Who is the manufacturer of OT EQUATOR?

Rhein'83 Srl filed the 510(k) submission for OT EQUATOR (K171409).

What is the FDA product code for OT EQUATOR?

NHA. It is classified under 21 CFR 872.3630 as a Class 2 device in the Dental panel.

What is the regulatory pathway for OT EQUATOR?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like OT EQUATOR?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

OT EQUATOR

K171409 · Rhein'83 Srl · NHA · Apr 9, 2018 · Dental

Device Facts

Record ID	K171409
Device Name	OT EQUATOR
Applicant	Rhein'83 Srl
Product Code	NHA · Dental
Decision Date	Apr 9, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3630
Device Class	Class 2
Attributes	Therapeutic

Intended 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; functions as a retentive component for complete or partial overdentures. Device consists of a semispherical head, base, and screw; manufactured from Ti-6Al-4V titanium with TiN (nitride) coating on the head. Used in dental clinics; operated by dentists or dental technicians. Abutment is screwed into an endosseous implant in the mandible or maxilla; provides a passive interface for removable prostheses. The system includes interchangeable retentive caps (Rilsan, Pebax, Kepital) and stainless steel housings. By providing a stable, passive connection, the device allows for secure retention of dentures, improving patient comfort and prosthetic function. Device is provided non-sterile and requires sterilization before use.

Clinical Evidence

Bench testing only. No clinical data provided. Equivalence established via reverse engineering analysis of implant interfaces using stereo microscopy and calibrated gauges to verify dimensional compatibility with the listed implant systems.

Technological Characteristics

Materials: Titanium Ti-6Al-4V (ASTM F-136), Stainless Steel AISI303, Rilsan, Pebax, Kepital. Surface: TiN coating on abutment head. Form factor: Semispherical head abutment with cuff heights 1-7mm. Sterilization: Steam sterilization (ISO 17664, ISO 11737-1/-2). Connectivity: Mechanical interface to endosseous implants.

Indications for Use

Indicated for use as an endosseous dental implant retentive component to retain complete or partial dentures in the mandible or maxilla. Compatible with specific implant systems from manufacturers including Nobel Biocare, Straumann, Zimmer, Astra Tech, Dentsply, Biomet 3i, Implant Direct, Neodent, MIS, Megagen, Neoss, Biohorizons, Keystone, TRI Dental, Altatec, and Dentis.

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

OT Equator (K142211)

Reference Devices

OT Equator (K160382)

Related Devices

K160382 — OT EQUATOR · Rhein'83 Srl · Aug 11, 2016
K142211 — OT EQUATOR · Rhein'83 Srl · Nov 25, 2015
K193046 — Straumann® Retentive System Novaloc TiN Abutments · Institut Straumann AG · Aug 13, 2020
K231874 — AOT & T-L Abutment · Truabutment, Inc. · Oct 30, 2023
K241183 — ISO Abutment · Seum Medi Co., Ltd. · Jul 28, 2025

