(385 days)
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.
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.