(329 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: (list of compatible implant systems follows)
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 abutments are for straight use only and are recommended for placement on straight implant bodies with no divergence or need for angle corrections.
The OT Equator is manufactured of titanium Ti-6Al-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.
This document is a 510(k) Premarket Notification from the U.S. Food and Drug Administration (FDA) for the OT Equator dental implant abutment. It is a regulatory document and does not contain information about the acceptance criteria or study performance of an AI/ML device.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method for the test set
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study effect size
- Standalone performance
- Type of ground truth used
- Sample size for the training set
- How the ground truth for the training set was established
The document focuses on demonstrating substantial equivalence of the OT Equator device to previously cleared predicate devices based on materials, design, intended use, and manufacturing processes, rather than presenting a study related to an AI/ML device and its performance metrics. The non-clinical tests mentioned (biocompatibility, sterilization validation, reverse engineering analysis) are performed on the physical dental implant abutment and its interaction with implant systems, not on an AI system.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the words "U.S. Food & Drug Administration" on the right. The Department of Health & Human Services logo is a stylized representation of a human figure, while the FDA text is in a blue sans-serif font.
Rhein'83 SRL Claudia Nardi President Rhein'83 SRL Via E. Zago, 10/abc Bologna, 40128 ITALY
Re: K171409
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: March 6, 2018 Received: March 8, 2018
Dear Claudia 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 may publish further announcements concerning your device in the Federal Register.
April 9, 2018
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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 Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related 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.
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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Mary S. Runner -S
forTina Kiang, Ph.D. Acting 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)
K 171409 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 following implant systems:
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) CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
| ImplantManufacturer | Implant Family Name | Implant Name | ImplantDiameter (mm) |
|---|---|---|---|
| NOBEL BIOCARE AB | NobelActive | NobelActive NP | 3.5 |
| NOBEL BIOCARE AB | NobelActive | NobelActive RP | 4.3 and 5 |
| NOBEL BIOCARE USALLC | Nobelreplace Tapered ConicalConnection | Replace Select TC NP | 3.5 |
| NOBEL BIOCARE UASINC | Replace Tiunite EndosseousImplant | Replace Select Straight TiUnitRP | 4.3 |
| NOBEL BIOCARE UASINC | Replace Tiunite EndosseousImplant | Replace Select Straight TiUnitWP | 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 and 6 |
| STRAUMANN USA | Straumann Bone Level TaperedImplant | Bone level NC | 3.3 |
| STRAUMANN USA | Straumann Bone Level TaperedImplant | Bone level RC | 4.1 and 4.8 |
| STRAUMANN USA | ITI Dental Implant System(Tissue Level TitaniumImplants) | Tissue level RN | 4.8 |
| STRAUMANN USA | ITI Dental Implant System(Tissue Level TitaniumImplants) | Tissue level WN | 6.5 |
| ZIMMER DENTAL INC. | Tapered Screw-Vent ImplantSystem | Tapered Screw-Vent | 3.5, 4.5 and 5.7 |
| ZIMMER DENTAL INC | Spline Dental Implant System | Spline | 3.25, 3.75, 4 and5 |
| ASTRA TECH AB | Astra Tech Implant System | OsseoSpeed™ TX | 3.5, 4, 4.5 and 5 |
| DENTSPLYINTERNATIONAL, INC. | Ankylos C/X Dental ImplantSystem | Ankylos C/ | 3.5 |
| DENTSPLYINTERNATIONAL, INC. | Frialit Plus, Xive S Plus, Xive TgPlus, Ankylos Plus, DentalImplant Systems | Frialit plus Stepped Screw | 3.4, 3.8, 4.5, 5.5and 6.5 |
