Who is the manufacturer of OT EQUATOR?

Rhein'83 Srl filed the 510(k) submission for OT EQUATOR (K160382).

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

K160382 · Rhein'83 Srl · NHA · Aug 11, 2016 · Dental

Device Facts

Record ID	K160382
Device Name	OT EQUATOR
Applicant	Rhein'83 Srl
Product Code	NHA · Dental
Decision Date	Aug 11, 2016
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3630
Device Class	Class 2

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 system; functions as a retentive component for complete or partial dentures. Device consists of a semispherical head, base, and screw; manufactured from titanium (Ti-6Al-4V) with TiN coating on the head. Used in healthcare facilities/hospitals by dentists and dental technicians. The abutment is screwed into an existing endosseous implant; interchangeable retentive caps (various materials) and metal housings facilitate coupling with the removable prosthesis. The system allows the prosthesis to unload chewing forces onto the natural gum of the intra-oral arch, rendering the abutment passive. Benefits include secure retention of overdentures. Device is provided non-sterile and requires sterilization before use.

Clinical Evidence

Bench testing only. Biocompatibility data and steam sterilization validation (ISO 17664, ISO 11737-1/-2) were leveraged from the predicate device. Reverse engineering analysis using stereo microscopy, calibrated plugs, and "go/no go" threaded gauges confirmed dimensional compatibility with the specified implant systems.

Technological Characteristics

Materials: Titanium Ti-6Al-4V (ASTM F-136), Stainless Steel AISI303, Kepital, Rilsan BMNO, PEBAX. Surface treatment: TiN (Nitride) coating on abutment head. Form factor: Semispherical head, 2.5mm diameter, 2.0mm height, cuff heights 1-7mm. Connectivity: Mechanical screw-in interface for various dental implant platforms. Sterilization: Non-sterile, steam sterilizable. Software: None.

Indications for Use

Indicated for patients requiring retention of complete or partial dentures via endosseous dental implants in the mandible or maxilla. Compatible with specific implant systems from Nobel Biocare, Straumann, Zimmer, Astra Tech, Dentsply, Biomet 3i, Implant Direct, Sybron, MIS, Megagen, Neodent, Neoss, BioHorizons, and Keystone Dental.

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)

Related Devices

K171409 — OT EQUATOR · Rhein'83 Srl · Apr 9, 2018
K142211 — OT EQUATOR · Rhein'83 Srl · Nov 25, 2015
K231874 — AOT & T-L Abutment · Truabutment, Inc. · Oct 30, 2023
K241183 — ISO Abutment · Seum Medi Co., Ltd. · Jul 28, 2025
K193046 — Straumann® Retentive System Novaloc TiN Abutments · Institut Straumann AG · Aug 13, 2020

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image is a logo for the Department of Health & Human Services - USA. The logo is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an emblem that features a stylized representation of three human profiles facing to the right, with flowing lines beneath them that could represent water or fabric. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 August 11, 2016 Rhein'83 SRL Ms. Claudia Nardi President Rhein'83 SRL Via E. Zago 10/abc Bologna, 40128 ITALY Re: K160382 Trade/Device Name: OT EQUATOR Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: July 05, 2016 Received: July 11, 2016 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 may publish further announcements concerning your device in the Federal Register. {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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Image /page/1/Picture/8 description: The image shows a signature of Tina Kiang. The signature is written in black ink on a white background. The signature is illegible, but the name Tina Kiang is clearly visible. There is also a faint FDA logo in the background. Tina 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) K160382 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: NOBEL BIOCARE AB - NobelActive NP 3.5 NOBEL BIOCARE AB - NobelActive RP 4.3 - 5 NOBEL BIOCARE USA LLC - Replace Select TC NP 3.5 NOBEL BIOCARE USA INC - Replace Select Straight TiUnit RP 4.3 NOBEL BIOCARE USA LLC - Replace Select Straight TiUnit WP 5 NOBEL BIOCARE AB - Brânemark System Mk III TiUnite NP 3.3 NOBEL BIOCARE AB - Brånemark System Mk III Shorty RP 4,1 NOBEL BIOCARE AB - Brånemark System Mk III TiUnite WP5 6 Straumann USA - Bone level NC 3.3 Straumann USA - Bone level RC 4.1 - 4.8 Straumann USA - Tissue level RN 4,8 Straumann USA - Tissue level WN 6.5 Zimmer Dental Inc. - Tapered Screw-Vent 3.5. 4.5. 5.7 Zimmer Dental Inc. - Spline 3.25. 3.75 - 4, 5 ASTRA TECH AB - OsseoSpeed™ TX 3.5-4, 4.5-5 DENTSPLY INTL., INC. - ANKYLOS C/ 3,5 DENTSPLY INTERNATIONAL, INC. - FRIALIT plus Stepped Screw 3.4, 3.8, 4.5, 5.5, 6.5 BIOMET 3i - Certain 3.25, 4.1, 5, 6 IMPLANT DIRECT LLC - Legacy 3, 3.75, 4.7 IMPLANT DIRECT LLC - Tri-Lobe 3.5, 4.3, 5 - 6 IMPLANT DIRECT LLC - Tri-Lobe 3.5, 4.3, 5 - 6 IMPLANT DIRECT SYBRON MANUFACTURING LLC - Swish Plus3.7, 4.1 - 4.8 MIS - IMPLANT TECHNOLOGIES LTD. - SEVEN 3.3, 3.75, 4.2, 5, 6 MIS - IMPLANT TECHNOLOGIES LTD. - C1 3.3, 3.75, 3.9, 4.2, 4.3, 5 MEGAGEN CO., LTD. - ANYRIDGE 3.5, 4, 4.5, 5, 5.5 NEODENT USA, INC. - CM Titamax 3.5, 3.75, 4, 4.3, 5 NEODENT USA, INC. - CM Drive 3.5, 3.75, 4, 4.3, 5 NEOSS, LTD. - ProActive 3.5, 4, 4.5, 5, 5.5, 6 BIOHORIZONS IMPLANT SYSTEMS, INC. - Laser-lok® 3.0 BIOHORIZONS IMPLANT SYSTEMS, INC. - Tapered internal 3.5, 4.5, 5.7 KEYSTONE DENTAL, INC. / LIFECORE BIOMEDICAL, INC - PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM SD 3.5 KEYSTONE DENTAL, INC. / LIFECORE BIOMEDICAL, INC - PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM RD 4.1 KEYSTONE DENTAL, INC. / LIFECORE BIOMEDICAL, INC - PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM WD 5 Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 {3}------------------------------------------------ #### Type of Use (Select one or both, as applicable) > 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." {4}------------------------------------------------ # Section 05 - 510(k) Summary | Applicant: | | |------------|--| |------------|--| Company Name: Company Address: Company Phone: Company Fax: Company e-mail Official Contact for Correspondence: Date Summary Prepared: ## DEVICE IDENTIFICATION Trade name: Generic/ Common Name: Classification : Classification name: Product Code: Panel: # Predicate Devices Predicate : Rhein'83 srl via E. Zago 10/abc - 40128 Bologna - Italy +39 051244510 +39 051245238 info@rhein83.com Claudia Nardi - President Rhein'83 srl July 11, 2016 OT EQUATOR Implant Abutment 21 CFR 872.3630 ENDOSSEOUS DENTAL IMPLANT ABUTMENT CLASS II (SPECIAL CONTROLS) NHA Dental OT Equator (K142211) # 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 Equator, allows the coupling with a removable prosthesis or "overdenture", which is properly built only if it is properly profiled and based on the patient's gingival arch. Therefore, the removable prosthesis unloads the chewer loads on the natural gum of the intra oral arch, making the OT Equator abutments passive with lacking of solicitation. The OT Equator is manufactured of titanium Ti-6AI-4V (meets ASTM Standard F-136) and it is designed to retain any compatible prosthetic restoration. The OT Equator overdenture system is comprised of a semispherical head, a base, and a screw. The part number, critical dimensions and materials for the OT Equator Abutment and accessories subject to this 510(k) are summarized below: {5}------------------------------------------------ | 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 | | Component name and drawing | Part Number | Critical Dimensions | Material | | OT EQUATOR - YELLOW RETENTIVE CAP Image: yellow cap | 140CEG | EXTERNAL Ø 3.8mm INTERNAL Ø 2.5mm | PEBAX | | OT EQUATOR HOUSING FOR CAP Image: gray cap | 141CAE | INTERNAL Ø 3.84 | STAINLESS STEEL AISI303 | {6}------------------------------------------------ # 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 NOBEL BIOCARE AB - NobelActive NP 3.5 NOBEL BIOCARE AB - NobelActive RP 4,3 - 5 NOBEL BIOCARE USA LLC - Replace Select TC NP 3.5 NOBEL BIOCARE USA INC - Replace Select Straight TiUnit RP 4.3 NOBEL BIOCARE USA LLC - Replace Select Straight TiUnit WP 5 NOBEL BIOCARE AB - Brånemark System Mk III TiUnite NP 3.3 NOBEL BIOCARE AB - Brånemark System Mk III Shorty RP 4,1 NOBEL BIOCARE AB - Brånemark System Mk III TiUnite WP5 6 Straumann USA - Bone level NC 3.3 Straumann USA - Bone level RC 4.1 - 4.8 Straumann USA - Tissue level RN 4.8 Straumann USA - Tissue level WN 6,5 Zimmer Dental Inc. - Tapered Screw-Vent 3.5, 4.5, 5.7 Zimmer Dental Inc. - Spline 3.25, 3.75 - 4, 5 ASTRA TECH AB - OsseoSpeed™ TX 3.5-4, 4.5-5 DENTSPLY INTL., INC. - ANKYLOS C/ 3,5 DENTSPLY INTERNATIONAL, INC. - FRIALIT plus Stepped Screw 3.4, 3.8, 4.5, 5.5, 6.5 BIOMET 3i - Certain 3.25, 4.1, 5, 6 IMPLANT DIRECT LLC - Legacy 3, 3.75, 4.7 IMPLANT DIRECT LLC - Tri-Lobe 3.5, 4.3, 5 - 6 IMPLANT DIRECT LLC - Tri-Lobe 3.5, 4.3, 5 - 6 IMPLANT DIRECT SYBRON MANUFACTURING LLC - Swish Plus3.7, 4.1 - 4.8 MIS - IMPLANT TECHNOLOGIES LTD. - SEVEN 3.3, 3.75, 4.2, 5, 6 {7}------------------------------------------------ MIS - IMPLANT TECHNOLOGIES LTD. - C1 3.3, 3.75, 3.9, 4.2, 4.3, 5 MEGAGEN CO., LTD. - ANYRIDGE 3.5, 4, 4.5, 5, 5.5 NEODENT USA. INC. - CM Titamax 3.5. 3.75. 4. 4.3. 5 NEODENT USA, INC. - CM Drive 3.5, 3.75, 4, 4.3, 5 NEOSS, LTD. - ProActive 3.5, 4, 4.5, 5, 5.5, 6 BIOHORIZONS IMPLANT SYSTEMS, INC. - Laser-lok® 3.0 BIOHORIZONS IMPLANT SYSTEMS, INC. - Tapered internal 3.5, 4.5, 5.7 KEYSTONE DENTAL, INC. / LIFECORE BIOMEDICAL, INC - PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM SD 3.5 KEYSTONE DENTAL, INC. / LIFECORE BIOMEDICAL, INC - PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM RD 4.1 KEYSTONE DENTAL, INC. / LIFECORE BIOMEDICAL, INC - PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM WD 5 ## DISCUSSION OF NON CLINICAL TESTS ### Biocompatibility The submitted device, as the predicate device, is classified as permanent duration (> 30 days), mucosal membranes contacting device. The materials of the submitted device are identical to the ones of the predicate, the already licensed OT EQUATOR (K142211). All materials, including the coating for the OT EQUATOR Abutment, TiN (Nitride), are identical to the materials used to manufacture the predicate OT EQUATOR and its components (all cleared with 510(K) n. K142211). All the components are manufactured using the same process. Therefore the results of the biocompatibility tests performed on the predicate device OT Equator apply also to the subject device and there was no need to perform new biocompatibility testing on the subject device OT EQUATOR. #### Sterilization Validation Steam sterilization validation test, conducted on the predicate device OT Equator 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. {8}------------------------------------------------ ## Reverseengineeringanalysis In order to ensure that the OT Equator abutment can be perfectly coupled with the related compatible implant a reverse engineering analysis was conducted, as for the predicate already licensed. 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. The results of nonclinical tests demonstrate that the device is substantalyequivalent 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. | Feature | Rhein'83 OT Equator (Submitted Product) | LEGALLY MARKETED PREDICATE DEVICE | |---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | K number | K160382 | K142211 | | Proprietary / Trade Name | OT EQUATOR | OT EQUATOR | | CFR Section | 872.3630 | 872.3630 | | Pro-code | NHA | NHA | | Classification name | ENDOSSEOUS DENTAL IMPLANT ABUTMENT Class II (special controls) | ENDOSSEOUS DENTAL IMPLANT ABUTMENT 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 is screwed into an endosseous implant in the mandible or maxilla. | 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. | | Intended Users | Adequately trained dental technicians and dentists. | Adequately trained dental technicians and dentists. | | Material | Titanium 6Al-4V | Titanium 6Al-4V | | Material (Male socket) | Rilsan, Pebax, Kepital | Rilsan, Pebax, Kepital | {9}------------------------------------------------ | Feature | Rhein'83 OT Equator (Submitted Product) | LEGALLY MARKETED PREDICATE DEVICE | |--------------------|------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------| | K number | K160382 | K142211 | | Material (Housing) | Stainless Steel AISI303 | Stainless Steel AISI303 | | Platform Diameter | According to the compatible implant (see table above, indication for use) | According to the compatible implant (see table above, indication for use) | | Surface treatment | TiN coating only for the head part of the abutment | TiN coating only for the head part of the abutment | | Cuff Width | 1mm - 2mm - 3mm - 4mm - 5mm - 6mm- 7mm | 1mm - 2mm - 3mm - 4mm 5mm - 6mm- 7mm | | Height | 2 mm | 2 mm | | Components | OT EQUATOR PROFILE kit contains: Ot Equator Profile abutment, metal housing, retentive caps, protective disk. | OT EQUATOR PROFILE kit contains: Ot Equator Profile abutment, metal 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. | | Reusable | No | No | ## COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE The proposed device and the predicate OT EQUATOR already licensed (K142211) are identical in all specifications as the materials, the manufacturing process, the technological characteristics and the indications for use except for the interface connections between the abutments and the compatible implant bodies,that have specific dimensions, according to the compatible implant systems. The subject device varies from the predicate already licensed only for the list of compatible implant systems. # 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 substantially equivalent to the predicate device.