Data / Medical devices / Germany / Altatec GMBH
Altatec GMBH: FDA-registered device maker in WIMSHEIM Baden-Wurttemberg, Germany, 13 510(k) clearances
Altatec GMBH is registered with the FDA (registration 9613866) in WIMSHEIM Baden-Wurttemberg, Germany. It lists 6 device types. The FDA files 13 510(k) clearances under its listings, the newest dated September 29, 2020. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 9613866
- FEI number
- 3002806355
- Address
- Maybachstrasse 5, WIMSHEIM Baden-Wurttemberg, Germany, D-71299
- Owner or operator
- CAMLOG Biotechnologies GmbH (9071675)
- Roles
- Manufacturer
- First device listed
- March 14, 2005
- Registered through
- 2027
- Brand names listed
- A2050.2600 Drill for CT-tube (for A2002.2000), d 2.6 mm, A2050.2600 Template drill for placement of CT-tubes, A2050.2600 Template drill for placement of CT-tubes d 2.6 mm, A2050.2800 Drill for CT-tube (for A2222.2200), d 2.8 mm, A2050.2800 Template drill for placement of CT-tubes, A2050.2800 Template drill for placement of CT-tubes d 2.8 mm, H5300070 Surgery set CERALOG® PROGRESSIVE-LINE Flex, J3713.3300 Guide Template drill and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Manufacturer | accessdata.fda.gov |
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Manufacturer | accessdata.fda.gov |
| Bur, Dental | EJL | 1 | Manufacturer | accessdata.fda.gov |
| Chisel, Osteotome, Surgical | EMM | 1 | Manufacturer | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | Manufacturer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 29, 2020 | K193401 | Altatec GmbH CAMLOG/CONELOG PROGRESSIVE-LINE Implants | DZE | Substantially Equivalent | Altatec GmbH | accessdata.fda.gov |
| September 14, 2016 | K160784 | CAM Titanium Blanks | NHA | Substantially Equivalent | Altatec GmbH | accessdata.fda.gov |
| March 31, 2016 | K153779 | Abutment for Bridges | NHA | Substantially Equivalent | Altatec GmbH | accessdata.fda.gov |
| January 12, 2016 | K152509 | CAMLOG and CONELOG Abutments for Screw-retained Restorations (ASR) | NHA | Substantially Equivalent | Altatec GmbH | accessdata.fda.gov |
| October 2, 2015 | K151599 | iSy Implant System | DZE | Substantially Equivalent | Altatec GmbH | accessdata.fda.gov |
| February 17, 2015 | K143337 | CONELOG Titanium base CAD/CAM | NHA | Substantially Equivalent | Altatec GmbH | accessdata.fda.gov |
| August 6, 2014 | K133991 | ISY | DZE | Substantially Equivalent | Altatec GmbH | accessdata.fda.gov |
| December 14, 2012 | K113779 | CONELOG IMPLANT SYSTEM | DZE | Substantially Equivalent | Altatec GmbH | accessdata.fda.gov |
| January 10, 2011 | K103252 | CAMLOG VARIO SR ABUTMENTS | NHA | Substantially Equivalent | Altatec GmbH | accessdata.fda.gov |
| June 18, 2009 | K090347 | CAMLOG ABUTMENTS PS | NHA | Substantially Equivalent | Altatec GmbH | accessdata.fda.gov |
| January 30, 2009 | K083496 | CAMLOG IMPLANT SYSTEM MODIFIED IMPLANTS AND ABUTMENTS | DZE | Substantially Equivalent | Altatec GmbH | accessdata.fda.gov |
| March 5, 2008 | K073553 | CAMLOG IMPLANT SYSTEM ABUTMENTS | NHA | Substantially Equivalent | Altatec GmbH | accessdata.fda.gov |
| February 17, 2006 | K051636 | CAMLOG DENTAL IMPLANT ABUTMENTS, HEALING CAPS, AND ACCESSORIES | NHA | Substantially Equivalent | Altatec GmbH | accessdata.fda.gov |
Compare with other makers
- All makers of Accessories, Implant, Dental, Endosseous
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Implant, Endosseous, Root-Form
- All makers of Bur, Dental
- All makers of Chisel, Osteotome, Surgical
- All makers of Tray, Surgical, Instrument
Updated September 29, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.