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510(k) Data Aggregation
K Number
K111177Device Name
JUELL HARD CURE
Manufacturer
Date Cleared
2011-09-12
(138 days)
Product Code
Regulation Number
872.3760Why did this record match?
Applicant Name (Manufacturer) :
JUELL DENTAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
JuellCure Hard is intended for use as a permanent hard relining for total and partial dentures. Hard permanent total or partial relining for restoring partial and complete dentures. Lengthening denture margins.
Device Description
JuellCure hard is a cold-curing, hard relining material for permanently relining dentures.
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K Number
K111178Device Name
JUELL SOFT CURE
Manufacturer
Date Cleared
2011-09-12
(138 days)
Product Code
Regulation Number
872.3760Why did this record match?
Applicant Name (Manufacturer) :
JUELL DENTAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
JUELLCure Soft is intended for use as a permanent soft relining for total and partial dentures
- . To relieve pressure from pressure points
- To dam the palatal vibrating line ●
- . In cases of flabby ridge and/or insufficient adhesion
- . To cushion sharp-edged alveolar processes
Device Description
JuellCure Soft is a self-curing, silicone-based and permanently soft relining material for removable dentures.
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K Number
K110548Device Name
OSI O-BALL ABUTMENT HEAD IMPLANTS
Manufacturer
Date Cleared
2011-07-29
(154 days)
Product Code
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
JUELL DENTAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The OSI O-ball Abutment implant is a self-tapping titanium threaded screw indicated for long term intra-bony fixation of upper and lower dentures in edentulous cases. These devices will permit immediate splinting and ability and short-term fixation of failing crown and bridge installations, for full or partial edentulism. They can be used in the anterior regions of the maxillary and mandibular arches and are indicated for immediate loading when there is good primary stability and appropriate occlusal load.
Device Description
The JUELL OSI O-Ball Abutment Dental Implant is available with a gingival collar in four diameters: 3.0mm, 3.5mm, 4.0mm and 4.5mm. The JUELL OSI O-Ball Abutment Dental Implant is available in thread lengths ranging from 10mm to 18mm. The implant is manufactured from ASTM F136 Ti6Al4V. The threaded surface is blasted with particulate media to increase the surface area.
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