510(k) · Cleared
ClearedNobelZygoma TiUltra Implant system
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nobel Biocare AB · DZE Implant, Endosseous, Root-Form
Cleared on Aug 25, 2025 as substantially equivalent to K152093 (Nobel Biocare AB, 2016) and 3 other predicates after a 255-day review. Its family tree reaches back 5 generations to 1993.
- Decided
- Aug 25, 2025
- Review
- 255 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K925771 (1993). 15 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK925771 Branemark System Titanium Cover ScrewsNobelpharma USA, Inc. · 1993
- 4 generations backK970499 Branemark System Zygomaticus Fixture SystemNobel Biocare Uas, Inc. · 1997
- 3 generations backK070182 Zygoma Implant (Immediate Function)Nobel Biocare AB · 2007
- 2 generations backK152093 NobelZygoma 45°Nobel Biocare AB · 2016
- 1 generation backK161598 NobelZygoma 0°Nobel Biocare AB · 2017
- This deviceK243834 NobelZygoma TiUltra Implant systemNobel Biocare AB · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K925771 | Branemark System Titanium Cover Screws | Nobelpharma USA, Inc. | 1993 | — |
| −4 | K970499 | Branemark System Zygomaticus Fixture System | Nobel Biocare Uas, Inc. | 1997 | — |
| −3 | K070182 | Zygoma Implant (Immediate Function) | Nobel Biocare AB | 2007 | — |
| −2 | K152093 | NobelZygoma 45° | Nobel Biocare AB | 2016 | — |
| −1 | K161598 | NobelZygoma 0° | Nobel Biocare AB | 2017 | — |
| 0 (this device) | K243834 | NobelZygoma TiUltra Implant system | Nobel Biocare AB | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 4 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 2005 | 2 | 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? (4)
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 |
|---|---|---|---|
| * | K152093 | NobelZygoma 45°Summary page 6…er: 21 CFR 872.3640 Device Class: II Primary Product Code: DZE Secondary Product Code: NHA 1.3 Predicate Devices Primary Predicate Device K152093, NobelZygoma 45° TiUnite, Nobel Biocare AB Reference Device: Reference Device #1: K161598, NobelZygoma 0° TiUnite, Nobel B… | 2016 |
| * | K050641 | Zygoma TiuniteSummary page 6…(Pty) Ltd Reference Device #3: K151909, Noris Medical Zygomatic Dental Implant, Noris Medical Reference Device #4: K050641, Brånemark System Zygoma Multi-Unit Abutment, Nobel Biocare AB Reference Device #5: K052885, Brå… | 2005 |
| * | K052885 | Zygoma 17 Abutment Multi-Unit RP 2MM, Model 29314; Zygoma 17 Abutment Multi-Unit RP 3MM…Summary page 6…Medical Reference Device #4: K050641, Brånemark System Zygoma Multi-Unit Abutment, Nobel Biocare AB Reference Device #5: K052885, Brånemark System Zygoma 17° Multi-unit Abutment, Nobel Biocare AB Reference Device #6: K161598,… | 2005 |
| * | K161598 | NobelZygoma 0°Summary page 6…y Product Code: NHA 1.3 Predicate Devices Primary Predicate Device K152093, NobelZygoma 45° TiUnite, Nobel Biocare AB Reference Device: Reference Device #1: K161598, NobelZygoma 0° TiUnite, Nobel Biocare AB Reference Device #2: K222497, Zaga Zygomatic system, Southern Implants… | 2017 |
| † | K222497 | Zaga Zygomatic System | 2022 |
| † | K151909 | Noris Medical Zygomatic Dental Implant System | 2016 |
| † | K202344 | TiUltra Implants and Xeal Abutments | 2020 |
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 3 companies; a new generation was cleared every 8.4 years on median.
- 1 of the 15 ancestors has a recall of any class.
- 1 other device also cites its predicate K152093.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
NobelZygoma TiUltra implants The NobelZygoma TiUltra implants are endosseous dental implants intended to be surgically placed in the zygomatic bone to support a dental prosthesis in the upper arch, in order to restore patient esthetics and chewing function. The NobelZygoma Implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Multi-Unite Abutment Xeal Zygoma The Multi-unit Abutments…
Read the full statement (124 words)
NobelZygoma TiUltra implants
The NobelZygoma TiUltra implants are endosseous dental implants intended to be surgically placed in the zygomatic bone to support a dental prosthesis in the upper arch, in order to restore patient esthetics and chewing function. The NobelZygoma Implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Multi-Unite Abutment Xeal Zygoma
The Multi-unit Abutments Xeal Zygoma are indicated to support the placement of multiple unit, screw-retained prosthetic restorations in the maxilla including full arch dentures.
NobelZygoma Multi-Unite Abutment Xeal Zygoma Screws
The NobelZygoma Multi-Unit Abutment Screws are indicated for use to secure a dental abutment or framework to a dental implant for supporting tooth replacements and are indicated as an aid in prosthetic rehabilitation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243834 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243834: NobelZygoma TiUltra 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/K243834
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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