# K024111: Astra Tech Implants-Dental System Fixture Osseospeed

- Pathway: 510(k) (Traditional)
- Applicant: Astra Tech, Inc.
- Decided: Jun 10, 2003 after 179 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: 2 generations back to K931767 (1994). 6 ancestors in all.
423 later devices descend from it; 5 cite it directly.
0 of 430 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K931767: Astra Tech Implants-Dental System, Astra Tech, Inc. (1994) Summary page 1.
- K990304: Modification to Astra Tech Implant - Dental System, Astra Tech, Inc. (1999) Summary page 1.
- K991053: Astra Tech Implants - Dental System: New Fixtures (Micromacro), Astra Tech, Inc. (1999) Summary page 1.
- K002513: Astra Tech Implants - Dental System, Astra Tech, Inc. (2001)
- K974738: Astra Tech Implant Dental System, Astra Tech, Inc. (1998) Summary page 1.
- K980698: Astra Tech Implants - Dental System, Astra Tech, Inc. (1998) Summary page 1.

## Cited in the summary but kept off the family tree
- K012965: Astra Tech fixtures. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree

## Most influential descendants
- K070833: Atlantis Abutment for Astra Implant (2007), 357 descendants of its own
- K081666: Atlantis, Atlantis Gemini, Atlantis Gemini+ Abutments for Astra Osseospeed 3.0 Implants (2008), 337 descendants of its own
- K100152: Sirona Cad/Cam System (2010), 240 descendants of its own
- K060958: Straumann Narrow Neck Implants (2006), 228 descendants of its own
- K111357: Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant System (2011), 222 descendants of its own

## Indications for use
Fixture OsseoSpeed and Fixture MicroMacro are intended for endosseous implantation in the mandible and maxilla supporting single-tooth replacements, partial and total fixed/fixed detachable bridges and overdentures. One or two stage surgical procedure can be used. When using the one stage surgical protocol, immediate loading may be applied in the anterior mandibular region (between the mental foramina) if at least four implants are splinted with a bar, or other continuous suprastructure.

Source page: https://510kreport.com/device/K024111
Methodology: https://510kreport.com/methodology