(91 days)
CAMLOG® and CONELOG® Abutments are intended to be used to fabricate prosthetic restorations in conjunction with CAMLOG® and CONELOG® implants to support prostheses in the maxillary and/or mandibular arch.
iSy® Abutments are intended to be used to fabricate prosthetic restorations in conjunction with iSy implants to support prostheses in the maxillary and/or mandibular arch.
Abutment for Bridges is a straight abutment designed for multi-unit, cement-retained restorations. It is available with two gingival heights (0.8 and 2.0 mm) for CONELOG and iSy and one gingival height for CAMLOG.
Abutment for Bridges is available for CAMLOG, CONELOG and iSy Implant Systems. It is available in five CAMLOG platform diameters (3.3 mm, 4.3 mm, 5.0 mm, and 6.0 mm), four CONELOG platform diameters (3.3 mm, 3.8 mm, 4.3 mm and 5.0 mm), and one iSy interface connection.
The Temporary Abutment is a straight, one-piece titanium abutment for cement-retained provisional restorations. It is available in a non-indexed bridge version for CAMLOG, CONELOG and iSy, and an indexed crown version for CAMLOG implant system.
This document is a 510(k) premarket notification from the FDA regarding a dental device called "Abutment for Bridges" by ALTATEC GmbH. It does not provide information about acceptance criteria and performances of an AI/ML-based medical device. Therefore, I cannot extract the requested information like acceptance criteria, study details, sample sizes, expert qualifications, or ground truth methods related to an AI device.
The document discusses the substantial equivalence of the "Abutment for Bridges" to previously marketed predicate devices. It includes:
- Device Name: Abutment for Bridges
- Regulation Number: 21 CFR 872.3630
- Regulation Name: Endosseous dental implant abutment
- Regulatory Class: II
- Product Code: NHA
- Intended Use: To fabricate prosthetic restorations in conjunction with CAMLOG®, CONELOG®, and iSy® implants to support prostheses in the maxillary and/or mandibular arch.
- Performance Data (Non-clinical): Sterilization validation (ISO 17665-1, ISO 17665-2), biological evaluation (ISO 10993-1), and reference to biocompatibility of the applicant's predicate devices (K113779, K133991, K0823496).
- Clinical Data: "No clinical data were included in this submission."
The document focuses on demonstrating substantial equivalence based on material, design, intended use, operating principle, and sterilization processes compared to predicate devices, not on evaluating performance against specific acceptance criteria for a new functionality through a clinical study.
§ 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.)