Who is the manufacturer of S.I.N. Dental Implant System?

S.I.N. - Sistema DE Implante Nacional S.A. filed the 510(k) submission for S.I.N. Dental Implant System (K200992).

What is the FDA product code for S.I.N. Dental Implant System?

DZE. It is classified under 21 CFR 872.3640 as a Class 2 device in the Dental panel.

What is the regulatory pathway for S.I.N. Dental Implant System?

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

What are the predicate devices for S.I.N. Dental Implant System?

S.I.N. Dental Implant System (K170392); S.I.N. Dental Implant System (K170398); Neodent Implant System - GM Line (K163194); Neodent Implant System (K101945).

Who can help prepare an FDA 510(k) submission like S.I.N. Dental Implant System?

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.

S.I.N. Dental Implant System

K200992 · S.I.N. - Sistema DE Implante Nacional S.A. · DZE · Nov 17, 2020 · Dental

Device Facts

Record ID	K200992
Device Name	S.I.N. Dental Implant System
Applicant	S.I.N. - Sistema DE Implante Nacional S.A.
Product Code	DZE · Dental
Decision Date	Nov 17, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3640
Device Class	Class 2
Attributes	Therapeutic

Intended Use

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.

Device Story

S.I.N. Dental Implant System comprises endosseous dental implants and prosthetic components (abutments, healing caps, screws). Implants are placed in maxillary or mandibular bone to support dental restorations. System uses Morse taper connections (11.5°, 16°, 4°, 3°) and external/internal hex interfaces. Implants are unalloyed titanium (ASTM F67) with acid-etched or hydroxyapatite (HA) coated surfaces. Prosthetic components are titanium alloy (ASTM F136) or PEEK (ASTM F2026). Device is used by dental clinicians in clinical settings. Components are provided sterile via gamma irradiation. Output is a stable foundation for prosthetic teeth; clinical benefit is functional and esthetic rehabilitation of edentulous or partially edentulous patients.

Clinical Evidence

No clinical data included. Substantial equivalence supported by non-clinical bench testing: static compression and compression fatigue testing (ISO 14801), biocompatibility (ISO 10993), sterilization validation (ISO 11137), bacterial endotoxin testing (ANSI/AAMI ST72), and shelf-life testing.

Technological Characteristics

Materials: Unalloyed titanium (ASTM F67), titanium alloy (ASTM F136), PEEK (ASTM F2026). Surface: Acid-etched or HA-coated. Connections: Morse taper (3°, 4°, 11.5°, 16°) and hex interfaces. Sterilization: Gamma irradiation (25 kGy, VDmax25).

Indications for Use

Indicated for patients requiring single-unit or multi-unit dental restorations in the maxillary or mandibular arch. Suitable for one-stage surgical approach with immediate loading if primary stability and occlusal conditions are met.

Regulatory Classification

Identification

An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.

Special Controls

*Classification.* (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2) *Classification.* Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use; (ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads; (iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system; (iv) The device must be demonstrated to be biocompatible; (v) Sterility testing must demonstrate the sterility of the device; (vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment; (vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians; (viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and (ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.

Predicate Devices

S.I.N. Dental Implant System (K170392)
S.I.N. Dental Implant System (K170398)
Neodent Implant System - GM Line (K163194)
Neodent Implant System (K101945)

Reference Devices

17° Angulated Abutment (K961736)
Angulated Abutment, Complete, Titanium SDCA 102 (K905434)
Multi-unit Abutment Plus (K161416)
Zimmer Dental Hex-lock Prepared Abutment (K052600)
AnyRidge Internal Implant System (K110955)

Related Devices

K222231 — S.I.N. Dental Implant System · S.I.N. - Sistema DE Implante Nacional S.A. · Oct 27, 2022
K193096 — S.I.N. Dental Implant System · S.I.N. - Sistema DE Implante Nacional S.A. · May 14, 2020
K170392 — S.I.N. Implant System · S.I.N. Sistema DE Implante Nacional S.A. · Dec 1, 2017
K221453 — S.I.N. Dental Implant System · S.I.N. Sistema DE Implante Nacional S.A. · Dec 15, 2022
K170398 — S.I.N. Dental Implant System · S.I.N. Sistema DE Implante Nacional S.A. · Nov 21, 2017

