S.I.N. Dental Implant System

K230069 · S.I.N. – Sistema DE Implante Nacional S.A. · NHA · Apr 6, 2023 · Dental

Device Facts

Record IDK230069
Device NameS.I.N. Dental Implant System
ApplicantS.I.N. – Sistema DE Implante Nacional S.A.
Product CodeNHA · Dental
Decision DateApr 6, 2023
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 872.3630
Device ClassClass 2
AttributesTherapeutic

Intended Use

S.I.N. Dental Implant System is intended for placement in the maxillary or mandbular arch to provide support for single-unit or multi-unit restorations. When a one-stage surgical approach is applied, the S.I.N. Dental Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading. All digitally-designed custom abutments for use with Pre-Milled CAD-CAM Abutments are to be sent to a S.I.N.-validated milling center for manufacture.

Device Story

S.I.N. Dental Implant System adds Pre-Milled CAD-CAM Abutments to existing implant line; components feature 11.5° or 16° CM connections. Abutments are titanium alloy (Ti-6Al-4V) blanks; clinicians or technicians design patient-specific abutments using CAD-CAM software; designs must be sent to S.I.N.-validated milling center for final manufacture. Device used in dental clinics; operated by dentists/oral surgeons. Output is custom-milled abutment providing support for prosthetic restorations. Benefits include patient-specific fit for dental rehabilitation. Abutments provided non-sterile; require end-user moist heat sterilization.

Clinical Evidence

No clinical data included. Substantial equivalence supported by bench testing: moist heat sterilization validation (ISO 17665), biocompatibility (ISO 10993-5), MR environment safety (ASTM F2052, F2213, F2182, F2119), and engineering analysis of mechanical performance (ISO 14801).

Technological Characteristics

Materials: Titanium alloy (Ti-6Al-4V) per ASTM F136. Connection: 11.5° or 16° CM conical interface. Design limits: 0.55 mm min wall/gingival height, 4.0 mm min post height, 30° max angulation. Sterilization: Moist heat (autoclave) by end user. Packaging: PET blister pack with Tyvek cover.

Indications for Use

Indicated for patients requiring functional and esthetic rehabilitation of the edentulous mandible or maxilla via single-unit or multi-unit restorations supported by dental implants.

