK160207 ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc. · 2016
- This deviceK163350 Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona · 2017
- Descendant · cites it directly · 2 of its ownK213449 DS Implants abutments provided with the EV connectionDentsply Sirona · 2021
- Descendant · 2 generations on · 0 of its ownK220841 PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV…Dentsply Sirona · 2022
- Descendant · 2 generations on · 0 of its ownK221094 OmniTaper EV Dental Implants, DS Implants abutments with EV connectionDentsply Sirona · 2022
- Descendant · cites it directly · 0 of its ownK193064 Atlantis suprastructuresDentsply Sirona, Inc. · 2020
Show all 14 generations
- Root · 14 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 13 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 12 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 11 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 10 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- 9 generations backK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
- 8 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 7 generations backK071370 Nobelactive Internal Connection ImplantNobel Biocare AB · 2007 · Recalled
- 6 generations backK101732 Astra Tech Implant SystemAstra Tech AB · 2011
- 5 generations backK111287 Astra Tech Implant SystemAstra Tech AB · 2011
- 4 generations backK112138 Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus ImplantAstra Tech, Inc. · 2011
- 3 generations backK120414 Osseospeed PlusAstra Tech AB · 2012
- 2 generations backK130999 Osseospeed Profile EVDentsply Implants Manufacturing GmbH · 2013
- 1 generation backK160207 ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc. · 2016
- This deviceK163350 Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona · 2017
Most influential descendants
Showing 4 of 4 · See all- K213449DS Implants abutments provided with the EV connectionDentsply Sirona · 2021 · cites it directly2descendants
- K220841PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)Dentsply Sirona · 2022 · 2 generations on0descendants
- K221094OmniTaper EV Dental Implants, DS Implants abutments with EV connectionDentsply Sirona · 2022 · 2 generations on0descendants
- K193064Atlantis suprastructuresDentsply Sirona, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −13 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −12 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −11 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −10 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| −9 | K050258 | Groovy Implants | Nobel Biocare AB | 2005 | 28 |
| −8 | K061003 | SFB & CFB Implants | Nobel Biocare AB | 2006 | — |
| −7 | K071370 | Nobelactive Internal Connection Implant | Nobel Biocare AB | 2007 | 4 |
| −6 | K101732 | Astra Tech Implant System | Astra Tech AB | 2011 | — |
| −5 | K111287 | Astra Tech Implant System | Astra Tech AB | 2011 | — |
| −4 | K112138 | Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus Implant | Astra Tech, Inc. | 2011 | — |
| −3 | K120414 | Osseospeed Plus | Astra Tech AB | 2012 | — |
| −2 | K130999 | Osseospeed Profile EV | Dentsply Implants Manufacturing GmbH | 2013 | — |
| −1 | K160207 | ATLANTIS ISUS Implant Suprastructures | Dentsply International, Inc. | 2016 | — |
| 0 (this device) | K163350 | Multibase Abutments EV and ATLANTIS Suprastructures | Dentsply Sirona | 2017 | — |
| +1 | K213449 | DS Implants abutments provided with the EV connection | Dentsply Sirona | 2021 | — |
| +2 | K220841 | PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection… | Dentsply Sirona | 2022 | — |
| +2 | K221094 | OmniTaper EV Dental Implants, DS Implants abutments with EV connection | Dentsply Sirona | 2022 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (5)
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 |
|---|---|---|---|
| * | K121810 | Osseospeed Angled Abutment EVSummary page 6…510(k) Company Name OsseoSpeed™ Angled Abutment EV Dentsply Sirona K121810 (Primary Predicate Device) (formerly ASTRA TECH) NobelActive Multi Unit Abutment… | 2013 |
| * | K072570 | Nobelactive Multi Unit AbutmentSummary page 6…imary Predicate Device) (formerly ASTRA TECH) NobelActive Multi Unit Abutment K072570 Nobel Biocare (Reference Predicate Device) OsseoSpeed™ Plus Dentsply Sirona… | 2007 |
| * | K120414 | Osseospeed PlusSummary page 6…care (Reference Predicate Device) OsseoSpeed™ Plus Dentsply Sirona K120414 (Reference Predicate Device) (formerly Astra Tech AB) OsseoSpeed™ Profile EV… | 2012 |
| * | K130999 | Osseospeed Profile EVSummary page 6…4 (Reference Predicate Device) (formerly Astra Tech AB) OsseoSpeed™ Profile EV K130999 Dentsply Sirona (Reference Predicate Device) Predicate device for the modifications relating to the proposed compatibility o… | 2013 |
| * | K160207 | ATLANTIS ISUS Implant SuprastructuresSummary page 6…redicate Device Name 510(k) Company Name ATLANTIS™ ISUS Implant Suprastructures K160207 Dentsply Sirona (Primary Predicate Device) 4. Description of Device: The subject of this bundled 510… | 2016 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 27 years and passes through 9 companies; a new generation was cleared every 1.2 years on median.
- 23 of the 236 ancestors have a recall of any class.
- Of its descendants, K213449 (Dentsply Sirona, 2021) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K121810.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
The Multibase Abutments EV are intended to be used in conjunction with Astra Tech Implant System EV in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for bridges or overdentures. 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…
Read the full statement (336 words)
The Multibase Abutments EV are intended to be used in conjunction with Astra Tech Implant System EV in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for bridges or overdentures.
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 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/ Tapered S-V 3.5/S-V 3.3, 3.7
Screw Vent /Tapered S-V 4.5/ S-V 4.5
Tapered Screw Vent 5.7
Abutments:
Manufacturer Name of Abutment
Biomet 3i Low Profile Abutment
DENTSPLY 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
ATIS Multibase Abutment EV
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 Abutment
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163350 · printed Nov 5, 2026
Cite this page
510(k) Report. “K163350: Multibase Abutments EV and ATLANTIS Suprastructures.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K163350
Report an extraction error
Are you the manufacturer?
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