| BIOMET 3i | Full OSSEOTITE® Certain® IIDental Implant | Certain | 3.25, 4.1, 5 and 6 |
| ImplantManufacturer | Implant Family Name | Implant Name | Implant Diameter(mm) |
| IMPLANT DIRECT LLC | Legacy Dental Implants | Legacy | 3, 3.75 and 4.7 |
| IMPLANT DIRECT LLC | Reactive Dental Implant System | Tri-Lobe | 3.5, 4.3, 5 and 6 |
| IMPLANT DIRECT LLC | Replus Dental Implants | Tri-Lobe | 3.5, 4.3, 5 and 6 |
| IMPLANT DIRECTSYBRONMANUFACTURING LLC | Interactive/ Swishplus2Implant System | Swish Plus | 3.7, 4.1 and 4.8 |
| NEODENT USA, INC. | Neodent Implant System | CM Titamax | 3.5, 3.75, 4, 4.3 and5 |
| NEODENT USA, INC. | Neodent Implant System | CM Drive | 3.5, 3.75, 4, 4.3 and5 |
| MIS - IMPLANTTECHNOLOGIES LTD. | Seven Implants; BiocomImplants; Lance Implants | Seven | 3.3, 3.75, 4.2, 5 and6 |
| MIS - IMPLANTTECHNOLOGIES LTD. | Conical Connection Implants | C1 | 3.3, 3.75, 3.9, 4.2,4.3 and 5 |
| MEGAGEN CO., LTD. | Anyridge Internal ImplantSystem | Anyridge | 3.5, 4, 4.5, 5 and 5.5 |
| NEOSS, LTD. | Neoss Proactive Implant | ProActive | 3.5, 4, 4.5, 5, 5.5 and6 |
| BIOHORIZONS IMPLANTSYSTEMS, INC. | Biohorizons Laser-Lok 3.0Implant System | Laser-lok® | 3.0 |
| BIOHORIZONS IMPLANTSYSTEMS, INC. | Biohorizons Tapered InternalImplant System | Tapered internal | 3.5, 4.5 and 5.7 |
| KEYSTONE DENTAL INC./ LIFECOREBIOMEDICAL INC | Primaconnex InternalConnection Implant System,Primaconnex InternalConnection Prosthetics | Primaconnex InternalConnection Implant SystemSD | 3.5 |
| KEYSTONE DENTAL INC./ LIFECOREBIOMEDICAL INC | Primaconnex InternalConnection Implant System,Primaconnex InternalConnection Prosthetics | Primaconnex InternalConnection Implant SystemRD | 4.1 |
| KEYSTONE DENTAL INC./ LIFECOREBIOMEDICAL INC | Primaconnex InternalConnection Implant System,Primaconnex InternalConnection Prosthetics | Primaconnex InternalConnection Implant SystemWD | 5 |
| TRI DENTAL IMPLANTSINT. AG | TRI® Dental Implant System | TRI Narrow | 3.3 |
| TRI DENTAL IMPLANTSINT. AG | TRI® Dental Implant System | TRI Vent | 3.75, 4.1 and 4.7 |
| TRI DENTAL IMPLANTSINT, AG | TRI® Dental Implant System | TRI OCTA | 3.75, 4.1 and 4.7 |
| ImplantManufacturer | Implant Family Name | Implant Name | Implant Diameter(mm) |
| ALTATEC GMBH | Camlog Implant SystemModified Implants andAbutments | Camlog | 3.3 , 3.8 , 4.3 , 5 and 6 |
| ALTATEC GMBH | Conelog Implant System | Conelog | 3.3 , 3.8 , 4.3 and 5 |
| DENTIS CO. | Dentis Dental Implant System | i-Clean | 3.7 , 4.3 and 4.8 |
| DENTIS CO. | OneQ-SL Implant SystemCommon | i-Clean | 3.7 , 4.3 and 4.8 |
| DENTIS CO. | OneQ-SL s-Clean ImplantSystems-Clean Tapered II RBM ImplantSystem | s-clean | 3.7 , 4.3 and 4.8 |
| DENTIS CO. | Dentis Dental Implant System | e-Clean | 3.5 , 4.1 and 5.1 |
| DENTSPLY IMPLANTSMANUFACTURING GMBH | Astra Tech Implant System | OsseoSpeed Profile EV | 3 , 3.6 , 4.2 and 4.8 |
| MEGAGEN IMPLANT CO. | Anyone Internal ImplantSystem | Anyone | 3.6 , 4.0 , 4.5 , 5 and 6 |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
K 171409 Separate page
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
Indications for Use
K 171409 Separate page
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510(k) Summary
Applicant:
| 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 |
| Phone: | +39 051244510 |
| E-mail: | info@rhein83.com |
Date Summary Prepared:
April 4, 2018
DEVICE IDENTIFICATION
| Trade name: | OT EQUATOR |
|---|---|
| Generic/ Common Name: | Implant Abutment |
| Classification: | 21 CFR 872.3630 |
| Classification name: | Endosseous dental implant AbutmentClass II |
| Product Code: | NHA |
| Panel: | Dental |
PREDICATE DEVICES:
Primary predicate: K142211, OT Equator, Rhein'83 srl Reference device: K160382, OT Equator, Rhein'83 srl
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. 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
{7}------------------------------------------------
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 abutments are for straight use only and are recommended for placement on straight implant bodies with no divergence or need for angle corrections.