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

Reference Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol is a stylized representation of a human figure, while the FDA name is written in blue and includes the words "U.S. Food & Drug Administration". S.I.N. - Sistema de Implante Nacional S.A. % Kevin Thomas Vice President & Director of Regulatory Affairs PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130 Re: K230069 Trade/Device Name: S.I.N. Dental Implant System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: January 9, 2023 Received: January 10, 2023 Dear Kevin Thomas: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. ## Andrew I. Steen -S Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### Indications for Use 510(k) Number (if known) K230069 Device Name S.I.N. Dental Implant System Indications for Use (Describe) S.I.N. Dental Implant System is intended for placement in the maxillary or mandbular arch to provide support for single-unit or multi-unit restorations. When a one-stage surgical approach is applied, the S.I.N. Dental Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading. All digitally-designed custom abutments for use with Pre-Milled CAD-CAM Abutments are to be sent to a S.I.N.-validated milling center for manufacture. Type of Use (Select one or both, as applicable) | <span style="font-size: large;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | |---------------------------------------------------------------------------------------| | <span style="font-size: large;">☐</span> 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}------------------------------------------------ #### 510(k) Summary K230069 S.I.N. - Sistema de Implante Nacional S.A. S.I.N Dental Implant System April 6, 2023 #### ADMINISTRATIVE INFORMATION | Manufacturer Name | S.I.N. - Sistema de Implante Nacional S.A.<br>Avenida Vereador Abel Ferreira, 1100<br>São Paulo, São Paulo<br>03340-000 Brazil<br>Telephone +55-11-21693000 ext 3236 | | | |---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--| | Official Contact | Denise Domiciano, Quality and Regulatory Manager | | | | Representative/Consultant | Kevin A. Thomas, PhD<br>Floyd G. Larson, MS, MBA<br>PaxMed International, LLC<br>12264 El Camino Real, Suite 400<br>San Diego, CA 92130<br>Telephone +1 858-792-1235<br>Fax +1 858-792-1236<br>Email kthomas@paxmed.com<br>flarson@paxmed.com | | | #### DEVICE NAME AND CLASSIFICATION | Trade/Proprietary Name | S.I.N. Dental Implant System | |------------------------|------------------------------------------------------------------------------------------------| | Common Names | Dental implant abutment | | Regulation Number | 21 CFR 872.3630 | | Regulation Name | Endosseous dental implant abutment | | Regulatory Class | Class II | | Product Code | NHA | | Classification Panel | Dental | | Reviewing Office | Office of Health Technology 1 (Ophthalmic, Anesthesia, Respiratory,<br>ENT and Dental Devices) | | Reviewing Division | Division of Dental and ENT Devices | #### PREDICATE DEVICE INFORMATION Primary Predicate Device K 193096, S.I.N. Dental Implant System, S.I.N. - Sistema de Implante Nacional S.A. Reference Devices K221453, S.I.N. Dental Implant System, S.I.N. - Sistema de Implante Nacional S.A. K222231, S.I.N. Dental Implant System, S.I.N. - Sistema de Implante Nacional S.A. {4}------------------------------------------------ K211921, S.I.N. Dental Implant System, S.I.N. - Sistema de Implante Nacional S.A. K200992, S.I.N. Dental Implant System, S.I.N. - Sistema de Implante Nacional S.A. K 170392, S.I.N. Dental Implant System, S.I.N. - Sistema de Implante Nacional S.A. #### INDICATIONS FOR USE STATEMENT S.I.N. Dental Implant System is intended for placement in the maxillary or mandibular arch to provide support for single-unit or multi-unit restorations. When a one-stage surgical approach is applied, the S.I.N. Dental Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading. All digitally-designed custom abutments for use with Pre-Milled CAD-CAM Abutments are to be sent to a S.I.N.-validated milling center for manufacture. #### SUBJECT DEVICE DESCRIPTION The purpose of this submission is to add components to the S.I.N. Dental Implant System, which includes components cleared previously in K221453, K222231, K211921, K193096, and K170392. This submission adds Pre-Milled CAD-CAM Abutments to the S.I.N. Dental Implant System. The subject device abutments are provided with 11.5° CM and 16° CM connections compatible with the above S.I.N. dental implants. The design parameters for the CAD-CAM fabrication of patient-specific abutments from Pre-Milled CAD-CAM Abutments are the same for the 11.5° CM implant connection and the 16° CM implant connection. The design limit parameters are: Minimum wall thickness - 0.55 mm Minimum post height for single-unit restoration - 4.0 mm