510(k) · Cleared
ClearedAedis (TM)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Embed Technology, LLC · DZE Implant, Endosseous, Root-Form
Cleared on Jun 24, 2010 as substantially equivalent to K031106 (Imtec Corp., 2003) and 3 other predicates after an 84-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Jun 24, 2010
- Review
- 84 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 1 generation to K972351 (1997). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK972351 Sendax Mdi (Mini Dental Implant)Sendax Mdic Management, Inc. · 1997
- This deviceK100902 Aedis (TM)Embed Technology, LLC · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K972351 | Sendax Mdi (Mini Dental Implant) | Sendax Mdic Management, Inc. | 1997 | — |
| 0 (this device) | K100902 | Aedis (TM) | Embed Technology, LLC | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 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? (5)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K031106 | Imtec Sendax Mdi and Mdi Plus Endosseous Implant, Models OB-XX, SH-XX, Mob-22, MSH-XXSummary page 1…e Endosseous implant Device alassification Caas ii Product Code OZE Identification of Predicate Device: lmntec 1.8 mm diameter implant K031106; (See too lntra-Lock 2 mm diameter implant K(070602; Sendax MDI 1.8 mm diameter implants 3972351; K990983; and K023067.) This su… | 2003 |
| Kept off the family tree | K070602 | FDA’s K070602 is C.T.M. Mobility Scooter# HS-265 Our reading of the summary gave K070602, FDA’s number for C.T.M. Mobility Scooter# HS-265 (C.T.M. Homecare Product, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Intra-Lock 2 mm diameter implant”. Kept off the family tree. Summary page 1…Caas ii Product Code OZE Identification of Predicate Device: lmntec 1.8 mm diameter implant K031106; (See too lntra-Lock 2 mm diameter implant K(070602; Sendax MDI 1.8 mm diameter implants 3972351; K990983; and K023067.) This submission is an abbreviated 510 (k) as discussed in t… | 2007 |
| * | K972351 | Sendax Mdi (Mini Dental Implant)Summary page 1…OZE Identification of Predicate Device: lmntec 1.8 mm diameter implant K031106; (See too lntra-Lock 2 mm diameter implant K(070602; Sendax MDI 1.8 mm diameter implants 3972351; K990983; and K023067.) This submission is an abbreviated 510 (k) as discussed in the FDA's guidance document entitled "The New… | 1997 |
| * | K990983 | Modification to Imtec Sendax MdiSummary page 1…ntification of Predicate Device: lmntec 1.8 mm diameter implant K031106; (See too lntra-Lock 2 mm diameter implant K(070602; Sendax MDI 1.8 mm diameter implants 3972351; K990983; and K023067.) This submission is an abbreviated 510 (k) as discussed in the FDA's guidance document entitled "The New 510(k) Pa… | 1999 |
| * | K023067 | Imtec Sendax Mdi ORTHO6 and ORTHO8Summary page 1…f Predicate Device: lmntec 1.8 mm diameter implant K031106; (See too lntra-Lock 2 mm diameter implant K(070602; Sendax MDI 1.8 mm diameter implants 3972351; K990983; and K023067.) This submission is an abbreviated 510 (k) as discussed in the FDA's guidance document entitled "The New 510(k) Paradigm - Alte… | 2002 |
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.
What does this lineage say?
- 1 of the 4 ancestors has a recall of any class.
- 22 other devices also cite its predicate K031106.
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?
AEDIS -provides a self tapping titanium screw indicated for immediate transitional splinting stability, or long term intra-bony applications such as fixation of new or existing crown, bridge or denture Installations in partially or fully edentulous mandibles and maxillae. Immediate loading is not recommended where there is inadequate stability. Immediate loading should occur when the position of the implant provides adequate bone quality and quantity to…
Read the full statement (106 words)
AEDIS -provides a self tapping titanium screw indicated for immediate transitional splinting stability, or long term intra-bony applications such as fixation of new or existing crown, bridge or denture Installations in partially or fully edentulous mandibles and maxillae.
Immediate loading is not recommended where there is inadequate stability. Immediate loading should occur when the position of the implant provides adequate bone quality and quantity to allow proper immediate mechanical stabilization of the self uapping screw into the bone, and where ocdlusal and lateral forces can be limited with appropriate occiusal design when splinted. Dietary restrictions may also be required by the surgeon performing the implant procedure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100902 · printed Nov 4, 2026
Cite this page
510(k) Report. “K100902: Aedis (TM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K100902
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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