Frantz Design, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 2
What Frantz Design, Inc. makes
Frantz Design, Inc. manufactures orthodontic appliances for mandibular advancement, including the Elastic Mandibular Advancement (EMA) Appliance and the Elastic Mandibular Advancement – Titration (EMA-T) Appliance. These devices are designed to reposition the jaw and manage obstructive sleep apnea or related airway disorders.
The company’s products are classified as Class II medical devices under FDA regulations and are supported by 510(k) clearance records. The portfolio is listed in the FDA’s 510(k) database, reflecting compliance with U.S. device authorisation requirements.
Catalogue
Elastic Mandibular Advancement (Ema) Appliance Ref K971794
510(k) 510(k)- 510(k) 510(k)
Frequently asked questions
How many devices does Frantz Design, Inc. have in the registry?
The registry currently lists 2 devices for Frantz Design, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Frantz Design, Inc.'s devices?
Among its 2 most recently registered devices, Frantz Design, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Frantz Design, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Frantz Design, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Frantz Design, Inc. in the registry?
The most recently registered devices listed for Frantz Design, Inc. include ELASTIC MANDIBULAR ADVANCEMENT (EMA) APPLIANCE and ELASTIC MANDIBULAR ADVANCEMENT - TITRATION (EMA-T) APPILANCE.