510(k) · Cleared
ClearedIdi Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Idi Biomedical, LLC · DZE Implant, Endosseous, Root-Form
Cleared on Nov 7, 2008 as substantially equivalent to K073142 (Nobel Biocare USA, LLC, 2008) after a 134-day review. Its family tree reaches back 9 generations to 1990. 2 later devices descend from it.
- Decided
- Nov 7, 2008
- Review
- 134 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K894595 (1990). 23 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 5 generations between
- 3 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 2 generations backK062566 Nobelreplace Tapered Conical ConnectionNobel Biocare USA, LLC · 2006 · Recalled
- 1 generation backK073142 Nobelreplace Hexagonal ImplantNobel Biocare USA, LLC · 2008 · Recalled
- This deviceK081806 Idi Implant SystemIdi Biomedical, LLC · 2008
- Descendant · cites it directly · 1 of its ownK101755 Aidi Dental Implant SystemAidi Biomedical, LLC · 2010
- Descendant · cites it directly · 0 of its ownK123861 Aidi Dental Implant SystemAidi Biomedical, LLC · 2013
Show all 9 generations
- Root · 9 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 8 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 7 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 6 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 5 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- 4 generations backK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
- 3 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 2 generations backK062566 Nobelreplace Tapered Conical ConnectionNobel Biocare USA, LLC · 2006 · Recalled
- 1 generation backK073142 Nobelreplace Hexagonal ImplantNobel Biocare USA, LLC · 2008 · Recalled
- This deviceK081806 Idi Implant SystemIdi Biomedical, LLC · 2008
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −8 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −7 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −6 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −5 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| −4 | K050258 | Groovy Implants | Nobel Biocare AB | 2005 | 28 |
| −3 | K061003 | SFB & CFB Implants | Nobel Biocare AB | 2006 | — |
| −2 | K062566 | Nobelreplace Tapered Conical Connection | Nobel Biocare USA, LLC | 2006 | 27 |
| −1 | K073142 | Nobelreplace Hexagonal Implant | Nobel Biocare USA, LLC | 2008 | 2 |
| 0 (this device) | K081806 | Idi Implant System | Idi Biomedical, LLC | 2008 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K073142 | Nobelreplace Hexagonal ImplantSummary page 1…osseous dental implant abutment 21 CFR 872.3630 Trade Name: IDI Implant Systems Legally Marketed Device: NobelReplace Hexagonal Implant K073142 Device Description: IDl Implant Systems are threaded root-form dental implants intended for use in the upper and lower jaw arch… | 2008 |
What descends from it? (2)
2 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?
- The line of descent spans 18 years and passes through 6 companies; a new generation was cleared every 1.1 years on median.
- 6 of the 23 ancestors have a recall of any class.
- Of its descendants, K101755 (Aidi Biomedical, LLC, 2010) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K073142.
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?
IDI Implant System 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 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/K081806 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081806: Idi Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081806
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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