(86 days)
No
The summary describes a dental implant system and its components, specifically pre-milled CAD-CAM abutments. While it mentions CAD-CAM fabrication, there is no indication or mention of AI or ML being used in the design, manufacturing, or function of the device. The performance studies focus on sterilization, biocompatibility, MR safety, and mechanical testing, none of which suggest the use of AI/ML.
No
The device, the S.I.N. Dental Implant System (abutments and corresponding implants), is intended for placement in the maxillary or mandibular arch to provide support for dental restorations. While it supports the restoration of a physiological condition (missing teeth), its primary function is structural support, not active treatment or mitigation of a disease or condition. Therapeutic devices typically actively treat, prevent, or mitigate a disease.
No
The device is an implant system designed to provide support for dental restorations, not to diagnose a condition.
No
The device description explicitly states that the device includes physical components (Pre-Milled CAD-CAM Abutments made of titanium alloy) and is intended for placement in the body. This is not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device for surgical placement in the body to support dental restorations. This is an in-vivo application, not an in-vitro (outside the body) diagnostic test.
- Device Description: The description details physical components like dental implants and abutments made of titanium alloy, designed for surgical implantation and mechanical support. This aligns with a surgical/restorative device, not a diagnostic one.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device is a dental implant system, which is a type of medical device used for surgical and restorative purposes.
N/A
Intended Use / Indications for 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. All digitally-designed custom abutments for use with Pre-Milled CAD-CAM Abutments are to be sent to a S.I.N.-validated milling center for manufacture.
Product codes
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 K221453, K222231, K211921, K193096, and K170392.
This submission adds Pre-Milled CAD-CAM Abutments to the S.I.N. Dental Implant System. The subject device abutments are provided with 11.5° CM and 16° CM connections compatible with the above S.I.N. dental implants.
The design parameters for the CAD-CAM fabrication of patient-specific abutments from Pre-Milled CAD-CAM Abutments are the same for the 11.5° CM implant connection and the 16° CM implant connection. The design limit parameters are:
Minimum wall thickness - 0.55 mm
Minimum post height for single-unit restoration - 4.0 mm
Minimum gingival height - 0.55 mm
Maximum gingival height - 3.5 mm
Minimum prosthetic platform diameter - 3.5 mm
Maximum prosthetic post height - 6 mm
Maximum angulation - 30°
The subject device abutments are compatible with previously cleared S.I.N. Dental Implant bodies summarized in the following table.
All subject device abutments are manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F136, and are to be used with compatible abutment screws previously cleared in K170392. All subject device abutments are provided non-sterile and are to be moist heat sterilized by the end user.
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 or referenced to demonstrate substantial equivalence included:
- . provided in this submission was moist heat sterilization for subject devices provided non-sterile to the end user, validated to a sterility assurance level of 105 by the overkill method according to ANSI/AAMI/ISO 17665-1 and ANSI/AAMI/ISO TIR 17665-2;
- . referenced from K170398 was biocompatibility testing according to ISO 10993-5 (cytotoxicity) for the abutment material ASTM F136;
- . referenced from K221453 was non-clinical analysis and testing to evaluate the metallic subject devices and compatible dental implants in the MR environment according to ASTM F2052 (magnetically induced displacement force), ASTM F2213 (magnetically induced torque), ASTM F2182 (RF induced heating), and ASTM F2119 (image artifact), and the FDA guidance document Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment (issued May 2021);
- . provided in this submission was engineering analysis to demonstrate that the subject device abutments, in combination with compatible previously cleared dental implants, do not create a new worst-case construct in terms of mechanical testing according to ISO 14801; and
- referenced from K200992 was mechanical testing conducted according to ISO 14801 to support the performance of the subject device abutments, in conjunction with the engineering analysis provided in this submission.
No clinical data were included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K221453, K222231, K211921, K200992, K170392
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol is a stylized representation of a human figure, while the FDA name is written in blue and includes the words "U.S. Food & Drug Administration".