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. November 17, 2020 S.I.N.-Sistema de Implante Nacional S.A. % Kevin Thomas Vice President and Director of Regulatory Affairs PaxMed International. LLC 12264 El Camino Real, Suite 400 San Diego, California 92130 Re: K200992 Trade/Device Name: S.I.N. Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous dental implant Regulatory Class: Class II Product Code: DZE, NHA Dated: October 16, 2020 Received: October 16, 2020 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 (OS) 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 medical devices and radiation-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. for Srinivas Nandkumar, Ph.D. Director DHT1B: Division of Dental 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) K200992 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 mandibular arch to single-unit or multi-unit restorations. When a one-stage surgical 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. 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}------------------------------------------------ ### 510(k) Summary K200992 S.I.N. - Sistema de Implante Nacional S.A. S.I.N Dental Implant System November 17, 2020 #### ADMINISTRATIVE INFORMATION | Manufacturer Name | S.I.N. - Sistema de Implante Nacional S.A. | | | | | |---------------------------|--------------------------------------------------|------------------------------------------|--|--|--| | | Avenida Vereador Abel Ferreira, 1100 | | | | | | | São Paulo, São Paulo | | | | | | | 03340-000 Brazil | | | | | | | Telephone: +55-11-21693000 ext 3236 | | | | | | Official Contact | Denise Domiciano, Quality and Regulatory Manager | | | | | | Representative/Consultant | Kevin A. Thomas, PhD | | | | | | | Floyd G. Larson, MS, MBA | | | | | | | PaxMed International, LLC | | | | | | | 12264 El Camino Real, Suite 400 | | | | | | | San Diego, CA 92130 | | | | | | | Telephone: | +1 858-792-1235 | | | | | | Fax: | +1 858-792-1236 | | | | | | Email: | kthomas@paxmed.com flarson@paxmed.com | | | | #### DEVICE NAME AND CLASSIFICATION | Trade/Proprietary Name | S.I.N. Dental Implant System | |------------------------|---------------------------------------------------------------------------------------------------------| | Common Names | Endosseous dental implant | | Regulation Number | 21 CFR 872.3640 | | Regulation Name | Endosseous dental implant | | Regulatory Class | Class II | | Product Code | DZE | | Secondary Product Code | NHA | | Classification Panel | Dental | | Reviewing Office | Office of Health Technology 1 (Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices) | | Reviewing Division | Division of Health Technology 1 B (Dental Devices) | #### PREDICATE DEVICE INFORMATION Primary Predicate Device K170392, S.I.N. Dental Implant System, S.I.N. - Sistema de Implante Nacional S.A. Additional Predicate Devices K170398, S.I.N. Dental Implant System, S.I.N. - Sistema de Implante Nacional S.A. K163194, Neodent Implant System - GM Line, JJGC Indústria e Comércio de Materiais Dentários SA K101945, Neodent Implant System, JJGC Indústria e Comércio de Materiais Dentários SA {4}------------------------------------------------ K961736, 17° Angulated Abutment, Nobel Biocare USA, LLC K905434, Angulated Abutment, Complete, Titanium SDCA 102, Nobelpharma USA, Inc. K161416, Multi-unit Abutment Plus, Nobel Biocare AB K052600, Zimmer Dental Incorporated, Zimmer Dental Hex-lock Prepared Abutment (Straight & Angled) K110955, MegaGen Company, Limited, AnyRidge Internal Implant System #### 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. #### SUBJECT DEVICE DESCRIPTION The purpose of this submission is to add to the S.I.N. Dental Implant System components cleared in K170392 and K170398. This submission adds the following components to the S.I.N. Dental Implant System: Tryon CM Conical implants, Tryon CM Cylindrical implants, Tryon CM Cylindrical Body and Conical Apex implants, and Strong SW implants, each with a Morse taper connection and the identical acidetched endosseous surface cleared in in K170392; Strong SW Plus implants with a Morse taper connection and an endosseous surface produced by acidetching followed by application of a hydroxyapatite coating (HA™M) identical to the coating cleared in K170392: conventional angled abutments and