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ ## 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." {3}------------------------------------------------ #### 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. | Implant Manufacturer | Implant Family Name | Implant Name | Implant Diameter (mm) | |------------------------------------------------------|------------------------------------------------------------------------------------------------------|---------------------------------------------------------|-----------------------------------| | NOBEL BIOCARE AB | NobelActive | NobelActive NP | 3.5 | | NOBEL BIOCARE AB | NobelActive | NobelActive RP | 4.3 and 5 | | NOBEL BIOCARE USA LLC | Nobelreplace Tapered Conical Connection | Replace Select TC NP | 3.5 | | NOBEL BIOCARE UAS INC | Replace Tiunite Endosseous Implant | Replace Select Straight TiUnit RP | 4.3 | | NOBEL BIOCARE UAS INC | Replace Tiunite Endosseous Implant | Replace Select Straight TiUnit WP | 5 | | NOBEL BIOCARE AB | Various Branemark System Implants-Immediate Function Indication | Brånemark System Mk III TiUnite NP | 3.3 | | NOBEL BIOCARE AB | Various Branemark System Implants-Immediate Function Indication | Brånemark System Mk III Shorty RP | 4.1 | | NOBEL BIOCARE AB | Various Branemark System Implants-Immediate Function Indication | Brånemark System Mk III TiUnite WP | 5 and 6 | | STRAUMANN USA | Straumann Bone Level Tapered Implant | Bone level NC | 3.3 | | STRAUMANN USA | Straumann Bone Level Tapered Implant | Bone level RC | 4.1 and 4.8 | | STRAUMANN USA | ITI Dental Implant System (Tissue Level Titanium Implants) | Tissue level RN | 4.8 | | STRAUMANN USA | ITI Dental Implant System (Tissue Level Titanium Implants) | Tissue level WN | 6.5 | | ZIMMER DENTAL INC. | Tapered Screw-Vent Implant System | Tapered Screw-Vent | 3.5, 4.5 and 5.7 | | ZIMMER DENTAL INC | 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 | | DENTSPLY INTERNATIONAL, INC. | Ankylos C/X Dental Implant System | Ankylos C/ | 3.5 | | DENTSPLY INTERNATIONAL, INC. | Frialit Plus, Xive S Plus, Xive Tg Plus, Ankylos Plus, Dental Implant Systems | Frialit plus Stepped Screw | 3.4, 3.8, 4.5, 5.5 and 6.5 | | BIOMET 3i | Full OSSEOTITE® Certain® II Dental Implant | Certain | 3.25, 4.1, 5 and 6 | | Implant Manufacturer | 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 DIRECT SYBRON MANUFACTURING LLC | Interactive/ Swishplus2 Implant 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 and 5 | | NEODENT USA, INC. | Neodent Implant System | CM Drive | 3.5, 3.75, 4, 4.3 and 5 | | MIS - IMPLANT TECHNOLOGIES LTD. | Seven Implants; Biocom Implants; Lance Implants | Seven | 3.3, 3.75, 4.2, 5 and 6 | | MIS - IMPLANT TECHNOLOGIES LTD. | Conical Connection Implants | C1 | 3.3, 3.75, 3.9, 4.2, 4.3 and 5 | | MEGAGEN CO., LTD. | Anyridge Internal Implant System | Anyridge | 3.5, 4, 4.5, 5 and 5.5 | | NEOSS, LTD. | Neoss Proactive Implant | ProActive | 3.5, 4, 4.5, 5, 5.5 and 6 | | BIOHORIZONS IMPLANT SYSTEMS, INC. | Biohorizons Laser-Lok 3.0 Implant System | Laser-lok® | 3.0 | | BIOHORIZONS IMPLANT SYSTEMS, INC. | Biohorizons Tapered Internal Implant System | Tapered internal | 3.5, 4.5 and 5.7 | | KEYSTONE DENTAL INC. / LIFECORE BIOMEDICAL INC | Primaconnex Internal Connection Implant System, Primaconnex Internal Connection Prosthetics | Primaconnex Internal Connection Implant System SD | 3.5 | | KEYSTONE DENTAL INC. / LIFECORE BIOMEDICAL INC | Primaconnex Internal Connection Implant System, Primaconnex Internal Connection Prosthetics | Primaconnex Internal Connection Implant System RD | 4.1 | | KEYSTONE DENTAL INC. / LIFECORE BIOMEDICAL INC | Primaconnex Internal Connection Implant System, Primaconnex Internal Connection Prosthetics | Primaconnex Internal Connection Implant System WD | 5 | | TRI DENTAL IMPLANTS INT. AG | TRI® Dental Implant System | TRI Narrow | 3.3 | | TRI DENTAL IMPLANTS INT. AG | TRI® Dental Implant System | TRI Vent | 3.75, 4.1 and 4.7 | | TRI DENTAL IMPLANTS INT, AG | TRI® Dental Implant System | TRI OCTA | 3.75, 4.1 and 4.7 | | Implant Manufacturer | Implant Family Name | Implant Name | Implant Diameter (mm) | | ALTATEC GMBH | Camlog Implant System Modified Implants and Abutments | 