(184 days)
No
The summary describes a dental implant system and its components, focusing on materials, dimensions, and mechanical testing. There is no mention of AI or ML technology.
No
The device, a dental implant system, aims to provide support for restorations or prostheses. While it modifies the structure and function of the body (providing support), its primary role is structural and restorative, not to treat or prevent a disease or condition in the way a therapeutic device would.
No
Explanation: The device is a dental implant system designed to support dental restorations, not to diagnose a condition or disease.
No
The device description clearly details physical components such as dental implants, abutments, and screws, which are hardware. The performance studies also focus on physical properties and testing of these hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for placement in the maxillary or mandibular arch to provide support for dental restorations. This is a surgical and prosthetic application, not a diagnostic test performed on samples from the human body.
- Device Description: The device description details the physical characteristics of dental implants and abutments, which are physical components used in dental procedures. It does not describe reagents, calibrators, controls, or other components typically associated with IVD devices.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health condition.
- Performance Studies: The performance studies described focus on sterilization, endotoxin testing, shelf life, biocompatibility, and mechanical testing (static compression and fatigue). These are relevant to the safety and performance of an implantable medical device, not an IVD.
In summary, the S.I.N. Dental Implant System is a medical device used for surgical implantation and prosthetic support in dentistry. It does not meet the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For Strong SW HE Implants
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 implants with lengths of 18, 20, 22, or 24 mm when placed in the maxilla are only indicated for multiple unit restorations in splinted applications that utilize at least two implants.
For Zygomatic Implants and Abutments
S.I.N. Dental Implant System Zygomatic implants are intended for placement in the maxillary arch to provide support for fixed or removable dental prostheses in patients with partially or fully edentulous maxillae. When a one-stage surgical approach is applied, the S.I.N. Dental Implant System Zygomatic implants are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
The purpose of this submission is to add components to the S.I.N. Dental Implant System cleared in K170398, including a line of zygomatic dental implants and abutments.
The subject device Strong SW HE dental implants are nearly identical to the Strong SW HE dental implants cleared in K170398, with a cylindrical design that tapers slightly to the apex, a body/endosseous thread diameter of 3.75 mm, and a platform diameter of 4.1 mm. This submission adds overall lengths of 18, 20, 22, and 24 mm. The endosseous threads have a uniform trapezoidal design and have an acidetched surface. The implants have an external hexagon ("HE") abutment interface connection, internal threads, and an internal hexolobular feature for instrument attachment.
The subject device Zygomatic dental implants have a body diameter of 4.5 mm at the coronal end and a body diameter of 3.85 mm at the apical end with additional tapering to the apex. The abutment platform is 4.1 mm and is angled 45° to the long axis of the implant. The coronal end of the Zygomatic implants have a micro-channel surface feature starting at approximately the angled abutment platform extending over a length of approximately 2.9 mm; the micro-channel blends to a micro-thread and extends apically over a length of 2.15 mm. The micro-thread major diameter is 4.5 mm. All Zygomatic implants also are threaded over a length of 10.7 mm at the apical end with a major thread diameter of 3.85 mm. The endosseous threads at the apical aspect of the Zygomatic implants have the same uniform trapezoidal design and acid-etched surface as the Strong SW HE implants are provided in a range of lengths from 34 mm to 59 mm increments. The implant length is measured from the start of the micro-threads to the apex.
This submission includes an implant cover for the subject Zygomatic implants, with a coronal diameter of 4.1 mm that matches the implant platform, and is threaded to match the internal thread of the Zygomatic implants. This submission also includes Mini Abutment Zygomatic Standard and Mini Abutment Zygomatic Conical; these abutments are straight, multi-unit, non-indexed abutments for the external hex connection of the Zygomatic implants. Mini Abutment Zygomatic Standard and Mini Abutment Zygomatic Conical are straight, multi-unit, non-indexed abutments for the external hex connection of the Zygomatic implants. Mini Abutment Zygomatic Standard are provided in one platform diameter (4.1 mm), one prosthetic platform diameter (4.5 mm), and in gingival heights of 3 mm, and 5.5 mm. Mini Abutment Zygomatic Conical are provided in one platform diameter (4.1 mm), one prosthetic platform diameter (4.8 mm), and in gingival heights of 2 mm, 3 mm, and 4 mm. Each abutment requires a corresponding subject device abutment screw to match the gingival height of the abutment. The Mini Abutment Standard and Mini Abutment Conical are the only abutments that are compatible with the subject device Zygomatic implants. For the Mini Abutment Zygomatic Standard, this submission also includes an Abutment Protector and a castable Co-Cr Base. For the Mini Abutment Zygomatic Conical, this submission also includes an Abutment Protector, Temporary Titanium Cylinder, and a castable Co-Cr Base. A Coping Screw is also included for use with all zygomatic abutments.
| Implant Line | Body Ø, mm | Platform Ø, mm | Lengths, mm |
|---|---|---|---|
| Strong SW HE | 3.75 | 4.1 | 18, 20, 22, 24 |
| Zygomatic | 4.5 coronal | ||
| 3.85 apical | 4.1 | 34, 36.5, 39, | |
| 41.5, 44, 46.5, 49, | |||
| 51.5, 54, 56.5, 59 |
All subject device dental implants are manufactured from unalloyed titanium conforming to ASTM F67. The subject device abutments, abutment screws, and implant cover are manufactured from titanium alloy conforming to ASTM F136. The materials in this submission (conforming to ASTM F67 and ASTM F136) are identical to the materials used to manufacture the dental implants and abutments cleared in K170398. The acid etching procedure is applied to all subject device dental implants. The acid etching process in this submission is identical to the process used to manufacture the dental implants cleared in K170398.
