(132 days)
The ERA® Micro 23° and 30° Females are intended to be used as a retention device in conjunction with the Sterngold Acid Etch Dental Implant System in the maxillary and/or mandibular arch to provide support for overdentures for partially and fully edentulous patients.
The ERA® Micro 23° and 30° Female Abutment is a prosthetic component intended to facilitate functional parallelism of the ERA® Females despite diverging implants during prosthetic rehabilitation. It is intended to be used in conjunction with the Sterngold Acid Etch Dental Implant System in the maxillary and/or mandibular arch to provide support for overdentures for partially and fully edentulous patients.
It is intended to support single and multiple tooth prostheses in the mandible or maxilla. It is provided in a 3.22mm diameter and two angles (23° and 30°).
These devices have a two piece design configuration; the two-piece assembly consists of a straight base which has a screw post that gets engaged into the internal threading of the dental implant and an angled female, which allows the user to achieve functional parallelism with divergent implants.
The ERA® Micro 23° and 30° Female Abutment is manufactured from the same materials as the predicate devices. The specification for the material used to manufacture the ERA® Micro 23º and 30º Female is 6AL-4V ELI titanium classified as ASTM F136-11. The female receptacle of the ERA® Micro 23° and 30° female abutment, which resides at or above the gingival crest and couples with the Stern ERA System male attachments, is coated with titanium nitride (TiN), which has been cleared under K921010. No coating is applied to snap-in post of the angled female insert or the bases.
These devices are supplied non-sterile in a sealed pouch including instructions for use. Instructions for Use indicate recommended method of sterilization prior to use. These parts are packaged individually.
The provided text describes the K130408 ERA® Micro 23° and 30° Female Abutment, a dental implant component. This submission is a traditional 510(k) for a Class II device. The acceptance criteria and the study that proves the device meets them are outlined in the performance testing section.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Device performs according to its intended use (sufficient mechanical strength and resistance to fatigue for the intended clinical application, and substantial equivalence to predicate devices). | "Fatigue testing demonstrated that the ERA® Micro 23° and 30° Females have sufficient mechanical strength and resistance to fatigue for the intended clinical application and that they are substantially equivalent to the listed predicate devices." |
| Compliance with "Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments." | "Performance testing was performed following 'Guidance for Industry and FDA Staff -Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments.'" |
| Compliance with ISO 14801:2007 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants. | "Fatigue testing was conducted in accordance with ISO 14801:2007 Dentistry - Implants-Dynamic fatigue test for endosseous dental implants." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document mentions that "Samples were tested with the implants long axis at 40° angle of correction." However, it does not specify the exact number of samples used for the fatigue testing. It also states that testing was "conducted on a 30° angled female abutment and a small diameter (3.75mm) Sterngold Acid Etch Dental Implant finished product. This was determined to be the worst case scenario, largest angle, smallest diameter implant." This implies that a representative sample of the "worst-case" configuration was tested, but the precise sample count is not provided.
- Data Provenance: Not explicitly stated, as this is a laboratory performance test rather than a clinical study with patient data. The testing was conducted by Sterngold Dental, LLC.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This information is not applicable as the study described is an in-vitro mechanical performance test (fatigue testing) and not a clinical study involving human readers or expert-established ground truth.
4. Adjudication Method for the Test Set
- This information is not applicable as the study described is an in-vitro mechanical performance test and does not involve adjudication of expert readings.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described in this submission. This is a premarket notification for a dental abutment, focusing on material and mechanical equivalence rather than diagnostic performance assessed by human readers.
6. Standalone Performance Study
- No, a standalone (algorithm only without human-in-the-loop performance) study was not conducted or described. This entire submission is for a medical device (dental abutment), not a software algorithm. The "performance testing" described refers to the mechanical integrity of the device itself.
7. Type of Ground Truth Used
- The "ground truth" for this device's performance is established by engineering and mechanical standards (ISO 14801:2007 and FDA Guidance for Class II Special Controls for Root-form Endosseous Dental Implants). The "truth" is whether the device withstands the specified mechanical forces and fatigue cycles without failure, demonstrating sufficient strength for its intended clinical application.
8. Sample Size for the Training Set
- This information is not applicable. There is no "training set" as this is a device and material equivalence submission, not an AI/ML algorithm.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable for the same reason as point 8.
§ 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.)