# Astra Tech, Inc.

- Location (FDA's records): San Diego, CA
- FDA decisions: 38 (1994–2013): 38 510(k) clearances
- Names in FDA's records: Astra Tech, Inc. (28); Astra Tech AB (10)
- Product codes: DZE (17), NHA (16), GBM (3), EZD (2)
- Predicates its devices cite: 81 (45 its own); citations of its devices by later devices: 165 (45 its own)
- Recalls linked to its devices: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Atlantis Components, Inc.: 11 (https://510kreport.com/company/atlantis-components)
- Nobel Biocare AB: 4 (https://510kreport.com/company/nobel-biocare)
- Astra Meditec AB: 4 (https://510kreport.com/company/astra-meditec)
- Altatec GmbH: 2 (https://510kreport.com/company/altatec)
- Institut Straumann AG: 2 (https://510kreport.com/company/institut-straumann)
- Dentsply Intl.: 2 (https://510kreport.com/company/dentsply-intl)
- Implant Innovations, Inc.: 2 (https://510kreport.com/company/implant-innovations)
- Altatec Biotechnologies: 2 (https://510kreport.com/company/altatec-biotechnologies)

## Firms that cite its devices most
- Dentsply International, Inc.: 7 (https://510kreport.com/company/dentsply-international)
- Dentsply Implants Manufacturing GmbH: 6 (https://510kreport.com/company/dentsply-implants-manufacturing)
- Dentsply Sirona: 6 (https://510kreport.com/company/dentsply-sirona)
- Prismatik Dentalcraft, Inc.: 5 (https://510kreport.com/company/prismatik-dentalcraft)
- Atlantis Components, Inc.: 4 (https://510kreport.com/company/atlantis-components)
- GC America, Inc.: 4 (https://510kreport.com/company/gc-america)
- Neoss, Ltd.: 4 (https://510kreport.com/company/neoss)
- Terrats Medical SL: 3 (https://510kreport.com/company/terrats-medical)

## Its most-cited devices
- K120414: Osseospeed Plus (2012), cited by 27
- K931767: Astra Tech Implants-Dental System (1994), cited by 13
- K053384: Fixature Microthread Osseospeed, a Component of the Astra Tech Implant System (2006), cited by 12
- K101732: Astra Tech Implant System (2011), cited by 11
- K080396: Osseospeed Narrow (2008), cited by 10
- K974738: Astra Tech Implant Dental System (1998), cited by 6

## Recent decisions
- K121810: Osseospeed Angled Abutment EV (Jan 23, 2013)
- K122078: Lofric Primo, Lofric Hydro-Kit (Oct 31, 2012)
- K120414: Osseospeed Plus (Jul 31, 2012)
- K120338: Atlantis in Zirconia for Dentsply Ankylos Implant, Atlantis Later Abutment in Zirconia (Jul 5, 2012)
- K113424: Lofric Single Use Urinary Catheter (Apr 17, 2012)
- K113003: Atlantis (TM) Abutment and Atlantis (TM) Crown Abutment for Keystone Genesis Implant, Atlantis Gemini (TM) Abutment... (Mar 1, 2012)
- K112138: Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus Implant (Dec 1, 2011)
- K111287: Astra Tech Implant System (Sep 26, 2011)

Source page: https://510kreport.com/company/astra-tech