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510(k) Data Aggregation
K Number
K133592Device Name
NEODENT IMPLANT SYSTEM, TITAMAX TI EX ACQUA AND TI DRIVE ACQUA, TITAMAX SMART EX ACQUA AND DRIVE SMART ACQUA, TITAMAX CM
Manufacturer
NEODENT USA, INC.
Date Cleared
2014-08-22
(273 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
NEODENT USA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Multiple tooth applications may be rigidly splinted.
Device Description
The subject Titamax Ti EX Acqua implants are provided in the same design variants as the predicate Titamax Ti EX implants. The only difference is the application of the Acqua hydrophilic surface treatment in place of the NeoPoros surface finish. The Titamax Ti EX Acqua are provided in two endosseous diameters (3.75 and 4.0 mm), one platform diameter (4.1 mm), and five lengths (9, 11, 13, 15, and 17 mm).
The subject Ti Drive Acqua implants have the same tapered, single thread design variants as the predicate CM Drive implants and the same external hex abutment interface and internal geometry as the predicate HE series implants. They also have the Acqua hydrophilic surface treatment in place of the NeoPoros surface finish. The Ti Drive Acqua implants are provided in three endosseous diameters (3.5, 4.3, and 5.0 mm), three platform diameters (3.3, 4.3, and 5.0 mm), and five lengths (8, 10, 11.5, 13, and 16 mm).
The subject Titamax CM EX Acqua implants are provided in the same design variants as the predicate Titamax CM EX implants. The only difference is the application of the Acqua hydrophilic surface treatment in place of the NeoPoros surface finish. The Titamax CM EX Acqua implants are provided in three endosseous diameters (3.5, 3.75, and 4.0 mm), three platform diameters (3.5, 3.75, and 4.0 mm), and five lengths (9, 11, 13, 15, 17 and 19 mm).
The subject CM Drive Acqua implants are provided in the same design variants as the predicate Titamax CM EX implants. The only difference is the application of the Acqua hydrophilic surface treatment in place of the NeoPoros surface finish. The CM Drive Acqua implants are provided in three endosseous diameters (3.5, 4.3, and 5.0 mm), three platform diameters (3.3, 4.3, and 5.0 mm), and five lengths (8, 10, 11.5, 13, and 16 mm).
The subject Titamax Smart EX Acqua implants are provided in the same design variants as the predicate. The only difference is the application of the Acqua hydrophilic surface treatment in place of the NeoPoros surface finish. The Titamax Smart EX Acqua implants are provided in two endosseous diameters (3.75 and 4.0 mm), one platform diameter (4.1 mm), and five lengths (9, 11, 13, 15, and 17 mm).
The subject device Drive Smart Acqua implants are provided in the same design variants as the predicate Drive Smart implants. The only difference is the application of the Acqua hydrophilic surface treatment in place of the NeoPoros surface finish. The Drive Smart Acqua implants are provided in three endosseous diameters (3.5, 4.3, and 5.0 mm), three platform diameters (3.3, 4.3, and 5.0 mm), and five lengths (8, 10, 11.5, 13, and 16 mm).
The Acqua surface finish is a traditional grit blast and acid etch surface that is further processed in a manner that renders it hydrophilic.
The subject implant devices are made of Grade 4 commercially pure titanium conforming to ASTM F67, Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700), with a surface that is grit blasted, acid etched and subjected to a process that renders them hydrophilic. The subject Smart mount devices are made of titanium alloy conforming to ASTM F136 Standard for Titanium-6Aluminum-Specification 4Vanadium ELI (Extra Low Interstitial) Allov for Surgical Implant Applications (UNS R56401).
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