(285 days)
No
The 510(k) summary describes a dental implant system and its components. There is no mention of AI, ML, image processing, or any data sets typically associated with AI/ML development or validation. The performance studies focus on sterilization, biocompatibility, and shelf life, which are standard for this type of device and do not involve AI/ML.
No
The device is a dental implant system used for structural support of restorations, not for treating a disease or condition.
No
This device, the S.I.N. Dental Implant System, is intended for placement in the jaw to support dental restorations, which is a therapeutic rather than a diagnostic function.
No
The device description clearly outlines physical components made of titanium and cobalt-chromium alloy, such as implants and abutments, which are hardware.
Based on the provided information, this 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 procedure performed directly on the patient's body.
- Device Description: The description details physical implants and abutments made of materials like titanium and cobalt-chromium alloy. These are physical devices implanted into bone.
- 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, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a physical implant.
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. Revolution Compact with a 6 mm length is intended for delayed loading only.
Product codes
DZE, NHA
Device Description
The subject device includes six product lines (Revolution Compact, Micro-Mini Revolution, Strong SW HE, TryOn, Strong SW HI). Five of the product lines have an external hex implant/abutment connection (HE) and one has an internal hex implant/abutment connection (HI). Each product line includes implants with an acid-etched surface and abutments in multiple designs (healing, provisional, cemented, UCLA, overdenture, conical and mini).
Revolution implants (Revolution Compact, Micro-Mini Revolution) are cylindrical implants with apical cutting flutes and are placed with the Revolution Assembler mount. Strong SW HI are cylindrical implants with apical cutting flutes and micro-threads on the collar. Strong SW HE has and external connection and Strong SW HI has an internal connection. TryOn implants with apical cutting flutes and a machined collar. Subject Device components are made of commercially pure titanium, titanium alloy or cobalt-chromium alloy. All subject device abutments have 0° angulation.
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
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included: radiation sterilization validation to an SAL of 10° according to ISO 11137-1, ISO 11137-2; Steam sterilization validation to an SAL of 10° according to ISO 17665-1 and ISO 17665-2; biocompatibility evaluation according to ISO 10993-1 by reference to K051859 and biocompatibility testing according to ISO 10993-5 (cytotoxicity), demonstrating acceptable biocompatibility ; Limulus amebocyte lysate (LAL) endotoxin testing in accordance with FDA Guidance documents Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile; shelf life testing seal leaks according to ASTM F88/F88M, seal integrity testing according to ASTM F1929, accelerated age testing according to ASTM F1980, and surface area analysis showing substantial equivalence to a predicate.
No clinical data were included in this submission.
Key Metrics
Not Found
Predicate Device(s)
K021859, K120414, K072570, K072363, K092035, K101945
Reference Device(s)
K120414, K072570, K072363, K092035, K101945
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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 contains 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 features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
S.I.N. - Sistema De Implante Nacional S.A. % Linda Schulz Regulatory Affairs PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130
November 21, 2017
Re: K170398
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 23, 2017 Received: October 24, 2017
Dear Linda Schulz:
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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Mary S. Runner -S
for
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control. and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
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 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.
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 S.I.N. - Sistema de Implante Nacional S.A. S.I.N. Dental Implant System K170398
November 21, 2017
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 | Dênis Oliveira
Quality and Regulatory Manager |
| Representative/Consultant | Linda K. Schulz, BSDH, RDH
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: lschulz@paxmed.com
flarson@paxmed.com |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name | S.I.N. Dental Implant System |
|---|---|
| Common Name | Dental implant |
| Dental implant abutment | |
| Classification Name | Implant, endosseous, root form |
| Endosseous dental implant abutment | |
| Classification Regulations | 21 CFR 872.3640, Class II |
| Product Code | DZE, NHA |
| Classification Panel | Dental Products Panel |
| Reviewing Branch | Dental Devices Branch |
PREDICATE DEVICE INFORMATION
Primary Predicate Sistema de Implante Nacional Dental Implant System K021859 Sistema de Implante Nacional, Ltda.
