OT EQUATOR

K142211 · Rhein'83 Srl · NHA · Nov 25, 2015 · Dental

Device Facts

• Record ID: K142211
• Device Name: OT EQUATOR
• Applicant: Rhein'83 Srl
• Product Code: NHA · Dental
• Decision Date: Nov 25, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2

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.

Device Story

OT Equator is an endosseous dental implant abutment system used to retain complete or partial dentures. The device consists of a titanium (Ti-6Al-4V) abutment with a semispherical head, a stainless steel housing, and elastic retentive caps (Kepital, Rilsan, Pebax). The abutment is screwed into a compatible dental implant; the semispherical head couples with a retentive cap housed within the patient's prosthesis. The system is used by dentists and dental technicians to provide a retentive interface for overdentures. By allowing the prosthesis to rest on the gingival arch, the device transfers chewing loads to the natural gum, reducing stress on the implant. The device is provided non-sterile and must be sterilized before use. It is intended for use with various specific implant systems listed in the documentation.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, including mechanical strength analysis (static and dynamic compression), fatigue testing per ISO 14801, and reverse engineering analysis to verify coupling precision with compatible implant systems.

Technological Characteristics

Materials: Titanium Grade 5 E.L.I. (ASTM F-136) with TiN coating on the head; stainless steel AISI303 housing; retentive caps in Kepital, Rilsan BMNO, and Pebax. Form factor: Abutment with threaded stem and semispherical head (2.5mm diameter, 2.0mm height). Connectivity: Mechanical coupling to dental implants. Sterilization: Steam sterilization (ISO 17664, ISO 11737-1/-2).

Indications for Use

Indicated for patients requiring retention of complete or partial dentures via endosseous dental implants in the mandible or maxilla.

Regulatory Classification

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.

Special Controls

*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.)

Predicate Devices

• Sphero Flex (K033630)
• Sphero Block (K033630)
• Pivot Flex (K033630)
• Quick Coupling For Dental Prostheses (K950260)