healing caps with a Morse taper connection that are compatible with the Strong SW CM implant line cleared in K170392; conventional angled abutments and healing caps with a Morse taper connection that are compatible with the subject device Tryon CM implant lines, the subject device Strong SW/Plus implant lines, and the Unitite implant line cleared in K17039; healing caps with a Morse taper connection that are compatible with the Unitite Compact implant line and the Unitite Slim implant line cleared in K170392; healing caps with an external hex (HE) or internal hex (HI) connection that are compatible with the Strong SW HE, the Tryon HE implant lines, and the Strong SW HI implant lines, cleared in K170398; abutment screws for use with the angled abutments or healing caps. | Implant Line | Body Ø, mm | Platform Ø, mm | Length, mm | | | | | | |----------------------|------------|----------------|------------|-----|------|------|----|----| | Tryon CM Conical | 3.5 | 3.5 | 8.5 | 10 | 11.5 | 13 | 15 | | | Tryon CM Conical | 4.5 | 4.5 | 8.5 | 10 | 11.5 | 13 | 15 | | | Tryon CM Conical | 5.0 | 5.0 | 8.5 | 10 | 11.5 | 13 | 15 | | | Tryon CM Cylindrical | 3.5 | 3.5 | 7 | 8.5 | 10 | 11.5 | 13 | 15 | | Tryon CM Cylindrical | 3.75 | 3.75 | 7 | 8.5 | 10 | 11.5 | 13 | 15 | | Tryon CM Cylindrical | 4.0 | 4.0 | 7 | 8.5 | 10 | 11.5 | 13 | 15 | | Tryon CM Cylindrical | 5.0 | 5.0 | 7 | 8.5 | 10 | 11.5 | 13 | 15 | The subject device dental implants are summarized in the following table. {5}------------------------------------------------ | Implant Line | Body Ø, mm | Platform Ø, mm | Length, mm | | | | | | |-----------------------------------------------|------------|----------------|------------|-----|----|------|----|----| | Tryon CM Cylindrical Body and Conical Apex | 3.5 | 3.5 | | 8.5 | 10 | 11.5 | 13 | 15 | | | 3.75 | 3.75 | | 8.5 | 10 | 11.5 | 13 | 15 | | | 4.0 | 4.0 | | 8.5 | 10 | 11.5 | 13 | 15 | | Strong SW | 3.5 | 3.5 | | 8.5 | 10 | 11.5 | 13 | 15 | | | 3.8 | 3.8 | | 8.5 | 10 | 11.5 | 13 | 15 | | Strong SW Plus | 4.5 | 4.5 | | 8.5 | 10 | 11.5 | 13 | 15 | | | 5.0 | 5.0 | | 8.5 | 10 | 11.5 | 13 | 15 | All subject device dental implants are made of the same unalloyed titanium as the dental implants cleared in K170398 and K170392, and the Strong SW Plus implants have the identical HA™® surface cleared in K170392. #### Prosthetic Components The subject device prosthetic components are summarized in the following table. | Types | Prosthetic Platform Ø, mm | Angle | Materials | Compatible with | |-------------------------------------------------------------|---------------------------|----------|----------------|----------------------------------------------------------| | Abutment Cemented Morse Angled (16° Morse taper) | 3.3, 4.5 | 17°, 30° | Titanium alloy | | | Abutment Angled Morse (16° Morse taper) | 3.5, 4.5 | 17° | Titanium alloy | | | Abutment Mini Angled Morse (16° Morse taper) | 4.8 | 17°, 30° | Titanium alloy | Strong SW CM implant line in K170392 | | Healing Cap Morse (16° Morse taper) | n/a | n/a | PEEK | | | Healing Cap Morse Indexed (16° Morse taper) | n/a | n/a | PEEK | | | Abutment Cemented Angled SIT (11.5° Morse taper) | 3.3, 4.5 | 17°, 30° | Titanium alloy | | | Abutment Cemented Angled Indexed SIT (11.5° Morse taper) | 3.3, 4.5 | 17°, 30° | Titanium alloy | Tryon CM implant lines, Strong SW, | | Abutment Mini Angled (11.5° Morse taper) | 4.8 | 17°, 30° | Titanium alloy | Strong SW Plus (this submission); | | Healing Cap (11.5° Morse taper) | n/a | n/a | PEEK | Unitite implant line in K170392 | | Healing Cap Indexed (11.5° Morse taper) | n/a | n/a | PEEK | | | Healing Cap Compact (4° Morse taper) | n/a | n/a | PEEK | Unitite Compact implant line in | | Healing Cap Compact Indexed (4° Morse taper) | n/a | n/a | PEEK | K170392 | | Healing Cap Slim (3° Morse taper) | n/a | n/a | PEEK | Unitite Slim implant line in K170392 | | Healing Cap Slim Indexed (3° Morse taper) | n/a | n/a | PEEK | | | Healing Cap HE | n/a | n/a | PEEK | Strong SW HE and Tryon HE implant lines in K170398 | | Healing Cap HE Indexed | n/a | n/a | PEEK | | | Healing Cap HI | n/a | n/a | PEEK | Strong SW HI implant | | Healing Cap HI Indexed | n/a | n/a | PEEK | line in K170398 | All subject device prosthetic components are manufactured from the same titanium alloy material conforming to ASTM