4
| Reference Predicates | ||
|---|---|---|
| K120414 | OsseoSpeed™ Plus | Astra Tech AB |
| K072570 | NobelActive Multi Unit Abutment | Nobel Biocare AB |
| K072363 | BIOMET 3i NanoTite™ Dental Implants | Biomet 3i, Inc. |
| K092035 | Bicon Implants with a 2.5mm Internal Connection | Bicon, L.L.C. |
| K101945 | Neodent Implant System | JJGC Industria e Comercio de Materiais |
| Dentarios SA |
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. Revolution Compact with a 6 mm length is intended for delayed loading only.
DEVICE DESCRIPTION
The subject device includes six product lines (Revolution Compact, Micro-Mini Revolution, Strong SW HE, TryOn, Strong SW HI). Five of the product lines have an external hex implant/abutment connection (HE) and one has an internal hex implant/abutment connection (HI). Each product line includes implants with an acid-etched surface and abutments in multiple designs (healing, provisional, cemented, UCLA, overdenture, conical and mini).
Revolution implants (Revolution Compact, Micro-Mini Revolution) are cylindrical implants with apical cutting flutes and are placed with the Revolution Assembler mount. Strong SW HI are cvlindrical implants with apical cutting flutes and micro-threads on the collar. Strong SW HE has and external connection and Strong SW HI has an internal connection. TryOn implants with apical cutting flutes and a machined collar. Subject Device components are made of commercially pure titanium, titanium alloy or cobalt-chromium alloy. All subject device abutments have 0° angulation.
| Summary of Implant Sizes | |||
|---|---|---|---|
| Body | |||
| Diameter | |||
| (mm) | Platform | ||
| Diameter | |||
| (mm) | Length | ||
| (mm) | |||
| Revolution | 4.0 | 4.1 | 7 |
| Revolution Compact | 4.0, 5.0 | 5.0 | 6 |
| Strong SW HE | 3.5 | 3.65 | 7, 8.5, 10, 11.5, 13, 15 |
| 3.75, 4.0 | 4.1 | 7, 8.5, 10, 11.5, 13, 15 | |
| 4.5 | 4.5 | 8.5, 10, 11.5, 13, 15 | |
| 5.0 | 5.0 | 7, 8.5, 10, 11.5, 13, 15 | |
| TryOn | 3.25 | 4.1 | 8.5, 10, 11.5, 13, 15 |
| 3.75, 4.0 | 4.1 | 7, 8.5, 10, 11.5, 13, 15 | |
| 5.0 | 5.0 | 7, 8.5, 10, 11.5, 13, 15 | |
| Strong SW HI | 3.8 | 3.8 | 8.5, 10, 11.5, 13, 15 |
| 4.5 | 4.5 | 8.5, 10, 11.5, 13, 15 | |
| 5.0 | 5.0 | 8.5, 10, 11.5, 13, 15 |
y of Implant Sizes
5
PERFORMANCE DATA
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included: radiation sterilization validation to an SAL of 10° according to ISO 11137-1, ISO 11137-2; Steam sterilization validation to an SAL of 10° according to ISO 17665-1 and ISO 17665-2; biocompatibility evaluation according to ISO 10993-1 by reference to K051859 and biocompatibility testing according to ISO 10993-5 (cytotoxicity), demonstrating acceptable biocompatibility ; Limulus amebocyte lysate (LAL) endotoxin testing in accordance with FDA Guidance documents Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile; shelf life testing seal leaks according to ASTM F88/F88M, seal integrity testing according to ASTM F1929, accelerated age testing according to ASTM F1980, and surface area analysis showing substantial equivalence to a predicate.
No clinical data were included in this submission.
EQUIVALENCE TO MARKETED DEVICE
The subject device is substantially equivalent in indications and design principles to the predicate devices shown above. Below are summary tables comparing the Indications for Use and the technological characteristics of the subject device and the predicate devices.