The OT Equator is manufactured of titanium Ti-6Al-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 part number, critical dimensions and materials for the OT Equator Abutment and accessories subject to this 510(k) are summarized below:
| Component name anddrawing | Part Number | Critical Dimensions | Material |
|---|---|---|---|
| OT EQUATOR ABUTMENTImage: OT EQUATOR ABUTMENT | 030 | HEAD DIAMETER: 2.5mmHEAD HEIGHT: 2.0 MMCUFF HEIGHT: From 1 to 7mmTHREAD DIAMETER:Congruent with implant ThreadedCONNECTIONS: Different implantplatforms | TITANIUM Medical Grade 5E.L.I. (Ti6AL4V)Surface treatment: TiNcoating (Nitride)ONLY IN THE HEAD OF THEABUTMENT |
| 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 |
| OT EQUATOR - YELLOWRETENTIVE CAPImage: OT EQUATOR - YELLOW RETENTIVE CAP | 140CEG | EXTERNAL Ø 3.8mmINTERNAL Ø 2.5mm | PEBAX |
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| Component name anddrawing | Part Number | Critical Dimensions | Material |
|---|---|---|---|
| STAINLESS STEELHOUSING FOR CAPImage: Stainless steel housing for cap | 141CAE | INTERNAL Ø 3.84 | STAINLESS STEEL AISI303 |
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 following implant systems:
| ImplantManufacturer | Implant Family Name | Implant Name | ImplantDiameter (mm) |
|---|---|---|---|
| NOBEL BIOCARE AB | NobelActive | NobelActive NP | 3.5 |
| NOBEL BIOCARE AB | NobelActive | NobelActive RP | 4.3 and 5 |
| NOBEL BIOCARE USALLC | Nobelreplace Tapered ConicalConnection | Replace Select TC NP | 3.5 |
| NOBEL BIOCARE UASINC | Replace Tiunite EndosseousImplant | Replace Select Straight TiUnitRP | 4.3 |
| NOBEL BIOCARE UASINC | Replace Tiunite EndosseousImplant | Replace Select Straight TiUnitWP | 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 and 6 |
| STRAUMANN USA | Straumann Bone Level TaperedImplant | Bone level NC | 3.3 |
| STRAUMANN USA | Straumann Bone Level TaperedImplant | Bone level RC | 4.1 and 4.8 |
| STRAUMANN USA | ITI Dental Implant System(Tissue Level TitaniumImplants) | Tissue level RN | 4.8 |
| STRAUMANN USA | ITI Dental Implant System(Tissue Level TitaniumImplants) | Tissue level WN | 6.5 |
| ZIMMER DENTALINC. | Tapered Screw-Vent ImplantSystem | Tapered Screw-Vent | 3.5, 4.5 and 5.7 |
| ZIMMER DENTALINC | Spline Dental Implant System | Spline | 3.25,3.75,4 and 5 |
| ASTRA TECH AB | Astra Tech Implant System | OsseoSpeed™ TX | 3.5 , 4 , 4.5 and 5 |
| DENTSPLYINTERNATIONAL, INC. | Ankylos C/X Dental ImplantSystem | Ankylos C/ | 3.5 |
| DENTSPLYINTERNATIONAL, INC. | Frialit Plus, Xive S Plus, Xive TgPlus, Ankylos Plus, DentalImplant Systems | Frialit plus Stepped Screw | 3.4, 3.8, 4.5, 5.5and 6.5 |
| BIOMET 3i | Full OSSEOTITE® Certain® IIDental Implant | Certain | 3.25, 4.1, 5 and 6 |
| IMPLANT DIRECT LLC | Legacy Dental Implants | Legacy | 3, 3.75 and 4.7 |
| IMPLANT DIRECT LLC | Reactive Dental Implant System | Tri-Lobe | 3.5, 4.3, 5 and 6 |
| IMPLANT DIRECT LLC | Replus Dental Implants | Tri-Lobe | 3.5, 4.3, 5 and 6 |
| IMPLANT DIRECTSYBRONMANUFACTURING LLC | Interactive/ Swishplus2Implant System | Swish Plus | 3.7, 4.1 and 4.8 |
| NEODENT USA, INC. | Neodent Implant System | CM Titamax | 3.5, 3.75, 4, 4.3and 5 |
| NEODENT USA, INC. | Neodent Implant System | CM Drive | 3.5, 3.75, 4, 4.3 and5 |
| MIS - IMPLANTTECHNOLOGIES LTD. | Seven Implants; BiocomImplants; Lance Implants | Seven | 3.3, 3.75, 4.2, 5 and6 |
| MIS - IMPLANTTECHNOLOGIES LTD. | Conical Connection Implants | C1 | 3.3, 3.75, 3.9, 4.2,4.3 and 5 |
| MEGAGEN CO., LTD. | Anyridge Internal ImplantSystem | Anyridge | 3.5, 4, 4.5, 5 and5.5 |
| NEOSS, LTD. | Neoss Proactive Implant | ProActive | 3.5, 4, 4.5, 5, 5.5and 6 |
| BIOHORIZONS IMPLANTSYSTEMS, INC. | Biohorizons Laser-Lok 3.0Implant System | Laser-lok® | 3.0 |
| BIOHORIZONS IMPLANTSYSTEMS, INC. | Biohorizons Tapered InternalImplant System | Tapered internal | 3.5, 4.5 and 5.7 |
