(470 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 implant systems listed in Attachment B.
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.
OT Equator technology represents a prosthetic abutment solution for "overdenture". The sphere 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 prosthetic restoration.
The OT Equator overdenture system is comprised of a semispherical head, a base, and a screw.
The approval of the OT Equator device is based on demonstrating substantial equivalence to predicate devices rather than meeting specific performance acceptance criteria from a standalone study. Therefore, the information provided does not contain a table of acceptance criteria and reported device performance in the traditional sense, nor details of a study directly designed to prove the device meets such criteria.
Instead, the submission focuses on non-clinical tests (biocompatibility, mechanical strength, fatigue, sterilization validation, and reverse engineering analysis) to show that the OT Equator is as safe and effective as its predicate devices, despite minor dimensional differences.
Here's an breakdown of the provided information relative to your request:
1. Table of Acceptance Criteria and Reported Device Performance
As mentioned, there isn't a table of acceptance criteria with corresponding performance metrics like sensitivity/specificity for this type of device (an endosseous dental implant abutment). The regulatory approval is based on demonstrating substantial equivalence. The "performance" is implicitly demonstrated through non-clinical testing that aligns with relevant standards and shows comparable structural integrity and biocompatibility to the predicate device.
"Performance" as demonstrated by Non-Clinical Tests (Implicit Acceptance):
| Test Category | Implicit "Acceptance Criteria" (Substantial Equivalence) | Reported Device Performance (Summary) |
|---|---|---|
| Biocompatibility | Materials are identical to the predicate device, conform to FDA recognized standards (e.g., ASTM F-136), and are manufactured using the same process as the predicate. | All materials, including the TiN coating, are identical to the predicate (Sphero-Block, K033630). Conforms to ASTM F-136. No additional biocompatibility testing was conducted as current materials are considered substantially equivalent. |
| Mechanical Strength | Product demonstrates adequate strength, meeting design requirements and demonstrating substantial equivalence to declared predicate devices when tested against FDA Guidance and ISO 14801. | Compression tests (static and dynamic) were performed to check various connections. Results demonstrate substantial equivalence performance to declared predicate devices, adhering to FDA Guidance Document: "Root-form Endosseous Dental Implants and Endosseous Dental Abutments, 2004" and ISO 14801 standard, "Dentistry- implants- dynamic Fatigue Test For Endosseous Dental Implants." |
| Fatigue | Product demonstrates substantial equivalence performance to declared predicate devices according to ISO 14801. | Fatigue tests were performed according to ISO 14801 on OT Equator models, using the smallest compatible implant as the worst-case scenario. Test results provide evidence of substantial equivalence performance compared to the predicate devices. |
| Sterilization | Demonstrates a Sterility Assurance Level (SAL) of 10^-6 related to the abutments, in accordance with ISO 17664, ISO 11737-1, and ISO 11737-2. | Steam sterilization validation test was conducted according to ISO 17664, ISO 11737-1, and ISO 11737-2. The test demonstrated an SAL of 10^-6 for the OT Equator abutments. The device is marketed non-sterile and requires sterilization before insertion. |
| Reverse Engineering | Abutment can be perfectly coupled with related compatible implants, with features critical to fit, dimensions, and tolerances identified and confirmed. | Reverse engineering analysis was conducted on OEM implant systems (statistically significant number). Implant dimensions, threaded hole dimensions, tolerances, and maximum depth were detected using stereo microscopes, calibrated plugs, "go/no go" threaded gauges, and profile projectors. Report included critical features, dimensions, tolerances, and CAD images showing assembled devices and interface gaps. Analysis demonstrated compatibility of the abutment to identified dental implant bodies. |
2. Sample Size Used for the Test Set and Data Provenance
- Biocompatibility: No specific sample size mentioned as no new testing was performed. Reliance on predicate device's prior clearance and material standards.
- Mechanical Strength & Fatigue: The document states "the smallest compatible implant was chosen as worst case" for fatigue testing, and compression tests were run on "various connections." For reverse engineering analysis, "tests were conducted on a statistically significant number of OEM implant systems." Specific numerical sample sizes are not provided for these tests.
- Sterilization Validation: No specific sample size mentioned. Standard validation protocols (ISO 17664, ISO 11737-1/-2) would imply a predetermined sample size based on the specific sterilization method and validation plan.
