510(k) · Cleared
ClearedUno - One Piece Screw-Type Dental Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mis Implants Technologies, Ltd. · DZE Implant, Endosseous, Root-Form
Cleared on Apr 22, 2008 as substantially equivalent to K052997 (Zimmer Dental, Inc., 2006) after a 90-day review. Its family tree reaches back 1 generation to 2006. 39 later devices descend from it.
- Decided
- Apr 22, 2008
- Review
- 90 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K052997 (2006). 39 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK052997 Zimmer Dental One-Piece ImplantZimmer Dental, Inc. · 2006 · Recalled
- This deviceK080162 Uno - One Piece Screw-Type Dental ImplantMis Implants Technologies, Ltd. · 2008
- Descendant · cites it directly · 36 of its ownK112440 AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd. · 2012
- Descendant · 2 generations on · 25 of its ownK132125 A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd. · 2014
- Descendant · cites it directly · 14 of its ownK140440 Noris Medical Dental Implants SystemNoris Medical, Ltd. · 2014
- Descendant · 2 generations on · 7 of its ownK151909 Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd. · 2016
- Descendant · 2 generations on · 6 of its ownK140728 Mpi - Molecular Precision Implant, Cpi - Cylindrical Precision…Ditron Precision, Ltd. · 2014
Showing 5 of 39 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 39 · See all- K112440AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd. · 2012 · cites it directly36descendants
- K132125A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd. · 2014 · 2 generations on25descendants
- K140440Noris Medical Dental Implants SystemNoris Medical, Ltd. · 2014 · cites it directly14descendants
- K151909Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd. · 2016 · 2 generations on7descendants
- K140728Mpi - Molecular Precision Implant, Cpi - Cylindrical Precision Implant, Opi - One Piece…Ditron Precision, Ltd. · 2014 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K052997 | Zimmer Dental One-Piece Implant | Zimmer Dental, Inc. | 2006 | 1 |
| 0 (this device) | K080162 | Uno - One Piece Screw-Type Dental Implant | Mis Implants Technologies, Ltd. | 2008 | — |
| +1 | K112440 | AB Dental Devices Implants and Accessories | A.B. Dental Devices, Ltd. | 2012 | — |
| +2 | K132125 | A.B. Dental Devices Dental Implants System | A.B. Dental Devices, Ltd. | 2014 | — |
| +1 | K140440 | Noris Medical Dental Implants System | Noris Medical, Ltd. | 2014 | — |
| +2 | K151909 | Noris Medical Zygomatic Dental Implant System | Noris Medical, Ltd. | 2016 | — |
| +2 | K140728 | Mpi - Molecular Precision Implant, Cpi - Cylindrical Precision Implant, Opi -… | Ditron Precision, Ltd. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 4 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 4 | 0 |
| 2024 | 5 | 0 |
| 2025 | 1 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K052997 | Zimmer Dental One-Piece ImplantSummary page 2…ntification: Dental Devices Panel Predicate Device: ZIMMER DENTAL ONE-PIECE IMPLANT from ZIMMER DENTAL INC., 1900 Aston ave. Carlsbad, CA 92008, cleared under 510(k) no. K052997. Description of the device: The Uno - One Piece Screw-Type Dental Implant is indicated for use in surgical and restorative appl… | 2006 |
What descends from it? (39)
See all 394 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 Uno - One Piece Screw-Type 3.0 mm Dental Implant is indicated for use in surgical and restorative applications for placement 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. The Uno - One Piece Screw-Type 3.0 mm Dental Implant is made of one piece solid material comprised…
Read the full statement (202 words)
The Uno - One Piece Screw-Type 3.0 mm Dental Implant is indicated for use in surgical and restorative applications for placement 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. The Uno - One Piece Screw-Type 3.0 mm Dental Implant is made of one piece solid material comprised of the implant and abutment combination. Mandibular central and lateral incisors must be splinted if using two or more 3.0 mm implants adjacent to one another. The Uno implants are manufactured of Titanium alloy Gr. 5 complying with standard ASTM F136-02.
The Uno - One Piece Screw-Type 3.5 mm Dental Implants are indicated for use in surgical and restorative applications for placement in the premolar, cuspid and incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function. The Uno - One Piece Screw-Type 3.5 mm Dental Implants are made of one piece solid material comprised of the implant and abutment combination. The Uno implants are manufactured of Titanium alloy Gr. 5 complying with standard ASTM F136-02.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080162 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080162: Uno - One Piece Screw-Type Dental Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080162
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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