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 System Common | i-Clean | 3.7 , 4.3 and 4.8 | | DENTIS CO. | OneQ-SL s-Clean Implant System s-Clean Tapered II RBM Implant System | 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 IMPLANTS MANUFACTURING GMBH | 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 and 6 | {4}------------------------------------------------ #### 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 {5}------------------------------------------------ #### 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 {6}------------------------------------------------ # 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 Abutment Class 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 and drawing | Part Number | Critical Dimensions | Material | |----------------------------------------------------------------------------------|-------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------| | OT EQUATOR ABUTMENT Image: OT EQUATOR ABUTMENT | 030 | HEAD DIAMETER: 2.5mm HEAD HEIGHT: 2.0 MM CUFF HEIGHT: From 1 to 7mm THREAD DIAMETER: Congruent with implant Threaded CONNECTIONS: 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 - VIOLET RETENTIVE CAP Image: OT EQUATOR - VIOLET RETENTIVE CAP | 140CEV | EXTERNAL Ø 3.8mm INTERNAL Ø 2.5mm | KEPITAL | | OT EQUATOR - WHITE RETENTIVE CAP Image: OT EQUATOR - WHITE RETENTIVE CAP | 140CET | EXTERNAL Ø 3.8mm INTERNAL Ø 2.5mm | RILSAN BMNO | | OT EQUATOR - PINK RETENTIVE CAP Image: OT EQUATOR - PINK RETENTIVE CAP | 140CER | EXTERNAL Ø 3.8mm INTERNAL Ø 2.5mm | RILSAN BMNO | | OT EQUATOR - YELLOW RETENTIVE CAP Image: OT EQUATOR - YELLOW RETENTIVE CAP | 140CEG | EXTERNAL Ø 3.8mm INTERNAL Ø 2.5mm | PEBAX | {8}------------------------------------------------ | Component name and drawing | Part Number | Critical Dimensions | Material | |------------------------------------------------------------------------------|-------------|---------------------|-------------------------| | STAINLESS STEEL HOUSING FOR CAP Image: 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: | Implant Manufacturer | Implant Family Name | Implant Name | Implant Diameter (mm) | |-----------------------------------------------------|------------------------------------------------------------------------------------------------------|------------------------------------------------------|-----------------------------------| | NOBEL BIOCARE AB | NobelActive | NobelActive NP | 3.5 | | NOBEL BIOCARE AB | NobelActive | NobelActive RP | 4.3 and 5 | | NOBEL BIOCARE USA LLC | Nobelreplace Tapered Conical Connection | Replace Select TC NP | 3.5 | | NOBEL BIOCARE UAS INC | Replace Tiunite Endosseous Implant | Replace Select Straight TiUnit RP | 4.3 | | NOBEL BIOCARE UAS INC | Replace Tiunite Endosseous Implant | Replace Select Straight TiUnit WP | 5 | | NOBEL BIOCARE AB | Various Branemark System Implants-Immediate Function Indication | Brånemark System Mk III TiUnite NP | 3.3 | | NOBEL BIOCARE AB | Various Branemark System Implants-Immediate Function Indication | Brånemark System Mk III Shorty RP | 4.1 | | NOBEL BIOCARE AB | Various Branemark System Implants-Immediate Function Indication | Brånemark System Mk III TiUnite WP | 5 and 6 | | STRAUMANN USA | Straumann Bone Level Tapered Implant | Bone level NC | 3.3 | | STRAUMANN USA | Straumann Bone Level Tapered Implant | Bone level RC | 4.1 and 4.8 | | STRAUMANN USA | ITI Dental Implant System (Tissue Level Titanium Implants) | Tissue level RN | 4.8 | | STRAUMANN USA | ITI Dental Implant System (Tissue Level Titanium Implants) | Tissue level WN | 6.5 | | ZIMMER DENTALINC. | Tapered Screw-Vent Implant System | 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 | | DENTSPLY INTERNATIONAL, INC. | Ankylos C/X Dental Implant System | Ankylos C/ | 3.5 | | DENTSPLY INTERNATIONAL, INC. | Frialit Plus, Xive S Plus, Xive Tg Plus, Ankylos Plus, Dental Implant Systems | Frialit plus Stepped Screw | 3.4, 3.8, 4.5, 5.5 and 6.5 | | BIOMET 3i | Full OSSEOTITE® Certain® II Dental 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 DIRECT SYBRON MANUFACTURING LLC | Interactive/ Swishplus2 Implant 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 and 5 | | NEODENT USA, INC. | Neodent Implant System | CM Drive | 3.5, 3.75, 4, 4.3 and 5 | | MIS - IMPLANT TECHNOLOGIES LTD. | Seven Implants; Biocom Implants; Lance Implants | Seven | 3.3, 3.75, 4.2, 5 and 6 | | MIS - IMPLANT TECHNOLOGIES LTD. | Conical Connection Implants | C1 | 3.3, 3.75, 3.9, 4.2, 4.3 and 5 | | MEGAGEN CO., LTD. | Anyridge Internal Implant System | Anyridge | 3.5, 4, 4.5, 5 and 5.5 | | NEOSS, LTD. | Neoss Proactive Implant | ProActive | 3.5, 4, 4.5, 5, 5.5 and 6 | | BIOHORIZONS IMPLANT SYSTEMS, INC. | Biohorizons Laser-Lok 3.0 Implant System | Laser-lok® | 3.0 | | BIOHORIZONS IMPLANT SYSTEMS, INC. | Biohorizons Tapered Internal Implant System | Tapered internal | 3.5, 4.5 and 5.7 | | KEYSTONE DENTAL INC. / LIFECORE BIOMEDICALINC | Primaconnex Internal Connection Implant System, Primaconnex Internal Connection Prosthetics | Primaconnex Internal Connection Implant System SD | 3.5 | | KEYSTONE DENTAL INC. / LIFECORE BIOMEDICALINC | Primaconnex Internal Connection Implant System, Primaconnex Internal Connection Prosthetics | Primaconnex Internal Connection Implant System RD | 4.1 | | KEYSTONE DENTAL INC. / LIFECORE BIOMEDICALINC | Primaconnex Internal Connection Implant System, Primaconnex Internal Connection Prosthetics | Primaconnex Internal Connection Implant System WD | 5 | | TRI DENTAL IMPLANTS INT. AG | TRI® Dental Implant System | TRI Narrow | 3.3 | | TRI DENTAL IMPLANTS INT. AG | TRI® Dental Implant System | TRI Vent | 3.75, 4.1 and 4.7 | | TRI DENTAL IMPLANTS INT. AG | TRI® Dental Implant System | TRI OCTA | 3.75, 4.1 and 4.7 | | ALTATEC GMBH | Camlog Implant System Modified Implants and Abutments | 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 System Common | i-Clean | 3.7, 4.3 and 4.8 | | DENTIS CO. | OneQ-SL s-Clean Implant System s-Clean Tapered II RBM Implant System | 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 IMPLANTS MANUFACTURING GMBH | 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 and 6 | {9}------------------------------------------------ {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 | | Classification name | ENDOSSEOUS DENTALIMPLANT ABUTMENT | ENDOSSEOUS DENTALIMPLANT ABUTMENT | ENDOSSEOUS DENTALIMPLANT ABUTMENT | | | Class II (special controls) | Class II (special controls) | Class II (special controls) | | Indications For Use / Intended Use | The OT Equator is designed as an endosseous dental implant retentive component used to retain a complete or partial denture. The OT Equator isscrewed into an endosseousimplant in the mandible or maxilla. (contains a list of compatible implant bodies) | 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. (contains a list of compatible implant bodies) | The OT Equator is designed as an endosseous dental implant retentive componentused to retain a complete or partial denture. The OT Equator is screwed into an endosseous implant in the mandible or maxilla. (contains a list of compatible implant bodies) | | Intended Users | Adequately trained dental technicians and dentists. | Adequately trained dental technicians and dentists. | Adequately trained dental technicians and 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 | | Platform Diameter | According to the compatible implant (see table above) | According to the compatible implant | According to the compatible implant | | Surface treatment | TiN coating only for the head part of the abutment | TiN coating only for the head part of the abutment | TiN coating only for the head part of the 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 kit contains: Ot Equator Profile abutment, Stainless Steel Housing, retentive caps, protective disk | OT EQUATOR PROFILE kit contains: Ot Equator Profile abutment, stainless steel housing , retentive caps, protective disk. | OT EQUATOR PROFILE kit contains: Ot Equator Profile abutment, stainless steel housing , retentive caps, protective disk | | Sterilization | Marketed non sterile, to be sterilized before insertion in patient's mouth. | Marketed non sterile, to be sterilized before insertion in patient's mouth. | Marketed non sterile, to be sterilized before insertion in patient's mouth. | | Reusable | No | No | No | {12}------------------------------------------------ ## 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.