510(k) · Cleared
ClearedZIT-Z
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ziterion · DZE Implant, Endosseous, Root-Form
Cleared on May 11, 2010 as substantially equivalent to K061971 (Nobel Biocare AB, 2007) and 1 other predicate after a 267-day review. Its family tree reaches back 2 generations to 2002.
- Decided
- May 11, 2010
- Review
- 267 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K022562 (2002). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K022562 | Various Branemark System Implants-Immediate Function Indication | Nobel Biocare AB | 2002 | — |
| −1 | K061971 | Zirconia Implant | Nobel Biocare AB | 2007 | — |
| 0 (this device) | K092507 | ZIT-Z | Ziterion | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2007 | 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 |
|---|---|---|---|
| * | K061971 | Zirconia ImplantSummary page 1…cation Name: Endlosseous dental implant 21 CFR 872.3640 Trade Name: zit-z Dental Implant System Legally Marketed Device: NobelBiocare Zirconia Implant K061971 and Z-systems Z-Look3 K06254 2 Device Description: Zit-z Dental Implant System is a root-form dental implant system with a one-p… | 2007 |
| * | K062542 | Z-LOOK3 Dental Implant System, Model Z3-XXXSummary page 1…ental implant 21 CFR 872.3640 Trade Name: zit-z Dental Implant System Legally Marketed Device: NobelBiocare Zirconia Implant K061971 and Z-systems Z-Look3 K06254 2 Device Description: Zit-z Dental Implant System is a root-form dental implant system with a one-piece cylindrical screw implant… | 2007 |
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 8 years and passes through 2 companies; a new generation was cleared every 4.4 years on median.
- None of the 4 ancestors has a recall.
- 3 other devices also cite its predicate K061971.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
Zit-z dental implants are root-form endosseous dental implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and, chewing function. They are indicated for single or multiple unit restorations in splinted or non-splinted applications. The zit-z dental implants are restored with fixed/cemented crowns and bridges. Not for immediate loading.
The 3.5mim implant is contraindicated for restorations of the posterior teeth in the upper or lower jaw and for single-tooth restoration of canines and central incisors in the upperjaw.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092507 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092507: ZIT-Z.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092507
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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