(24 days)
For use in cement retained crown and bridge construction.
The following table describes the indication for use for each component listed as part of this 510(k) submission:
| Component | Part | Indication for Use |
|---|---|---|
| Cast-to Abutment 3.5 | 22827 | Used as a base for cast-to customized abutment post construction. |
| Allowing for compensation of poorly aligned fixtures and for meeting | ||
| esthetic demands for design and position of the crown margin. | ||
| Cast-to Abutment 4.0 | 22828 | Used as a base for cast-to customized abutment post construction. |
| Allowing for compensation of poorly aligned fixtures and for meeting | ||
| esthetic demands for design and position of the crown margin. | ||
| Cast-to Abutment ST | 22829 | Used as a base for cast-to customized abutment post construction. |
| Allowing for compensation of poorly aligned fixtures and for meeting | ||
| esthetic demands for design and position of the crown margin. | ||
| Abutment Screw, Ultra- | ||
| gold (sterile) | 22838 | Attachment element for connection/fixation of abutments to fixtures |
| Abutment Screw, ST- gold | ||
| (sterile) | 22839 | Attachment element for connection/fixation of abutments to fixtures |
Cast-to Abutment, Cast-to Abutment ST and Abutment Screws- Gold - are ADDITIONAL COMPONENTS to the Astra Tech Dental Implant System.
The Cast-to abutments are manufactured in gold alloy and are used as a base for castto customized abutment post construction. Allowing for compensation of poorly aligned fixtures and for meeting esthetic demands for design and position of the crown margin.
The Abutment Screws are manufactured in gold alloy and are attachment elements for connection/fixation of abutments to fixtures.
The provided text, a 510(k) summary for the Astra Tech Implants - Dental System, does not contain information about acceptance criteria, device performance, or any studies conducted to prove the device meets such criteria.
The document is a premarket notification for additional components (Cast-to Abutments and Abutment Screws) to an existing dental implant system. It primarily focuses on:
- Identification of the device and submitter.
- Description of the device and its intended use: These are additional components for cement-retained crown and bridge constructions, allowing for customization and fixation of abutments to fixtures.
- Classification and predicate devices: It states the device is an Endosseous Implant and references previously approved similar devices.
- List of components: Details the specific product names, diameters, and part numbers.
- FDA correspondence: The letter from the FDA confirms review of the 510(k) notification and a determination of "substantial equivalence" to devices marketed prior to May 28, 1976. It also mentions device tracking requirements.
- Indications for Use: Specifically lists the indications for each component, which mostly relate to their function as a base for customized abutment construction or as attachment elements.
Therefore, I cannot provide the requested information regarding acceptance criteria and the study proving device performance because it is not present in the provided text.
This type of 510(k) submission generally relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive new performance studies to establish safety and effectiveness from scratch. The assumption is that if the new device is substantially equivalent in design, materials, and intended use to an already approved device, then its safety and effectiveness are also similar. Specific performance studies with detailed acceptance criteria might have been performed for the predicate device, or for the original implant system, but not necessarily for these "additional components" in this specific 510(k) submission.
§ 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.