- Data Provenance: The document does not specify country of origin for the test data, nor whether the tests were retrospective or prospective. It is implied these were prospective tests conducted specifically for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of device does not typically involve "ground truth" derived from expert consensus in the clinical sense (e.g., radiologist reads of images). The "ground truth" for non-clinical engineering tests is established by adherence to recognized standards and objective measurements. Experts involved would be engineering and material science professionals carrying out the laboratory tests. Their specific numbers and qualifications are not detailed in this submission.
4. Adjudication Method for the Test Set
Not applicable for this type of non-clinical device testing. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or image interpretation scenarios for consensus on diagnoses.
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. The OT Equator is a physical dental implant abutment, not an AI-powered diagnostic device or software. Therefore, MRMC studies and AI assistance metrics are irrelevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. As a physical medical device, the concept of "standalone algorithm only" performance does not apply.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests is based on:
- Material Standards: Conformance to ASTM Standard F-136 for titanium.
- Mechanical Testing Standards: Adherence to FDA Guidance Document: "Root-form Endosseous Dental Implants and Endosseous Dental Abutments, 2004" and ISO 14801 standard for dynamic fatigue.
- Sterilization Standards: Conformance to ISO 17664 and ISO 11737-1/-2.
- Objective Engineering Measurements: Dimensions, tolerances, and fit confirmed through various calibrated instruments during reverse engineering analysis.
8. The Sample Size for the Training Set
Not applicable. This device is a physical product, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, arranged in a way that suggests depth and connection. The profiles are simple and abstract, with smooth lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 25, 2015
Rhein '83 Srl Ms. Claudia Nardi President Via Emilio Zago, 10/abc 40128 Bologna ITALY
Re: K142211
Trade/Device Name: OT EQUATOR Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: October 19, 2015 Received: October 26, 2015
Dear Ms. Nardi:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 898. In addition, FDA mav publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR
{1}------------------------------------------------
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Erin | Keith -S
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K142211
Device Name OT Equator
Indications for Use (Describe)
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 implant systems listed in Attachment B.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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| Manufacturer | Implant Family Name | Implant Name | Implant Diameter |
|---|---|---|---|
| NOBEL BIOCARE AB | NobelActive | NobelActive NP | 3.5 |
| NOBEL BIOCARE AB | NobelActive | NobelActive RP | 4,3 - 5 |
| NOBEL BIOCARE USA LLC | Nobelreplace Tapered ConicalConnection | Replace Select TC NP | 3.5 |
| NOBEL BIOCARE USA INC | Replace Tiunite EndosseousImplant | Replace Select StraightTiUnit RP | 4.3 |
| NOBEL BIOCARE USA LLC | Replace Tiunite EndosseousImplant | Replace Select StraightTiUnit WP | 5 |
| NOBEL BIOCARE AB | Various Branemark SystemImplants-Immediate FunctionIndication | Brånemark System Mk IIITiUnite NP | 3.3 |
| NOBEL BIOCARE AB | Various Branemark SystemImplants-Immediate FunctionIndication | Brånemark System Mk IIIShorty RP | 4,1 |
| NOBEL BIOCARE AB | Various Branemark SystemImplants-Immediate FunctionIndication | Brånemark System Mk IIITiUnite WP | 5 |
| Straumann USA | Straumann Bone Level TaperedImplant | Bone level NC | 3.3 |
| Straumann USA | Straumann Bone Level TaperedImplant | Bone level RC | 4.1 - 4.8 |