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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 Conical<br>Connection | Replace Select TC NP | 3.5 |
| NOBEL BIOCARE USA INC | Replace Tiunite Endosseous<br>Implant | Replace Select Straight<br>TiUnit RP | 4.3 |
| NOBEL BIOCARE USA LLC | Replace Tiunite Endosseous<br>Implant | Replace Select Straight<br>TiUnit WP | 5 |
| NOBEL BIOCARE AB | Various Branemark System<br>Implants-Immediate Function<br>Indication | Brånemark System Mk III<br>TiUnite NP | 3.3 |
| NOBEL BIOCARE AB | Various Branemark System<br>Implants-Immediate Function<br>Indication | Brånemark System Mk III<br>Shorty RP | 4,1 |
| NOBEL BIOCARE AB | Various Branemark System<br>Implants-Immediate Function<br>Indication | Brånemark System Mk III<br>TiUnite WP | 5 |
| Straumann USA | Straumann Bone Level Tapered<br>Implant | Bone level NC | 3.3 |
| Straumann USA | Straumann Bone Level Tapered<br>Implant | Bone level RC | 4.1 - 4.8 |
| Straumann USA | ITI Dental Implant System<br>(Tissue Level<br>Titanium Implants) | Tissue level RN | 4,8 |
| Straumann USA | ITI Dental Implant System<br>(Tissue Level<br>Titanium Implants) | Tissue level WN | 6,5 |
| Zimmer Dental Inc. | Tapered Screw-Vent Implant<br>System | Tapered Screw-Vent | 3.5 |
| Zimmer Dental Inc. | Tapered Screw-Vent Implant<br>System | Tapered Screw-Vent | 4.5 |
| Zimmer Dental Inc. | Tapered Screw-Vent Implant<br>System | 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 IMPLANT<br>SYSTEM | ANKYLOS C/ | 3,5 |
| DENTSPLY INTERNATIONAL, INC. | Frialit Plus, Xive S Plus, Xive Tg<br>Plus, Ankylos Plus, Dental<br>Implant Systems | FRIALIT plus Stepped<br>Screw | 3.4 |
| DENTSPLY INTERNATIONAL, INC. | Frialit Plus, Xive S Plus, Xive Tg<br>Plus, Ankylos Plus, Dental<br>Implant Systems | FRIALIT plus Stepped<br>Screw | 3.8 |
| DENTSPLY INTERNATIONAL, INC. | Frialit Plus, Xive S Plus, Xive Tg<br>Plus, Ankylos Plus, Dental<br>Implant Systems | FRIALIT plus Stepped<br>Screw | 4.5 |
| DENTSPLY INTERNATIONAL, INC. | Frialit Plus, Xive S Plus, Xive Tg<br>Plus, Ankylos Plus, Dental<br>Implant Systems | FRIALIT plus Stepped<br>Screw | 5.5 |
| DENTSPLY INTERNATIONAL, INC. | Frialit Plus, Xive S Plus, Xive Tg<br>Plus, Ankylos Plus, Dental<br>Implant Systems | FRIALIT plus Stepped<br>Screw | 6.5 |
| BIOMET 3i | Full OSSEOTITE® Certain® II<br>Dental Implant | Certain | 3.25 |
| BIOMET 3i | Full OSSEOTITE® Certain® II<br>Dental Implant | Certain | 4.1 |
| BIOMET 3i | Full OSSEOTITE® Certain® II<br>Dental Implant | Certain | 5 |
| BIOMET 3i | Full OSSEOTITE® Certain® II<br>Dental 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 SYBRON<br>MANUFACTURING LLC | Interactive/ Swishplus2 Implant<br>System | Swish Plus | 3,7 |
| IMPLANT DIRECT SYBRON<br>MANUFACTURING LLC | Interactive/ Swishplus2 Implant<br>System | 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: | [phone] |
| Company Fax: | [phone] |
| Company e-mail | [e-mail] |
| 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 Abutment<br>Class 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 name<br>and drawing | Part Number | Critical Dimensions | Material |
|----------------------------------------------------------------------------------|-------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| OT EQUATOR<br>ABUTMENT<br>Image: OT EQUATOR ABUTMENT | 130 | HEAD DIAMETER: 2.5mm<br><br>HEAD HEIGHT: 2.0 MM<br><br>CUFF HEIGHT: From 1 to 7mm<br><br>THREAD DIAMETER:<br>Congruent with implant threaded<br><br>CONNETIONS: Different implant platforms | TITANIUM Medical Grade 5 E.L.I. (Ti6AL4V)<br><br>Surface treatment:<br>TiN coating (Nitride)<br><br>ONLY IN THE HEAD OF THE ABUTMENT |
| OT EQUATOR – VIOLET<br>RETENTIVE CAP<br>Image: OT EQUATOR – VIOLET RETENTIVE CAP | 140CEV | EXTERNAL Ø 3.8mm<br><br>INTERNAL Ø 2.5mm | KEPITAL |
| OT EQUATOR – WHITE<br>RETENTIVE CAP<br>Image: OT EQUATOR – WHITE RETENTIVE CAP | 140CET | EXTERNAL Ø 3.8mm<br><br>INTERNAL Ø 2.5mm | RILSAN BMNO |
| OT EQUATOR – PINK<br>RETENTIVE CAP<br>Image: OT EQUATOR – PINK RETENTIVE CAP | 140CER | EXTERNAL Ø 3.8mm<br><br>INTERNAL Ø 2.5mm | RILSAN BMNO |
| Component name<br>and drawing | Part Number | Critical Dimensions | Material |
| OT EQUATOR<br>YELLOW<br>RETENTIVE CAP<br>Image: Yellow cap | 140CEG | EXTERNAL Ø 3.8mm<br>INTERNAL Ø 2.5mm | PEBAX |
| OT EQUATOR<br>HOUSING FOR<br>CAP<br>Image: 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 Tapered<br>Conical Connection | Replace Select TC NP | 3.5 |
| NOBEL BIOCARE USA INC | Replace Tiunite<br>Endosseous Implant | Replace Select<br>Straight TiUnit RP | 4.3 |
| NOBEL BIOCARE USA LLC | Replace Tiunite<br>Endosseous Implant | Replace Select<br>Straight TiUnit WP | 5 |
| NOBEL BIOCARE AB | Various Branemark<br>System Implants-<br>Immediate Function<br>Indication | Brånemark System<br>Mk III TiUnite NP | 3.3 |
| NOBEL BIOCARE AB | Various Branemark<br>System Implants-<br>Immediate Function<br>Indication | Brånemark System<br>Mk 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 Level<br>Tapered Implant | Bone level NC | 3.3 |
| Straumann USA | Tapered Implant | Bone level RC | 4.1 - 4.8 |
| Straumann USA | ITI Dental Implant System<br>(Tissue Level | Tissue level RN | 4,8 |
| Straumann USA | (Tissue Level<br>Titanium Implants) | Tissue level WN | 6,5 |
| Zimmer Dental Inc. | Tapered Screw-Vent<br>Implant System | Tapered Screw-Vent | 3.5 |
| Zimmer Dental Inc. | Implant System | | 4.5 |
| Zimmer Dental Inc. | | | 5.7 |
| Zimmer Dental Inc. | Spline Dental Implant<br>System | Spline | 3.25 |
| Zimmer Dental Inc. | System | | 3.75 - 4 |
| Zimmer Dental Inc. | | | 5 |
| ASTRA TECH AB | Astra Tech Implant<br>System | OsseoSpeed™ TX | 3.5-4 |
| ASTRA TECH AB | System | | 4.5-5 |
| DENTSPLY INTL., INC. | ANKYLOS C/X DENTAL<br>IMPLANT SYSTEM | ANKYLOS C/ | 3,5 |
| DENTSPLY<br>INTERNATIONAL, INC. | Frialit Plus, Xive S Plus,<br>Xive Tg Plus, Ankylos Plus,<br>Dental Implant Systems | FRIALIT plus Stepped<br>Screw | 3.4 |
| DENTSPLY<br>INTERNATIONAL, INC. | Dental Implant Systems | Screw | 3.8 |
| DENTSPLY<br>INTERNATIONAL, INC. | | | 4.5 |
| DENTSPLY<br>INTERNATIONAL, INC. | | | 5.5 |
| DENTSPLY<br>INTERNATIONAL, INC. | | | 6.5 |
| BIOMET 3i | Full OSSEOTITE® Certain®<br>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 Implant<br>System | 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 SYBRON<br>MANUFACTURING LLC | Interactive/ Swishplus2<br>Implant System | Swish Plus | 3,7 |
| IMPLANT DIRECT SYBRON<br>MANUFACTURING 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

