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510(k) Data Aggregation
K Number
K190552Device Name
JJ Implant System
Manufacturer
JJ Implants
Date Cleared
2019-12-06
(276 days)
Product Code
DZE, NHA
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
JJ Implants
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
JJ Implant System Genesis Active implants and Genesis Normo implants are indicated for placement in the maxillary or mandibular arch to provide support for single-unit or multi-unit restorations for functional and esthetic rehabilitation. JJ Implant System Genesis Active implants and Genesis Normo implants are indicated for immediate loading when good primary stability is achieved and the occlusal loading is appropriate.
JJ Implant System Mini implants may be used for denture stabilization using multiple implants in the anterior mandible and the anterior maxilla, and are indicated for immediate loading when good primary stability is achieved and the occlusal loading is appropriate.
Device Description
The JJ Implant System comprises three lines of endosseous root-form dental implants: two lines with an internal hexagonal prosthetic interface (Genesis Normo), mating abutments, abutments, abutment screws, and other associated components; and a line of one-piece, small diameter dental implants (Mini) for retention of overdentures.
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