Nobel Biocare Usa Llc

Model Numbers: 1600870-001, 1700470-001, 1700471-001.

Dental Devices

1

No

Worldwide Distribution - USA (nationwide) United States and Internationally to Austria, Belgium, Brazil, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Hungary, India, Ireland, Italy, Japan, Latvia, Lithuania, Luxembourg, Mexico, Netherlands, Norway, Philippines, Poland, Portugal, Romania, Russia, South Africa, Spain, Sweden, Switzerland, Turkey, and the United Kingdom.

Osseocare Pro Console & Set Osseocare Pro, Model 1600870-001, 1700470-001, and 1700471-001. || Device Name: Osseocare Pro console & Set Osseocare Pro. || Model: 1600870-001, 1700470-001, 1700471-001. || Marketing status: Class I, under K092214. || Device description: Software-based, electronically controlled tabletop device. || In dentistry for dental surgery, endodontics and implantology.

Article 38072-all lots

Dental Devices

2

No

Worldwide Distribution: US (nationwide) and Countries of: Austria, Belgium, Canada, Germany, Denmark, Spain, France, Great Britain, Italy, Netherlands, Norway, Poland, Portugal, Russia, and Turkey.

Instructions for Use (IFU) and Manual NobPrl CC Guided Surgery Kit || Instructions for Use (IFU): "NobelGuide for NobelParallel Conical Connection", id # 2002 and Manual: Guided Surgery with NobelParallel Conical Connection", id # 79423. Article # 38072, Nobel Parallel CC Guided Surgery Kit. || The Guided Surgery Kit is used as part of the installation process of NobelParallel CC Implants. The purpose of the IFU is to instruct the user how to use the products safely. The purpose of the manual is to guide the user through the usage of NobelGuide for NobelParallel CC.

13030677

Dental Devices

2

Yes

Worldwide Distribution - US including OR, OH, NY and Internationally to Taiwan and Brazil Non US: Taiwan, SC

Replace Select Tapered TiU NP 3.5x11.5mm, Article No. 36105 || Replace Select Tapered implants are root-form endosseous implants intended to be surgically placed in the bone of the upper and lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore patient esthetics and chewing function.

Article No. 37882, Batch No. 96149; Article No. 37508, Batch No. 814929, 815096, 815140, and 855021.

Dental Devices

1

No

Worldwide Distribution-US (nationwide) and the countries of Australia, Austria, Belgium, Canada, Finland, France, Germany, Greece, Hong Kong, Hungary, Italy, Luxembourg, Netherlands, New Zealand, Norway, Portugal, South Africa, Spain, Switzerland, and United Kingdom.

Abutment Retrieval Instrument Zirconia CC RP/WP, Article No. 37882 and Abutment Retrieval Kit, Article No. 37508 (Article No. 37882 was assembled in this kit). Used to remove a zirconia abutment if the abutment is stuck in the implant connection due to a tight seat. Endosseous dental implant instrument.

Batch No. 13010296

Dental Devices

2

Yes

Worldwide Distribution - US (nationwide) and Internationally to Austria, Australia, Belgium, Bulgaria, Canada, Switzerland, Czech Republic, Germany, Denmark, Estonia, Spain, Finland, France, United Kingdom, Greece, Croatia, Hungary, Ireland, Italy, Lithuania, Luxembourg, Mexico, Netherlands, Norway, Poland, Portugal, Romania, Russian Fed., Saudi Arabia, Sweden, Turkey, and United Arab Emirates.

NobelReplace CC PMC RP 5.0x13mm, Article No. 37298.