Anthofit OI, Anthofit HE, Ossfit, and Axiom
by Anthogyr Sas EUDAMED510(k)
Active
510(k) K101913
Overview
The Anthofit OI, Anthofit HE, Ossfit, and Axiom are orthodontic appliances designed for dental use. These devices are intended for intraoral application in orthodontic treatment, including the correction of dental alignment and occlusion, as classified under the Dental category (Product Code DZE).
These devices are supplied sterile and intended for single-use, adhering to FDA 510K clearance under an Abbreviated review process (K101913). They are manufactured by Anthogyr SAS and comply with both FDA and MDR regulatory standards. Storage and handling must follow manufacturer guidelines to maintain sterility and functionality.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK101913 | Date11 Mar 2011 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Recalls
-
- Terminated Z-2753-2016
Following a FDA inspection showing that the firm failed to validate the design and process of its implants.
Specification
- 510(k) Number
- FDA Product Code
- DZE
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3640
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Other devices from Anthogyr Sas
Questions
Are these orthodontic appliances reusable or designed for single-use, and how does that affect their sterility?
The Anthofit OI, Anthofit HE, Ossfit, and Axiom are explicitly designed for single-use and are supplied sterile by Anthogyr SAS. This means each device is intended to be used once and then discarded, eliminating the need for reprocessing. The sterility is maintained through proper storage and handling as directed by the manufacturer to ensure functionality and patient safety.
What types of orthodontic corrections are these devices intended to assist with, and how are they classified?
These devices—Anthofit OI, Anthofit HE, Ossfit, and Axiom—are intraoral orthodontic appliances classified under Product Code DZE (Dental category). They are designed for correcting dental alignment and occlusion, which are common goals in orthodontic treatment. The classification reflects their role in improving bite and tooth positioning.
How should I store these devices to ensure they remain effective and sterile?
To maintain sterility and functionality, storage must follow manufacturer guidelines provided by Anthogyr SAS. Since they are single-use and sterile upon packaging, they should be kept in their original, unopened packaging until use. Avoid exposure to moisture, extreme temperatures, or contamination, as these can compromise sterility and performance.
What regulatory pathways have these devices undergone, and what does that mean for their use?
These devices have received FDA 510(k) clearance (K101913) under an Abbreviated review process, meaning they were determined to be substantially equivalent to a legally marketed predicate device. They also comply with MDR (Medical Device Regulation) standards, ensuring they meet both U.S. and EU regulatory requirements for safety and performance. This clearance does not indicate an indication but confirms their adherence to regulatory standards for orthodontic appliances.