Minimum gingival height - 0.55 mm Maximum gingival height - 3.5 mm Minimum prosthetic platform diameter - 3.5 mm Maximum prosthetic post height - 6 mm Maximum angulation - 30° The subject device abutments are compatible with previously cleared S.I.N. Dental Implant bodies summarized in the following table. | Compatible Previously Cleared Implants, 11.5° CM | 510(k) Number | |------------------------------------------------------------------------------------|---------------| | Unitite Implant, body Ø 3.5 mm, 4.3 mm, 5.0 mm | K170392 | | Implant Strong SW, body Ø 3.5 mm, 3.8 mm, 4.5 mm, 5.0 mm | | | Implant Strong SW Plus, body Ø 3.5 mm, 3.8 mm, 4.5 mm, 5.0 mm | | | Implant Tryon CM Conical, body Ø 3.5 mm, 4.0 mm, 5.0 mm | K200992 | | Implant Tryon CM Cylindrical Body and Conical Apex, body Ø 3.5 mm, 3.75 mm, 4.0 mm | | | Implant Tryon CM Cylindrical, body Ø 3.5 mm, 3.75 mm, 4.0 mm, 5.0 mm | | | Implant Epikut CM, body Ø 3.5 mm, 3.8 mm, 4.5 mm, 5.0 mm | | | Implant Epikut Plus CM, body Ø 3.5 mm, 3.8 mm, 4.5 mm, 5.0 mm | K211921 | | Implant Epikut CM, body Ø 3.8 mm, 4.0 mm, 4.5 mm | | | Implant Epikut Plus CM, body Ø 3.8 mm, 4.0 mm, 4.5 mm | K221453 | {5}------------------------------------------------ | Compatible Previously Cleared Implants, 16° CM | 510(k) Number | |----------------------------------------------------------------------|---------------| | Strong SW CM Implant, body Ø 3.5 mm, 3.8 mm, 4.5 mm, 5.0 mm | K170392 | | Strong SW CM Plus Implant, body Ø 3.5 mm, 3.8 mm, 4.5 mm, 5.0 mm | K193096 | | Implant Epikut S, body Ø 3.5 mm, 3.8 mm, 4.0 mm, 4.5 mm, 5.0 mm | K222231 | | Implant Epikut S Plus, body Ø 3.5 mm, 3.8 mm, 4.0 mm, 4.5 mm, 5.0 mm | | All subject device abutments are manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F136, and are to be used with compatible abutment screws previously cleared in K170392. All subject device abutments are provided non-sterile and are to be moist heat sterilized by the end user. #### PERFORMANCE DATA Non-clinical data submitted or referenced to demonstrate substantial equivalence included: - . provided in this submission was moist heat sterilization for subject devices provided non-sterile to the end user, validated to a sterility assurance level of 105 by the overkill method according to ANSI/AAMI/ISO 17665-1 and ANSI/AAMI/ISO TIR 17665-2; - . referenced from K170398 was biocompatibility testing according to ISO 10993-5 (cytotoxicity) for the abutment material ASTM F136; - . referenced from K221453 was non-clinical analysis and testing to evaluate the metallic subject devices and compatible dental implants in the MR environment according to ASTM F2052 (magnetically induced displacement force), ASTM F2213 (magnetically induced torque), ASTM F2182 (RF induced heating), and ASTM F2119 (image artifact), and the FDA guidance document Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment (issued May 2021); - . provided in this submission was engineering analysis to demonstrate that the subject device abutments, in combination with compatible previously cleared dental implants, do not create a new worst-case construct in terms of mechanical testing according to ISO 14801; and - referenced from K200992 was mechanical testing conducted according to ISO 14801 to support the ● performance of the subject device abutments, in conjunction with the engineering analysis provided in this submission. No clinical data were included in this submission. #### EQUIVALENCE TO MARKETED DEVICES The subject device is substantially equivalent in indications and design principles to the primary predicate device and the reference devices listed above. Provided at the end of this summary is a table comparing the Indications for Use Statements and the technological characteristics of the subject device, the primary predicate device, and the reference devices. The primary predicate device K193096 is in support of substantial equivalence of the Indications for Use including CAD-CAM abutments, abutment designs, materials, manufacturing, sterilization, and compatible implants. The reference devices K221453, K222231, K211921, K200992, and K170392 are in support of substantial equivalence of the Indications for Use including CAD-CAM abutments (K221453), abutment designs, materials, manufacturing, sterilization, and compatible implants. {6}------------------------------------------------ The Indications for Use Statement (IFUS) for the subject device includes language concerning placement in the maxillary or mandibular arches and regarding immediate loading that is identical to the language in K193096. The IFUS for the subject device also includes language concerning CAD-CAM abutments and validated milling centers that is identical, besides the trade name, to that included in K193096. Differences between the IFUS for the subject device and the reference devices include: language in K221453 and K222231 regarding indications for implants with lengths of 18-24 mm that is not relevant to the subject device; language in K170392 regarding implant lengths less than 7 mm that is not relevant to the subject device; and the IFUS for K222231, K211921, K200992, and K170392 do not contain language regarding CAD-CAM abutments and validated milling centers. The subject device abutments with the 11.5° CM interface are compatible with implants cleared in K200992, K221453, K211921, and K170392 in terms of the abutment-implant connection. The subject device abutments with the 11.5° CM interface in final finished form are substantially equivalent to the Abutment Cemented Angled Indexed SIT cleared in K200992 in terms of material and design limit parameters including prosthetic platform diameter, maximum gingival height, and maximum angulation. The subject device abutments with the 16° CM interface are compatible with implants cleared in K222231, K193096, and K170392 in terms of the abutment-implant connection. The subject device abutments with the 16° CM interface in final finished form are substantially equivalent to the Abutment Cemented Morse Angled cleared in K200992 in terms of material and design limit parameters including prosthetic platform diameter, maximum gingival height, and maximum angulation. The subject device abutments are to be end user sterilization instructions are provided in the Instructions for Use. Similar components to be end-user sterilized (abutments manufactured from Ti-6Al-4V alloy material) were cleared in K221453, K193096, and K170392. The subject device abutments are packaged in a polyethylene terephthalate blister pack with a Tyvek cover. The Tyvek cover for the blister pack is printed with the appropriate label for the corresponding component. This is the same packaging used for similar abutments (provided non-sterile) in K221453. An engineering rationale was provided to demonstrate that the use of the subject device abutments in combination with the compatible implants raise no new risks and that mechanical testing data provided in a prior submission (K200992) are applicable to the subject abutments. #### CONCLUSION The subject device, the primary predicate device, and the reference devices have the same intended use, have similar technological characteristics, and are made of identical or similar materials. The subject device, the primary predicate, and the reference devices encompass the same range of physical dimensions, are packaged in similar materials, and are sterilized using similar methods. The data included in this submission demonstrate substantial equivalence to the primary predicate device and the reference devices listed above. {7}------------------------------------------------ ### Table of Substantial Equivalence | | Subject Device | Primary Predicate Device | Reference Device | Reference Device | Reference Device | |-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | K230069<br>S.I.N. Dental Implant System | K193096<br>S.I.N. Dental Implant System | K200992<br>S.I.N. Dental Implant System | K221453<br>S.I.N. Dental Implant System | K170392<br>S.I.N. Dental Implant System | | | S.I.N. - Sistema de Implante Nacional S.A. | S.I.N. - Sistema de Implante Nacional S.A. | S.I.N. - Sistema de Implante Nacional S.A. | S.I.N. - Sistema de Implante Nacional S.A. | S.I.N. - Sistema de Implante Nacional S.A. | | Indications for Use Statement<br>(IFUS) | S.I.N. Dental Implant System is intended for placement<br>in the maxillary or mandibular arch to provide support<br>for single-unit or multi-unit restorations. When a one-<br>stage surgical approach is applied, the S.I.N. Dental<br>Implant System is intended for immediate loading when<br>good primary stability is achieved and with appropriate<br>occlusal loading.<br>All digitally-designed custom abutments for use with<br>Pre-Milled CAD-CAM abutments are to be sent to a<br>S.I.N .- validated milling center for manufacture. | S.I.N. Dental Implant System is intended for placement<br>in the maxillary or mandibular arch to provide support<br>for single-unit or multi-unit restorations. When a one-<br>stage surgical approach is applied, the S.I.N. Dental<br>Implant System is intended for immediate loading when<br>good primary stability is achieved and with appropriate<br>occlusal loading.<br>All digitally-designed custom abutments for use with<br>Interface CAD-CAM abutments are to be sent to a<br>S.I.N.-validated milling center for manufacture. | S.I.N. Dental Implant System is intended for placement<br>in the maxillary or mandibular arch to provide support<br>for single-unit or multi-unit restorations. When a one-<br>stage surgical approach is applied, the S.I.N. Dental<br>Implant System is intended for immediate loading when<br>good primary stability is achieved and with appropriate<br>occlusal loading. | S.I.N. Dental Implant System is intended for placement<br>in the maxillary or mandibular arch to provide support<br>for single-unit or multi-unit restorations. When a one-<br>stage surgical approach is applied, the S.I.N. Dental<br>Implant System is intended for immediate loading when<br>good primary stability is achieved and with appropriate<br>occlusal loading.