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Titanium abutment designed as an endosseous dental implant retentive component used to retain a complete or partial denture. The device is screwed into an endosseous implant in the mandible or maxilla.
RHEIN 83 SRL
S/BLOCK M NOBEL ACTIVE RP ø 4,3/5 h5 TiN
Not in Commercial Distribution
- D821003NAC395R0 ()
- Dental implant suprastructure, permanent, preformed
DISPOSABLE medical device to be screwed into a dental implant. The connection and the thread are compatible with the specific implant. Available in different cuff heights. Retentive caps, metal housing for the caps, directional rings and protective disc.
RHEIN 83 SRL
S/BLOCK M NOBEL ACTIVE RP ø 4,3/5 h5 TiN
003NAC395R
- Dental implant suprastructure, permanent, preformed
ENHANCED ALGORITHM ECG EVENT RECORDER
BRAEMAR MANUFACTURING, LLC
900-0557-06
In Commercial Distribution
- B146ER9R0 ()
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&
- Electrocardiography telemetric monitoring system
Orion in the chemical cure form is a paste/paste system. The dentist has a choice of using self or light-cure form, depending upon the clinical situation. There is a virtually unlimited working time in the lhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=930859#ight-cure form, and a convenient working time in the self-cure (chemical) form. It is moldable and non-sticky yet has an adhesive consistency. Material has well-balanced x-ray opacity that permits easy distinguishing from tooth structure, pins and posts. It contains moderately hard filler for easier carving and shaping. The standard Orion kit comes in two shades: the contrasting one, for easy distinguishing from the tooth structure; the other is tooth colored for use under shell crowns.
DENT ZAR, INC.
0065
In Commercial Distribution
- D83600650 ()
0065
- Dental composite resin
Orion in the chemical cure form is a paste/paste system. The dentist has a choice of using self or light-cure form, depending upon the clinical situation. There is a virtually unlimited working time in the lhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=930859#ight-cure form, and a convenient working time in the self-cure (chemical) form. It is moldable and non-sticky yet has an adhesive consistency. Material has well-balanced x-ray opacity that permits easy distinguishing from tooth structure, pins and posts. It contains moderately hard filler for easier carving and shaping. The standard Orion kit comes in two shades: the contrasting one, for easy distinguishing from the tooth structure; the other is tooth colored for use under shell crowns.
DENT ZAR, INC.
0064
In Commercial Distribution
- D83600640 ()
0064
- Dental composite resin
Orion in the chemical cure form is a paste/paste system. The dentist has a choice of using self or light-cure form, depending upon the clinical situation. There is a virtually unlimited working time in the lhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=930859#ight-cure form, and a convenient working time in the self-cure (chemical) form. It is moldable and non-sticky yet has an adhesive consistency. Material has well-balanced x-ray opacity that permits easy distinguishing from tooth structure, pins and posts. It contains moderately hard filler for easier carving and shaping. The standard Orion kit comes in two shades: the contrasting one, for easy distinguishing from the tooth structure; the other is tooth colored for use under shell crowns.
DENT ZAR, INC.
0063
In Commercial Distribution
- D83600630 ()
0063
- Dental composite resin
Orion in the chemical cure form is a paste/paste system. The dentist has a choice of using self or light-cure form, depending upon the clinical situation. There is a virtually unlimited working time in the lhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=930859#ight-cure form, and a convenient working time in the self-cure (chemical) form. It is moldable and non-sticky yet has an adhesive consistency. Material has well-balanced x-ray opacity that permits easy distinguishing from tooth structure, pins and posts. It contains moderately hard filler for easier carving and shaping. The standard Orion kit comes in two shades: the contrasting one, for easy distinguishing from the tooth structure; the other is tooth colored for use under shell crowns.
DENT ZAR, INC.
0062
In Commercial Distribution
- D83600620 ()
0062
- Dental composite resin
The Welldoc App is Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCP) and their patients – aged 18 years and older – who have
prediabetes, diabetes, heart failure, high blood pressure, liver disease, kidney disease, and/or sleep apnea. The Welldoc App also supports weight management and mental wellbeing.
