510(k) · Cleared
ClearedW Zirconia Implants
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tav Medical, Ltd. · DZE Implant, Endosseous, Root-Form
Cleared on Oct 29, 2019 as substantially equivalent to K172668 (Tav Medical, Ltd., 2018) and 2 other predicates after a 90-day review. Its family tree reaches back 12 generations to 1995. 1 later device descends from it.
- Decided
- Oct 29, 2019
- Review
- 90 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 12 generations to K944964 (1995). 94 ancestors in all, the oldest K871863 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 12 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
- 8 generations between
- 3 generations backK091920 Atlantis Abutment in Zirconia, Atlantis Gemini Abutment for Nobel…Astra Tech, Inc. · 2009
- 2 generations backK132881 Z5CZ-Systems AG · 2014
- 1 generation backK172668 W Zirconia ImplantsTav Medical, Ltd. · 2018
- This deviceK192053 W Zirconia ImplantsTav Medical, Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK221488 Z7 Zirconia Implant SystemZ7, LLC · 2023
Show all 12 generations
- Root · 12 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
- 11 generations backK961728 Miruscone Abutment SystemNobelpharma USA, Inc. · 1996
- 10 generations backK962403 Noblepharma Wide AccessoriesNobelpharma USA, Inc. · 1996
- 9 generations backK971706 Tiadapt Abutment SystemNobel Biocare Uas, Inc. · 1997
- 8 generations backK974150 Procera Preparable Abutment SystemNobel Biocare Uas, Inc. · 1998 · Recalled
- 7 generations backK032263 3I Patient-Specific Dental Abutment and Overdenture BarImplant Innovations, Inc. · 2004 · Recalled
- 6 generations backK042658 Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001…Nobel Biocare Uas, Inc. · 2004
- 5 generations backK052070 Atlantis Abutment in Zirconia, Atlantis Gemini Abutment in Zirconia…Atlantis Components, Inc. · 2005
- 4 generations backK062277 Atlantis Abutment in Zirconia for Nobel Biocare ReplaceAtlantis Components, Inc. · 2006
- 3 generations backK091920 Atlantis Abutment in Zirconia, Atlantis Gemini Abutment for Nobel…Astra Tech, Inc. · 2009
- 2 generations backK132881 Z5CZ-Systems AG · 2014
- 1 generation backK172668 W Zirconia ImplantsTav Medical, Ltd. · 2018
- This deviceK192053 W Zirconia ImplantsTav Medical, Ltd. · 2019
Most influential descendants
Showing 1 of 1 · See all- K221488Z7 Zirconia Implant SystemZ7, LLC · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K944964 | Branemark System Miruscone Abutment System | Nobelpharma USA, Inc. | 1995 | — |
| −11 | K961728 | Miruscone Abutment System | Nobelpharma USA, Inc. | 1996 | — |
| −10 | K962403 | Noblepharma Wide Accessories | Nobelpharma USA, Inc. | 1996 | — |
| −9 | K971706 | Tiadapt Abutment System | Nobel Biocare Uas, Inc. | 1997 | — |
| −8 | K974150 | Procera Preparable Abutment System | Nobel Biocare Uas, Inc. | 1998 | 2 |
| −7 | K032263 | 3I Patient-Specific Dental Abutment and Overdenture Bar | Implant Innovations, Inc. | 2004 | 1 |
| −6 | K042658 | Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004… | Nobel Biocare Uas, Inc. | 2004 | — |
| −5 | K052070 | Atlantis Abutment in Zirconia, Atlantis Gemini Abutment in Zirconia, Atlantis… | Atlantis Components, Inc. | 2005 | — |
| −4 | K062277 | Atlantis Abutment in Zirconia for Nobel Biocare Replace | Atlantis Components, Inc. | 2006 | — |
| −3 | K091920 | Atlantis Abutment in Zirconia, Atlantis Gemini Abutment for Nobel Replace… | Astra Tech, Inc. | 2009 | — |
| −2 | K132881 | Z5C | Z-Systems AG | 2014 | — |
| −1 | K172668 | W Zirconia Implants | Tav Medical, Ltd. | 2018 | — |
| 0 (this device) | K192053 | W Zirconia Implants | Tav Medical, Ltd. | 2019 | — |
| +1 | K221488 | Z7 Zirconia Implant System | Z7, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 10 | 0 |
| 1994 | 9 | 0 |
| 1995 | 7 | 0 |
| 1996 | 8 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 4 | 0 |
| 2000 | 4 | 0 |
| 2001 | 4 | 0 |
| 2002 | 6 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2007 | 2 | 0 |
| 2009 | 4 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 |
|---|---|---|---|
| * | K172668 | W Zirconia ImplantsSummary page 4…Class ll Primary Product Code: DZE Secondary Product Code: NHA 3. Predicate Devices Primary Predicate: K172668 W Zirconia Implants Reference Devices: K151328 Pure Ceramic Implants… | 2018 |
| * | K151328 | PURE Ceramic ImplantsSummary page 4…ondary Product Code: NHA 3. Predicate Devices Primary Predicate: K172668 W Zirconia Implants Reference Devices: K151328 Pure Ceramic Implants K180477 Straumann Pure Ceramic Implants TAV Medical 510(k)… | 2016 |
| * | K180477 | Straumann PURE Ceramic Implant SystemSummary page 4…ry Predicate: K172668 W Zirconia Implants Reference Devices: K151328 Pure Ceramic Implants K180477 Straumann Pure Ceramic Implants TAV Medical 510(k) Summary Page 2 of 16… | 2019 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221488 | Z7 Zirconia Implant System | 2023 | 0 |
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 24 years and passes through 7 companies; a new generation was cleared every 1.2 years on median.
- 8 of the 94 ancestors have a recall of any class.
- Of its descendants, K221488 (Z7, LLC, 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K172668.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
TAV Medical's W Zirconia Implants are intended for surgical placement in the patient's upper and lower jaw to provide support for prosthetic devices, such as artificial teeth and in order to restore the patient chewing function. The implants are indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
The ø3.6mm reduced diameter implants are recommended for central and lateral incisors only.
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/K192053 · printed Nov 3, 2026
Cite this page
510(k) Report. “K192053: W Zirconia Implants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K192053
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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