510(k) · Cleared
ClearedOmniTaper EV Dental Implants, DS Implants abutments with EV connection
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply Sirona · DZE Implant, Endosseous, Root-Form
Cleared on Nov 16, 2022 as substantially equivalent to K120414 (Astra Tech AB, 2012) and 1 other predicate after a 216-day review. Its family tree reaches back 16 generations to 1990.
- Decided
- Nov 16, 2022
- Review
- 216 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 16 generations to K894595 (1990). 238 ancestors in all, the oldest K781060 (1978). No later device cites it as a predicate yet.
- Root · 16 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 12 generations between
- 3 generations backK160207 ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc. · 2016
- 2 generations backK163350 Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona · 2017
- 1 generation backK213449 DS Implants abutments provided with the EV connectionDentsply Sirona · 2021
- This deviceK221094 OmniTaper EV Dental Implants, DS Implants abutments with EV connectionDentsply Sirona · 2022
Show all 16 generations
- Root · 16 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 15 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 14 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 13 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 12 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- 11 generations backK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
- 10 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 9 generations backK071370 Nobelactive Internal Connection ImplantNobel Biocare AB · 2007 · Recalled
- 8 generations backK101732 Astra Tech Implant SystemAstra Tech AB · 2011
- 7 generations backK111287 Astra Tech Implant SystemAstra Tech AB · 2011
- 6 generations backK112138 Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus ImplantAstra Tech, Inc. · 2011
- 5 generations backK120414 Osseospeed PlusAstra Tech AB · 2012
- 4 generations backK130999 Osseospeed Profile EVDentsply Implants Manufacturing GmbH · 2013
- 3 generations backK160207 ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc. · 2016
- 2 generations backK163350 Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona · 2017
- 1 generation backK213449 DS Implants abutments provided with the EV connectionDentsply Sirona · 2021
- This deviceK221094 OmniTaper EV Dental Implants, DS Implants abutments with EV connectionDentsply Sirona · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −15 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −14 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −13 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −12 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| −11 | K050258 | Groovy Implants | Nobel Biocare AB | 2005 | 28 |
| −10 | K061003 | SFB & CFB Implants | Nobel Biocare AB | 2006 | — |
| −9 | K071370 | Nobelactive Internal Connection Implant | Nobel Biocare AB | 2007 | 4 |
| −8 | K101732 | Astra Tech Implant System | Astra Tech AB | 2011 | — |
| −7 | K111287 | Astra Tech Implant System | Astra Tech AB | 2011 | — |
| −6 | K112138 | Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus Implant | Astra Tech, Inc. | 2011 | — |
| −5 | K120414 | Osseospeed Plus | Astra Tech AB | 2012 | — |
| −4 | K130999 | Osseospeed Profile EV | Dentsply Implants Manufacturing GmbH | 2013 | — |
| −3 | K160207 | ATLANTIS ISUS Implant Suprastructures | Dentsply International, Inc. | 2016 | — |
| −2 | K163350 | Multibase Abutments EV and ATLANTIS Suprastructures | Dentsply Sirona | 2017 | — |
| −1 | K213449 | DS Implants abutments provided with the EV connection | Dentsply Sirona | 2021 | — |
| 0 (this device) | K221094 | OmniTaper EV Dental Implants, DS Implants abutments with EV connection | Dentsply Sirona | 2022 | — |
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 |
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 DZE? 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 DZE device
- #1 K211090 ZENEX Implant Systemscore 25.4 · 15 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 |
|---|---|---|---|
| * | K120414 | Osseospeed PlusSummary page 6…es (A) and (B): Predicate Device (A) Name 510(k) Company Name OsseoSpeed Plus Implants* K120414 Dentsply Sirona (Formerly: Astra… | 2012 |
| * | K213449 | DS Implants abutments provided with the EV connectionSummary page 6…: Astra Tech AB) Predicate Device (B) Name 510(k) Company Name DS Implants abutments K213449 Dentsply Sirona provided with the EV connection *NOTE… | 2021 |
| † | K073075 | Frialit Plus, Xive S Plus, Xive TG Plus, Ankylos Plus, Dental Implant Systems | 2008 |
| † | K210610 | PrimeTaper EV Dental Implant | 2021 |
| † | K013867 | Xive Dental Implant System | 2002 |
| † | K030639 | Xive 3.0 Dental Implant System | 2003 |
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 32 years and passes through 9 companies; a new generation was cleared every 1.2 years on median.
- 23 of the 238 ancestors have a recall of any class.
- 26 other devices also cite its predicate K120414.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · DZE
31in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DZE
184in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DZE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DZE
465,788in 2025
MAUDE reports naming product code DZE, 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 | 43 | 107 | 11 | 225 |
| 2008 | 61 | 118 | 4 | 393 |
| 2009 | 41 | 110 | 3 | 164 |
| 2010 | 34 | 162 | 3 | 360 |
| 2011 | 26 | 194 | 0 | 362 |
| 2012 | 39 | 174 | 11 | 358 |
| 2013 | 42 | 195 | 1 | 391 |
| 2014 | 36 | 265 | 7 | 1,124 |
| 2015 | 36 | 215 | 3 | 2,894 |
| 2016 | 40 | 219 | 15 | 1,116 |
| 2017 | 48 | 223 | 4 | 9,719 |
| 2018 | 41 | 200 | 4 | 12,892 |
| 2019 | 31 | 231 | 8 | 167,016 |
| 2020 | 41 | 230 | 0 | 255,524 |
| 2021 | 34 | 182 | 6 | 479,618 |
| 2022 | 34 | 243 | 0 | 483,224 |
| 2023 | 35 | 248 | 0 | 537,585 |
| 2024 | 40 | 222 | 1 | 473,629 |
| 2025 | 31 | 184 | 1 | 465,788 |
| 2026 | 15 | 194 | 2 | — |
What is it indicated for?
The implants are intended for both one- and two-stage surgical procedures in the following situations and with the following clinical protocols: • Replacing missing teeth in single or multiple unit applications in the mandible or maxilla. • Immediate placement in extraction sites and in situations with a partially or completely healed alveolar ridge. • Especially indicated for use in soft bone applications where implants with other implant surface…
Read the full statement (213 words)
The implants are intended for both one- and two-stage surgical procedures in the following situations and with the following clinical protocols:
• Replacing missing teeth in single or multiple unit applications in the mandible or maxilla.
• Immediate placement in extraction sites and in situations with a partially or completely healed alveolar ridge.
• Especially indicated for use in soft bone applications where implants with other implant surface treatments may be less effective.
• Immediate and early loading for all indications, except in single tooth situations on implants shorter than 8 mm or in soft bone (type 4) where implant stability may be difficult to obtain and immediate loading may not be appropriate.
• The intended use for OmniTaper EV Ø3.0 implant is limited to replacement of maxillary lateral incisors and mandibular incisors.
DS Implants abutments provided with the EV connection are intended to be used in conjunction with implants with the EV connection in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for crowns, bridges or overdentures.
MultiBase Abutments EV:
DS Implants abutments provided with the EV connection are intended to be used in conjunction with implants with the EV connection in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for bridges or overdentures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221094 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221094: OmniTaper EV Dental Implants, DS Implants abutments with EV connection.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221094
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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