(29 days)
Zimmer® One-Piece 4.7mm, Straight implants are indicated for the support and retention of fixed single tooth and fixed partial denture restorations in the premolar, cuspid, and incisor regions of partially edentulous jaws. Zimmer® One-Piece 4.7mm, Straight implants may be loaded immediately in the anterior mandibular arch if four are splinted together with a bar. The Zimmer® One-Piece 4.7mm, Straight implant may be immediately restored with a temporary prosthesis that is not in functional occlusion.
The Zimmer One-Piece Implant, 4.7mm, Straight is a one-piece endosseous dental implant which is a combination of implant and abut pent sections. The implant is composed of titanium alloy. The abutment portion is pre-prepared and contoured for esthetic restoration. The abutment portion of the implant features a pre-prepared margin to facilitate the restoration process. The implant section is designed for ease of implantation and with greater surface are for osseointegration. The implant section surface is treated to facilitate osseointegration. In addition, the implant section is tapered with double-lead threads.
This document does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria in the format requested. The document is a 510(k) premarket notification for a Zimmer® One-Piece Implant, 4.7mm, Straight. It describes the device, its intended use, and its substantial equivalence to predicate devices based on mechanical testing, but it does not provide:
- A table of specific acceptance criteria and reported device performance.
- Details on sample size for a test set or data provenance (country, retrospective/prospective).
- Information about experts used for ground truth or their qualifications.
- Adjudication methods.
- A multi-reader multi-case (MRMC) comparative effectiveness study, effect size, or human improvement with AI assistance.
- Standalone algorithm performance without human-in-the-loop.
- The type of ground truth used (expert consensus, pathology, outcome data).
- The sample size for a training set.
- How ground truth for a training set was established.
This document focuses on regulatory approval based on substantial equivalence, primarily supported by mechanical testing mentioned in section 6, "Device Comparison," not on a clinical or performance study with the specifics requested.
§ 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.