(89 days)
Zimmer 3.1mmD Dental Implants are designed for use in the anterior maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load. Zimmer 3.1mmD Dental Implants may be placed immediately following an extraction or loss of natural teeth provided there is sufficient volume of alveolar bone to minimally support the implant (minimum 1mm circumferential and 2mm apical). The Zimmer 3.1mmD Dental Implants should be splinted to additional implants when used in the pre-molar region and should not be used in the molar region.
The 2.9mm Angled Abutment and the 2.9mm Angled Abutment, Straight Hex are used for attachment of restorations requiring off-axis correction. The 2.9mm Angled Abutment and the 2.9mm Angled Abutment, Straight Hex are designed to be used in edentulous or partially edentulous mandibles or maxillae for attachment of complete denture prostheses, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a freestanding single tooth replacement.
The 2.9mm Contour Abutment and the 2.9mm Contour Abutment, Straight Hex are used as a terminal or intermediate abutment for a cemented prosthesis. Abutment can be used for a singleor multiple-unit restoration. The 2.9mm Angled Contour Abutment and the 2.9mm Angled Contour Abutment, Straight Hex are designed to be used as a terminal or intermediate abutment for a cemented prosthesis where the angle needs to be offset by 17°. Abutment can be used for a single- or multiple-unit restoration.
The 2.9mm Temporary Abutment is intended to be used to fabricate and support provisional restorations that aid in creating an esthetic emergence through the gingiva during the healing period and prior to final restoration. The 2.9mm Temporary Abutment can be used for cementretained or screw-retained provisional restorations. The abutments can be used for single-unit and multi-unit restorations.
The Ball Abutment is used for retaining overdentures or partial dentures when resilience and facilitated oral hygiene are desired.
The Healing Collar is used to assist in the forming of the soft tissue during healing before a final restoration is placed. The Healing Collar is for single use only.
The Healing Screw is used to seal the implant internal connection and separate it from the soft tissue which is sutured over the implant during healing.
The Retaining Screws are intended to be used for securing the temporary abutments, final abutments and impression transfers to the implant or implant analog. The long Retaining Screw is intended to be used with Temporary Abutments for fabrication of screw-retained provisional restorations and with Impression Transfers for direct impressions.
The Zimmer 3.1mmD Dental Implant System consists of 3.1mm threaded endosseous dental implants, as well as prosthetic components, and ancillary components for placement and restoration of these implants. The prosthetic components include 2.9mm Angled Abutment, 2.9mm Angled Abutment, Straight Hex, 2.9mm Contour Abutment, 2.9mm Contour Abutment, Straight Hex , 2.9mm Temporary Abutment, and 2.9mm Ball Abutment. The 2.9mm Angled, 2.9mm Contour, and 2.9mm Temporary Abutments are made to support single or multiple unit restorations. The 2.9mm Ball Abutments are made to support overdentures. The ancillary components for the Zimmer 3.1mmD Dental Implant System include 2.9mm Healing Collars and 2.9mm Healing Screws which are used during the healing process.
Zimmer 3.1mmD Dental Implant is an endosseous dental implant composed of titanium alloy. The implant body is designed for ease of implantation and with greater surface area for osseointegration. The implant surface is treated to facilitate osseointegration. In addition, the implant body is tapered with triple-lead threads. The Zimmer Dental 3.1mmD Dental Implant is currently offered in 3.1mm diameter in lengths of 8, 10, 11.5, 13, and 16mm. They include two different texturing configurations: full texture to the top of the implant and texture to 0.5mm from the top of the implant. In addition, both texturing configurations of the implant have coronal grooves on the collar to within 0.64mm of the top of the implant similar to the predicate #1: Tapered Screw-Vent Implant Dental Implant. The implant-abutment interface platform diameter will be offered in a size of 2.9mm. The new device will feature MTX surface equivalent to existing Zimmer Dental implants.
The Abutments, Healing Collars, and Healing Screw are titanium alloy devices that are made to mate with the Zimmer 3.1mmD Dental Implant, which is also made of titanium alloy. The abutments are designed for use as a terminal or intermediate abutment prostheses.
The provided text is a 510(k) Premarket Notification for the Zimmer 3.1mmD Dental Implant System. It describes a medical device, not a diagnostic AI system, therefore most of the requested information regarding AI study design and performance metrics is not applicable.
However, I can extract the relevant information about the non-clinical testing performed to establish substantial equivalence.
Acceptance Criteria and Device Performance for Zimmer 3.1mmD Dental Implant System
The Zimmer 3.1mmD Dental Implant System is evaluated based on non-clinical testing to demonstrate substantial equivalence to predicate devices, focusing on mechanical performance and MRI compatibility.
1. Table of Acceptance Criteria and Reported Device Performance
The document states that non-clinical testing indicates the new devices are "strong enough to withstand the anticipated forces and demonstrated improvements over the predicate device(s)." It also confirms that the device "poses no additional restrictions on MRI beyond those that would otherwise occur for the patient."
While specific numerical acceptance criteria (e.g., minimum fatigue strength in MPa or compression load in N) and exact reported device performance values are not explicitly provided in this summary, the general acceptance criteria can be inferred from the nature of the tests and the conclusions drawn:
| Acceptance Criterion (Inferred from Test Objective) | Reported Device Performance (Summary) |
|---|---|
| Mechanical Strength & Durability: | |
| Withstand anticipated forces without failure | "strong enough to withstand the anticipated forces" |
| Demonstrate improvement over predicate device(s) | "demonstrated improvements over the predicate device(s)" |
| MRI Safety & Compatibility: | |
| No additional restrictions on MRI for the patient | "poses no additional restrictions on MRI beyond those that would otherwise occur for the patient" |
2. Sample Size and Data Provenance for the Test Set
- Sample Size for Test Set: The document does not specify the sample size used for the fatigue, compression, or MRI compatibility tests. It only states "Non-clinical test data was used."
- Data Provenance: The tests were non-clinical, meaning they were likely conducted in a laboratory setting by Zimmer Dental Inc. The country of origin for the data is not specified, but the applicant information is for Zimmer Dental Inc. in Carlsbad, CA, USA. The data is prospective, as it involves testing of the new device.
3. Number of Experts and Qualifications for Ground Truth
- This is not applicable as the device is a dental implant system being evaluated through non-clinical mechanical and physical property testing, not an AI diagnostic device requiring expert interpretation for ground truth.
4. Adjudication Method for the Test Set
- This is not applicable, as the evaluation is based on objective measurements from mechanical and physical testing, not subjective expert judgment, which would require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- This is not applicable. The document describes a medical device (dental implant and associated components), not a diagnostic AI system. Therefore, no MRMC study testing human reader improvement with or without AI assistance was performed.
6. Standalone (Algorithm Only) Performance Study
- This is not applicable. The device is a physical dental implant system, not a software algorithm.
7. Type of Ground Truth Used
The "ground truth" for this device is based on objective measurements derived from standardized non-clinical performance tests conforming to FDA guidance and ASTM standards. Specifically:
- Mechanical Integrity: Measured by fatigue and compression testing results.
- MRI Compatibility: Measured by interactions with magnetic fields during MRI.
8. Sample Size for the Training Set
- This is not applicable. The product is a physical device, not an AI model, and therefore does not have a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
- This is not applicable, as there is no training set for an AI model.
§ 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.