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510(k) Data Aggregation
K Number
K222738Device Name
Point implant system
Manufacturer
Date Cleared
2023-04-13
(216 days)
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
PointNix Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Point implant system is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple units restorations including; cemented retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading.
Device Description
Point implant system is a dental implant system consisting of fixtures, mount & mount screws, abutments (cemented, solid, angled, temporary, healing), abutment screws, and cover screws. The applied part is oral and the contact duration is C (>30 days). The patient population is dental prosthetic patients. The materials used include Unalloyed Titanium (ASTM F67), Alloyed Titanium (ASTM F136), and Polyoxymethylene (CAS No.: 30846-29-8).
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K Number
K121800Device Name
POINT 500 HD POINT500C HD
Manufacturer
Date Cleared
2013-01-24
(219 days)
Product Code
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
POINTNIX CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Point 500 HD/500C HD which is the dental panoramic/panoramic and cephalometric device is intended to produce diagnostic quality radiographic images by acquiring digital 2D X-ray images. The cephalometric system produces cephalomertric radiographic images that maybe used in orthodontic diagnosis procedures.
Device Description
The Point 500 HD/500C HD is a dental panoramic and cephalometric device which is digital X-ray imaging device. It is intended for dental radiographic examinations of teeth, jaw and TMJ areas by exposing X-ray and then converts this information to the digital signals to acquire images. High-defined images are provided by controlling acquired image with computer and this is used to obtain panoramic and cephalometric images for dental purpose. This equipment is equipped with an X-ray generator and Sensor for panoramic and cephalometric at Rotation unit which are supported by Main frame and Column. When rotation unit is rotating around the patient's teeth and jaw for acquiring panoramic image, X-ray exposes and sensor detects the data from X-ray generator. Detected data from each frame is transferred to PC, and combined together to display panoramic image on PC screen by installed software on PC.
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