S.I.N. - Sistema de Implante Nacional S.A. % Kevin Thomas Vice President & Director of Regulatory Affairs PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130
Re: K230069
Trade/Device Name: S.I.N. Dental Implant System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: January 9, 2023 Received: January 10, 2023
Dear Kevin Thomas:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Andrew I. Steen -S
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
S.I.N. Dental Implant System
Indications for Use (Describe)
S.I.N. Dental Implant System is intended for placement in the maxillary or mandbular arch to provide support for single-unit or multi-unit restorations. When a one-stage surgical approach is applied, the S.I.N. Dental Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
All digitally-designed custom abutments for use with Pre-Milled CAD-CAM Abutments are to be sent to a S.I.N.-validated milling center for manufacture.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary K230069 S.I.N. - Sistema de Implante Nacional S.A. S.I.N Dental Implant System
April 6, 2023
ADMINISTRATIVE INFORMATION
| Manufacturer Name | S.I.N. - Sistema de Implante Nacional S.A.
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 | Dental implant abutment |
| Regulation Number | 21 CFR 872.3630 |
| Regulation Name | Endosseous dental implant abutment |
| Regulatory Class | Class II |
| Product Code | NHA |
| Classification Panel | Dental |
| Reviewing Office | Office of Health Technology 1 (Ophthalmic, Anesthesia, Respiratory, |
| ENT and Dental Devices) | |
| Reviewing Division | Division of Dental and ENT Devices |
PREDICATE DEVICE INFORMATION
Primary Predicate Device K 193096, S.I.N. Dental Implant System, S.I.N. - Sistema de Implante Nacional S.A.
Reference Devices K221453, S.I.N. Dental Implant System, S.I.N. - Sistema de Implante Nacional S.A. K222231, S.I.N. Dental Implant System, S.I.N. - Sistema de Implante Nacional S.A.
4
K211921, S.I.N. Dental Implant System, S.I.N. - Sistema de Implante Nacional S.A. K200992, S.I.N. Dental Implant System, S.I.N. - Sistema de Implante Nacional S.A. K 170392, S.I.N. Dental Implant System, S.I.N. - Sistema de Implante Nacional S.A.
INDICATIONS FOR USE STATEMENT
S.I.N. Dental Implant System is intended for placement in the maxillary or mandibular arch to provide support for single-unit or multi-unit restorations. When a one-stage surgical approach is applied, the S.I.N. Dental Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
All digitally-designed custom abutments for use with Pre-Milled CAD-CAM Abutments are to be sent to a S.I.N.-validated milling center for manufacture.
SUBJECT DEVICE DESCRIPTION
The purpose of this submission is to add components to the S.I.N. Dental Implant System, which includes components cleared previously in K221453, K222231, K211921, K193096, and K170392.
This submission adds Pre-Milled CAD-CAM Abutments to the S.I.N. Dental Implant System. The subject device abutments are provided with 11.5° CM and 16° CM connections compatible with the above S.I.N. dental implants.
The design parameters for the CAD-CAM fabrication of patient-specific abutments from Pre-Milled CAD-CAM Abutments are the same for the 11.5° CM implant connection and the 16° CM implant connection. The design limit parameters are:
Minimum wall thickness - 0.55 mm Minimum post height for single-unit restoration - 4.0 mm Minimum gingival height - 0.55 mm Maximum gingival height - 3.5 mm Minimum prosthetic platform diameter - 3.5 mm Maximum prosthetic post height - 6 mm Maximum angulation - 30°
The subject device abutments are compatible with previously cleared S.I.N. Dental Implant bodies summarized in the following table.
| Compatible Previously Cleared Implants, 11.5° CM | 510(k) Number |
|---|---|
| Unitite Implant, body Ø 3.5 mm, 4.3 mm, 5.0 mm | K170392 |
| Implant Strong SW, body Ø 3.5 mm, 3.8 mm, 4.5 mm, 5.0 mm | |
| Implant Strong SW Plus, body Ø 3.5 mm, 3.8 mm, 4.5 mm, 5.0 mm | |
| Implant Tryon CM Conical, body Ø 3.5 mm, 4.0 mm, 5.0 mm | K200992 |
| Implant Tryon CM Cylindrical Body and Conical Apex, body Ø 3.5 mm, 3.75 mm, 4.0 mm | |
| Implant Tryon CM Cylindrical, body Ø 3.5 mm, 3.75 mm, 4.0 mm, 5.0 mm | |
| Implant Epikut CM, body Ø 3.5 mm, 3.8 mm, 4.5 mm, 5.0 mm | |
| Implant Epikut Plus CM, body Ø 3.5 mm, 3.8 mm, 4.5 mm, 5.0 mm | K211921 |
| Implant Epikut CM, body Ø 3.8 mm, 4.0 mm, 4.5 mm | |
| Implant Epikut Plus CM, body Ø 3.8 mm, 4.0 mm, 4.5 mm | K221453 |
5
| Compatible Previously Cleared Implants, 16° CM | 510(k) Number |
|---|---|
| Strong SW CM Implant, body Ø 3.5 mm, 3.8 mm, 4.5 mm, 5.0 mm | K170392 |
| Strong SW CM Plus Implant, body Ø 3.5 mm, 3.8 mm, 4.5 mm, 5.0 mm | K193096 |
| Implant Epikut S, body Ø 3.5 mm, 3.8 mm, 4.0 mm, 4.5 mm, 5.0 mm | K222231 |
| Implant Epikut S Plus, body Ø 3.5 mm, 3.8 mm, 4.0 mm, 4.5 mm, 5.0 mm |
All subject device abutments are manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F136, and are to be used with compatible abutment screws previously cleared in K170392. All subject device abutments are provided non-sterile and are to be moist heat sterilized by the end user.