F136 used to manufacture similar components abutments cleared in K170392 and K 170398, or from polyetheretherketone (PEEK) conforming to ASTM F2026. {6}------------------------------------------------ #### PERFORMANCE DATA Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence included: gamma irradiation sterilization validated for all subject devices (dental implants manufactured from unalloyed titanium with the acid-etched surface and implants with the HA™® hydroxyapatite coating, abutments and prosthetic components manufactured from titanium alloy, and healing caps manufactured from PEEK) to a sterility assurance level of 10th by selecting and substantiating a 25 kGy dose using method VDmax25, according to ISO 11137-1 and ISO 11137-2; bacterial endotoxin testing (referenced from K170398 and K170392) including Limulus amebocyte lysate (LAL) test according to ANSI/AAMI ST72 on samples of water used in manufacturing on a weekly basis and on samples from sterilized product on a quarterly basis to demonstrate all sterile product meets a limit of < 20 EU/device: shelf life testing (referenced from K170398 and K170392) including testing of samples after 4 years of real time aging according to ASTM F1929 and F88/F88M (packaging sterile barrier) and sterility testing of product: biocompatibility testing for the subject device PEEK material performed according to ISO 10993-5 (cytotoxicity) and ISO 10993-12; biocompatibility testing for the HA100 hydroxyapatite coating leveraged from and provided in K170392 included ISO 10993-3 (genotoxicity), ISO 10993-5 (cytotoxicity), ISO 10993-6 (implantation), ISO 10993-10 (sensitization, irritation), and ISO 10993-11 (systemic toxicity); characterization of the HAMM hydroxyapatite coating leveraged from and provided in K170392 included scanning electron microscopy (SEM), x-ray photoelectron spectroscopy (XPS), transmission electron microscopy (TEM), x-ray diffraction (XRD), and testing of the adherence of the coating; and static compression and compression fatigue testing according to ISO 14801 of worst-case constructs of the subject device abutments and subject device implants with the 11.5° Morse taper connection, and of worst-case constructs of the subject device abutments with the 16° Morse taper connection and previously-cleared compatible implants (cleared in K170392 and K193096). 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 additional predicate 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 selected additional predicate devices. The Indications for Use Statement (IFUS) for the subject device is substantially equivalent to that of the primary predicate K170392 and the additional predicate device K170398; slight differences in language of the Indications for Use statements do not affect the intended use as an endosseous dental implant abutment for support of a prosthesis to restore chewing function. Minor differences between the IFUS for the subject device and the primary predicate K170392 include the exact wording regarding immediate loading and language concerning implants less than 7 mm in length. The minor differences between the IFUS for the subject device and the additional predicate device {7}------------------------------------------------ K170398 include the exact wording regarding immediate loading and language concerning the Revolution Compact implant. Minor differences between the IFUS for the subject device and the additional predicate K163194 include the exact wording regarding immediate loading, language in K163194 concerning titanium base abutments (not applicable to the subject device), and language in K163194 regarding the temporary abutments. Minor differences between the IFUS for the subject device and the additional predicate K101945 include the exact wording regarding immediate loading and splinting of multiple tooth applications. None of these minor differences impact safety or effectiveness because all IFUS express equivalent intended use to facilitate functional and esthetic rehabilitation of the edentulous mandible or maxilla, and the indications are expressed equivalently using different specific wording. #### Subject Device Dental Implants The subject device Strong SW and Strong SW Plus implants are similar in design and sizes to the Strong SW CM implants cleared in K170392. The