510(k) · Cleared
ClearedAidi Dental Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aidi Biomedical, LLC · DZE Implant, Endosseous, Root-Form
Cleared on Nov 22, 2010 as substantially equivalent to K071370 (Nobel Biocare AB, 2007) and 1 other predicate after a 152-day review. Its family tree reaches back 10 generations to 1990. 1 later device descends from it.
- Decided
- Nov 22, 2010
- Review
- 152 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K894595 (1990). 25 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 10 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 6 generations between
- 3 generations backK062566 Nobelreplace Tapered Conical ConnectionNobel Biocare USA, LLC · 2006 · Recalled
- 2 generations backK073142 Nobelreplace Hexagonal ImplantNobel Biocare USA, LLC · 2008 · Recalled
- 1 generation backK081806 Idi Implant SystemIdi Biomedical, LLC · 2008
- This deviceK101755 Aidi Dental Implant SystemAidi Biomedical, LLC · 2010
- Descendant · cites it directly · 0 of its ownK123861 Aidi Dental Implant SystemAidi Biomedical, LLC · 2013
Show all 10 generations
- Root · 10 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 9 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 8 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 7 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 6 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- 5 generations backK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
- 4 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 3 generations backK062566 Nobelreplace Tapered Conical ConnectionNobel Biocare USA, LLC · 2006 · Recalled
- 2 generations backK073142 Nobelreplace Hexagonal ImplantNobel Biocare USA, LLC · 2008 · Recalled
- 1 generation backK081806 Idi Implant SystemIdi Biomedical, LLC · 2008
- This deviceK101755 Aidi Dental Implant SystemAidi Biomedical, LLC · 2010
Most influential descendants
Showing 1 of 1 · See all- K123861Aidi Dental Implant SystemAidi Biomedical, LLC · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −9 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −8 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −7 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −6 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| −5 | K050258 | Groovy Implants | Nobel Biocare AB | 2005 | 28 |
| −4 | K061003 | SFB & CFB Implants | Nobel Biocare AB | 2006 | — |
| −3 | K062566 | Nobelreplace Tapered Conical Connection | Nobel Biocare USA, LLC | 2006 | 27 |
| −2 | K073142 | Nobelreplace Hexagonal Implant | Nobel Biocare USA, LLC | 2008 | 2 |
| −1 | K081806 | Idi Implant System | Idi Biomedical, LLC | 2008 | — |
| 0 (this device) | K101755 | Aidi Dental Implant System | Aidi Biomedical, LLC | 2010 | — |
| +1 | K123861 | Aidi Dental Implant System | Aidi Biomedical, LLC | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2002 | 3 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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? (2)
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 |
|---|---|---|---|
| * | K071370 | Nobelactive Internal Connection ImplantSummary page 2…is safe and effective for its intended use and performs as well as predicated ID] Implant System (K081806) and predicated NobelActive Internal Connection Implant System (K071370) for the following reasons: A. The torque strength test data revealed a high torque strength for AIDI Dental Implants.… | 2007 |
| * | K081806 | Idi Implant SystemSummary page 2…usion In Sum, we can conclude that AIDI Dental Implant System (K101755) is safe and effective for its intended use and performs as well as predicated ID] Implant System (K081806) and predicated NobelActive Internal Connection Implant System (K071370) for the following reasons: A. The torque strength t… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123861 | Aidi Dental Implant System | 2013 | 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?
- The line of descent spans 20 years and passes through 7 companies; a new generation was cleared every 1.2 years on median.
- 7 of the 25 ancestors have a recall of any class.
- Of its descendants, K123861 (Aidi Biomedical, LLC, 2013) has gone furthest, with 0 descendants of its own.
- 28 other devices also cite its predicate K071370.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
AIDI Dental Implant Systems® (AIDI Fixtures and AIDI Abutments with screws) are endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Straight abutments indicated for both screw retained and cemented restorations are included. The implants are indicated for single or multiple unit restorations and can be used in splinted and non-splinted applications. The device is intended for immediate placement and immediate loading when good primary stability has been achieved and with appropriate occlusal loading.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101755 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101755: Aidi Dental 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/K101755
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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