The patient software, running on a mobile phone, collects health data, promotes healthy behavior, and encourages adherence to treatment plans and self-monitoring practices as advised by a HCP. The software also generates electronic reports intended for a HCP.
The web-based HCP software allows HCPs to view patient health data and communicate directly with their patients.
The software provides secure transfer, storage, and secondary display of data from devices such as continuous glucose monitors (CGM), blood glucose meters, blood
pressure monitors, activity trackers, and weight scales as well as self-reported health information. The software also performs retrospective analysis of CGM data which may
be used by people with diabetes and their HCP when determining therapeutic strategies.
The software provides educational content to encourage behaviors which may help living well with cardiometabolic conditions based on guidance from healthcare professional organizations. This may include promoting healthy lifestyle choices such as getting enough sleep, eating a balanced diet, maintaining a healthy weight, and promoting physical activity.
The software is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment nor is it intended to replace
self-monitoring practices as advised by a physician. The software does not provide treatment recommendations.
WELLDOC, INC.
3.X
In Commercial Distribution
- B553202303OTC0 ()
- Self-care monitoring/reporting software
The Welldoc App is Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCP) and their patients – aged 18 years and older – who have
prediabetes, diabetes, heart failure, high blood pressure, liver disease, kidney disease, and/or sleep apnea. The Welldoc App also supports weight management and mental wellbeing.
The patient software, running on a mobile phone, collects health data, promotes healthy behavior, and encourages adherence to treatment plans and self-monitoring practices as advised by a HCP. The software also generates electronic reports intended for a HCP.
The web-based HCP software allows HCPs to view patient health data and communicate directly with their patients.
The software provides secure transfer, storage, and secondary display of data from devices such as continuous glucose monitors (CGM), blood glucose meters, blood
pressure monitors, activity trackers, and weight scales as well as self-reported health information. The software also performs retrospective analysis of CGM data which may
be used by people with diabetes and their HCP when determining therapeutic strategies.
The software provides educational content to encourage behaviors which may help living well with cardiometabolic conditions based on guidance from healthcare professional organizations. This may include promoting healthy lifestyle choices such as getting enough sleep, eating a balanced diet, maintaining a healthy weight, and promoting physical activity.
The software is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment nor is it intended to replace
self-monitoring practices as advised by a physician. The software does not provide treatment recommendations.
WELLDOC, INC.
3.X
In Commercial Distribution
- B553202302OTC0 ()
- Self-care monitoring/reporting software
The Welldoc App is Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCP) and their patients – aged 18 years and older – who have
prediabetes, diabetes, heart failure, high blood pressure, liver disease, kidney disease, and/or sleep apnea. The Welldoc App also supports weight management and mental wellbeing.
The patient software, running on a mobile phone, collects health data, promotes healthy behavior, and encourages adherence to treatment plans and self-monitoring practices as advised by a HCP. The software also generates electronic reports intended for a HCP.
The web-based HCP software allows HCPs to view patient health data and communicate directly with their patients.
The software provides secure transfer, storage, and secondary display of data from devices such as continuous glucose monitors (CGM), blood glucose meters, blood
pressure monitors, activity trackers, and weight scales as well as self-reported health information. The software also performs retrospective analysis of CGM data which may
be used by people with diabetes and their HCP when determining therapeutic strategies.
The software provides educational content to encourage behaviors which may help living well with cardiometabolic conditions based on guidance from healthcare professional organizations. This may include promoting healthy lifestyle choices such as getting enough sleep, eating a balanced diet, maintaining a healthy weight, and promoting physical activity.
The software is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment nor is it intended to replace
self-monitoring practices as advised by a physician. The software does not provide treatment recommendations.
WELLDOC, INC.
3.X
In Commercial Distribution
- B553202301OTC0 ()
- Self-care monitoring/reporting software