(122 days)
VARIOflex Thommen Medical VARIOflex Abutments are intended to be used in conjunction with Thommen System dental implants in the maxillary and/or mandibular arch to provide support for crowns, bridges and overdentures. VARIOtemp Thommen Medical VARIOtemp Abutments are intended to be used in conjunction with Thommen System dental implants in the maxillary and/or mandibular arch to provide support for crowns, bridges and overdentures.
VARIOunite is a straight titanium dental implant abutment with retention groves that can be used for either permanent or temporary screw-retained or cement-retained restorations. Labeled as VARIOflex, it is provided with a burn-out sleeve for fabrication of a permanent restoration. Labeled as VARIOtemp, it is provided with a fabrication screw for fabrication of a temporary restoration. VARIOunite can be prepared to the appropriate occlusal height prior to fabrication of the restoration using the retention rings for guidance. VARIOunite is available with an indexed connection for crowns or a non-indexed connection for bridges. It is available in five platform diameters (3.5, 4.0, 4.5, 5.0 and 6.0 mm) corresponding to existing platform diameters of the Thommen System dental implants.
The provided text does not contain information about acceptance criteria for a medical device or a study proving its performance against such criteria. The document is an FDA 510(k) premarket notification letter for a dental implant abutment called "VARIOunite."
It focuses on establishing substantial equivalence to previously marketed predicate devices, rather than presenting a performance study with acceptance criteria.
The document discusses:
- Device Name: VARIOunite
- Regulation Number/Name: 21 CFR 872.3630, Endosseous Dental Implant Abutment
- Product Code: NHA
- Predicate Devices: K121334 (VARIOeco) and K120414 (OsseoSpeed™ Plus)
- Indications for Use: Support for crowns, bridges, and overdentures in conjunction with Thommen System dental implants.
- Device Description: Straight titanium dental implant abutment, available as VARIOflex (for permanent restorations) and VARIOtemp (for temporary restorations).
- Performance Data (Non-clinical): Sterilization validation (ISO 17665-1, ISO/TR 17665-2) and biocompatibility evaluation (ISO 10993-1).
- Clinical Data: Explicitly states, "Clinical data were not submitted in this premarket notification."
- Equivalence Comparison: A table comparing the subject device (VARIOunite) with the primary and reference predicate devices in terms of indications, design (straight, prepable/non-prepable), diameter, restoration type, implant connection, and material.
Therefore, I cannot provide the requested table or details about a performance study, sample sizes, experts, adjudication methods, or MRMC studies, as this information is not present in the provided text. The document clearly states that "Clinical data were not submitted in this premarket notification." and instead relies on non-clinical testing and comparison to predicate devices to establish substantial equivalence.
§ 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.)