FDA releases July 2016 510(k) clearances

510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD July 2016 TOTAL 510(k)s THIS PERIOD 236 TOTAL WITH SUMMARIES 220 TOTAL WITH STATEMENTS 16 DEVICE: Dakin's Skin and Wound Cleanser CENTURY PHARMACEUTICALS, INC. 510(k) NO: K150208(Traditional) ATTN: Stephen Deardorff PHONE NO : 1 317 8494210 10377 HAGUE RD. SE DECISION MADE: 21-JUL-16 INDIANAPOLIS IN 46256 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Sheath Introducer BIOTEQUE CORP. 510(k) NO: K150932(Traditional) ATTN: Simon Lin PHONE NO : 886 2 25710269 5 F-6, NO. 23, SEC. 1 CHANG-AN E. SE DECISION MADE: 22-JUL-16 TAIPEI TW 104 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: The Progressive Orthopaedic Total Hip System The Progressive Orthopaedic Compan510(k) NO: K151424(Traditional) ATTN: Scott Keiser PHONE NO : 561 4404460 801 US Highway 1, Suite B SE DECISION MADE: 27-JUL-16 North Palm Beach FL 33408 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ET III Bio-SA Fixture System HiOSSEN Inc. 510(k) NO: K151626(Traditional) ATTN: David Kim PHONE NO : 267 759 7031 85 Ben Fairless Dr. SE DECISION MADE: 21-JUL-16 Fairless Hills PA 19030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PMT Platinum Depthalon Depth Electrode PMT CORPORATION 510(k) NO: K151790(Traditional) ATTN: KIM SCHMELZER PHONE NO : 1 952 4700866 1500 PARK RD SE DECISION...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news

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Conclusion: H. pylori-induced follicular gastritis is considered as an additional risk factor for bleeding from gastric varices. PMID: 30881448 [PubMed]
Source: Gastroenterology Research and Practice - Category: Gastroenterology Tags: Gastroenterol Res Pract Source Type: research
CONCLUSION: MRI in combination with the presented workflow may be used in edentulous cases for guided implant surgery. Further studies are needed to prove the promising accuracy of this alternative approach in clinical trials. PMID: 30883626 [PubMed - in process]
Source: International Journal of Oral and Maxillofacial Implants - Category: ENT & OMF Tags: Int J Oral Maxillofac Implants Source Type: research
Authors: Chen Z, Li J, Wang HL, Yu H Abstract PURPOSE: The aim of this cone beam computed tomography (CBCT) study was to assess bone volume changes in molar sites after modified immediate implant placement with xenografts. MATERIALS AND METHODS: This prospective study was performed between June 2015 and September 2016. Surgical procedures included modified implant site preparation, atraumatic tooth extraction, implant placement, and bone grafting with deproteinized bovine bone mineral. CBCT scans were taken at the day of surgery and 6 months after surgery. Horizontal and vertical bone dimensional changes were e...
Source: International Journal of Oral and Maxillofacial Implants - Category: ENT & OMF Tags: Int J Oral Maxillofac Implants Source Type: research
CONCLUSION: The described tunneling flap approach allows a hermetic soft tissue closure, characterized by a reduction of dehiscence and a secure bone graft healing. The combination of thin autogenous bone blocks and bone particles according to the SBB technique allows an acceleration of transplant revascularization, and thus, of graft regeneration, allowing a shortening of the patient treatment time as well as long-term three-dimensional volumetric bone stability. PMID: 30883623 [PubMed - in process]
Source: International Journal of Oral and Maxillofacial Implants - Category: ENT & OMF Tags: Int J Oral Maxillofac Implants Source Type: research
This study investigated the effect of fracture strength and fracture mode characteristics related to reduced interocclusal space on computer-aided design/computer-aided manufacturing (CAD/CAM). ZrO2 fixed partial denture (FPD) frameworks subjected to quasi-static loads. MATERIALS AND METHODS: First, two dental implants (4 × 10 mm) were positioned simulating a three-unit FPD (second premolar and second molar abutments). The implants were distributed into two groups: control group (n = 10), positioned at the same level; and the test group (n = 10), where the interocclusal space corresponding to the second molar was...
Source: International Journal of Oral and Maxillofacial Implants - Category: ENT & OMF Tags: Int J Oral Maxillofac Implants Source Type: research
CONCLUSION: This study confirmed that implant fracture is an unlikely adverse event. A clear pattern of effective distribution greater than fatigue limit stresses could be noticed when the misfit was present. The dynamic load simulation demonstrated that the crack is more likely to occur when implants are fully supported by marginal bone compared with a bone loss scenario. Within the limitations of this study, it is speculated that marginal bone loss might follow the appearance of an undetected crack. Further research is needed to develop safe clinical protocols with regard to ILFPD. PMID: 30883615 [PubMed - in process]
Source: International Journal of Oral and Maxillofacial Implants - Category: ENT & OMF Tags: Int J Oral Maxillofac Implants Source Type: research
AbstractThe role of viral load in the outcome of patients requiring hospital admission due to influenza is not well established. We aim to assess if there is an association between the viral load and the outcome in hospitalized patients with a confirmed influenza virus infection. A retrospective observational study including all adult patients who were hospitalized in our center with a confirmed influenza virus infection from January to May 2016. Viral load was measured by real-time reverse-transcriptase –polymerase chain reaction (rRT-PCR) cycle threshold (Ct) value on upper respiratory tract samples. Its value was ...
Source: European Journal of Clinical Microbiology and Infectious Diseases - Category: Microbiology Source Type: research
In this study, an annular high intensity focused ultrasound (HIFU) array transducer was developed to suppress the level of sidelobes below a given requirement with a minimum number of channels. The electrode patterns analyzed for the transducer were equal electrode area pattern and variable electrode width pattern. In finite element analysis of the transducer performance, the variable electrode width pattern transducer was proven to be able to suppress the level of sidelobes below -12 dB with 9 channels, while the equal electrode area pattern transducer required at least 10 channels to suppress the level of sidelobe...
Source: Sensors and Actuators A: Physical - Category: Physics Source Type: research
Publication date: Available online 18 March 2019Source: Sensors and Actuators A: PhysicalAuthor(s): Seung-Han Chung, Seung-Ki Lee, Chang-Hyeon Ji, Jae-Hyoung ParkAbstractWe herein present the design, fabrication, and wafer-level packaging of an electromagnetic biaxial scanning micromirror. The vacuum packaging of the micromirror was implemented by anodically bonding the glass cap wafer to both sides of the silicon substrate with the micromirror. The measured quality factor of the vacuum packaged micromirror is 1,923.2 for the horizontal scan, whereas that of the device in the air is 649.6. The maximum optical scan angle of...
Source: Sensors and Actuators A: Physical - Category: Physics Source Type: research
Publication date: Available online 19 March 2019Source: Biosensors and BioelectronicsAuthor(s): Neda Bagheri, Stefano Cinti, Veronica Caratelli, Renato Massoud, Mohammad Saraji, Danila Moscone, Fabiana ArduiniAbstractIn the last decades, there is a growing search for analytical strategies to ensure clinical analysis without the need of laboratory set-up and skilled personnel. Indeed, user-friendly and low-cost devices are highly valued in the era of sustainability for their capability to be applied in low-resource contexts, such as developing countries. To address this issue, herein we report a 96-well paper-based and labo...
Source: Biosensors and Bioelectronics - Category: Biotechnology Source Type: research
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