510(k) · Cleared
ClearedImplanova
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dental Evolutions, Inc. · DZE Implant, Endosseous, Root-Form
Cleared on Aug 27, 2015 as substantially equivalent to K121787 (BioHorizons Implant Systems, Inc., 2012) and 2 other predicates after a 230-day review. Its family tree reaches back 7 generations to 1993.
- Decided
- Aug 27, 2015
- Review
- 230 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K925765 (1993). 28 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 6 generations backK994376 Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating…Friadent GmbH · 2000
- 5 generations backK014235 Osseotite NT Dental Implants & AccessoriesImplant Innovations, Inc. · 2002
- 4 generations backK062069 Atlantis Abutment for 3I Micromini ImplantAtlantis Components, Inc. · 2007
- 3 generations backK070833 Atlantis Abutment for Astra ImplantAtlantis Components, Inc. · 2007
- 2 generations backK071946 Atlantis, Gemini and Gemini+ Abutments in Zirconia for Astra ImplantsAtlantis Components, Inc. · 2007
- 1 generation backK101005 Astra Tech Implant System, New ComponentAstra Tech AB · 2011
- This deviceK150040 ImplanovaDental Evolutions, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K925765 | Branemark System Standard 3.75MM Fixture | Nobelpharma USA, Inc. | 1993 | — |
| −6 | K994376 | Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating; Frialit-2… | Friadent GmbH | 2000 | — |
| −5 | K014235 | Osseotite NT Dental Implants & Accessories | Implant Innovations, Inc. | 2002 | — |
| −4 | K062069 | Atlantis Abutment for 3I Micromini Implant | Atlantis Components, Inc. | 2007 | — |
| −3 | K070833 | Atlantis Abutment for Astra Implant | Atlantis Components, Inc. | 2007 | — |
| −2 | K071946 | Atlantis, Gemini and Gemini+ Abutments in Zirconia for Astra Implants | Atlantis Components, Inc. | 2007 | — |
| −1 | K101005 | Astra Tech Implant System, New Component | Astra Tech AB | 2011 | — |
| 0 (this device) | K150040 | Implanova | Dental Evolutions, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 5 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2012 | 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? (3)
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 |
|---|---|---|---|
| * | K121787 | Biohorizons Tapered Internal Plus ImplantsSummary page 5…Class II 4. Predicate Device: - Primary Predicate Device ▪ BioHorizons Tapered Internal Plus Implants by BioHorizons Implant Systems, Inc. (K121787) - Reference Predicate Devices ▪ BioHorizons Internal Implants by BioHorizons Implant Systems, Inc. (K073268)… | 2012 |
| * | K101005 | Astra Tech Implant System, New ComponentSummary page 6…Page 1 of 14 ▪ Astra Tech Implant System, New Components , Angled TiDesign Abutment by Astra Tech AB (K101005, K072624) ▪ NC Closure Screws, Straumann Closure Screws by Straumann USA (K130808, K071585) ▪ Straumann Healing… | 2011 |
| * | K072624 | Astra Tech Implant System, New ComponentSummary page 6…Page 1 of 14 ▪ Astra Tech Implant System, New Components , Angled TiDesign Abutment by Astra Tech AB (K101005, K072624) ▪ NC Closure Screws, Straumann Closure Screws by Straumann USA (K130808, K071585) ▪ Straumann Healing Abutments… | 2007 |
| † | K073268 | Biohorizons Internal Implant System | 2008 |
| † | K132956 | U Fit Dental Implant System | 2014 |
| † | K052997 | Zimmer Dental One-Piece Implant | 2006 |
| † | K070857 | Nobeldirect 3.0-Immediate Load, 3.0 X 13 MM and 3.0 X 15 MM | 2007 |
| † | K080156 | Osseospeed TM Profile System | 2008 |
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 22 years and passes through 6 companies; a new generation was cleared every 3.7 years on median.
- 1 of the 28 ancestors has a recall of any class.
- 2 other devices also cite its predicate K121787.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 Implanova® Bone Level implants are intended for endosseous implantation in the mandible and maxilla for use as an artificial root structure. These root form implants can be used to replace single or multiple missing teeth and/or to support a fixed or removable prosthesis in partially or completely edentulous upper and lower dental arches. All devices in the Implanova® Bone Level system, including implant fixtures, abutments, healing caps, cover…
Read the full statement (222 words)
The Implanova® Bone Level implants are intended for endosseous implantation in the mandible and maxilla for use as an artificial root structure. These root form implants can be used to replace single or multiple missing teeth and/or to support a fixed or removable prosthesis in partially or completely edentulous upper and lower dental arches. All devices in the Implanova® Bone Level system, including implant fixtures, abutments, healing caps, cover screws, and retention screws are intended for use by prescription only. Implanova® Bone Level implants are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Implanova® All-in-One3.0mm implants are indicated for the support and retention of fixed single tooth and fixed partial denture restorations in the mandibular central and lateral incisor and maxillary lateral incisor regions of partially edentulous jaws. The Implanova® All-in-One 3.0mm implant must be splinted if two or more are used adjacent to each other. Implanova® All-in-One 3.0mm implant are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
All Implanova® Bone Level implant fixtures are compatible with the straight type restorative components listed in the table below, including straight type abutments, straight type abutment screws and straight type temporary abutments that are intended to be on Astra Tech’s OsseoSpeed™ TX 3.5S and OsseoSpeed™ TX 4.0S implant fixtures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K150040 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150040: Implanova.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150040
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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