Anthogyr
FDA Regulatory Profile
Anthogyr appears in FDA public data with 2 recalls, 16 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-2753-2016, Class II) was initiated on June 20, 2016. Its most recent 510(k) clearance was granted on January 4, 2024.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 16
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2753-2016 | Class II | Axiom REG implants Sterile The Axiom REG implants are used as artificial root structures for repl | June 20, 2016 |
| Z-2754-2016 | Class II | Axiom 2.8 implants Sterile The Axiom REG implants are used as artificial root structures for rep | June 20, 2016 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K231072 | Anthogyr FlexiBase® titanium bases for Axiom® BL | January 4, 2024 |
| K233264 | Anthogyr INTEGRAL Guided Surgery Cassettes | December 22, 2023 |
| K230104 | Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BL | October 16, 2023 |
| K230680 | Anthogyr Surgical Cassettes | July 11, 2023 |
| K161177 | Axiom PX | June 15, 2017 |
| K160730 | Instrument kits | April 27, 2017 |
| K141450 | AXIOM 2.8 | September 17, 2014 |
| K131066 | AXIOM REG | February 21, 2014 |
| K111532 | MONTBLANC SURGICAL CONTRA-ANGLE AND STRAIGHT HANDPIECE | October 7, 2011 |
| K102241 | ANTHOGYR IMPLANTEO IMPLANTOLOGY AND DENTAL SURGICAL MOTOR UNIT | March 23, 2011 |
| K101913 | ANTHOFIT OI, ANTHOFIT HE, OSSFIT AND AXIOM | March 11, 2011 |
| K093894 | ANTHOGYR IMPULSION IMPLANTOLOGY CONTRA-ANGLE | March 3, 2010 |
| K090676 | MONTBLANC IMPLANTOLOGY AND OMNIPRATIQUE CONTRA-ANGLES | May 22, 2009 |
| K040671 | EROJECT, MINIJECT, SELF ASPIRATING SYRINGES, ASPIRATING SYRINGES, NON ASPIRATING SYRINGES | December 14, 2004 |
| K041279 | IMPLANTEO IMPLANTOLOGY MOTOR | September 23, 2004 |
| K040674 | IMPLANTOLOGY CONTRA ANGLES, ENDODONTIC CONTRA ANGLES, GENERAL DENTISTRY CONTRA ANGLES | June 30, 2004 |