<br>S.I.N. Dental Implant System implants with lengths of<br>18, 20, 22, or 24 mm may be tilted up to 30°. When used<br>in the mandible or maxilla with implants with lengths of<br>18, 20, 22, or 24 mm at an angulation of 30°, a<br>minimum of four implants must be used and must be<br>splinted. When placed in the maxilla with lengths of 18,<br>20, 22, or 24 mm at angulations between 0° and less<br>than 30°, the S.I.N. Dental Implant System implants are<br>only indicated for multiple unit restorations in splinted<br>applications that utilize at least two implants.<br>All digitally-designed custom abutments for use with<br>Interface CAD-CAM abutments are to be sent to a<br>S.I.N.-validated milling center for manufacture. | S.I.N. Dental Implant System is intended for placement<br>in the maxillary or mandibular arch to provide support<br>for single-unit or multi-unit restorations. When a one-<br>stage surgical approach is applied, the S.I.N. Dental<br>Implant System is intended for immediate loading when<br>good primary stability is achieved and with appropriate<br>occlusal loading. Implants with lengths less than 7 mm<br>are intended for delayed loading only. | | Reason for<br>Predicate Device | Not applicable | IFUS including CAD-CAM abutments and validated<br>milling centers;<br>Compatible implants | Abutment designs; materials; manufacturing;<br>sterilization;<br>Compatible implants | IFUS including CAD-CAM abutments and validated<br>milling centers;<br>Compatible implants | Abutment designs; materials; manufacturing;<br>sterilization<br>Compatible implants | | Product Codes | NHA | DZE, NHA | DZE, NHA | DZE, NHA | DZE, NHA | | Intended Use | Functional and esthetic rehabilitation of the edentulous<br>mandible or maxilla | Functional and esthetic rehabilitation of the edentulous<br>mandible or maxilla | Functional and esthetic rehabilitation of the edentulous<br>mandible or maxilla | Functional and esthetic rehabilitation of the edentulous<br>mandible or maxilla | Functional and esthetic rehabilitation of the edentulous<br>mandible or maxilla | | Abutment Designs | | | | | | | CM 11.5° interface | Pre-Milled Blank Abutments<br>CM 11.5° interface<br>Minimum post height for single-unit restoration: 4 mm<br>Prosthetic platform Ø: 3.5 mm (min)<br>Gingival height: 3.5 mm (max), 0.55 mm (min)<br>Angle: 30° (max)<br>Indexed | | Abutment Cemented Angled Indexed SIT<br>CM 11.5° interface<br>Prosthetic platform Ø: 3.3, 4.5 mm<br>Gingival height: 1.5-3.5 mm<br>Angle: 17°, 30°<br>Indexed | | | | CM 16° interface | Pre-Milled Blank Abutments<br>CM 16° interface<br>Minimum post height for single-unit restoration: 4 mm<br>Prosthetic platform Ø: 3.5 mm (min)<br>Gingival height: 3.5 mm (max), 0.55 mm (min)<br>Angle: 30° (max)<br>Indexed | | Abutment Cemented Morse Angled<br>CM 16° interface<br>Prosthetic platform Ø: 3.3, 4.5 mm<br>Gingival height: 1.5-3.5 mm<br>Angle: 17°, 30<br>Indexed | | | | Abutment Materials | Titanium alloy, ASTM F136 | Titanium alloy, ASTM F136 | Titanium alloy, ASTM F136 | Titanium alloy, ASTM F136 | Titanium alloy, ASTM F136 | | | Subject Device | Primary Predicate Device | Reference Device | Reference Device | Reference Device | | | K230069<br>S.I.N. Dental Implant System | K193096<br>S.I.N. Dental Implant System | K200992<br>S.I.N. Dental Implant System | K221453<br>S.I.N. Dental Implant System | K170392<br>S.I.N. Dental Implant System | | | S.I.N. - Sistema de Implante Nacional S.A. | S.I.N. - Sistema de Implante Nacional S.A. | S.I.N. - Sistema de Implante Nacional S.A. | S.I.N. - Sistema de Implante Nacional S.A. | S.I.N. - Sistema de Implante Nacional S.A. | | Compatible Implants | | | | | | | CM 11.5° Connection | | | Strong SW and<br>Strong SW Plus<br>Body/platform $Ø$ 3.5/3.5; 3.8/3.8; 4.5/4.5; 5.0/5.0 mm<br>Lengths 8.5-15 mm | Epikut CM<br>Epikut Plus CM<br>Body/platform $Ø$ 3.8/3.8; 4.0/4.0; 4.5/4.5 mm<br>Lengths 18-24 mm | Unitite<br>Body/platform $Ø$ 3.5/3.5; 4.3/4.3, 5.0/5.0 mm<br>Lengths 8.5-15 mm | | | | | Tryon CM Conical<br>Body/platform $Ø$ 3.5/3.5, 4.0/4.0; 5.0/5.0 mm<br>Lengths 8.5-15 mm | | | | | | | Tryon CM Cylindrical Body and Conical Apex<br>Body/platform $Ø$ 3.5/3.5, 3.8/3.8, 4.5/4.5; 5.0/5.0 mm<br>Lengths 8.5-15 mm | | | | | | | Tryon CM Cylindrical<br>Body/platform $Ø$ 3.5/3.5, 3.75/3.75, 4.0/4.0; 5.0/5.0 mm<br>Lengths 7-15 mm | | | | CM 16° Connection |…
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510(k) Summary
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