510(k) · Cleared
ClearedDental Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
A.B. Dental Devices, Ltd. · DZE Implant, Endosseous, Root-Form
Cleared on Jun 18, 2026 after a 458-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jun 18, 2026
- Review
- 458 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
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?
The A.B. Dental Devices dental implant system is indicated for prosthodontic reconstruction in partially or completely edentulous patients. The dental implants are intended for placement in the maxilla or mandible to anchor and support dental prosthetic restorations. Implant placement may be performed using either a one-stage or two-stage surgical protocol. One-piece implants are intended for use only with a one-stage surgical procedure. When a one-stage…
Read the full statement (173 words)
The A.B. Dental Devices dental implant system is indicated for prosthodontic reconstruction in partially or completely edentulous patients.
The dental implants are intended for placement in the maxilla or mandible to anchor and support dental prosthetic restorations.
Implant placement may be performed using either a one-stage or two-stage surgical protocol.
One-piece implants are intended for use only with a one-stage surgical procedure.
When a one-stage surgical approach is applied, the implants are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Narrow (3.0 mm) implants from the I5 and I55 families are intended for single-unit restorations in maxillary or mandibular incisor positions.
Short (length <7 mm) implants are intended for use only with straight abutments and should be placed using a two-stage surgical approach only.
Prosthetic products are intended for integration with a dental implant to support single or multiple tooth prostheses.
All digitally designed abutments for use with AB Dental Pre-Face Blank Abutments are intended to be sent to AB Dental validated milling center for manufacture.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K250806 · printed Nov 5, 2026
Cite this page
510(k) Report. “K250806: Dental Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K250806
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)
- Page last updated Nov 3, 2026