| KEYSTONE DENTAL INC./ LIFECOREBIOMEDICALINC | Primaconnex InternalConnection Implant System,Primaconnex InternalConnection Prosthetics | Primaconnex InternalConnection Implant System SD | 3.5 |
| KEYSTONE DENTAL INC./ LIFECOREBIOMEDICALINC | Primaconnex InternalConnection Implant System,Primaconnex InternalConnection Prosthetics | Primaconnex InternalConnection Implant System RD | 4.1 |
| KEYSTONE DENTAL INC./ LIFECOREBIOMEDICALINC | Primaconnex InternalConnection Implant System,Primaconnex InternalConnection Prosthetics | Primaconnex InternalConnection Implant System WD | 5 |
| TRI DENTAL IMPLANTSINT. AG | TRI® Dental Implant System | TRI Narrow | 3.3 |
| TRI DENTAL IMPLANTSINT. AG | TRI® Dental Implant System | TRI Vent | 3.75, 4.1 and 4.7 |
| TRI DENTAL IMPLANTSINT. AG | TRI® Dental Implant System | TRI OCTA | 3.75, 4.1 and 4.7 |
| ALTATEC GMBH | Camlog Implant SystemModified Implants andAbutments | Camlog | 3.3, 3.8, 4.3, 5 and6 |
| ALTATEC GMBH | Conelog Implant System | Conelog | 3.3, 3.8, 4.3 and 5 |
| DENTIS CO. | Dentis Dental Implant System | i-Clean | 3.7, 4.3 and 4.8 |
| DENTIS CO. | OneQ-SL Implant SystemCommon | i-Clean | 3.7, 4.3 and 4.8 |
| DENTIS CO. | OneQ-SL s-Clean ImplantSystems-Clean Tapered II RBM ImplantSystem | s-clean | 3.7, 4.3 and 4.8 |
| DENTIS CO. | Dentis Dental Implant System | e-Clean | 3.5, 4.1 and 5.1 |
| DENTSPLY IMPLANTSMANUFACTURINGGMBH | Astra Tech Implant System | OsseoSpeed Profile EV | 3, 3.6, 4.2 and 4.8 |
| MEGAGEN IMPLANT CO. | Anyone Internal Implant System | Anyone | 3.6, 4.0, 4.5, 5 and6 |
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{10}------------------------------------------------
DISCUSSION OF NON CLINICAL TESTS
Biocompatibility
The submitted device, as the predicate devices already licensed (OT EQUATOR K142211 and K160382), is classified as permanent duration (> 30 days), mucosal membranes contacting device. The materials used to manufacture the submitted device are identical to the materials used for the identified predicate devices, the already licensed OT EQUATOR (K142211 and K160382). The materials used to manufacture the submitted device are identical to the materials used for the identified predicate devices and the same process is performed, including the TiN (Titanium Nitride) coating for the OT EQUATOR abutment; the modified surface of the abutment after the coating process is identical to the surface of the predicate devices. The type and duration of patient contact are the same as well.
Therefore, the results of the biocompatibility tests performed on the predicate devices OT EQUATOR apply also to the subject device and there was no need to perform new biocompatibility testing on the subject device OT EQUATOR. No additional biocompatibility testing is needed for the determination of substantial equivalence.
Sterilization Validation
Steam sterilization validation test, conducted on the predicate device OT EQUATOR (K142211) according to ISO 17664 and ISO 11737-1/-2 in order to demonstrate as SAL of 10-6 related to the OT Equator abutments, are considered still valid, since the materials and packing of the subject device are the same of the predicate.
Reverse engineering analysis
In order to ensure that the OT Equator abutment can be coupled with the related compatible implant a reverse engineering analysis was conducted on the submitted device, as for the predicate devices already licensed; 10 samples of OEM implant system were used in the reverse engineering analysis: 10 OEM implant bodies and 10 OEM screws were reversed as for the predicate and reference devices, and the results were reported in a chart form.
The implant dimensions were detected with a stereo microscope and with a wide range of calibrated plugs. The dimensions of the threaded holes and the related tolerance degree were detected with the "qo/no qo" 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.
