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510(k) Data Aggregation
K Number
K133298Device Name
ENDO SMART
Manufacturer
META BIOMED, INC.
Date Cleared
2014-09-19
(329 days)
Product Code
EKX
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
META BIOMED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Endo Smart ES-100 Endo Motor is indicated for use in standard endodontic procedures using rotary endodontic files and rotary endodontic drills
Device Description
Endo Smart, Model ES-100 is a controller for micro motor and contra angle headpieces which is designed to assist dentists and dental surgeons perform standard endodontic procedures. It provides power to the hand-held micromotor and contra angle which holds the drill bit and/or file used in endodontic procedures.
Endosmart is only intended to be used with motor hand piece (manufactured by Saeshin Precision Company; part name CUBE EP) and Contra angle headpiece (Manufactured by Saeshin Precision Company; part name ACL (B) - 42P) at 16:1 gear ratio.
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K Number
K134008Device Name
MD-FLEX HEAVY BODY
Manufacturer
META BIOMED, INC.
Date Cleared
2014-04-09
(100 days)
Product Code
ELW
Regulation Number
872.3660Why did this record match?
Applicant Name (Manufacturer) :
META BIOMED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MD-flex Heavy Body is used to record the shape of the patient's teeth and alveolar ridges.
Device Description
MD-flex Heavy body is hydrophilic Polyvinylsiloxane Impression Material with thixotropic property, dimensional accuracy and excellent recovery from deformation. It complies with the requirements of ISO 4823:2000 Type 1 for dental elastomeric impression materials. It is supplied as a two-part base/catalyst formulation preloaded in a dual-barrel cartridge.
The MD Flex Heavy Body package includes two dual-barrel 50 ml cartridges, and six mixing tips that allows for easy mixing of the base and catalyst. The device (cartridge) and accessories (mixing tip) are to be sold non-sterile. Testing demonstrates that MD-Flex has a shelf life 2 years from the manufacturing date.
MD-Flex can be used to make a mold of a patient teeth and alveolar ridges. The mold can be used to generate Gypsum model within 30 minutes of removal of the mold from patient's mouth. The Gypsum model will be effectively reproduced without transformation due to an excellent reproducibility and volume stability of MD Flex.
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K Number
K132041Device Name
REXTAR X
Manufacturer
META BIOMED, INC.
Date Cleared
2013-07-31
(29 days)
Product Code
EHD
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
META BIOMED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
REXTAR X is a portable X-ray system to be used by trained dentists and dental technicians as a mobile, extraoral x-ray source for producing diagnostic x-ray lmages using intraoral image receptors. It is intended for both adult and pediatric subjects.
Device Description
The REXTAR X consists of an X-ray tube, X-Ray tube assembly, X-Ray Controller built into a hand held camera-like device. The Rextar model contains additional accessories. The REXTAR X is an extraoral source x-ray system with a DC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source a, X-ray camera, is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.
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K Number
K122016Device Name
REXTAR, REXTAR LCD
Manufacturer
META BIOMED, INC.
Date Cleared
2013-03-01
(234 days)
Product Code
EHD
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
META BIOMED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
REXTAR LCD is a portable X-ray systems to be used by trained dentists and dental technicians as a mobile, extraoral x-ray source for producing diagnostic x-ray images using intraoral image receptors. It is intended for both adult and pediatric subjects.
Device Description
The REXTAR LCD consists of an X-ray tube, X-Ray tube assembly, X-Ray Controller built into a hand held camera-like device. The REXTAR LCD is an extraoral source x-ray system with a DC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source a, X-ray camera, is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.
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