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510(k) Data Aggregation
K Number
K173575Device Name
OsteoReady Dental Implant System
Manufacturer
OsteoReady LLC
Date Cleared
2018-08-17
(270 days)
Product Code
DZE, NHA
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
OsteoReady LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
OsteoReady® Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. RidgeReady® 3.0 implants are intended to replace a lateral incisor in the maxilla and/or a central or lateral incisor in the mandible.
Device Description
OsteoReady® Dental Implant System is consist of endosseous form dental implants, internal hex implants, tapered design; cover screws, healing caps and abutment systems;
Dental Implants:
Performance implants are available as follow: Diameters 3.85, 4.2, 5.0 and 6.0mm with lengths, 7 ( 7mm only to 5&6 dmm), 8, 10, 11.5, 13, & 15 (15mm not for 6.0 dm);
Performance Hybrid Implants are available as follow: Diameter 3.85mm with lengths of 10, 11.5, 13 and 15mm;
RidgeReady Implants are available as follow: Diameter 3.0mm with lengths of 8.0, 10, 12, and 14mm;
Dental Abutments:
Healing Caps, Temporary Abutment, Anatomic Angulated Abutment 15, Anti-Rotation Abutment Slim / Standard, Anatomic Abutment, Angulated Abutment 15, Anti-Rotation Abutment with Collar, Ball Attachments, PEEK Temporary Abutment, O-Ring Abutments, Direct Clip Abutments, attachments for ball.
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K Number
K151169Device Name
OsteoReady ZircoSeal Abutments
Manufacturer
OsteoReady LLC
Date Cleared
2015-10-08
(160 days)
Product Code
NHA
Regulation Number
872.3630Why did this record match?
Applicant Name (Manufacturer) :
OsteoReady LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
OsteoReady ® ZircoSeal® Dental Abutments are intended to be used with an endosseous implant to aid prosthetic rehabilitation in order to restore the patient's chewing function. OsteoReady® ZircoSeal® Abutments are compatible with DENTIN® Dental Implant System - Prestige Implant System diameters 3.75, 4.2, 5 & 6;
Device Description
OsteoReady® ZircoSeal® Abutments are Straight Anti-Rotation Abutments made of titanium alloy. OsteoReady® ZircoSeal® Abutments are available in the following measurements:
Slim Anti-Rotation Titanium Abutment with ZircoSeal®: Length 5,7,9,11,13 mm with Diameter 3.75 mm.
Anti-Rotation Titanium Abutment with ZircoSeal®: Length 5,7,9,11,13 mm Diameter 4.5 mm.
Anti-Rotation Straight Titanium Abutment with ZircoSeal®: Shoulder Length 1,2,3,4 mm Diameter 4.5 mm.
OsteoReady® ZiroSeal® Abutments are straight only and are not intended to be modified chairside or by CAD/CAM to provide an angle correction.
The ZircoSeal surface treatment is the trade name of zirconium nitride.
The ZircoSeal® simply indicates the signature zirconium nitride surface treatment of the abutment. The trade name is unrelated to claims of "sealing" of implant/abutment connection platform.
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