France Orthodontie Headgear, Extraoral, Orthodontic
by France Orthodontie 510(k)
Active
510(k) K950121
Overview
The France Orthodontie Headgear, Extraoral, Orthodontic is a Class II dental device designed for orthodontic treatment. It is an extraoral appliance used to apply controlled forces to the teeth and jaws, aiding in the correction of malocclusions, skeletal discrepancies, or dental alignment issues. This device falls under the regulatory category of headgear systems, which are external to the oral cavity and intended for long-term orthodontic adjustment.
This device is supplied as a reusable orthodontic appliance and is regulated under FDA 510(k) clearance (K950121) with a decision classification of Substantially Equivalent (SESE). It is intended for use in clinical dental settings by orthodontists or trained professionals. The device adheres to regulatory standards outlined in 21 CFR 872.5500 and is manufactured by France Orthodontie, based in Tours, France. No third-party certification is indicated.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK950121 | Date8 Mar 1995 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- Full name
- France Orthodontie
- 510(k) Number
- FDA Product Code
- DZB
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.5500
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Questions
What types of dental issues is the France Orthodontie Headgear designed to address in clinical practice?
The France Orthodontie Headgear is an extraoral orthodontic appliance intended for correcting malocclusions, skeletal discrepancies, or dental alignment issues. It applies controlled forces externally to the teeth and jaws, aiding in long-term orthodontic adjustments as part of a broader treatment plan by orthodontists or trained professionals.
How is the France Orthodontie Headgear supplied, and is it intended for single-use or reuse?
The device is supplied as a reusable orthodontic appliance, meaning it is designed for repeated use in clinical settings after proper cleaning and maintenance. It is not intended for single-use, aligning with its classification as a durable extraoral orthodontic tool.
What regulatory pathway was followed for FDA clearance of this device, and what does that mean for clinicians?
The France Orthodontie Headgear received FDA clearance through a 510(k) submission (K950121) with a Substantially Equivalent (SESE) decision, meaning it was determined to be as safe and effective as a legally marketed predicate device. Clinicians can rely on this clearance as evidence of compliance with FDA standards for Class II orthodontic headgear systems, as outlined under 21 CFR 872.5500.
Does this device require third-party certification, and what standards does it adhere to?
The France Orthodontie Headgear does not require third-party certification (third_party_flag: N). Its compliance is established through the FDA’s 510(k) review process, adhering to regulatory standards specified in 21 CFR 872.5500 for extraoral orthodontic headgear systems. No additional external certifications are indicated in the data.
Are there multiple models or variations of this headgear, and how would a clinician determine the correct fit?
The device data lists multiple FEI numbers (e.g., 3001778198, 3016543896), which may correspond to different models or configurations of the France Orthodontie Headgear. Clinicians should consult the manufacturer’s documentation or catalog to match the specific patient’s skeletal or dental needs, as the appliance is adjustable for controlled force application. No size specifications are provided, but the variability in FEI numbers suggests customization options.