| Straumann USA | ITI Dental Implant System(Tissue LevelTitanium Implants) | Tissue level RN | 4,8 |
| Straumann USA | ITI Dental Implant System(Tissue LevelTitanium Implants) | Tissue level WN | 6,5 |
| Zimmer Dental Inc. | Tapered Screw-Vent ImplantSystem | Tapered Screw-Vent | 3.5 |
| Zimmer Dental Inc. | Tapered Screw-Vent ImplantSystem | Tapered Screw-Vent | 4.5 |
| Zimmer Dental Inc. | Tapered Screw-Vent ImplantSystem | Tapered Screw-Vent | 5.7 |
| Zimmer Dental Inc. | Spline Dental Implant System | Spline | 3.25 |
| Zimmer Dental Inc. | Spline Dental Implant System | Spline | 3.75 - 4 |
| Zimmer Dental Inc. | Spline Dental Implant System | Spline | 5 |
| ASTRA TECH AB | Astra Tech Implant System | OsseoSpeed™ TX | 3.5-4 |
| ASTRA TECH AB | Astra Tech Implant System | OsseoSpeed™ TX | 4.5-5 |
| DENTSPLY INTL., INC. | ANKYLOS C/X DENTAL IMPLANTSYSTEM | ANKYLOS C/ | 3,5 |
| DENTSPLY INTERNATIONAL, INC. | Frialit Plus, Xive S Plus, Xive TgPlus, Ankylos Plus, DentalImplant Systems | FRIALIT plus SteppedScrew | 3.4 |
| DENTSPLY INTERNATIONAL, INC. | Frialit Plus, Xive S Plus, Xive TgPlus, Ankylos Plus, DentalImplant Systems | FRIALIT plus SteppedScrew | 3.8 |
| DENTSPLY INTERNATIONAL, INC. | Frialit Plus, Xive S Plus, Xive TgPlus, Ankylos Plus, DentalImplant Systems | FRIALIT plus SteppedScrew | 4.5 |
| DENTSPLY INTERNATIONAL, INC. | Frialit Plus, Xive S Plus, Xive TgPlus, Ankylos Plus, DentalImplant Systems | FRIALIT plus SteppedScrew | 5.5 |
| DENTSPLY INTERNATIONAL, INC. | Frialit Plus, Xive S Plus, Xive TgPlus, Ankylos Plus, DentalImplant Systems | FRIALIT plus SteppedScrew | 6.5 |
| BIOMET 3i | Full OSSEOTITE® Certain® IIDental Implant | Certain | 3.25 |
| BIOMET 3i | Full OSSEOTITE® Certain® IIDental Implant | Certain | 4.1 |
| BIOMET 3i | Full OSSEOTITE® Certain® IIDental Implant | Certain | 5 |
| BIOMET 3i | Full OSSEOTITE® Certain® IIDental Implant | Certain | 6 |
| IMPLANT DIRECT LLC | Legacy Dental Implants | Legacy | 3 |
| IMPLANT DIRECT LLC | Legacy Dental Implants | Legacy | 3.75 |
| IMPLANT DIRECT LLC | Legacy Dental Implants | Legacy | 4.7 |
| IMPLANT DIRECT LLC | Reactive Dental Implant System | Tri-Lobe | 3.5 |
| IMPLANT DIRECT LLC | Reactive Dental Implant System | Tri-Lobe | 4.3 |
| IMPLANT DIRECT LLC | Reactive Dental Implant System | Tri-Lobe | 5 - 6 |
| IMPLANT DIRECT LLC | Replus Dental Implants | Tri-Lobe | 3.5 |
| IMPLANT DIRECT LLC | Replus Dental Implants | Tri-Lobe | 4.3 |
| IMPLANT DIRECT LLC | Replus Dental Implants | Tri-Lobe | 5 - 6 |
| IMPLANT DIRECT SYBRONMANUFACTURING LLC | Interactive/ Swishplus2 ImplantSystem | Swish Plus | 3,7 |
| IMPLANT DIRECT SYBRONMANUFACTURING LLC | Interactive/ Swishplus2 ImplantSystem | Swish Plus | 4.1 - 4.8 |
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Section 05 - 510(k) Summary
| Applicant: | Rhein'83 srl |
|---|---|
| Company Name: | Rhein'83 srl |
| Company Address: | via E. Zago 10/abc - 40128 Bologna - Italy |
| Company Phone: | +39 051244510 |
| Company Fax: | +39 051245238 |
| Company e-mail | info@rhein83.com |
| Official Contact for Correspondence: | Claudia Nardi - President Rhein'83 srl |
| Date Summary Prepared: | October 19, 2015 |
| DEVICE IDENTIFICATION | |
| Trade name: | OT EQUATOR |
| Generic/ Common Name: | Implant Abutment |
| Classification : | 21 CFR 872.3630 |
| Classification name: | Endosseous dental implant AbutmentClass II (special controls) |
| Product Code: | NHA |
| Panel: | Dental |
Predicate Devices
Primary Predicate : -Sphero Flex, Sphero Block, Pivot Flex (K033630)
Reference Predicates:
-
Quick Coupling For Dental Prostheses (K950260)
-
-Device For Providing Quick Coupling For Dental Prostheses (K950260)
DEVICE DESCRIPTION
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.
OT Equator technology represents a prosthetic abutment solution for "overdenture". The sphere 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 prosthetic restoration.
The OT Equator overdenture system is comprised of a semispherical head, a base, and a screw.