The subject device Mini Abutment Zygomatic Standard and Mini Abutment Zygomatic Conical abutments and corresponding abutment screws manufactured from titanium alloy (ASTM F136) are anodized using standard electrolytic passivation processing to increase the thickness of the natural oxide layer on the surface and to impart a distinctive gold surface color. The anodization process used in this submission is identical to the anodization process used on abutments cleared in K170398. The Abutment Protectors and Coping Screw are manufactured from titanium alloy (ASTM F136), the Co-Cr Bases are manufactured from Co-Cr-Mo alloy (ASTM F1537), and the Temporary Titanium Cylinder is manufactured from unalloyed titanium (ASMT F67).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillary or mandibular arch
maxillae
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence included: gamma irradiation sterilization for all subject devices (to a sterility assurance level of 10-6 by selecting and substantiating a 25 kGy dose using method VDmax25, according to ISO 11137-1 and ISO 11137-2, referenced from K170398);
bacterial endotoxin testing (referenced from K170398) 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
§ 872.3640 Endosseous dental implant.
(a)
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.(b)
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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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: K203725
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: March 30, 2021 Received: March 31, 2021
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 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.
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)
Device Name
S.I.N. Dental Implant System
Indications for Use (Describe)
For Strong SW HE Implants
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 implants with lengths of 18, 20, 22, or 24 mm when placed in the maxilla are only indicated for multiple unit restorations in splinted applications that utilize at least two implants.
For Zygomatic Implants and Abutments
S.I.N. Dental Implant System Zygomatic implants are intended for placement in the maxillary arch to provide support for fixed or removable dental prostheses in patients with partially or fully edentulous maxillae. When a one-stage surgical approach is applied, the S.I.N. Dental Implant System Zygomatic implants are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
| Type of Use (Select one or both, as applicable) |
|---|
| Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
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FORM FDA 3881 (6/20) .svg
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510(k) Summary K203725 S.I.N. - Sistema de Implante Nacional S.A.
S.I.N Dental Implant System
June 23, 2021
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 | |
| kthomas@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 K170398, S.I.N. Dental Implant System, S.I.N. - Sistema de Implante Nacional S.A.
Reference Devices K160119, NobelSpeedy® Groovy, Nobel Biocare AB K173343, Zygomatic Implant System, Southern Implants (Pty) Ltd
4
INDICATIONS FOR USE STATEMENTS
For Strong SW HE Implants
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 implants with lengths of 18, 20, 22, or 24 mm when placed in the maxilla are only indicated for multiple unit restorations in splications that utilize at least two implants.
For Zygomatic Implants and Abutments
S.I.N. Dental Implant System Zygomatic implants are intended for placement in the maxillary arch to provide support for fixed or removable dental prostheses in patients with partially or fully edentulous maxillae. When a one-stage surgical approach is applied, the S.I.N. Dental Implant System Zygomatic implants are 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 components to the S.I.N. Dental Implant System cleared in K170398, including a line of zygomatic dental implants and abutments.
The subject device Strong SW HE dental implants are nearly identical to the Strong SW HE dental implants cleared in K170398, with a cylindrical design that tapers slightly to the apex, a body/endosseous thread diameter of 3.75 mm, and a platform diameter of 4.1 mm. This submission adds overall lengths of 18, 20, 22, and 24 mm. The endosseous threads have a uniform trapezoidal design and have an acidetched surface. The implants have an external hexagon ("HE") abutment interface connection, internal threads, and an internal hexolobular feature for instrument attachment.
The subject device Zygomatic dental implants have a body diameter of 4.5 mm at the coronal end and a body diameter of 3.85 mm at the apical end with additional tapering to the apex. The abutment platform is 4.1 mm and is angled 45° to the long axis of the implant. The coronal end of the Zygomatic implants have a micro-channel surface feature starting at approximately the angled abutment platform extending over a length of approximately 2.9 mm; the micro-channel blends to a micro-thread and extends apically over a length of 2.15 mm. The micro-thread major diameter is 4.5 mm. All Zygomatic implants also are threaded over a length of 10.7 mm at the apical end with a major thread diameter of 3.85 mm. The endosseous threads at the apical aspect of the Zygomatic implants have the same uniform trapezoidal design and acid-etched surface as the Strong SW HE implants are provided in a range of lengths from 34 mm to 59 mm increments. The implant length is measured from the start of the micro-threads to the apex.
