(124 days)
The ORA Implant Abutment System is indicated for use with dental implants to support and/or retain removable dental prostheses in the treatment of partially edentulous patients to restore chewing function. The abutment screws directly into endosseous implants or they screw into SFI Abutments which are screwed into endosseous implants.
The ORA Implant Abutment is a precision machined ball shaped abutment that connects a compatible dental implant system with a removable partial or complete overdenture. The implant abutment is screwed into the dental implant. Connection to and retention of a denture is provided by a rubber o-ring, which may or may not be held within a metal housing. There are two color o-rings, a red processing o-ring and a white final o-ring. The retaining ring (metal housing) comes with the red o-ring (which is a firm rubber) inside. The retaining ring (metal housing) with the red o-ring is pushed over the wide part of the ball until seated. The stiffness of the red o-ring holds the housing in position. Any exposed areas of the abutment are blocked out so that only the metal housing is exposed. The retaining ring (metal housing) is then processed into the denture. After the material has cured, the denture is removed. The red o-ring is pulled out of the metal housing and the white o-ring is inserted into its place. The white o-ring is more flexible making insertion and removal easier. The bottom portion of the abutment (cuff area to end of threads) is an exact replica of the SFI Implant Abutments previously cleared by K130183 and K132814. ORA Implant Abutments are available in sixteen different platforms and each platform is compatible with one or more implant types.
Here's a breakdown of the acceptance criteria and the study information for the ORA Implant Abutment System, based on the provided text:
ORA Implant Abutment System
1. Table of Acceptance Criteria and Reported Device Performance
This 510(k) summary does not explicitly state quantitative performance acceptance criteria (e.g., specific thresholds for force, displacement, or reliability percentages). Instead, the acceptance criterion for the ORA Implant Abutment System is substantial equivalence to its predicate devices in terms of design, materials, intended use, operating principles, and manufacturing.
The reported device performance is that it meets this criterion through application and functional testing.
| Attribute | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Overall Performance | Substantially equivalent to predicate devices in form and function | Equivalent in performance characteristics to predicate devices. |
| Design/Construction | Machined, screw-retained | Machined, screw-retained |
| Anatomical Site | Oral Cavity | Oral Cavity |
| Device Material | Wrought Titanium-6AL-4 Vanadium ELI Alloy | Wrought Titanium-6AL-4 Vanadium ELI Alloy |
| Indications for Use | Matches predicate device indications for use. | Matches predicate device indications for use. |
| Operating Principle | Abutment Implant connection: Screw fixation; Retentive system for overdenture. | Same as predicate devices. |
| Cleaning Procedures | Common procedure for oral hygiene | Same as predicate devices. |
| Patient Handling | Common cleaning and insertion of denture | Same as predicate devices. |
| Manufacturing/Packaging | Produced in controlled CNC process, pouch, non-sterile | Same as predicate devices. |
| Cuff Sizes | Within range or comparable to predicate devices. | 0.4, 1.0, 1.25, 2.0, 3.0, 4.0, 5.0mm (Predicate ranges also provided). |
| Prosthetic Connection Types | Matches predicate devices. | RP, Conical, NP, WP, 3.5 Head, 4.0 Head, 4.1 Head, 4.5 Head, 4.8 Head |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "non-clinical test data" and "application and functional testing" to evaluate performance characteristics.
- Sample Size for Test Set: Not explicitly stated as a number of devices tested. The testing involved "tolerance analysis of platforms to identify worst case test samples." This suggests a selection of representative samples based on design variations, rather than a large statistical sample size of identical units.
- Data Provenance: The document does not specify the country of origin of the data. The testing appears to be internal (conducted by or for Sterngold Dental, LLC) and is retrospective in the sense that it's comparing a new device to existing predicate devices' performance characteristics, rather than collecting new clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This section is not applicable as the study described is non-clinical performance testing for substantial equivalence, not a study involving human expert interpretation for ground truth.
4. Adjudication Method for the Test Set
This section is not applicable as the described study is non-clinical performance testing, not a study requiring expert adjudication of results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not necessary." The comparison is for substantial equivalence to predicate devices based on technical characteristics and non-clinical performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as the ORA Implant Abutment System is a physical medical device (implant abutment), not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this submission is demonstration of equivalent performance characteristics to legally marketed predicate devices through non-clinical testing. The predicate devices themselves represent established safe and effective designs in the market.
8. The Sample Size for the Training Set
This section is not applicable as the ORA Implant Abutment System is a physical device and no machine learning algorithm was described that would require a "training set."
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the same reasons 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.)