Ormco Corporation

Lot Number: 08E182E.

Dental Devices

1

No

Worldwide Distribution -- US, including the territory of St. Thomas, and countries of Australia, Canada, New Zealand, China, Singapore, India, and Chile.

K3 Engine File G-Pack, || Product: Endodontic Pulp Canal File, Part Number: 830-9925. || For use in root canal preparation.

Lot #02112284

Dental Devices

2

No

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.

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.

Lot #111069607, 031144457

Dental Devices

2

No

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.

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.

Part Number: 211-1402; Lot Number: 10K291

Dental Devices

1

No

Worldwide Distribution -- USA including the states of Indiana and Minnesota; and the countries of Canada, Europe and Australia.

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.

Part Number: Lot Number: 454-1210 08H599H 454-0210 08H358H, 08J174J, and 08J175J

Dental Devices

1

No

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.

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.