This submission includes an implant cover for the subject Zygomatic implants, with a coronal diameter of 4.1 mm that matches the implant platform, and is threaded to match the internal thread of the Zygomatic implants. This submission also includes Mini Abutment Zygomatic Standard and Mini Abutment Zygomatic Conical; these abutments are straight, multi-unit, non-indexed abutments for the external hex connection of the Zygomatic implants. Mini Abutment Zygomatic Standard and Mini Abutment Zygomatic Conical are straight, multi-unit, non-indexed abutments for the external hex connection of the
5
Zygomatic implants. Mini Abutment Zygomatic Standard are provided in one platform diameter (4.1 mm), one prosthetic platform diameter (4.5 mm), and in gingival heights of 3 mm, and 5.5 mm. Mini Abutment Zygomatic Conical are provided in one platform diameter (4.1 mm), one prosthetic platform diameter (4.8 mm), and in gingival heights of 2 mm, 3 mm, and 4 mm. Each abutment requires a corresponding subject device abutment screw to match the gingival height of the abutment. The Mini Abutment Standard and Mini Abutment Conical are the only abutments that are compatible with the subject device Zygomatic implants. For the Mini Abutment Zygomatic Standard, this submission also includes an Abutment Protector and a castable Co-Cr Base. For the Mini Abutment Zygomatic Conical, this submission also includes an Abutment Protector, Temporary Titanium Cylinder, and a castable Co-Cr Base. A Coping Screw is also included for use with all zygomatic abutments.
| Implant Line | Body Ø, mm | Platform Ø, mm | Lengths, mm |
|---|---|---|---|
| Strong SW HE | 3.75 | 4.1 | 18, 20, 22, 24 |
| Zygomatic | 4.5 coronal | ||
| 3.85 apical | 4.1 | 34, 36.5, 39, | |
| 41.5, 44, 46.5, 49, | |||
| 51.5, 54, 56.5, 59 |
The subject device dental implants are summarized in the following table.
All subject device dental implants are manufactured from unalloyed titanium conforming to ASTM F67. The subject device abutments, abutment screws, and implant cover are manufactured from titanium alloy conforming to ASTM F136. The materials in this submission (conforming to ASTM F67 and ASTM F136) are identical to the materials used to manufacture the dental implants and abutments cleared in K170398. The acid etching procedure is applied to all subject device dental implants. The acid etching process in this submission is identical to the process used to manufacture the dental implants cleared in K170398.
The subject device Mini Abutment Zygomatic Standard and Mini Abutment Zygomatic Conical abutments and corresponding abutment screws manufactured from titanium alloy (ASTM F136) are anodized using standard electrolytic passivation processing to increase the thickness of the natural oxide layer on the surface and to impart a distinctive gold surface color. The anodization process used in this submission is identical to the anodization process used on abutments cleared in K170398. The Abutment Protectors and Coping Screw are manufactured from titanium alloy (ASTM F136), the Co-Cr Bases are manufactured from Co-Cr-Mo alloy (ASTM F1537), and the Temporary Titanium Cylinder is manufactured from unalloyed titanium (ASMT F67).
PERFORMANCE DATA
Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence included: gamma irradiation sterilization for all subject devices (to a sterility assurance level of 10 % by selecting and substantiating a 25 kGy dose using method VDmax25, according to ISO 11137-1 and ISO 11137-2, referenced from K170398);
bacterial endotoxin testing (referenced from K170398) including Limulus amebocyte lysate (LAL) test according to ANSI/AAMI ST72 on samples of water used in manufacturing on a weekly basis and on
6
samples from sterilized product on a quarterly basis to demonstrate all sterile product meets a limit of Not in 510(k) Summary |
| | Apical thread diameter: 3.4 mm |
| | Apical thread length: 15 mm |
| | Unalloyed titanium, ASTM F67 |
| | Aluminum oxide grit blasted |
10
| Reference Device | |
|---|---|
| K173343 | |
| Zygomatic Implant System | |
| Southern Implants (Pty) Ltd | |
| Not stated in 510(k) Summary | |
| Compact Conical Abutments | |
| Platform Ø: not in 510(k) Summary | |
| Prosthetic Platform Ø: not in 510(k) Summary | |
| Gingival height: 2, 3, 4, 5.5 mm | |
| Straight | |
| Titanium Cylinder Abutment | |
| (Coping for Compact Conical Abutments) | |
| Gingival height 5 mm | |
| Titanium Cylinder Abutment, prosthetic platform | |
| Ø 3.4 mm | |
| Screw-retained, multi-unit | |
| Unalloyed titanium, ASTM F67; | |
| Titanium alloy, ASTM F136 | |
| Not stated in 510(k) Summary | |
| Sterile, method not stated in 510(k) Summary | |
| Not stated in 510(k) Summary | |
| Not stated in 510(k) Summary |