(210 days)
No
The summary describes physical dental implants and related components, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is a dental implant system used to provide support for restorations in the mouth, which falls under the definition of a therapeutic device designed to treat or alleviate a medical condition (tooth loss).
No
The S.I.N. Dental Implant System is described as being for "placement in the maxillary or mandibular arch to provide support for single-unit or multi-unit restorations." Its function is structural support and restoration, not to diagnose a condition or disease.
No
The device description clearly details physical components like dental implants, abutments, and screws made from materials like titanium and Co-Cr-Mo alloy. The performance studies also focus on physical characteristics and testing of these hardware components.
Based on the provided text, the device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for placement in the maxillary or mandibular arch to support dental restorations. This is a surgical and prosthetic application within the body.
- Device Description: The description details dental implants, abutments, and related components used for dental procedures. These are physical devices implanted or attached to the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or compatibility testing.
The device is a dental implant system, which is a type of medical device used in dentistry.
N/A
Intended Use / Indications for 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. S.I.N. Dental Implant System implants with lengths of 18, 20, 22, or 24 mm may be tilted up to 30°. When used in the mandible or maxilla with implants with lengths of 18, 20, 22, or 24 mm at an angulation of 30°, a minimum of four implants must be used and must be splinted. When placed in the maxilla with lengths of 18, 20, 22, or 24 mm at angulations between 0° and less than 30°, the S.I.N. Dental Implants are only indicated for multiple unit restorations in splinted applications that utilize at least two implants. All digitally-designed custom abutments for use with Interface CAD-CAM abutments are to be sent to a S.I.N.-validated milling center for manufacture.
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, which includes components cleared previously in K211921, K203725, K200992, K193096, K170398, and K051859. This submission includes dental implants Epikut CM with a Morse taper (CM) abutment interface and an acid-etched endosseous surface, and Epikut Plus CM implants with an endosseous surface produced by acid-etching followed by application of a hydroxyapatite coating (HA "0"). The implant design and endosseous surfaces are identical to those cleared in K211921, with the exception of the additional body/platform diameter (4.0 mm) and the longer lengths (18, 20, 22, and 24 mm). This submission includes Multifunctional Abutments with Morse taper connections (16°, 11.5°, and 4°), and protectors and temporary cylinders for these abutments; the subject device Multifunctional Abutments are compatible with subject device implants (CM 11.5°) and previously-cleared implants (CM 16° and 4°). This submission also includes Multifunctional Abutment components (cylinders) manufactured from Co-Cr-Mo alloy compatible with the subject Multifunctional Abutments and with abutments cleared in K170392; CAD-CAM abutment components (called "Interface") manufactured from Ti-6A1-4V alloy and Co-Cr-Mo alloy, compatible with the subject Multifunctional Abutments and with abutments cleared in K170392; and screws compatible with subject device components and previously cleared components with the 11.5° Morse taper connection. All subject device abutments are straight, with no angulation allowed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillary or mandibular arch
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 subject devices provided sterile to the end user 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 K211921 and K203725); bacterial endotoxin testing (referenced from K211921) 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). 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.
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: K221453
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: November 14, 2022 Received: November 15, 2022
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) K221453
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.
S.I.N. Dental Implant System implants with lengths of 18, 20, 22, or 24 mm may be tilted up to 30°. When used in the mandible or maxilla with implants with lengths of 18, 20, 22, or 24 mm at an angulation of 30°, a minimum of four implants must be used and must be splinted. When placed in the maxilla with lengths of 18, 20, 22, or 24 mm at angulations between 0° and less than 30°, the S.I.N. Dental Implants are only indicated for multiple unit restorations in splinted applications that utilize at least two implants.
All digitally-designed custom abutments for use with Interface 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) | |
|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary K221453 S.I.N. - Sistema de Implante Nacional S.A.
S.I.N Dental Implant System
December 14, 2022
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 |
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 Dental Devices and ENT |
PREDICATE DEVICE INFORMATION
Primary Predicate Device K222231, S.I.N. Dental Implant System, S.I.N. - Sistema de Implante Nacional S.A. Reference Devices K211921, S.I.N. Dental Implant System, S.I.N. - Sistema de Implante Nacional S.A. K 193096, 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. K200992, S.I.N. Dental Implant System, S.I.N. - Sistema de Implante Nacional S.A.
4
24
24
24
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 implants with lengths of 18, 20, 22, or 24 mm may be tilted up to 30°. When used in the mandible or maxilla with implants with lengths of 18, 20, 22, or 24 mm at an angulation of 30°, a minimum of four implants must be used and must be splinted. When placed in the maxilla with lengths of 18, 20, 22, or 24 mm at angulations between 0° and less than 30°, the S.I.N. Dental Implant System implants are only indicated for multiple unit restorations in splications that utilize at least two implants.
All digitally-designed custom abutments for use with Interface CAD-CAM abutments are to be sent to a S.I.N.-validated milling center for manufacture.
SUBJECT DEVICE DESCRIPTION
Epikut Plus CM
The purpose of this submission is to add components to the S.I.N. Dental Implant System, which includes components cleared previously in K211921, K203725, K200992, K193096, K170398, and K051859.