PERFORMANCE DATA
Non-clinical data submitted or referenced to demonstrate substantial equivalence included:
- . provided in this submission was moist heat sterilization for subject devices provided non-sterile to the end user, validated to a sterility assurance level of 105 by the overkill method according to ANSI/AAMI/ISO 17665-1 and ANSI/AAMI/ISO TIR 17665-2;
- . referenced from K170398 was biocompatibility testing according to ISO 10993-5 (cytotoxicity) for the abutment material ASTM F136;
- . referenced from K221453 was non-clinical analysis and testing to evaluate the metallic subject devices and compatible dental implants in the MR environment according to ASTM F2052 (magnetically induced displacement force), ASTM F2213 (magnetically induced torque), ASTM F2182 (RF induced heating), and ASTM F2119 (image artifact), and the FDA guidance document Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment (issued May 2021);
- . provided in this submission was engineering analysis to demonstrate that the subject device abutments, in combination with compatible previously cleared dental implants, do not create a new worst-case construct in terms of mechanical testing according to ISO 14801; and
- referenced from K200992 was mechanical testing conducted according to ISO 14801 to support the ● performance of the subject device abutments, in conjunction with the engineering analysis provided in this submission.
No clinical data were included in this submission.
EQUIVALENCE TO MARKETED DEVICES
The subject device is substantially equivalent in indications and design principles to the primary predicate device and the reference devices listed above. Provided at the end of this summary is a table comparing the Indications for Use Statements and the technological characteristics of the subject device, the primary predicate device, and the reference devices.
The primary predicate device K193096 is in support of substantial equivalence of the Indications for Use including CAD-CAM abutments, abutment designs, materials, manufacturing, sterilization, and compatible implants. The reference devices K221453, K222231, K211921, K200992, and K170392 are in support of substantial equivalence of the Indications for Use including CAD-CAM abutments (K221453), abutment designs, materials, manufacturing, sterilization, and compatible implants.
6
The Indications for Use Statement (IFUS) for the subject device includes language concerning placement in the maxillary or mandibular arches and regarding immediate loading that is identical to the language in K193096. The IFUS for the subject device also includes language concerning CAD-CAM abutments and validated milling centers that is identical, besides the trade name, to that included in K193096.
Differences between the IFUS for the subject device and the reference devices include: language in K221453 and K222231 regarding indications for implants with lengths of 18-24 mm that is not relevant to the subject device; language in K170392 regarding implant lengths less than 7 mm that is not relevant to the subject device; and the IFUS for K222231, K211921, K200992, and K170392 do not contain language regarding CAD-CAM abutments and validated milling centers.
The subject device abutments with the 11.5° CM interface are compatible with implants cleared in K200992, K221453, K211921, and K170392 in terms of the abutment-implant connection. The subject device abutments with the 11.5° CM interface in final finished form are substantially equivalent to the Abutment Cemented Angled Indexed SIT cleared in K200992 in terms of material and design limit parameters including prosthetic platform diameter, maximum gingival height, and maximum angulation.
The subject device abutments with the 16° CM interface are compatible with implants cleared in K222231, K193096, and K170392 in terms of the abutment-implant connection. The subject device abutments with the 16° CM interface in final finished form are substantially equivalent to the Abutment Cemented Morse Angled cleared in K200992 in terms of material and design limit parameters including prosthetic platform diameter, maximum gingival height, and maximum angulation.
