(31 days)
The Atlantis Abutment is intended for use as an accessory to an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.
The devices covered in this submission are abutments which are placed into the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for cemented restorations. The Atlantis™ Abutments for Astra Implant and abutment screws are made from Titanium grade Ti-6A1-4V ELI (Meets ASTM Standard F-136). The abutment is placed over the implant shoulder and is mounted into the implant with a screw. The abutments are compatible with Astra's Microthread ST 4.0mm, 4.5mm, and 5.0mm Implants.
The provided text does not contain any information about acceptance criteria, device performance, or a study to prove the device meets acceptance criteria.
The document is a 510(k) Pre-Market Notification for a dental implant abutment. It primarily focuses on:
- Device Identification: Trade name, common name, classification, and product code.
- Predicate Device: Identifying a legally marketed device for comparison.
- Device Description: Materials, compatibility with implants.
- Intended Use: What the device is designed to do and for whom.
- Basis for Substantial Equivalence: Stating that the new device is substantially equivalent to a previously cleared device.
- FDA Correspondence: A letter from the FDA confirming receipt and review of the 510(k) and its determination of substantial equivalence.
- Indications for Use: Formal statement of how the device is intended to be used.
In the context of a 510(k) submission, "substantial equivalence" means the new device is as safe and effective as a legally marketed predicate device. This often relies on demonstrating similar technological characteristics and performance to the predicate, rather than an independent de novo study with acceptance criteria in the way a novel high-risk device might require.
Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving device performance from this document. It does not contain details on:
- Acceptance criteria table or reported device performance.
- Sample size, data provenance, number of experts, adjudication method for a test set.
- MRMC comparative effectiveness study or effect size.
- Standalone (algorithm only) performance.
- Type of ground truth used.
- Training set sample size or how its ground truth was established.
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)