(66 days)
Camlog Implant System implants are intended for immediate or delayed placement in the bone of the maxillary or mandibular arch. Camlog Implant System Abutments are intended for use as support for crowns, bridges or overdentures. When a one-stage surgical approach is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate.
The Camlog Implant System includes various sizes of threaded root-form dental implants and abutments intended to support prosthetic restorations in edentulous or partially edentulous patients. The implants can be placed immediately following extraction or after a healing period. If good primary stability is reached the implants may be immediately loaded. The complete system includes a variety of laboratory (burnout) copings, impression copings, analogs and other components intended to facilitate the preparation of prosthetic restorations.
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific performance criteria. The document is a 510(k) summary for the CAMLOG Implant System, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, not on presenting performance study results against predefined acceptance criteria.
The 510(k) summary states:
- "The components of the CAMLOG Implant System, including the modified implants and abutments, have the same basic design as the predicate devices."
- It highlights similarities such as "same intended use," "same operating principle," "same basic design," "same materials," and "similar packaging and is sterilized using the same materials and processes."
This type of submission relies on demonstrating that the new device is as safe and effective as an already cleared device, rather than on new performance studies with acceptance criteria. Therefore, I cannot provide the requested information.
§ 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.