Ormco Corporation

7 devices in the database

  • Model / Serial
    Lot Number: 08E182E.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US, including the territory of St. Thomas, and countries of Australia, Canada, New Zealand, China, Singapore, India, and Chile.
  • Product Description
    K3 Engine File G-Pack, || Product: Endodontic Pulp Canal File, Part Number: 830-9925. || For use in root canal preparation.
  • Model / Serial
    Lot #02112284
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including the states of FL, MN, TX, and VA, and the countries of Australia, France, Germany, Italy, Japan, Mexico, Morocco, Netherlands, New Zealand, South Africa, Turkey, and Ukraine.
  • Product Description
    Spirit MB Brackets, part #494-1210. || The brand name of the device is Spirit MB Brackets, an orthodontic bracket. Spirit MB Brackets have been assigned the product code 76 DYW (Plastic Orthodontic Bracket) by the FDA and is classified as a Class II Medical Device. Spirit MB Brackets are to be fixed attachment on a tooth which holds an archwire during orthodontic treatment.
  • Model / Serial
    Lot #111069607, 031144457
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including the states of FL, MN, TX, and VA, and the countries of Australia, France, Germany, Italy, Japan, Mexico, Morocco, Netherlands, New Zealand, South Africa, Turkey, and Ukraine.
  • Product Description
    Spirit MB Brackets, part #494-1211. || The brand name of the device is Spirit MB Brackets, an orthodontic bracket. Spirit MB Brackets have been assigned the product code 76 DYW (Plastic Orthodontic Bracket) by the FDA and is classified as a Class II Medical Device. Spirit MB Brackets are to be fixed attachment on a tooth which holds an archwire during orthodontic treatment.
  • Model / Serial
    Part Number: 211-1402; Lot Number: 10K291
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA including the states of Indiana and Minnesota; and the countries of Canada, Europe and Australia.
  • Product Description
    TMA Archwires, Part Number 211-1402, Lot Number 10K291, Product Description and Intended Use: The intended use of this device is an archwire during orthodontic treatment.
  • Model / Serial
    Part Number: Lot Number: 454-1210 08H599H 454-0210 08H358H, 08J174J, and 08J175J
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and worldwide to Canada, Colombia, Hong Kong, Kuwait, United Arab Emirates, Mexico, Russia, South Africa, Croatia, Japan, France, Bulgaria, Germany, Estonia, United Kingdom, Hungary, Ireland, Italy, Netherlands, Australia, and New Zealand.
  • Product Description
    Brand name: Orthos CM Bracket, Orthodontic Metal Bracket, || Part Numbers: 454-1210, 454-0210. || The intended use of this device is a fixed attachment on a tooth which holds an archwire during orthodontic treatment.
2 more

13 manufacturers with a similar name

Learn more about the data here

  • Manufacturer Address
    Ormco Corporation, 1332 S Lone Hill Ave, Glendora CA 91740-5339
  • Source
    USFDA
8 more