(183 days)
The OT Equator is designed as an endosseous dental implant retentive component used to retain a complete or partial denture. The OT Equator is screwed into an endosseous implant in the mandible or maxilla. The OT Equator abutments are indicated for use with the following implant systems: NOBEL BIOCARE AB - NobelActive NP 3.5 NOBEL BIOCARE AB - NobelActive RP 4.3 - 5 NOBEL BIOCARE USA LLC - Replace Select TC NP 3.5 NOBEL BIOCARE USA INC - Replace Select Straight TiUnit RP 4.3 NOBEL BIOCARE USA LLC - Replace Select Straight TiUnit WP 5 NOBEL BIOCARE AB - Brânemark System Mk III TiUnite NP 3.3 NOBEL BIOCARE AB - Brånemark System Mk III Shorty RP 4,1 NOBEL BIOCARE AB - Brånemark System Mk III TiUnite WP5 6 Straumann USA - Bone level NC 3.3 Straumann USA - Bone level RC 4.1 - 4.8 Straumann USA - Tissue level RN 4,8 Straumann USA - Tissue level WN 6.5 Zimmer Dental Inc. - Tapered Screw-Vent 3.5. 4.5. 5.7 Zimmer Dental Inc. - Spline 3.25. 3.75 - 4, 5 ASTRA TECH AB - OsseoSpeed™ TX 3.5-4, 4.5-5 DENTSPLY INTL., INC. - ANKYLOS C/ 3,5 DENTSPLY INTERNATIONAL, INC. - FRIALIT plus Stepped Screw 3.4, 3.8, 4.5, 5.5, 6.5 BIOMET 3i - Certain 3.25, 4.1, 5, 6 IMPLANT DIRECT LLC - Legacy 3, 3.75, 4.7 IMPLANT DIRECT LLC - Tri-Lobe 3.5, 4.3, 5 - 6 IMPLANT DIRECT LLC - Tri-Lobe 3.5, 4.3, 5 - 6 IMPLANT DIRECT SYBRON MANUFACTURING LLC - Swish Plus3.7, 4.1 - 4.8 MIS - IMPLANT TECHNOLOGIES LTD. - SEVEN 3.3, 3.75, 4.2, 5, 6 MIS - IMPLANT TECHNOLOGIES LTD. - C1 3.3, 3.75, 3.9, 4.2, 4.3, 5 MEGAGEN CO., LTD. - ANYRIDGE 3.5, 4, 4.5, 5, 5.5 NEODENT USA, INC. - CM Titamax 3.5, 3.75, 4, 4.3, 5 NEODENT USA, INC. - CM Drive 3.5, 3.75, 4, 4.3, 5 NEOSS, LTD. - ProActive 3.5, 4, 4.5, 5, 5.5, 6 BIOHORIZONS IMPLANT SYSTEMS, INC. - Laser-lok® 3.0 BIOHORIZONS IMPLANT SYSTEMS, INC. - Tapered internal 3.5, 4.5, 5.7 KEYSTONE DENTAL, INC. / LIFECORE BIOMEDICAL, INC - PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM SD 3.5 KEYSTONE DENTAL, INC. / LIFECORE BIOMEDICAL, INC - PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM RD 4.1 KEYSTONE DENTAL, INC. / LIFECORE BIOMEDICAL, INC - PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM WD 5
The OT Equator Implant Anchor abutment for endosseous dental implants is appropriate for use with overdentures or partial denture retained in whole or in part by endosseous implants in the mandibula or maxilla. The device is intended for use in healthcare facilities/hospitals.
The sphere OT Equator technology represents a prosthetic abutment solution for "overdenture". The emerging profile, specifically designed to accommodate the relative interchangeable copings OT Equator, allows the coupling with a removable prosthesis or "overdenture", which is properly built only if it is properly profiled and based on the patient's gingival arch. Therefore, the removable prosthesis unloads the chewer loads on the natural gum of the intra oral arch, making the OT Equator abutments passive with lacking of solicitation.
