510(k) · Cleared
ClearedZ7 Zirconia Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Z7, LLC · DZE Implant, Endosseous, Root-Form
Cleared on Jun 26, 2023 as substantially equivalent to K192053 (Tav Medical, Ltd., 2019) after a 399-day review. Its family tree reaches back 13 generations to 1995.
- Decided
- Jun 26, 2023
- Review
- 399 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K944964 (1995). 95 ancestors in all, the oldest K871863 (1987). No later device cites it as a predicate yet.
- Root · 13 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
- 9 generations between
- 3 generations backK132881 Z5CZ-Systems AG · 2014
- 2 generations backK172668 W Zirconia ImplantsTav Medical, Ltd. · 2018
- 1 generation backK192053 W Zirconia ImplantsTav Medical, Ltd. · 2019
- This deviceK221488 Z7 Zirconia Implant SystemZ7, LLC · 2023
Show all 13 generations
- Root · 13 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
- 12 generations backK961728 Miruscone Abutment SystemNobelpharma USA, Inc. · 1996
- 11 generations backK962403 Noblepharma Wide AccessoriesNobelpharma USA, Inc. · 1996
- 10 generations backK971706 Tiadapt Abutment SystemNobel Biocare Uas, Inc. · 1997
- 9 generations backK974150 Procera Preparable Abutment SystemNobel Biocare Uas, Inc. · 1998 · Recalled
- 8 generations backK032263 3I Patient-Specific Dental Abutment and Overdenture BarImplant Innovations, Inc. · 2004 · Recalled
- 7 generations backK042658 Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001…Nobel Biocare Uas, Inc. · 2004
- 6 generations backK052070 Atlantis Abutment in Zirconia, Atlantis Gemini Abutment in Zirconia…Atlantis Components, Inc. · 2005
- 5 generations backK062277 Atlantis Abutment in Zirconia for Nobel Biocare ReplaceAtlantis Components, Inc. · 2006
- 4 generations backK091920 Atlantis Abutment in Zirconia, Atlantis Gemini Abutment for Nobel…Astra Tech, Inc. · 2009
- 3 generations backK132881 Z5CZ-Systems AG · 2014
- 2 generations backK172668 W Zirconia ImplantsTav Medical, Ltd. · 2018
- 1 generation backK192053 W Zirconia ImplantsTav Medical, Ltd. · 2019
- This deviceK221488 Z7 Zirconia Implant SystemZ7, LLC · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K944964 | Branemark System Miruscone Abutment System | Nobelpharma USA, Inc. | 1995 | — |
| −12 | K961728 | Miruscone Abutment System | Nobelpharma USA, Inc. | 1996 | — |
| −11 | K962403 | Noblepharma Wide Accessories | Nobelpharma USA, Inc. | 1996 | — |
| −10 | K971706 | Tiadapt Abutment System | Nobel Biocare Uas, Inc. | 1997 | — |
| −9 | K974150 | Procera Preparable Abutment System | Nobel Biocare Uas, Inc. | 1998 | 2 |
| −8 | K032263 | 3I Patient-Specific Dental Abutment and Overdenture Bar | Implant Innovations, Inc. | 2004 | 1 |
| −7 | K042658 | Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004… | Nobel Biocare Uas, Inc. | 2004 | — |
| −6 | K052070 | Atlantis Abutment in Zirconia, Atlantis Gemini Abutment in Zirconia, Atlantis… | Atlantis Components, Inc. | 2005 | — |
| −5 | K062277 | Atlantis Abutment in Zirconia for Nobel Biocare Replace | Atlantis Components, Inc. | 2006 | — |
| −4 | K091920 | Atlantis Abutment in Zirconia, Atlantis Gemini Abutment for Nobel Replace… | Astra Tech, Inc. | 2009 | — |
| −3 | K132881 | Z5C | Z-Systems AG | 2014 | — |
| −2 | K172668 | W Zirconia Implants | Tav Medical, Ltd. | 2018 | — |
| −1 | K192053 | W Zirconia Implants | Tav Medical, Ltd. | 2019 | — |
| 0 (this device) | 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 |
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? (1)
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 |
|---|---|---|---|
| * | K192053 | W Zirconia ImplantsSummary page 4…conia Implant System Common Name Endosseous Dental Implant Code – DZE, NHA Classification 21 CFR 872.3640: Class II Primary Predicate K192053 TAV Medical Ltd. W Zirconia Implants K172668 TAV Medical Ltd. W Zirconia Implants Reference Device… | 2019 |
| † | K172668 | W Zirconia Implants | 2018 |
| † | K132585 | Zibone Ceramic Dental Implant System | 2014 |
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 28 years and passes through 8 companies; a new generation was cleared every 1.2 years on median.
- 8 of the 95 ancestors have a recall of any class.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 Z7 Zirconia Implant System is 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 ø3.7 mm reduced diameter implants are recommended for central and lateral incisors only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221488 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221488: Z7 Zirconia Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221488
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