# K100902: Aedis (TM)

- Pathway: 510(k) (Abbreviated)
- Applicant: Embed Technology, LLC
- Decided: Jun 24, 2010 after 84 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K972351 (1997). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031106: Imtec Sendax Mdi and Mdi Plus Endosseous Implant, Models OB-XX, SH-XX, Mob-22, MSH-XX, Imtec Corp. (2003) Summary page 1.
- K972351: Sendax Mdi (Mini Dental Implant), Sendax Mdic Management, Inc. (1997) Summary page 1.
- K990983: Modification to Imtec Sendax Mdi, Imtec Corp. (1999) Summary page 1.
- K023067: Imtec Sendax Mdi ORTHO6 and ORTHO8, Imtec Corp. (2002) Summary page 1.

## Cited in the summary but kept off the family tree
- K070602: C.T.M. Mobility Scooter# HS-265, C.T.M. Homecare Product, Inc. (2007). 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.

## Indications for use
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.

Source page: https://510kreport.com/device/K100902
Methodology: https://510kreport.com/methodology