subject device Strong SW and Strong SW Plus implants have an 11.5° Morse taper connection, whereas the Strong SW CM implants have a 16° Morse taper connection. The Unitite implant line also cleared in K170932 have the 11.5° Morse taper connection. The subject device Strong SW Plus implants have the identical HAnano surface cleared in K170392. The subject device Tryon CM implant lines are substantially equivalent in design and sizes to the Tryon HE implants cleared in K170398. The subject device Tryon CM implant lines have the same 11.5° Morse taper connection as the Unitite implant line cleared in K170932. The subject device dental implants are made of the same unalloyed titanium as the dental implants cleared in K170392 and K170398, and the identical HAnano surface cleared in K170392 (for the subject device Strong SW Plus implants). The 1.5 mm sub-crestal placement of the subject device implants is substantially equivalent to the subcrestal placement of implants cleared in K170398, K163194, and K101945. #### Subject Device Prosthetic Components All subject device conventional abutments are manufactured from the same titanium alloy material conforming to ASTM F136 used to manufacture S.I.N. Dental Implant System abutments cleared in K170392 and K170398, or from polyetheretherketone (PEEK) conforming to ASTM F2026. The subject device Abutment Cemented Morse Angled and Abutment Angled Morse (with 16° Morse taper) are substantially equivalent to the corresponding abutment Cemented Strong SW CM cleared in K170392, having the same sizes or ranges of sizes for prosthetic platform diameter and gingival height. The subject device Abutment Cemented Morse Angled and Abutment Angled Morse are substantially equivalent to the GM Exact Click Universal Abutment cleared in K163194 in terms of prosthetic diameter, indexing, and angulation. The additional predicate devices K05260 and K110955 are in support of substantial equivalence of the Abutment Angled Morse with 17° of angulation and gingival heights of 1 mm, 4 mm, and 5 mm. {8}------------------------------------------------ The subject device Abutment Mini Angled Morse (with 16° Morse taper) are substantially equivalent to the corresponding abutment design Mini Abutment Strong SW CM cleared in K170392, having the same sizes or ranges of sizes for prosthetic platform diameter and gingival height. The subject device Abutment Mini Angled Morse is substantially equivalent to the GM Mini Conical Abutment cleared in K163194 in terms of prosthetic diameter, indexing, and angulation. The additional predicates K961736, and K 161416 are in support of substantial equivalence of the Abutment Mini Angled Morse with 17° and 30° of angulation and a gingival height of 4 mm. The subject device Abutment Cemented Angled SIT and Abutment Cemented Angled Indexed SIT (with 11.5° Morse taper) are substantially equivalent to the corresponding abutment design Abutment Cemented SIT Unitite cleared in K170392, having the same sizes of sizes for prosthetic platform diameter and gingival height. The subject device Abutment Cemented Angled SIT and Abutment Cemented Angled Indexed SIT are substantially equivalent to the CM Universal Abutment cleared in K101945 in terms of indexing and angulation. The subject device Abutment Mini Angled (with 11.5° Morse taper) are substantially equivalent to the corresponding abutment design Mini Abutment Unitite cleared in K170392, having the same sizes or ranges of sizes for prosthetic platform diameter and gingival height. The subject device Abutment Mini Angled is substantially equivalent to the CM Mini Conical Abutment cleared in K101945 in terms of indexing and angulation. The subject device Healing Cap Morse and Healing Cap Morse Indexed (with 16° Morse taper) are substantially equivalent to the corresponding design Healing Abutment Strong SW CM cleared in K170392, and to the GM Pro PEEK (Temporary) Abutment cleared in K163194. The GM Pro PEEK (Temporary) Abutment is for support of substantial equivalence of the PEEK material. The subject device Healing Cap and Healing Cap Indexed (with 11.5° Morse taper) are substantially equivalent to the corresponding design Healing Abutment Unitite cleared in K 170392, and to the GM Pro PEEK (Temporary) Abutment cleared in K163194. The GM Pro PEEK (Temporary) Abutment is for