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The proposed device and the predicates SPHERO FLEX and SPHERO BLOCK (K950260 -K950261 - K033630) are equivalent in some specifications (the dimensions of the head between the predicate Sphero-Block and OT Equator differ slightly), and identical in other specifications as the interface connections between the abutments and the implant body, the materials, the manufacturing process, the technological characteristics and the Indications for Use.
The Titanium abutment has one side with a thread to secure the connection to a dental implant. On the other side there is a hemisphere that must be connected to the prosthesis.
The OT Equator varies from the predicate Sphero Block as follows: on the Sphero block the complete round sphere inclusive of the hexagon base is 3.4mm in height; the OT Equator does not contain a complete round sphere or a hexagon base, and it is 2mm in height. The diameter of the Sphero Block sphere and the OT Equator half-sphere is the same of 2.5 mm, they vary only in height.
The anchoring of the prosthesis to the attachments is ensured by the coupling precision between the retentive cap inserted in a steel housing and the spherical section of the upper part of the abutments. In order to enable this connection the following components have been made:
The METAL HOUSING is a stainless steel prefabricated device with proper internal dimensions able to host the OT EQUATOR retentive cap in order to secure a coupling between abutment/retentive cap as precise as possible.
The metal housing must be placed into the prosthesis, then a RETENTIVE CAP must be inserted into the metal housing, then the prosthesis must press on the abutments for the connection of the denture.
Retention caps are elastic elements that allow the union between the steel housing and the abutment by regulating the retention strength in a prosthetic project. The special internal design of the cap allows embracing the attachment's ball when it is snapped into the cap .
The retention caps are manufactured in different materials that give to the product different retention strength. They are also made in different color in order to permit to selection of the elastic properties of the material of which they are composed. The different colors allow distinguishing the different retention strength.
The subject device is provided with a threaded stem to be screwed into a dental implant. This component is coated with TiN in the upper part, where it must be connected with Retentive caps.
The OT Equator and the predicate Sphero-Block are identical in every way (materials, additives, manufacturing process and intended use) except the dimensions, in that the dimension of the head of the OT Equator is not a complete sphere but semi-sphere. The Indications for Use Statement for the subject abutment has been modified to add new compatible implant fixtures has compared to the predicate; however the new compatibility does not change the intended use as compared to the declared predicate.
The other components listed below are also different only in size (they must fit with the semisphere and a complete sphere). The tools are the same as used with the Sphero-Block.
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The part number, critical dimensions and materials for the OT Equator Abutment and accessories subject to this 510(k) are summarized below:
| Component nameand drawing | Part Number | Critical Dimensions | Material |
|---|---|---|---|
| OT EQUATORABUTMENTImage: OT EQUATOR ABUTMENT | 130 | HEAD DIAMETER: 2.5mmHEAD HEIGHT: 2.0 MMCUFF HEIGHT: From 1 to 7mmTHREAD DIAMETER:Congruent with implant threadedCONNETIONS: Different implant platforms | TITANIUM Medical Grade 5 E.L.I. (Ti6AL4V)Surface treatment:TiN coating (Nitride)ONLY IN THE HEAD OF THE ABUTMENT |
| OT EQUATOR – VIOLETRETENTIVE CAPImage: OT EQUATOR – VIOLET RETENTIVE CAP | 140CEV | EXTERNAL Ø 3.8mmINTERNAL Ø 2.5mm | KEPITAL |
| OT EQUATOR – WHITERETENTIVE CAPImage: OT EQUATOR – WHITE RETENTIVE CAP | 140CET | EXTERNAL Ø 3.8mmINTERNAL Ø 2.5mm | RILSAN BMNO |
| OT EQUATOR – PINKRETENTIVE CAPImage: OT EQUATOR – PINK RETENTIVE CAP | 140CER | EXTERNAL Ø 3.8mmINTERNAL Ø 2.5mm | RILSAN BMNO |
| Component nameand drawing | Part Number | Critical Dimensions | Material |
| OT EQUATORYELLOWRETENTIVE CAPImage: Yellow cap | 140CEG | EXTERNAL Ø 3.8mmINTERNAL Ø 2.5mm | PEBAX |
| OT EQUATORHOUSING FORCAPImage: Silver cap | 141CAE | INTERNAL Ø 3.84 | STAINLESS STEEL AISI303 |
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The only device and components for which clearance is requested in this 510(k) are identified above. All other components not identified below were cleared in the predicate Sphero-Block 510(k) submission.
The OT EQUATOR abutments are provided straight and do not contain any inherent angulation to provide an angle correction.
INTENDED USE /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.