| Subject Device | |
|---|---|
| K170398 | |
| S.I.N Implant System | |
| SIN - Sistema de Implante Nacional | |
| S.A. | 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. | |
| Primary Predicate Device | |
| K051859 | |
| Sistema de Implante Nacional Dental | |
| Implant System | |
| SIN - Sistema de Implante Nacional, | |
| Ltda. | The Sistema de Implante Nacional Dental Implant System is intended to be surgically placed in the bone of |
| the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures. Implants may be | |
| placed immediately after tooth extraction or following bone healing. Restorations supported by two or more | |
| Sistema de Implante Nacional implants may be loaded immediately after implant placement if primary | |
| implant stability has been achieved. | |
| Reference Predicate Devices | |
| K120414 | |
| OsseoSpeedTM Plus | |
| Astra Tech AB | Implants: The Astra Tech Dental Implants are intended for both one- and two-stage surgical procedures in the |
| following situations and with the following clinical protocols: | |
| replacing single and multiple missing teeth in the mandible and maxilla, immediate placement in extraction sites and in situations with a partially or completely healed alveolar ridge, especially indicated for use in soft bone applications where implants with other implant surface treatments may be less effective, immediate loading in all indications, except in single tooth situations on implants shorter than 8 mm, or in soft bone (type IV) where implant stability may be difficult to obtain and immediate loading may not be appropriate. The intended use for OsseoSpeedTM Plus 3.0S is limited to replacement of maxillary lateral incisors and mandibular incisors. | |
| Abutments: Astra Tech Implant System Plus abutments are intended to be used in conjunction with Astra | |
| Tech Implant System Plus in fully edentulous or partially edentulous maxillary and/or mandibular arches to | |
| provide support for crowns, bridges or overdentures. | |
| Atlantis Abutments: The AtlantisTM Abutment is intended for use with an endosseous implant to support a | |
| prosthetic device in a partially or completely edentulous; patient. It is intended for use to support single and | |
| multiple tooth prostheses, in the mandible or maxilla. The prosthesis can be cemented, screw retained or | |
| friction fit to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant. | |
| The AtlantisTM Crown Abutment in Zirconia is intended for use with an endosseous; implant to function as a | |
| substructure that also serves as the final restoration, in partially or completely edentulous; patients. The | |
| prosthesis is screw retained. The abutment screw is intended to secure the crown abutment to the endosseous | |
| implant. | |
| K072570 | |
| NobelActive Multi Unit Abutment | |
| Nobel Biocare AB | NobelActive Multi Unit Abutment is a pre-manufactured prosthetic component directly |
| connected to the endosseous dental implant and intended for use as an aid in prosthetic | |
| rehabilitation. |
Comparison of Indications for Use Statements
6
| K072363
BIOMET 3i NanoTite™ Dental
Implants
BIOMET 3i, Incorporated | BIOMET 3i dental implants are intended for surgical placement in the upper or lower jaw to provide a means
for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple
single teeth utilizing delayed or immediate loading, or as a terminal or intermediary abutment for fixed or
removable bridgework, and to retain overdentures.
BIOMET 3i NanoTite dental implants are intended for immediate function on single tooth and/or multiple
tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to
restore chewing function. |
|------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K092035 | The Bicon implant is designed for use in edentulous sites in the mandible or maxilla for support of a complete |
| Bicon Implants with a 2.5mm Internal
Connection | denture prosthesis, a final or intermediate abutment for fixed bridgework or for partial dentures, or as a single
tooth replacement. |
| Bicon, L.L.C. | |
| K101945 | 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 |
| Neodent Implant System | 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 |
| JJGC Industria e Comercio de Materiais
Dentarios SA | may be rigidly splinted. |
7
Comparison of Technological Characteristics
| | Subject Device | Primary
Predicate Device | Reference Predicate Devices | | | | |
|-------------------------------|--------------------------------------------------|----------------------------------------------------------|---------------------------------------------|------------------------------------|-------------------------------------------|-------------------------------------------------------|-----------------------------------------------------------|
