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SGS® Dental Implants System is intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in edentulous or partially edentulous patients. SGS® Dental Implants System may be immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Two Stage Implants: P1, P7, P7N.

One Stage: P7S, P9S.

One Stage & One-Piece 3.0 mm diameter implants: P7S, P9S are intended for placement at the mandibular central and lateral incisors and maxillary and lateral incisors. Indicated also for denture stabilization using multiple implants.

One stage & One-Piece 2.4 mm diameter implants for temporary use or long term use: P9S permit immediate splint stability and long term fixation of new or existing crown, bridge and prosthesis.

PEEK Temporary Abutments are for 30 days.

SGS® Dental Implants System consists of one and two stage endosseous form dental implants, internal hexagonal and one piece implants system;

P1 - Screw Type Groovy Implant- Diameter 3.2, 3.75,4.2, 5, 6 Length 8, 10,11.5,13,16
P7 - Conical Groovy Implant - Diameter 3.2, 3.75,4.2, 4.5, 5, 6 Length 8, 10,11.5,13,16 (13,16 not for 3.2 dmm).

P7N - Narrow Conical Implant - Diameter 3, 3.2 Length 10, 11.5, 13, 16

P7S - Integral Groovy Implant - Diameter 3, 3.2, 3.75, 4.2, 5, 6 Length, 10, 11.5, 13, 16
P9S - Thin Integral Implant - Diameter 2.4. 3. 3.2 Length 10. 11.5. 13. 16

Abutments System is compromised of Healing Abutments, Overdenture ball attachments, Straight Titanium Abutments, Angulated Titanium Abutments 15,25, Anatomic Straight Titanium Abutments, Anatomic Angular Titanium Abutments, Anatomic Straight Zirconium Abutments, Straight PEEK Abutments, Temporary Abutments, Screw Type Abutments, Screw Type Angular Abutments and Attachments for Overdenture; impression copy system & surgical instruments are also provided.

The provided document [K133362] pertains to the SGS® Dental Implants System and its substantial equivalence to predicate devices, rather than a study demonstrating the device meets a specific set of acceptance criteria for an AI/algorithm-based medical device.

The document focuses on:

• The FDA's determination of substantial equivalence (K133362) for the SGS® Dental Implants System.
• The intended use and indications for the dental implant system.
• A comparison of the SGS® Dental Implants System's characteristics (e.g., material, dimensions, surface treatment) to several predicate dental implants (e.g., A.B.Dental Devices, M.I.S, Alpha Bio Tec, Nobel Active, DIO Biotite-H).
• Non-clinical testing, including mechanical fatigue testing according to ISO 14801, and other safety and effectiveness testing (sterilization, cleaning validation, packaging validation, shelf life).

Therefore, it is not possible to extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth, or expert involvement for an AI/algorithm-based device from this document.

The document confirms that mechanical testing was performed in compliance with ISO 14801:2007, demonstrating high resistance and ability, and that other safety and effectiveness tests were done (sterilization, cleaning, packaging, shelf life), concluding no new safety or effectiveness issues compared to predicate devices. However, this is for a physical medical device, not an AI.

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