Oral Osteodistraction, L.P.
United StatesFDA applicant, unverified
- Devices
- 3
What Oral Osteodistraction, L.P. makes
Oral Osteodistraction, L.P. manufactures distraction rod appliances used in orthodontic and maxillofacial procedures, including models designed for controlled bone lengthening in the jaw. These devices include specific rod appliances (e.g., ROD 5, ROD 4) and distraction osteogenesis systems (Models 1, 2, and 3) for gradual skeletal expansion.
The company’s products are classified as Class II medical devices under FDA regulations and are supported by 510(k) clearance records. These devices are listed in the FDA’s 510(k) database, reflecting their authorised status for distraction-based orthodontic and surgical applications.
Catalogue
Oral Osteodistraction Rod Appliance (Rod 5) Ref K042278
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Oral Osteodistraction, L.P. have in the registry?
The registry currently lists 3 devices for Oral Osteodistraction, L.P.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Oral Osteodistraction, L.P.'s devices?
Among its 3 most recently registered devices, Oral Osteodistraction, L.P. has devices listed in FDA 510(k) (3 devices).
What risk classes do Oral Osteodistraction, L.P.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Oral Osteodistraction, L.P.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Oral Osteodistraction, L.P. in the registry?
The most recently registered devices listed for Oral Osteodistraction, L.P. include ORAL OSTEODISTRACTION ROD APPLIANCE (ROD 5), ORAL OSTEODISTRACTION DISTRACTION ROD APPLIANCES, ROD 4 and DISTRACTION OSTEOGENESIS ROD APPLIANCES, MODELS 1, 2, AND 3.