| | | K051859 | K120414 | K072570 | K072363 | K092035 | K101945 |
| | S.I.N. Implant
System | Sistema de Implante
Nacional
Dental Implant System | OsseoSpeed™ Plus | NobelActive Multi
Unit Abutment | BIOMET 3i
NanoTite™
Dental Implants | Bicon Implants with
a 2.5mm Internal
Connection | Neodent Implant System |
| | S.I.N. - Sistema
de Implante
Nacional S.A. | S.I.N. - Sistema de
Implante Nacional,
Ltda. | Astra Tech AB | Nobel Biocare AB | BIOMET 3i, Inc. | Bicon, L.L.C. | JJGC Industria e
Comercio de Materiais
Dentarios SA |
| DESIGN | | | | | | | |
| Prosthesis Attachment | Screw-retained
Cement-retained | Screw-retained
Cement-retained | Screw-retained
Cement-retained | Screw-retained | Screw-retained
Cement-retained | Screw-retained
Cement-retained | Screw-retained
Cement-retained |
| Restoration | Single-unit
Multi-unit | Single-unit
Multi-unit | Single-unit
Multi-unit | Multi-unit | Single-unit
Multi-unit | Single-unit
Multi-unit | Single-unit
Multi-unit |
| Implant/Abutment
Interface | External
Internal | External
Internal | Internal | Internal | External
Internal | Internal | Internal |
| Implant Diameter, mm | 3.25 - 5.0 | 3.25 - 6.3 | 3.0 - 5.4 | NA | 3.25 - 6.0 | 4.0 - 4.5 | 3.3 - 5.0 |
| Implant Length, mm | 6.0 - 18 | 7.0 - 18 | 6.0 - 17 | NA | 8.5 - 18 | 5 - 11 | 7.0 - 19 |
| Abutment Diameter, mm | 3.4 - 5.0 | 3.4 - 5.5 | 3.0 - 5.4 | NP, RP | NA | 4.0 - 6.5 | 3.3 - 5.0 |
| Abutment Angle | 0° | 0° - 19° | 0° - 30° | 0° - 30° | NA | 0° - 25° | 0° - 30° |
| MATERIAL | | | | | | | |
| Implant | CPTi Gr 4 | CPTi Gr 4 | CPTi Gr 4 | NA | CPTi Gr 4 | TI6AL4V | CPTi Gr 4 |
| Surface | Acid-Etched | Acid-Etched | OsseoSpeed™ | NA | NanoTite™ | HA, TPS, Integra Ti,
NanoTite™ | Grit blasted and
acid etched |
| Abutment | Ti-6Al-4V
CoCr | CPTi Gr 2
Ti-6Al-4V
CoCr
Gold alloy | Ti-6Al-4V
Zirconia
Gold alloy
PEEK | Ti-6Al-4V | NA | Ti-6Al-4V | Ti-6Al-4V
Zirconia
Gold alloy
POM |
| Abutment Screw | Ti-6Al-4V | Ti-6Al-4V | Ti-6Al-4V | Ti-6Al-4V | NA | Ti-6Al-4V | Ti-6Al-4V |
8
510(k) Summary Page 6 of 6
The subject device and predicate devices are substantially equivalent in intended use. Small differences in language in the Indications for Use Statement between the subject device and the primary predicate K051859 do not change the intended use of implant placement and function. Both are implant systems placed in the maxilla or mandible to support single or multi-unit restore chewing function, with possible immediate loading. A comparison of equivalent phrasing for the subject device and primary predicate device is shown in the table below.
| Subject Device | Primary Predicate Device – K051859 |
|---|---|
| S.I.N. Dental Implant System is intended for placement | |
| in the maxillary or mandibular arch. | The Sistema de Implante Nacional Dental Implant |
| System is intended to be surgically placed in the bone of | |
| the maxillary and/or mandibular arch | |
| to provide support for single-unit or multi-unit | |
| restorations. | to provide support for crowns, bridges or overdentures |
| Implants may be placed immediately after tooth | |
| extraction or following bone healing. | |
| 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. | Restorations supported by two or more Sistema de |
| Implante Nacional implants may be loaded immediately | |
| after implant placement if primary implant stability has | |
| been achieved. |
Subject device implants are substantially equivalent to K051859 implants in body, connection design, material and acid etched surface. The short is substantially equivalent to K092035 in size, surface area and function. Subject device abutments are substantially equivalent to K051859 abutments in material, design and function, with the exception of the design of the ball abutment. Subject device abutments are substantially equivalent to K120414 abutments in material, design and function. Subject device multi-unit abutments are substantially equivalent to K072570 abutments in material, design and function.
CONCLUSION
The subject device and the predicate devices have the same intended use, have similar technological characteristics, and are made of the same or similar materials. The subject device and predicate devices encompass the same range of physical dimensions, including diameter, length and angle of the abutments. The subject and predicate devices are packaged in similar materials and are to be sterilized using similar methods.
The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.