support of substantial equivalence of the PEEK material. The subject device Healing Cap Compact and Healing Cap Compact Indexed (with 4° Morse taper) are substantially equivalent to the corresponding design Healing Abutment Unitite Compact cleared in K 170392, and to the GM Pro PEEK (Temporary) Abutment cleared in K163194. The GM Pro PEEK (Temporary) Abutment is for support of substantial equivalence of the PEEK material. The subject device Healing Cap Slim and Healing Cap Slim (with 3° Morse taper) are substantially equivalent to the corresponding design Healing Abutment Unitite Slim cleared in K170392, and to the GM Pro PEEK (Temporary) Abutment cleared in K163194. The GM Pro PEEK (Temporary) Abutment is for support of substantial equivalence of the PEEK material. The subject device Healing Cap HE and Healing Cap HE Indexed (external hex interface) are substantially equivalent to the corresponding designs Healing Abutment and Cover Screw with external hex interfaces cleared in K170398, and to the GM Pro PEEK (Temporary) Abutment cleared in K163194. The GM Pro PEEK (Temporary) Abutment is for support of substantial equivalence of the PEEK material. The additional predicate K110955 is in support of substantial equivalence of the Healing Cap HE and Healing Cap HE Indexed with a coronal diameter of 8 mm and a gingival height of 6.8 mm. {9}------------------------------------------------ The subject device Healing Cap HI and Healing Cap HI Indexed (internal hex interface) are substantially equivalent to the corresponding designs Healing Abutment and Cover Screw with internal hex interfaces cleared in K170398, and to the GM Pro PEEK (Temporary) Abutment cleared in K163194. The GM Pro PEEK (Temporary) Abutment is for support of substantial equivalence of the PEEK material. The additional predicate K110955 also is in support of substantial equivalence of the Healing Cap HI and Healing Cap HI Indexed with a coronal diameter of 8 mm and a gingival height of 6.8 mm. All subject device healing caps are designed for the healing period between implant placement and final abutment placement, and are not intended to support a temporary prosthesis. The GM Pro PEEK (Temporary) Abutment cleared in K163194 is used to support a provisional prosthesis. This difference does not impact the substantial equivalence of the use of PEEK material for a healing cap or healing abutment. Minor differences in the exact dimensions of the subject device abutments as compared to the primary predicate and additional predicate devices does not impact safety, effectiveness, or substantial equivalence. The subject device abutments screws are substantially equivalent in material (titanium alloy) and designs to abutment screws cleared in K170392 and K170398. Selected abutments manufactured from titanium alloy are anodized using a standard anodization process is identical to the anodization process used on abutments cleared in K170392 and K170398. All subject device components are provided sterile by gamma irradiation, the same sterilization method used in K170392 and K170398. #### CONCLUSION The subject device, the primary predicate device, and the additional predicate 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 additional predicate 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 predicate devices listed above. {10}------------------------------------------------ # Table of Substantial Equivalence | | | | | | icate | Additional Predicate | |-----------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Subject Device | Primary Predicate Device | Additional Predicate | Additional Predicate | m - GM Line Materiais Dentários SA | K101945 Neodent Implant System JJGC Indústria e Comércio de Materiais Dentários SA | | | K200992 S.I.N. Dental Implant System S.I.N. - Sistema de Implante Nacional S.A. | K170392 S.I.N. Dental Implant System S.I.N. - Sistema de Implante Nacional S.A. | K170398 S.I.N. Dental Implant System S.I.N. - Sistema de Implante Nacional S.A. | K163194 Neodent Implant System JJGC Indústria e Comércio de Ma | conventional abutments: to be surgically placed in ovide support for , to restore chewing ge or two-stage estorations, and may be stability is achieved and se abutments: ase placed onto Neodent astomized prosthetic crown, or crown alone, gle or multi-unit torations. All