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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<br>(Submitted Product) | LEGALLY MARKETED<br>PREDICATE DEVICES OF |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K number | n.a. | K950260 |
| | | K950261 |
| | | K033630 |
| Proprietary / Trade Name | OT EQUATOR | SPHERO FLEX-SPHERO<br>BLOCK |
| CFR Section | 872.3630 | 872.3640 |
| Pro-code | NHA | DZE |
| Classification name | Endosseous dental implant<br>Abutment<br>Class II (special controls) | Endosseous dental implant |
| Indications For Use / Intended<br>Use | The OT Equator is designed as an<br>endosseous dental implant<br>retentive component used to<br>retain a complete or partial<br>denture. The OT Equator is<br>screwed into an endosseous<br>implant in the mandible or maxilla. | The Sphero Block Implant Anchors<br>abutments for endosseous dentam<br>implants are appropriate for use<br>with overdentures or partial<br>retained in whole or in part by<br>endosseous implants in the<br>mandibular or maxilla. |
| Intended Users | Adequately trained dental<br>technicians and dentists. | Adequately trained dental<br>technicians and dentists. |
| Material | Titanium 6Al-4V | Titanium 6Al-4V |
| Material (Male socket) | Rilsan, Pebax, Kepital | Rilsan, Pebax, Kepital |
| Platform Diameter | According to the compatible<br>implant | According to the compatible<br>implant |
| Surface treatment | TiN coating only for the<br>head part of the abutment | TiN coating only for the<br>head part of the abutment |
| Cuff Width | 1mm – 2mm<br>- 3mm – 4mm - 5mm - | 1mm – 2mm<br>- 3mm – 4mm - 5mm - |
| | 6mm- 7mm | 6mm- 7mm |
| Height | 2 mm | 2.8 mm - 3.4 mm |
| Sterilization | Marketed non sterile, to be<br>sterilized before insertion in<br>patient's mouth. | Marketed non sterile, to be<br>sterilized before insertion in<br>patient'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.