The subject device abutments are to be end user sterilization instructions are provided in the Instructions for Use. Similar components to be end-user sterilized (abutments manufactured from Ti-6Al-4V alloy material) were cleared in K221453, K193096, and K170392.
The subject device abutments are packaged in a polyethylene terephthalate blister pack with a Tyvek cover. The Tyvek cover for the blister pack is printed with the appropriate label for the corresponding component. This is the same packaging used for similar abutments (provided non-sterile) in K221453.
An engineering rationale was provided to demonstrate that the use of the subject device abutments in combination with the compatible implants raise no new risks and that mechanical testing data provided in a prior submission (K200992) are applicable to the subject abutments.
CONCLUSION
The subject device, the primary predicate device, and the reference devices have the same intended use, have similar technological characteristics, and are made of identical or similar materials. The subject device, the primary predicate, and the reference devices encompass the same range of physical dimensions, are packaged in similar materials, and are sterilized using similar methods.
The data included in this submission demonstrate substantial equivalence to the primary predicate device and the reference devices listed above.
7
Table of Substantial Equivalence
| Subject Device | Primary Predicate Device | Reference Device | Reference Device | Reference Device | |
|---|---|---|---|---|---|
| K230069 | |||||
| S.I.N. Dental Implant System | K193096 | ||||
| S.I.N. Dental Implant System | K200992 | ||||
| S.I.N. Dental Implant System | K221453 | ||||
| S.I.N. Dental Implant System | K170392 | ||||
| S.I.N. Dental Implant System | |||||
| S.I.N. - Sistema de Implante Nacional S.A. | S.I.N. - Sistema de Implante Nacional S.A. | S.I.N. - Sistema de Implante Nacional S.A. | S.I.N. - Sistema de Implante Nacional S.A. | S.I.N. - Sistema de Implante Nacional S.A. | |
| Indications for Use Statement | |||||
| (IFUS) | S.I.N. Dental Implant System is intended for placement | ||||
| in the maxillary or mandibular arch to provide support | |||||
| for single-unit or multi-unit restorations. When a one- | |||||
| stage surgical approach is applied, the S.I.N. Dental | |||||
| Implant System is intended for immediate loading when | |||||
| good primary stability is achieved and with appropriate | |||||
| occlusal loading. | |||||
| All digitally-designed custom abutments for use with | |||||
| Pre-Milled CAD-CAM abutments are to be sent to a | |||||
| S.I.N .- validated milling center for manufacture. | S.I.N. Dental Implant System is intended for placement | ||||
| in the maxillary or mandibular arch to provide support | |||||
| for single-unit or multi-unit restorations. When a one- | |||||
| stage surgical approach is applied, the S.I.N. Dental | |||||
| Implant System is intended for immediate loading when | |||||
| good primary stability is achieved and with appropriate | |||||
| occlusal loading. | |||||
| All digitally-designed custom abutments for use with | |||||
| Interface CAD-CAM abutments are to be sent to a | |||||
| S.I.N.-validated milling center for manufacture. | 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. | |||||
| 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 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. | 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. | |||||
| Reason for | |||||
| Predicate Device | Not applicable | IFUS including CAD-CAM abutments and validated | |||
| milling centers; | |||||
| Compatible implants | Abutment designs; materials; manufacturing; | ||||
| sterilization; | |||||
| Compatible implants | IFUS including CAD-CAM abutments and validated | ||||
| milling centers; | |||||