The OT Equator abutments are indicated for use with the implant systems listed in the Table below:
| Manufacturer | Implant Family Name | Implant Name | Implant Diameter |
|---|---|---|---|
| NOBEL BIOCARE AB | NobelActive | NobelActive NP | 3.5 |
| NOBEL BIOCARE AB | NobelActive | NobelActive RP | 4,3 - 5 |
| NOBEL BIOCARE USA LLC | Nobelreplace TaperedConical Connection | Replace Select TC NP | 3.5 |
| NOBEL BIOCARE USA INC | Replace TiuniteEndosseous Implant | Replace SelectStraight TiUnit RP | 4.3 |
| NOBEL BIOCARE USA LLC | Replace TiuniteEndosseous Implant | Replace SelectStraight TiUnit WP | 5 |
| NOBEL BIOCARE AB | Various BranemarkSystem Implants-Immediate FunctionIndication | Brånemark SystemMk III TiUnite NP | 3.3 |
| NOBEL BIOCARE AB | Various BranemarkSystem Implants-Immediate FunctionIndication | Brånemark SystemMk III Shorty RP | 4,1 |
| Manufacturer | Implant Family Name | Implant Name | Implant Diameter |
| Brånemark System | 5 | ||
| Mk III TiUnite WP | 6 | ||
| Straumann USA | Straumann Bone LevelTapered Implant | Bone level NC | 3.3 |
| Straumann USA | Tapered Implant | Bone level RC | 4.1 - 4.8 |
| Straumann USA | ITI Dental Implant System(Tissue Level | Tissue level RN | 4,8 |
| Straumann USA | (Tissue LevelTitanium Implants) | Tissue level WN | 6,5 |
| Zimmer Dental Inc. | Tapered Screw-VentImplant System | Tapered Screw-Vent | 3.5 |
| Zimmer Dental Inc. | Implant System | 4.5 | |
| Zimmer Dental Inc. | 5.7 | ||
| Zimmer Dental Inc. | Spline Dental ImplantSystem | Spline | 3.25 |
| Zimmer Dental Inc. | System | 3.75 - 4 | |
| Zimmer Dental Inc. | 5 | ||
| ASTRA TECH AB | Astra Tech ImplantSystem | OsseoSpeed™ TX | 3.5-4 |
| ASTRA TECH AB | System | 4.5-5 | |
| DENTSPLY INTL., INC. | ANKYLOS C/X DENTALIMPLANT SYSTEM | ANKYLOS C/ | 3,5 |
| DENTSPLYINTERNATIONAL, INC. | Frialit Plus, Xive S Plus,Xive Tg Plus, Ankylos Plus,Dental Implant Systems | FRIALIT plus SteppedScrew | 3.4 |
| DENTSPLYINTERNATIONAL, INC. | Dental Implant Systems | Screw | 3.8 |
| DENTSPLYINTERNATIONAL, INC. | 4.5 | ||
| DENTSPLYINTERNATIONAL, INC. | 5.5 | ||
| DENTSPLYINTERNATIONAL, INC. | 6.5 | ||
| BIOMET 3i | Full OSSEOTITE® Certain®II Dental Implant | Certain | 3.25 |
| BIOMET 3i | II Dental Implant | 4.1 | |
| BIOMET 3i | 5 | ||
| BIOMET 3i | 6 | ||
| IMPLANT DIRECT LLC | Legacy Dental Implants | Legacy | 3 |
| IMPLANT DIRECT LLC | 3.75 | ||
| IMPLANT DIRECT LLC | 4.7 | ||
| IMPLANT DIRECT LLC | Reactive Dental ImplantSystem | Tri-Lobe | 3.5 |
| IMPLANT DIRECT LLC | System | 4.3 | |
| IMPLANT DIRECT LLC | 5 - 6 | ||
| IMPLANT DIRECT LLC | Replus Dental Implants | Tri-Lobe | 3.5 |
| IMPLANT DIRECT LLC | 4.3 | ||
| IMPLANT DIRECT LLC | 5 - 6 | ||
| IMPLANT DIRECT SYBRONMANUFACTURING LLC | Interactive/ Swishplus2Implant System | Swish Plus | 3,7 |
| IMPLANT DIRECT SYBRONMANUFACTURING LLC | Implant System | 4.1 - 4.8 |
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DISCUSSION OF NON CLINICAL TESTS
Biocompatibility
The materials are identical to the predicate, the Sphero-Block (K033630). All materials, including the coating for the OT EQUATOR Abutment, TiN (Nitride), are identical to the Sphero-Block and
{9}------------------------------------------------
components cleared in the predicate 510(k). Therefore, no biocompatibility testing was conducted for the subject OT EQUATOR based on the materials being identical to the predicate, conformance to an FDA recognized standard (i.e. ASTM F136), and all components being manufactured using the same process. No additional biocompatibility testing is needed for the determination of substantial equivalence.
