510(k) · Cleared
ClearedSendax Mdi (Mini Dental Implant)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sendax Mdic Management, Inc. · DZE Implant, Endosseous, Root-Form
Cleared on Nov 24, 1997 after a 153-day review. The FDA summary names its predicate without a number. 548 later devices descend from it.
- Decided
- Nov 24, 1997
- Review
- 153 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 0
548 later devices descend from it, 8 citing it directly.
- This deviceK972351 Sendax Mdi (Mini Dental Implant)Sendax Mdic Management, Inc. · 1997
- Descendant · cites it directly · 322 of its ownK980620 Dentatus Mti Modular Transitional Implants and Prosthetic SystemDentatus USA, Ltd. · 1998
- Descendant · 2 generations on · 319 of its ownK030614 3I Dental ImplantsImplant Innovations, Inc. · 2003
- Descendant · 3 generations on · 318 of its ownK041402 Modification to Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2004
- Descendant · 4 generations on · 317 of its ownK051189 Prevail Dental ImplantsImplant Innovations, Inc. · 2005
- Descendant · cites it directly · 313 of its ownK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
Showing 5 of 548 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 548 · See all- K980620Dentatus Mti Modular Transitional Implants and Prosthetic SystemDentatus USA, Ltd. · 1998 · cites it directly322descendants
- K0306143I Dental ImplantsImplant Innovations, Inc. · 2003 · 2 generations on319descendants
- K041402Modification to Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2004 · 3 generations on318descendants
- K051189Prevail Dental ImplantsImplant Innovations, Inc. · 2005 · 4 generations on317descendants
- K032351The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003 · cites it directly313descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K972351 | Sendax Mdi (Mini Dental Implant) | Sendax Mdic Management, Inc. | 1997 | — |
| +1 | K980620 | Dentatus Mti Modular Transitional Implants and Prosthetic System | Dentatus USA, Ltd. | 1998 | — |
| +2 | K030614 | 3I Dental Implants | Implant Innovations, Inc. | 2003 | — |
| +3 | K041402 | Modification to Osseotite NT Certain Implants | Implant Innovations, Inc. | 2004 | — |
| +4 | K051189 | Prevail Dental Implants | Implant Innovations, Inc. | 2005 | — |
| +1 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 5 | 0 |
| 2005 | 11 | 0 |
| 2006 | 12 | 0 |
| 2007 | 13 | 0 |
| 2008 | 19 | 0 |
| 2009 | 9 | 0 |
| 2010 | 7 | 0 |
| 2011 | 20 | 0 |
| 2012 | 17 | 0 |
| 2013 | 19 | 0 |
| 2014 | 20 | 0 |
| 2015 | 23 | 0 |
| 2016 | 27 | 0 |
| 2017 | 25 | 0 |
| 2018 | 22 | 0 |
| 2019 | 29 | 0 |
| 2020 | 34 | 0 |
| 2021 | 32 | 0 |
| 2022 | 39 | 0 |
| 2023 | 44 | 0 |
| 2024 | 46 | 0 |
| 2025 | 43 | 0 |
| 2026 | 25 | 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 |
|---|---|---|---|
| * | — | Dentatus MTI® Anchor Post/Modular Transitional Implant Named without a submission number |
What descends from it? (548)
See all 5488 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K980620 | Dentatus Mti Modular Transitional Implants and Prosthetic System | 1998 | 322 |
| K032351 | The Maestro System 3.0MM Diameter Implant | 2003 | 313 |
| K983120 | Bicortical Screw | 1999 | 94 |
| K982509 | Ortho Implant and Accessories | 1998 | 66 |
| K100902 | Aedis (TM) | 2010 | 0 |
| K083669 | OBI | 2009 | 0 |
| K072917 | JJG Evolution Orthodontic Implant System | 2008 | 0 |
| K021915 | Transitional Implants | 2002 | 0 |
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?
- Of its descendants, K980620 (Dentatus USA, Ltd., 1998) has gone furthest, with 322 descendants of its own.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
This device is a self-tapping titanium threaded screw indicated for intra-bony and inter-radicular transitional applications, to permit immediate splinting stability and ongoing fixation of new or existing crown & bridge installations, for full or partial edentulism, and employing minimally invasive surgical intervention. Representative applications include the following: * Temporary (transitional) supports for fixed or removable implant-supported…
Read the full statement (145 words)
This device is a self-tapping titanium threaded screw indicated for intra-bony and inter-radicular transitional applications, to permit immediate splinting stability and ongoing fixation of new or existing crown & bridge installations, for full or partial edentulism, and employing minimally invasive surgical intervention.
Representative applications include the following:
* Temporary (transitional) supports for fixed or removable implant-supported prostheses while conventional implants are integrating.
* Stabilizing interim prostheses in graft sites and guided tissue regeneration applications to avoid iatrogenic damage to healing grafts, membranes or
* Introductory system for nervous or apprehensive potential implant patients, offering a simple methodology for testing out the actual "feel"™ of bone-anchored implants, without the major commitment to final restorations; or as an interim system for medically compromised, handicapped or terminally ill patients to enhance their comfort by maintaining a reasonable level of speech, mastication & general well-being, at modest cost levels.
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/K972351 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972351: Sendax Mdi (Mini Dental Implant).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972351
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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