The OT Equator is manufactured of titanium Ti-6AI-4V (meets ASTM Standard F-136) and it is designed to retain any compatible prosthetic restoration.
The OT Equator overdenture system is comprised of a semispherical head, a base, and a screw.
This document is a 510(k) premarket notification for the "OT EQUATOR" device, an endosseous dental implant abutment. The primary purpose of this submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than to establish new performance metrics through clinical trials. As such, the information typically found in acceptance criteria and detailed study results for novel devices is not explicitly provided in the same format.
However, based on the provided text, we can infer how the device meets acceptance criteria through its demonstrated substantial equivalence to the predicate.
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
Since this is a substantial equivalence submission, the "acceptance criteria" are implied by the characteristics of the legally marketed predicate device (OT EQUATOR, K142211). The "reported device performance" for the new submission (OT EQUATOR, K160382) is its equivalence to these characteristics.
| Feature/Acceptance Criterion (Implied by Predicate) | Reported Device Performance (Submitted OT EQUATOR K160382) |
|---|---|
| Indications for Use | "The OT Equator is designed as an endosseous dental implant retentive component used to retain a complete or partial denture. The OT Equator is screwed into an endosseous implant in the mandible or maxilla." (Same as predicate) |
| Intended Users | Adequately trained dental technicians and dentists. (Same as predicate) |
| Material (Abutment) | Titanium 6Al-4V (Same as predicate) |
| Material (Male socket) | Rilsan, Pebax, Kepital (Same as predicate) |
| Material (Housing) | Stainless Steel AISI303 (Same as predicate) |
| Platform Diameter | According to the compatible implant (see table above, indication for use) (Same as predicate) |
| Surface treatment | TiN coating only for the head part of the abutment (Same as predicate) |
| Cuff Width | 1mm - 2mm - 3mm - 4mm - 5mm - 6mm- 7mm (Same as predicate) |
| Height | 2 mm (Same as predicate) |
| Components | OT EQUATOR PROFILE kit contains: Ot Equator Profile abutment, metal housing, retentive caps, protective disk. (Same as predicate) |
| Sterilization | Marketed non sterile, to be sterilized before insertion in patient's mouth. (Same as predicate) |
| Reusable | No (Same as predicate) |
| Biocompatibility | Meets standards for permanent duration (> 30 days), mucosal membranes contacting device (demonstrated by predicate). |
| Sterilization Validation | Achieves SAL of 10-6 (demonstrated by predicate). |
| Coupling with compatible implant | Successful coupling as validated by reverse engineering analysis (results reported in a chart form, not detailed in text). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily relies on non-clinical tests to demonstrate substantial equivalence. For the reverse engineering analysis:
- Sample Size: "a statistically significant number of OEM implant systems" were used. The exact number is not specified.
- Data Provenance: Not explicitly stated, but the company (Rhein'83 SRL) is based in Italy. The testing would have been performed on commercially available implant systems. It is not a clinical study, so terms like retrospective/prospective don't directly apply.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This submission concerns a physical device and its material/design characteristics validated against a predicate device and engineering standards, not diagnostic performance requiring expert interpretation of medical images or conditions. The "ground truth" for the non-clinical tests (like reverse engineering) would be the technical specifications of the implants and the device, measured by calibrated instruments, not expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically used in clinical studies with subjective interpretations. The non-clinical tests described (biocompatibility, sterilization validation, reverse engineering) rely on objective measurements and established standards.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a dental implant abutment, not an AI-powered diagnostic tool, and no MRMC study was performed or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the non-clinical tests:
- Biocompatibility: Ground truth is established by international standards (e.g., ISO 10993 series, though not explicitly detailed here, it's implied by the reference to "permanent duration (> 30 days), mucosal membranes contacting device").
- Sterilization Validation: Ground truth is established by international standards (e.g., ISO 17664 and ISO 11737-1/-2) for a Sterility Assurance Level (SAL) of 10-6.
- Reverse Engineering Analysis: Ground truth is the precise dimensions and specifications of the compatible OEM implant systems. These are objective engineering measurements.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. No training set exists.
§ 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.)