Mechanical strength
In order to verify whether the final strength of the product meets the design requirements the mechanical strength was analyzed according both to FDA Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments, 2004 and ISO 14801 standard, Dentistry- implants- dynamic Fatigue Test For Endosseous Dental Implants.
Compression tests (static and dynamic) were run to check the various connections for adequate strength. The test results demonstrate that the products demonstrate substantial equivalence performance to the declared predicate devices.
Fatique
Fatigue tests were performed according to ISO 14801 on the OT Equator models. Also for this test the smallest compatible implant was chosen as worst case. Test results provide evidence that OT Equator demonstrates substantial equivalence performance as compared to the declared predicate devices.
Sterilization Validation
Steam sterilization validation test was conducted according to ISO 17664 and ISO 11737-1/-2 in order to demonstrate as SAL of 10-6 related to the OT Equator abutments.
Reverse engineering analysis
In order to ensure that the OT Equator abutment can be perfectly coupled with the related compatible implant a reverse engineering analysis was conducted,
The implant dimension were detected with a stereo microscope and with a wide range of calibrated plugs. The exact dimensions of the threaded holes and the related tolerance degree were detected with the "go/no go" threaded gauges. In the same way the maximum depth of the threaded hole was detected with the related threaded gauge, with the aid of the profile projector.
The tests were conducted on a statistically significant number of OEM implant systems, and the results were reported in a chart form.
Information provided, in the reverse engineering analysis report included identification of features critical to fit, dimensions, tolerances, and cross-sections CAD images showing the assembled devices, dimensions, and interface gaps. The analysis demonstrated the compatibility of the subject abutment to the identified dental implant body.
The results of nonclinical tests demonstrate that the device is equivalent to the predicate device.
SUBSTANTIAL EQUIVALENCE
The OT EQUATOR is same or similar in materials, design and intended use to the predicate devices. In further support of a substantial equivalence determination, hereunder is a comparison chart with the submitted device and the predicate devices.
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| Feature | Rhein83 OT Equator(Submitted Product) | LEGALLY MARKETEDPREDICATE DEVICES OF |
|---|---|---|
| K number | n.a. | K950260 |
| K950261 | ||
| K033630 | ||
| Proprietary / Trade Name | OT EQUATOR | SPHERO FLEX-SPHEROBLOCK |
| CFR Section | 872.3630 | 872.3640 |
| Pro-code | NHA | DZE |
| Classification name | Endosseous dental implantAbutmentClass II (special controls) | Endosseous dental implant |
| Indications For Use / IntendedUse | The OT Equator is designed as anendosseous dental implantretentive component used toretain a complete or partialdenture. The OT Equator isscrewed into an endosseousimplant in the mandible or maxilla. | The Sphero Block Implant Anchorsabutments for endosseous dentamimplants are appropriate for usewith overdentures or partialretained in whole or in part byendosseous implants in themandibular or maxilla. |
| Intended Users | Adequately trained dentaltechnicians and dentists. | Adequately trained dentaltechnicians and dentists. |
| Material | Titanium 6Al-4V | Titanium 6Al-4V |
| Material (Male socket) | Rilsan, Pebax, Kepital | Rilsan, Pebax, Kepital |
| Platform Diameter | According to the compatibleimplant | According to the compatibleimplant |
| Surface treatment | TiN coating only for thehead part of the abutment | TiN coating only for thehead part of the abutment |
| Cuff Width | 1mm – 2mm- 3mm – 4mm - 5mm - | 1mm – 2mm- 3mm – 4mm - 5mm - |
| 6mm- 7mm | 6mm- 7mm | |
| Height | 2 mm | 2.8 mm - 3.4 mm |
| Sterilization | Marketed non sterile, to besterilized before insertion inpatient's mouth. | Marketed non sterile, to besterilized before insertion inpatient's mouth. |
| Reusable | No | No |
Based on the available information, we conclude that the OT Equator is substantially equivalent to the existing legally marketed devices under Federal Food, Drug and Cosmetic Act. Therefore, the subject device is determined to be equivalent to the predicate device.
§ 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.)