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510(k) Data Aggregation
K Number
K170732Device Name
Biomate Dental Implant System
Manufacturer
Biomate Medical Devices Technology Co., Ltd.
Date Cleared
2018-10-26
(595 days)
Product Code
DZE, NHA
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
Biomate Medical Devices Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
An endosseous dental implant is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple unit prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional 2 stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading. It is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Patients must be subject for dental treatment with endosseous implants.
Device Description
The Biomate Dental Implant System consists of Bone Type Implant Plus, Shaping Abutment and Healing Abutment. The Biomate Dental Implant System is made of commercial pure titanium (ASTM F67, Grade 4). Threaded dental implants are with Precision Dimension Laser (PDLTM) surface treatment, while Shaping Abutment and Healing Abutment are with TiN coated surface treatment. The device is designed for conventional two-stage and single stage procedures for single and multiple unit prosthetics. It is intended to replace missing teeth.
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K Number
K142174Device Name
BIOMATE DENTAL IMPLANT SYSTEM
Manufacturer
BIOMATE MEDICAL DEVICES TECHNOLOGY CO., LTD.
Date Cleared
2015-03-20
(225 days)
Product Code
DZE, NHA
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
BIOMATE MEDICAL DEVICES TECHNOLOGY CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
An endosseous dental implant is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple unit prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional 2 stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading. It is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Patients must be subject for dental treatment with endosseous implants.
Device Description
The BIOMATE Dental Implant System consists of threaded dental implants in 3.3, 4.1, 4.8, 5.5 mm diameters with 8, 10, 12, 14 mm lengths. The implants are made of commercial pure titanium and coated with the laser-modified Surface. BIOMATE Dental Implant System is comprised of Bone Type Implant, Solid Abutment, Simple Abutment, Angled Abutment, Temporary Abutment, Ball Abutment, Screw, Cover Screw, Healing Abutment. The system is designed for conventional two-stage and single stage procedures for single and multiple unit prosthetics. It is intended to be used to replace missing teeth.
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K Number
K103061Device Name
BIOMATE STERILE ACUPUNCTURE NEEDLE
Manufacturer
BIOMATE MEDICAL DEVICES TECHNOLOGY CO., LTD.
Date Cleared
2011-06-20
(245 days)
Product Code
MQX, MOX
Regulation Number
880.5580Why did this record match?
Applicant Name (Manufacturer) :
BIOMATE MEDICAL DEVICES TECHNOLOGY CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Biomate Sterile Acupuncture Needle, Model: Nano, Nano-PI, Nano-EI is intended to be used to pierce the skin in the practice of acupuncture (by qualified practitioner of acupuncture) as determined by the States.
Device Description
Not Found
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