This submission includes dental implants Epikut CM with a Morse taper (CM) abutment interface and an acid-etched endosseous surface, and Epikut Plus CM implants with an endosseous surface produced by acid-etching followed by application of a hydroxyapatite coating (HA ""0"). The implant design and endosseous surfaces are identical to those cleared in K211921, with the exception of the additional body/platform diameter (4.0 mm) and the longer lengths (18, 20, 22, and 24 mm).
| Implant Lines | Body Ø, mm | Platform Ø, mm | Lengths, mm | |||
|---|---|---|---|---|---|---|
| Enikut CM | J:U | 00 | ||||
| راهان وال | 1 C | 00 | ||||
| ﮯ ﮐﺎ ﺭﻗﺒﮧ 1998 ﻣﺮﺑﻊ ﮐﯿﻠﺌﮯ ﺳﺎﺗﮫ ﺍﻭﺭ ﺍﺱ ﮐﮯ ﺍﯾﮏ ﺭﮨﺎﺋﺸﯽ ﮨﮯ ﺍﻭﺭ ﺍﺱ ﮐﮯ ﺍﯾﮏ ﺍﯾﮏ ﺭﮨﺎﺋﺸﯽ ﮨﮯ ﺍﻭﺭ ﺍﺱ ﮐﮯ ﺳﺎﺗﮫ ﺍﻭﺭ ﺍﺱ ﮐﮯ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍ | C | |||||
| سك سك |
4.0
4.5
18
18
20
20
22
22
The subject device dental implants are summarized in the following table.
4.0
4.5
This submission includes Multifunctional Abutments with Morse taper connections (16°, 11.5°, and 4°), and protectors and temporary cylinders for these abutments; the subject device Multifunctional Abutments are compatible with subject device implants (CM 11.5°) and previously-cleared implants (CM 16° and 4°). This submission also includes Multifunctional Abutment components (cylinders) manufactured from Co-Cr-Mo alloy compatible with the subject Multifunctional Abutments and with abutments cleared in K170392; CAD-CAM abutment components (called "Interface") manufactured from Ti-6A1-4V alloy and Co-Cr-Mo alloy, compatible with the subject Multifunctional Abutments and with abutments cleared in K170392; and screws compatible with subject device components and previously cleared components with the 11.5° Morse taper connection. All subject device abutments are straight, with no angulation allowed. The subject device abutments and prosthetic components are summarized in the following table.
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| Abutment | Connection | Prosthetic Platform
diameter, mm | Gingival
Height, mm | Material |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|-------------------------------------|------------------------|-----------|
| Multifunctional | CM 16°, CM 11.5°, CM 4°
implants | 4.8 | 0.8-5.5 | Ti-6Al-4V |
| Protector for Multifunctional | n/a | n/a | n/a | Ti-6Al-4V |
| Temporary Cylinder Abutment | Micro Mini, Multifunctional | 3.5, 4.8 | 0.2-0.5 | Ti-6Al-4V |
| Chrome Cobalt Multifunctional | Multifunctional | 5.0 | 0.5-2.0 | Co-Cr-Mo |
| Chrome Cobalt Micro Mini | Micro Mini | 3.3 | 2.0 | Co-Cr-Mo |
| Interface Titanium Multifunctional | Multifunctional | 5.5 | 0.35 | Ti-6Al-4V |
| Interface Titanium Micro Mini | Micro Mini | 3.8 | 0.5 | Ti-6Al-4V |
| Interface Chrome Cobalt Multifunctional | Multifunctional | 5.5 | 0.35 | Co-Cr-Mo |
| Interface Chrome Cobalt Micro Mini | Micro Mini | 3.8 | 0.5 | Co-Cr-Mo |
| Screw for Protector Multifunctional | Multifunctional | n/a | n/a | Ti-6Al-4V |
| Screws for
Temporary Cylinder Multifunctional;
Interface Titanium Multifunctional;
Cobalt Chrome Multifunctional:
Interface Titanium Multifunctional;
Interface Chrome Cobalt Multifunctional | Multifunctional | n/a | n/a | Ti-6Al-4V |
For the Abutment Chrome Cobalt Multifunctional and Abutment Chrome Cobalt Micro Mini, the design limit parameters are:
Wall thickness of the final abutment before glazing must be at least 1.1 mm (0.3 mm after casting + 0.8 mm overlay)
Gingival margin diameter must be at least 0.5 mm beyond the prosthetic platform of the abutment. Gingival margin height must be at least 1 mm up to 3 mm.
Height of the abutment post must be between 4-9.5 mm.
Maximum angle - 0°, Straight only
For the Interface Titanium Multifunctional and Interface Titanium Micro Mini abutments, the design limit parameters are:
Minimum wall thickness - 0.5 mm Minimum post height for single-unit restoration - 4.0 mm Maximum angle - 0°, Straight only Maximum gingival height - 5.0 mm Minimum Gingival height of superstructure - 0 mm (gingival height provided by underlying apical base) Maximum allowable Post Height – 6 mm Total abutment height - 10 mm
For the Interface Chrome Cobalt Multifunctional and Interface Chrome Cobalt Micro Mini abutments, the design limits are:
Minimum wall thickness - 0.5 mm Minimum post height for single-unit restoration - 4.0 mm Maximum angle - 0°, Straight only Maximum gingival height - 5.0 mm Minimum Gingival height - 0 mm (gingival height provided by underlying apical base) Maximum allowable Post Height – 6 mm Total abutment height - 10 mm
6
All subject device dental implants are manufactured from unalloyed titanium conforming to ASTM F67. 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 K211921, and the HAM00 surface treatment is identical to that cleared in K211921.
The subject device implants are compatible with abutments and prosthetic components in this submission and components cleared previously in K200992, K193096, K170392, and K051859.
The subject device abutments and prosthetic components are compatible with implants and components in this submission and components cleared previously in K211921. K200992. K193096, and K170392.
PERFORMANCE DATA
Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence included:
gamma irradiation sterilization for subject devices provided sterile to the end user 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 K211921 and K203725);
bacterial endotoxin testing (referenced from K211921) 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