digitally with the Neodent nded to be sent to d milling center. butments: to be used on Neodent or prosthesis structure for or two stage procedures ood primary stability. | The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Multiple tooth applications may be rigidly splinted. | | 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. | 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. Implants with lengths less than 7 mm are intended for delayed loading only. | 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. Revolution Compact with a 6 mm length is intended for delayed loading only. | Indications for Use for GM implants and The Neodent Implant System is intended for the bone of the upper or lower jaw to provide prosthetic devices such as artificial teeth, to function. It may be used with single-stage procedures, for single or multiple unit restorations, loaded immediately when good primary stability with appropriate occlusal loading. Indications for Use for GM Titanium Base Abutment: Titanium Base Abutment is a titanium base for dental implants to provide support for custom restorations. It is used with a coping and or cap and is indicated for cement-retained single unit restorations, or screw-retained single restorations, designed copings and/or crowns for use with the Titanium Base Abutment System are intended by Straumann for manufacture at a validated site. Indications for Use for GM Pro Peek Abutment: The Pro PEEK Abutments are indicated to support implants to provide temporary support for up up to 6 months. They can be used in one or two stage and also immediate load when there is good | designs Material | Abutment designs | | Reason for Predicate / Reference Devices | Not applicable | Implant designs; abutment designs; HAnano implant surface | Implant designs; abutment designs | Abutment designs; PEEK material | | DZE, NHA | | Product Codes | DZE, NHA | DZE, NHA | DZE, NHA | DZE, NHA | bilitation of the or maxilla | Functional and esthetic rehabilitation of the edentulous mandible or maxilla | | Intended Use | Functional and esthetic rehabilitation of the edentulous mandible or maxilla | Functional and esthetic rehabilitation of the edentulous mandible or maxilla | Functional and esthetic rehabilitation of the edentulous mandible or maxilla | Functional and esthetic rehabilitation of edentulous mandible or maxilla | | Morse taper (CM, 11.5°) | | Implant Designs | | | | | Implant lines | Titamax and Alvim implant lines 3.5/3.5 - 5.0/5.0 8 - 18 Morse taper (CM, 11.5°) | | Prosthetic Interface Connections | Morse taper (CM, 11.5°) | Morse taper (CM, various angles) | External hex (HE), Internal hex (HI) | Morse taper (CM, 16°; "GM") | | | | Body/Platform Diameters, mm Lengths, mm Interface | Strong SW / Strong SW Plus 3.5/3.5; 3.8/3.8; 4.5/4.5; 5.0/5.0 8.5, 10, 11.5, 13, 15 Morse taper interface (CM, 11.5°) | Strong SW CM 3.5/3.5; 3.8/3.8; 4.5/4.5; 5.0/5.0 8.5, 10, 11.5, 13, 15 Morse taper interface (CM, 16°) | | Titamax, Helix, and Drive inplant 3.5/3.5 - 5.0/5.0 8 - 18 Morse taper (CM, 16°, "GM") | | | | Body/Platform Diameters, mm Lengths, mm Interface | | Unitite, Unitite Slim, Unitite Compact Various sizes, 2.9/2.9 to 6.0/6.0 Various lengths, 5 mm to 15 mm Reference for HAnano surface Morse taper interfaces (CM): Unitite 11.5°, Unitite Slim 3°, Unitite Compact 4° | Strong SW HE 3.5/3.65; 3.75/4.1; 4.0/4.1; 4.5/4.5; 5.0/5.0 7*, 8.5, 10, 11.5, 13, 15 * no 7 mm length for 4.5 mm body External hex interface (HE) | | K10(k) Summary) | 1-2 sub-crestally (in public labeling) | | Body/Platform Diameters, mm Lengths, mm Interface | | | Strong SW HI 3.8/3.8; 4.5/4.5; 5.0/5.0 8.5, 10, 11.5, 13, 15 Internal hex interface (HI) | | | Unalloyed titanium | | Body/Platform Diameters, mm Lengths, mm Body/Platform Diameters, mm Lengths, mm Body/Platform Diameters, mm Lengths, mm Interface | Tryon CM Conical 3.5/3.5, 4.0/4.0; 5.0/5.0 8.5, 10, 11.5, 13, 15 Tryon CM Cylindrical 3.5/3.5, 3.75/3.75, 4.0/4.0; 5.0/5.0 7, 8.5, 10, 11.5, 13, 15 Tryon CM Cylindrical Body and Conical Apex 3.5/3.5, 3.8/3.8, 4.5/4.5; 5.0/5.0 8.5, 10, 11.5, 13, 15 Morse taper interface (CM, all implants 11.5°) | | Tryon HE 3.25/4.1; 3.75/4.1; 4.0/4.1; 5.0/5.0 7*, 8.5, 10, 11.5, 13, 15 * no 7 mm length for 3.25 mm body External hex interface (HE) | | etched ("Neoporos") drophilic treatment…