Anthogyr
SALLANCHES Haute-Savoie, FR
ANTHOGYR appears in FDA device records in SALLANCHES Haute-Savoie, FR. FDA records list 10 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 10 510(k) clearances for Anthogyr between 2004 and 2024. The busiest year on record is 2004, with 3. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2004 | 3 |
| 2009 | 1 |
| 2010 | 1 |
| 2017 | 1 |
| 2023 | 3 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K231072 | Anthogyr FlexiBase® titanium bases for Axiom® BL | NHA | Substantially Equivalent | |
| K233264 | Anthogyr INTEGRAL Guided Surgery Cassettes | KCT | Substantially Equivalent | |
| K230104 | Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BL | DZE | Substantially Equivalent | |
| K230680 | Anthogyr Surgical Cassettes | KCT | Substantially Equivalent | |
| K160730 | Instrument kits | KCT | Substantially Equivalent | |
| K093894 | ANTHOGYR IMPULSION IMPLANTOLOGY CONTRA-ANGLE | EFA | Substantially Equivalent | |
| K090676 | MONTBLANC IMPLANTOLOGY AND OMNIPRATIQUE CONTRA-ANGLES | EFA | Substantially Equivalent | |
| K040671 | EROJECT, MINIJECT, SELF ASPIRATING SYRINGES, ASPIRATING SYRINGES, NON ASPIRATING SYRINGES | EJI | Substantially Equivalent | |
| K041279 | IMPLANTEO IMPLANTOLOGY MOTOR | EKX | Substantially Equivalent | |
| K040674 | IMPLANTOLOGY CONTRA ANGLES, ENDODONTIC CONTRA ANGLES, GENERAL DENTISTRY CONTRA ANGLES | EFA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 8020776 | 4224 | ANTHOGYR | 2237, AVENUE ANDRE LASQUIN, SALLANCHES Haute-Savoie 74700 FR | 2026 | and 15 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- NHAAbutment, Implant, Dental, Endosseous
- NDPAccessories, Implant, Dental, Endosseous
- KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- KWPAppliance, Fixation, Spinal Interlaminal
- EMMChisel, Osteotome, Surgical
- EBWController, Foot, Handpiece And Cord
- PNPDental Abutment Design Software For Dental Laboratory
- DZADrill, Dental, Intraoral
- EHZEvacuator, Oral Cavity
- EJBHandle, Instrument, Dental
- EFAHandpiece, Belt And/Or Gear Driven, Dental
- EGSHandpiece, Contra- And Right-Angle Attachment, Dental
- EKXHandpiece, Direct Drive, Ac-Powered
- DZEImplant, Endosseous, Root-Form
- ODPIntervertebral Fusion Device With Bone Graft, Cervical
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar
- OVEIntervertebral Fusion Device With Integrated Fixation, Cervical
- OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar
- DZMNeedle, Dental
- MNIOrthosis, Spinal Pedicle Fixation
- MNHOrthosis, Spondylolisthesis Spinal Fixation
- ELRPost, Root Canal
- EISRemover, Crown
- MQPSpinal Vertebral Body Replacement Device
- KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories
- EJISyringe, Cartridge
- NKBThoracolumbosacral Pedicle Screw System
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2754-2016 | Axiom 2.8 implants Sterile The Axiom REG implants are used as artificial root structures for replacement of missing teeth. They can be used for stabilization of removable prostheses or fixation of single tooth restorations or partial dentures. There are different diameters and different lengths for each diameter. | Following a FDA inspection showing that the firm failed to validate the design and process of its implants. | Class II | Terminated | |
| Z-2753-2016 | Axiom REG implants Sterile The Axiom REG implants are used as artificial root structures for replacement of missing teeth. They can be used for stabilization of removable prostheses or fixation of single tooth restorations or partial dentures. There are different diameters and different lengths for each diameter. | Following a FDA inspection showing that the firm failed to validate the design and process of its implants. | Class II | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Anthogyr edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain