Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a mechanical dental implant component and its intended use, materials, and performance testing. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.

Therapeutic

No.
A therapeutic device is one that treats, prevents, or diagnoses a disease or condition. This device is a dental implant component used to retain dentures, which is a supportive and restorative function, not directly therapeutic in the sense of treating a disease.

Diagnostic

No

The device is described as an "endosseous dental implant retentive component used to retain a complete or partial denture." Its function is mechanical retention of a prosthesis, not to diagnose a condition or disease.

SaMD (Software as a Medical Device)

No

The device is a physical dental implant component made of titanium, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to retain a complete or partial denture by being screwed into an endosseous dental implant. This is a mechanical function within the body.
Device Description: The description details a physical component made of titanium designed to connect a denture to an implant. It describes its physical properties and how it functions mechanically.
Lack of Diagnostic Function: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
Anatomical Site: The device is used within the body (mandible or maxilla), not for testing samples from the body.
Performance Studies: The performance studies focus on biocompatibility, sterilization, and mechanical coupling with implants, not on diagnostic accuracy or performance metrics like sensitivity or specificity.

In summary, the OT Equator is a medical device used for prosthetic retention within the body, not a device used for in vitro diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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 (NobelActive NP - 3.5mm; NobelActive RP - 4.3 and 5mm); Various Branemark System Implants-Immediate Function Indication (Brånemark System Mk III TiUnite NP - 3.3mm; Brånemark System Mk III Shorty RP - 4.1mm; Brånemark System Mk III TiUnite WP - 5 and 6mm)
NOBEL BIOCARE USA LLC: Nobelreplace Tapered Conical Connection (Replace Select TC NP - 3.5mm)
NOBEL BIOCARE UAS INC: Replace Tiunite Endosseous Implant (Replace Select Straight TiUnit RP - 4.3mm; Replace Select Straight TiUnit WP - 5mm)
STRAUMANN USA: Straumann Bone Level Tapered Implant (Bone level NC - 3.3mm; Bone level RC - 4.1 and 4.8mm); ITI Dental Implant System (Tissue Level Titanium Implants) (Tissue level RN - 4.8mm; Tissue level WN - 6.5mm)
ZIMMER DENTAL INC.: Tapered Screw-Vent Implant System (Tapered Screw-Vent - 3.5, 4.5 and 5.7mm); Spline Dental Implant System (Spline - 3.25, 3.75, 4 and 5mm)
ASTRA TECH AB: Astra Tech Implant System (OsseoSpeed™ TX - 3.5, 4, 4.5 and 5mm)
DENTSPLY INTERNATIONAL, INC.: Ankylos C/X Dental Implant System (Ankylos C/ - 3.5mm); 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 6.5mm)
BIOMET 3i: Full OSSEOTITE® Certain® II Dental Implant (Certain - 3.25, 4.1, 5 and 6mm)
IMPLANT DIRECT LLC: Legacy Dental Implants (Legacy - 3, 3.75 and 4.7mm); Reactive Dental Implant System (Tri-Lobe - 3.5, 4.3, 5 and 6mm); Replus Dental Implants (Tri-Lobe - 3.5, 4.3, 5 and 6mm)
IMPLANT DIRECT SYBRON MANUFACTURING LLC: Interactive/ Swishplus2 Implant System (Swish Plus - 3.7, 4.1 and 4.8mm)
NEODENT USA, INC.: Neodent Implant System (CM Titamax - 3.5, 3.75, 4, 4.3 and 5mm; CM Drive - 3.5, 3.75, 4, 4.3 and 5mm)
MIS - IMPLANT TECHNOLOGIES LTD.: Seven Implants; Biocom Implants; Lance Implants (Seven - 3.3, 3.75, 4.2, 5 and 6mm); Conical Connection Implants (C1 - 3.3, 3.75, 3.9, 4.2, 4.3 and 5mm)
MEGAGEN CO., LTD.: Anyridge Internal Implant System (Anyridge - 3.5, 4, 4.5, 5 and 5.5mm)
NEOSS, LTD.: Neoss Proactive Implant (ProActive - 3.5, 4, 4.5, 5, 5.5 and 6mm)
BIOHORIZONS IMPLANT SYSTEMS, INC.: Biohorizons Laser-Lok 3.0 Implant System (Laser-lok® - 3.0mm); Biohorizons Tapered Internal Implant System (Tapered internal - 3.5, 4.5 and 5.7mm)
KEYSTONE DENTAL INC. / LIFECORE BIOMEDICAL INC: Primaconnex Internal Connection Implant System, Primaconnex Internal Connection Prosthetics (Primaconnex Internal Connection Implant System SD - 3.5mm; Primaconnex Internal Connection Implant System RD - 4.1mm; Primaconnex Internal Connection Implant System WD - 5mm)
TRI DENTAL IMPLANTS INT. AG: TRI® Dental Implant System (TRI Narrow - 3.3mm; TRI Vent - 3.75, 4.1 and 4.7mm; TRI OCTA - 3.75, 4.1 and 4.7mm)
ALTATEC GMBH: Camlog Implant System Modified Implants and Abutments (Camlog - 3.3, 3.8, 4.3, 5 and 6mm); Conelog Implant System (Conelog - 3.3, 3.8, 4.3 and 5mm)
DENTIS CO.: Dentis Dental Implant System (i-Clean - 3.7, 4.3 and 4.8mm); OneQ-SL Implant System Common (i-Clean - 3.7, 4.3 and 4.8mm); OneQ-SL s-Clean Implant System s-Clean Tapered II RBM Implant System (s-clean - 3.7, 4.3 and 4.8mm); Dentis Dental Implant System (e-Clean - 3.5, 4.1 and 5.1mm)
DENTSPLY IMPLANTS MANUFACTURING GMBH: Astra Tech Implant System (OsseoSpeed Profile EV - 3, 3.6, 4.2 and 4.8mm)
MEGAGEN IMPLANT CO.: Anyone Internal Implant System (Anyone - 3.6, 4.0, 4.5, 5 and 6mm)

Product codes (comma separated list FDA assigned to the subject device)

NHA

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 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:

OT EQUATOR ABUTMENT: Part Number 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, Material: 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: Part Number 140CEV, EXTERNAL Ø 3.8mm, INTERNAL Ø 2.5mm, Material: KEPITAL
OT EQUATOR - WHITE RETENTIVE CAP: Part Number 140CET, EXTERNAL Ø 3.8mm, INTERNAL Ø 2.5mm, Material: RILSAN BMNO
OT EQUATOR - PINK RETENTIVE CAP: Part Number 140CER, EXTERNAL Ø 3.8mm, INTERNAL Ø 2.5mm, Material: RILSAN BMNO
OT EQUATOR - YELLOW RETENTIVE CAP: Part Number 140CEG, EXTERNAL Ø 3.8mm, INTERNAL Ø 2.5mm, Material: PEBAX
STAINLESS STEEL HOUSING FOR CAP: Part Number 141CAE, INTERNAL Ø 3.84, Material: STAINLESS STEEL AISI303

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Mandible or maxilla (endosseous implant)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Adequately trained dental technicians and dentists.
healthcare facilities/hospitals.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

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.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Biocompatibility: The materials used in the subject device are identical to the predicate devices (OT EQUATOR K142211 and K160382), which were classified as permanent duration (> 30 days), mucosal membranes contacting devices. The previous biocompatibility test results for the predicate devices are considered valid for the subject device.
Sterilization Validation: Steam sterilization validation conducted on predicate device K142211 according to ISO 17664 and ISO 11737-1/-2, demonstrating an SAL of 10-6, remains valid because the subject device uses the same materials and packing as the predicate.
Reverse engineering analysis: Performed on 10 samples of OEM implant systems (10 OEM implant bodies and 10 OEM screws). Dimensions were measured using a stereo microscope, calibrated plugs, "go/no go" threaded gauges, and a profile projector. Key results were that the OT Equator abutment can be coupled with the related compatible implants.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K142211

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K160382

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.)

Summary

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
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.