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-Healing Abutment, Cover Screw (previously cleared per K210826) MegaGen Prosthetics are intended for use as an aid in prosthetic rehabilitation.
-Multi-unit Abutment, Multi-unit Angled Abutment (previously cleared per K203808) The Multi-unit Abutment, Multi-unit Angled Abutment is intended to be surgically placed in the maxillary or mandbular arches for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals.
-AnyOne External Implant System (previously cleared per K203554) The AnyOne External Implant System is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function. Smaller implants (less than 6.0 mm) are dedicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading, Larger implants are dedicated for the molar region and are indicated for delayed loading.
-AnyOne Onestage Implant System (previously cleared per K210161) The AnyOne Onestage Implant System is intended to be surgically placed in the maxillary or mandibular arches for the purpose of providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function in the following situations and with the clinical protocols: -Delayed loading. -Immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated for the molar region.
-Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment (previously cleared per K192614) Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment is intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function. Intended for fully edentulous jaw retaining a tissue supported overdenture. The abutments in combination with endosseous implants are used as the foundation for anchoring tooth replacements in either jaw. The attachments are used in fixed overdenture restorations that can be attached with a snap-in system.
-ST Internal Implant System (previously cleared per K192347) The ST Internal Implant System is intended to be surgically placed in the maxillary or mandibular arches for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function. Smaller implants (less than 6.0 mm) are dedicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated for the molar region and are indicated for delayed loading.
-AnyRidge Octa 1 Implant System (previously cleared per K182448) The AnyRidge Octa 1 Implant System is intended to be surgically placed in the maxillary or mandibular arches for the purpose of providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing situations and with the clinical protocols: - Delayed loading. - Immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated for the molar region.

• Advanced Intermezzo Implant System (previously cleared per K191127) Advanced Intermezzo Implant Systems is threaded one-piece implants designed for orthodontic onestage surgical procedures in upper and lower jaw to provide a means of prosthetic attachment to restore a patient's chewing function. Advanced Intermezzo Implant System consists of single-stage, root-form dental implants. The system is designed to provide immediate provisional implant to provide temporary support for prosthetic devices during the healing phase of permanent root form implants. Depends on a patient's quality of bone condition, Advanced Intermezzo Fixtures are to be removed within six to ten weeks after the surgery. The system is intended for immediate placement in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations.
  -MiNi Internal Implant System (previously cleared per K150537) The MiNi Internal Implant System is intended for two-stage surgical procedures in the following situations and with the following clinical protocols: - The intended use for the 3.0 mm diameter MiNi implant is limited to the replacement of maxillary lateral incisors and mandibular incisors. - Immediate placement in extraction situations with a partially or completely healed alveolar ridge. - It is intended for delayed loading.
  -XPEED ANYRIDGE INTERNAL IMPLANT SYSYEM (previously cleared per K140091) The Xpeed AnyRidge Internal Implant System is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function. Smaller implants (less than 06.0 mm) are dedicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated for the molar region and are indicated for delayed loading.
  -ANYONE™ INTERNAL IMPLANT SYSTEM (previously cleared per K123988) The AnyOne™ Internal Implant System is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function. Smaller implants (less than Ø6.0 mm) are dedicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated for the molar region and are indicated for delayed loading.
  -XPEED ANYRIDGE INTERNAL IMPLANT SYSTEM (previously cleared per K123870) The Xpeed®AnyRidge®Intemal Implant System is intended to be surgically placed in the maxillaryor mandbular molar areas for the purpose providing prosthetic support for dental restorations(Crown, bridges, and overdentures) in partially or filly edentulous individuals. It is used to restore a patient's chewing function. Smaller implants (less than Ø6.0mm) are dedicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated for the molar region and are indicated for delayed loading.

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I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving that a device meets such criteria. The document is primarily an FDA 510(k) clearance letter for the "MegaGen Dental Implant Systems Portfolio - MR Conditional." It lists various implant systems and their indications for use, many of which were previously cleared.

The letter focuses on regulatory approval, substantial equivalence, and compliance with general controls and other FDA regulations for medical devices. It does not include details on specific performance metrics, clinical studies, sample sizes, ground truth establishment, or expert evaluations that would be necessary to answer your request.

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