# K100993: Inclusive Titanium Abutments for Astra Tech Osseospeed Implants

- Pathway: 510(k) (Abbreviated)
- Applicant: Prismatik Dentalcraft, Inc.
- Decided: Dec 28, 2010 after 263 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K925765 (1993). 22 ancestors in all.
33 later devices descend from it; 5 cite it directly.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081666: Atlantis, Atlantis Gemini, Atlantis Gemini+ Abutments for Astra Osseospeed 3.0 Implants, Astra Tech, Inc. (2008) Summary page 1.
- K990304: Modification to Astra Tech Implant - Dental System, Astra Tech, Inc. (1999) Summary page 1.
- K931767: Astra Tech Implants-Dental System, Astra Tech, Inc. (1994) Summary page 1.

## Most influential descendants
- K183518: Preat Abutments (2019), 22 descendants of its own
- K193096: S.I.N. Dental Implant System (2020), 8 descendants of its own
- K200817: URIS OMNI Narrow System & Prosthetic (2020), 6 descendants of its own
- K211921: S.I.N. Dental Implant System (2021), 5 descendants of its own
- K170044: Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant System (2017), 5 descendants of its own

## Indications for use
The Inclusive' Titanium Abutments for Astra OsseoSpeedM Implants are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. They are compatible with the Astra Tech OsseoSpeed t " 3.0, 3.5, 4.0,4.5, 5.0 implants.

Source page: https://510kreport.com/device/K100993
Methodology: https://510kreport.com/methodology