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Crédits
Devices
standard Abutment
Modèle / numéro de série
Product Code: THA54 Lot No. 249229
Classification du dispositif
Dental Devices
Classe de dispositif
2
Dispositif implanté ?
Yes
Distribution
Distributed to 34 direct accounts throughout the United States and four international accounts in Europe, Asia, South America and the middle East.
Description du dispositif
EP Healing Abutment- An abutment device is a premanufactured prosthetic component directly connected to the endosseous dental implant.
Manufacturer
Implant Innovations, Inc.
1 Event
Rappel de standard Abutment
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Fabricant
Implant Innovations, Inc.
Adresse du fabricant
Implant Innovations, Inc., 4555 Riverside Dr, Palm Beach Gardens FL 33410-4200
Source
USFDA
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Device Recall Standard Abutment
Modèle / numéro de série
Item: AB200, AB300, AB400, AB500 and AB700.
Classification du dispositif
Dental Devices
Classe de dispositif
2
Dispositif implanté ?
Yes
Distribution
Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.
Description du dispositif
Standard Abutment || Dental implants
Manufacturer
Biomet 3i, LLC
Device Recall Standard Abutment Pick Up Coping
Modèle / numéro de série
Item: SQIC7
Classification du dispositif
Dental Devices
Classe de dispositif
2
Dispositif implanté ?
Yes
Distribution
Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.
Description du dispositif
Standard Abutment Pick -Up Coping || Dental implants
Manufacturer
Biomet 3i, LLC
Device Recall Standard Abutment Temporary Screw
Modèle / numéro de série
Item: TS250
Classification du dispositif
Dental Devices
Classe de dispositif
2
Dispositif implanté ?
Yes
Distribution
Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.
Description du dispositif
Standard Abutment Temporary Screw || Dental implants
Manufacturer
Biomet 3i, LLC
Device Recall Standard Abutment Transfer Coping
Modèle / numéro de série
Item: SIC70
Classification du dispositif
Dental Devices
Classe de dispositif
2
Dispositif implanté ?
Yes
Distribution
Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.
Description du dispositif
Standard Abutment Transfer Coping || Dental implants
Manufacturer
Biomet 3i, LLC
Device Recall Certain Standard Abutment
Modèle / numéro de série
Items: IAB200, IAB300, IAB400, IAB550 and IAB700.
Classification du dispositif
Dental Devices
Classe de dispositif
2
Dispositif implanté ?
Yes
Distribution
Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.
Description du dispositif
Certain Standard Abutment || Dental implants
Manufacturer
Biomet 3i, LLC
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