510(k) · Cleared
ClearedUNIQA® Dental Implants System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Uniqa Dental, Ltd. · DZE Implant, Endosseous, Root-Form
Cleared on Jun 25, 2026 as substantially equivalent to K180598 (Uniqa Dental, Ltd., 2018) after a 434-day review. Its family tree reaches back 6 generations to 1993.
- Decided
- Jun 25, 2026
- Review
- 434 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K925765 (1993). 31 ancestors in all, the oldest K874590 (1988). No later device cites it as a predicate yet.
- Root · 6 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 5 generations backK994376 Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating…Friadent GmbH · 2000
- 4 generations backK014235 Osseotite NT Dental Implants & AccessoriesImplant Innovations, Inc. · 2002
- 3 generations backK022009 3I Implants; Osseotite Dental Implants; Osseotite NT Dental ImplantsImplant Innovations, Inc. · 2002
- 2 generations backK040807 Mis Dental Implant SystemMis - Implant Technologies, Ltd. · 2004
- 1 generation backK180598 UNIQA Dental Implants SystemUniqa Dental, Ltd. · 2018
- This deviceK251188 UNIQA® Dental Implants SystemUniqa Dental, Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K925765 | Branemark System Standard 3.75MM Fixture | Nobelpharma USA, Inc. | 1993 | — |
| −5 | K994376 | Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating; Frialit-2… | Friadent GmbH | 2000 | — |
| −4 | K014235 | Osseotite NT Dental Implants & Accessories | Implant Innovations, Inc. | 2002 | — |
| −3 | K022009 | 3I Implants; Osseotite Dental Implants; Osseotite NT Dental Implants | Implant Innovations, Inc. | 2002 | — |
| −2 | K040807 | Mis Dental Implant System | Mis - Implant Technologies, Ltd. | 2004 | — |
| −1 | K180598 | UNIQA Dental Implants System | Uniqa Dental, Ltd. | 2018 | — |
| 0 (this device) | K251188 | UNIQA® Dental Implants System | Uniqa Dental, Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 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 |
|---|---|---|---|
| * | K180598 | UNIQA Dental Implants SystemSummary page 6…Page 1 8 Identification of Legally Marketed Predicate Devices : Primary Predicate: UNIQA® Dental Implants System K180598, UNIQA Dental Ltd Reference Predicate for Implants: NobelActive® K142260, Nobel Biocare AB Reference Predicates for A… | 2018 |
| † | K142260 | NobelActive | 2015 |
| † | K040807 | Mis Dental Implant System | 2004 |
| † | K163349 | MIS V3 Conical Connection Dental Implant System | 2017 |
| † | K180282 | MIS Internal Hex Dental Implant System | 2018 |
| † | K072570 | Nobelactive Multi Unit Abutment | 2007 |
| † | K182219 | SGS Dental Implants System | 2019 |
| † | K252944 | LOCATOR® Angled Abutment | 2025 |
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 33 years and passes through 5 companies; a new generation was cleared every 6.5 years on median.
- 2 of the 31 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. 2026, 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?
UNIQA Dental® Dental Implants System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. UNIQA Dental® Dental Implants System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Conical Mini implants (&3.3mm)…
Read the full statement (133 words)
UNIQA Dental® Dental Implants System is indicated for use in surgical and restorative applications
for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such
as artificial teeth, in order to restore the patient's chewing function. UNIQA Dental® Dental Implants
System is indicated also for immediate loading when good primary stability is achieved and with
appropriate occlusal loading.
Conical Mini implants (&3.3mm) are indicated for use in surgical and restorative applications for
placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of
partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth, in order to
restore the patient chewing function. Mandibular central and lateral incisors must be splinted if using
two or more narrow implants adjacent to one another.
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/K251188 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251188: UNIQA® Dental Implants System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251188
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026