{11}------------------------------------------------
The results of nonclinical tests demonstrate that the device is equivalent to the predicate devices.
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.
| Feature | Rhein83 OT Equator(Submitted Product) | PREDICATE DEVICE | REFERENCE DEVICE |
|---|---|---|---|
| K number | N.A. | K160382 | K142211 |
| Proprietary /Trade Name | OT EQUATOR | OT EQUATOR | OT EQUATOR |
| CFR Section | 872.3630 | 872.3630 | 872.3630 |
| Pro-code | NHA | NHA | NHA |
| Classificationname | ENDOSSEOUS DENTALIMPLANTABUTMENT | ENDOSSEOUS DENTALIMPLANTABUTMENT | ENDOSSEOUS DENTALIMPLANTABUTMENT |
| Class II (special controls) | Class II (special controls) | Class II (special controls) | |
| Indications ForUse / IntendedUse | The OT Equator is designed as anendosseous dental implant retentivecomponent used to retain acomplete or partial denture. The OTEquator isscrewed into anendosseousimplant in the mandibleor maxilla. (contains a list ofcompatible implant bodies) | The OT Equator is designed as anendosseous dental implant retentivecomponent used to retain a completeor partial denture. The OT Equator isscrewed into an endosseous implantin the mandible or maxilla. (containsa list of compatible implant bodies) | The OT Equator is designed as anendosseous dental implant retentivecomponentused to retain a completeor partial denture. The OT Equator isscrewed into an endosseous implantin the mandible or maxilla. (containsa list of compatible implant bodies) |
| Intended Users | Adequately trained dentaltechnicians and dentists. | Adequately trained dental techniciansand dentists. | Adequately trained dental techniciansand dentists. |
| Material | Titanium 6Al-4V | Titanium 6Al-4V | Titanium 6Al-4V |
| Material(Male socket) | Rilsan, Pebax, Kepital | Rilsan, Pebax, Kepital | Rilsan, Pebax, Kepital |
| Material(Housing) | Stainless Steel AISI303 | Stainless Steel AISI303 | Stainless Steel AISI303 |
| PlatformDiameter | According to the compatible implant(see table above) | According to the compatible implant | According to the compatible implant |
| Surfacetreatment | TiN coating only for the head part ofthe abutment | TiN coating only for the head part ofthe abutment | TiN coating only for the head part ofthe abutment |
| Cuff Width | 1 mm - 2mm - 3mm - 4mm -5mm -6mm - 7mm | 1 mm - 2mm - 3mm - 4mm -5mm -6mm – 7mm | 1mm - 2mm - 3mm - 4mm -5mm -6mm – 7mm |
| Height | 2 mm | 2 mm | 2 mm |
| Components | OT EQUATOR PROFILE kitcontains: Ot Equator Profileabutment, Stainless Steel Housing,retentive caps, protective disk | OT EQUATOR PROFILE kitcontains: Ot Equator Profileabutment, stainless steel housing ,retentive caps, protective disk. | OT EQUATOR PROFILE kit contains:Ot Equator Profile abutment, stainlesssteel housing , retentive caps,protective disk |
| Sterilization | Marketed non sterile, to be sterilizedbefore insertion in patient's mouth. | Marketed non sterile, to be sterilizedbefore insertion in patient's mouth. | Marketed non sterile, to be sterilizedbefore insertion in patient's mouth. |
| Reusable | No | No | No |
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COMPARISON OF TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE DISCUSSION:
The Indications for Use Statements shown above in the comparison chart a list of compatible implant bodies. The differences between the Indications for Use of the subject device and the primary predicate device is the addition of compatible implant bodies (Tri Dental Implants Int. AG, Altatec GMBH, Dentis Co., Dentsply Implants Manufacturing GMBH and Megagen Implant Co.).
As shown in the table above, the submitted device is substantial equivalent in all features: indications for use and intended users, materials, manufacturing process, cuff width, height, status, components.
The subject device varies from the predicate devices only for the list of compatible implant systems, thus the only difference is in the interface connections between the abutments and the compatible implant bodies, that have specific dimensions according to the compatible implant systems. As for the predicate devices, in order to ensure that the OT Equator abutment can be coupled with the related compatible implant a reverse engineering analysis was conducted on the submitted device.
There are no additional differences, thus it was concluded that the subject dental implant is substantially equivalent to the predicate devices.
CONCLUSIONS
Based on the available information, we conclude that the OT Equator is substantially equivalent to the existing legally marketed device under Federal Food, Drug and Cosmetic Act. Therefore, the subject device is determined to be equivalent to the predicate devices.
§ 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.)