| Compatible implants | Abutment designs; materials; manufacturing; | ||||
| sterilization | |||||
| Compatible implants | |||||
| Product Codes | NHA | DZE, NHA | DZE, NHA | DZE, NHA | DZE, NHA |
| 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 the edentulous | ||||
| mandible or maxilla | Functional and esthetic rehabilitation of the edentulous | ||||
| mandible or maxilla | |||||
| Abutment Designs | |||||
| CM 11.5° interface | Pre-Milled Blank Abutments | ||||
| CM 11.5° interface | |||||
| Minimum post height for single-unit restoration: 4 mm | |||||
| Prosthetic platform Ø: 3.5 mm (min) | |||||
| Gingival height: 3.5 mm (max), 0.55 mm (min) | |||||
| Angle: 30° (max) | |||||
| Indexed | Abutment Cemented Angled Indexed SIT | ||||
| CM 11.5° interface | |||||
| Prosthetic platform Ø: 3.3, 4.5 mm | |||||
| Gingival height: 1.5-3.5 mm | |||||
| Angle: 17°, 30° | |||||
| Indexed | |||||
| CM 16° interface | Pre-Milled Blank Abutments | ||||
| CM 16° interface | |||||
| Minimum post height for single-unit restoration: 4 mm | |||||
| Prosthetic platform Ø: 3.5 mm (min) | |||||
| Gingival height: 3.5 mm (max), 0.55 mm (min) | |||||
| Angle: 30° (max) | |||||
| Indexed | Abutment Cemented Morse Angled | ||||
| CM 16° interface | |||||
| Prosthetic platform Ø: 3.3, 4.5 mm | |||||
| Gingival height: 1.5-3.5 mm | |||||
| Angle: 17°, 30 | |||||
| Indexed | |||||
| Abutment Materials | Titanium alloy, ASTM F136 | Titanium alloy, ASTM F136 | Titanium alloy, ASTM F136 | Titanium alloy, ASTM F136 | Titanium alloy, ASTM F136 |
| Subject Device | Primary Predicate Device | Reference Device | Reference Device | Reference Device | |
| K230069 | |||||
| S.I.N. Dental Implant System | K193096 | ||||
| S.I.N. Dental Implant System | K200992 | ||||
| S.I.N. Dental Implant System | K221453 | ||||
| S.I.N. Dental Implant System | K170392 | ||||
| S.I.N. Dental Implant System | |||||
| S.I.N. - Sistema de Implante Nacional S.A. | S.I.N. - Sistema de Implante Nacional S.A. | S.I.N. - Sistema de Implante Nacional S.A. | S.I.N. - Sistema de Implante Nacional S.A. | S.I.N. - Sistema de Implante Nacional S.A. | |
| Compatible Implants | |||||
| CM 11.5° Connection | Strong SW and | ||||
| Strong SW Plus | |||||
| Body/platform $Ø$ 3.5/3.5; 3.8/3.8; 4.5/4.5; 5.0/5.0 mm | |||||
| Lengths 8.5-15 mm | Epikut CM | ||||
| Epikut Plus CM | |||||
| Body/platform $Ø$ 3.8/3.8; 4.0/4.0; 4.5/4.5 mm | |||||
| Lengths 18-24 mm | Unitite | ||||
| Body/platform $Ø$ 3.5/3.5; 4.3/4.3, 5.0/5.0 mm | |||||
| Lengths 8.5-15 mm | |||||
| Tryon CM Conical | |||||
| Body/platform $Ø$ 3.5/3.5, 4.0/4.0; 5.0/5.0 mm | |||||
| Lengths 8.5-15 mm | |||||
| Tryon CM Cylindrical Body and Conical Apex | |||||
| Body/platform $Ø$ 3.5/3.5, 3.8/3.8, 4.5/4.5; 5.0/5.0 mm | |||||
| Lengths 8.5-15 mm | |||||
| Tryon CM Cylindrical | |||||
| Body/platform $Ø$ 3.5/3.5, 3.75/3.75, 4.0/4.0; 5.0/5.0 mm | |||||
| Lengths 7-15 mm | |||||
| CM 16° Connection | Strong SW CM Plus | ||||
| Body/platform $Ø$ 3.5/3.5; 3.8/3.8; 4.5/4.5; 5.0/5.0 mm | |||||
| Lengths 8.5-15 mm | Strong SW CM | ||||
| Body/platform $Ø$ 3.5/3.5; 3.8/3.8; 4.5/4.5; 5.0/5.0 mm | |||||
| Lengths 8.5-15 mm | |||||
| How Provided | |||||
| Abutments | Non-sterile, | ||||
| to be sterilized by moist heat by the end user | Sterile by gamma irradiation | ||||
| and | |||||
| Non-sterile, | |||||
| to be sterilized by moist heat by the end user | Sterile by gamma irradiation | Sterile by gamma irradiation | |||
| and | |||||
| Non-sterile, | |||||
| to be sterilized by moist heat by the end user | Sterile by gamma irradiation | ||||
| and | |||||
| Non-sterile, | |||||
| to be sterilized by moist heat by the end user | |||||
| Usage - All Components | Single patient, single use | Single patient, single use | Single patient, single use | Single patient, single use | Not stated in 510(k) Summary |
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