(296 days)
No
The summary describes a dental implant system with various physical components and materials. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies focus on sterilization, shelf life, biocompatibility, and mechanical properties, not algorithmic performance.
No
The device is a dental implant system used for structural support of dental restorations, rather than for treating a disease or condition.
No.
Explanation: The device is a dental implant system designed to provide support for restorations, which is a therapeutic rather than a diagnostic function.
No
The device description clearly outlines physical components made of titanium, cobalt-chromium, and polycarbonate, which are hardware materials. The performance studies also focus on physical properties and sterilization, not software validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that the S.I.N. Dental Implant System is a physical device intended for surgical placement in the jawbone to support dental restorations. It is made of materials like titanium and cobalt-chromium.
- Intended Use: The intended use is for providing support for dental restorations, which is a structural and mechanical function, not a diagnostic one performed on a biological sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information about a patient's health status.
Therefore, the S.I.N. Dental Implant System is a medical device, but it falls under the category of a dental implant system and not an in vitro diagnostic device.
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. Implants with lengths less than 7 mm are intended for delayed loading only.
Product codes
DZE, NHA
Device Description
The subject device consists of four Morse taper connection product lines: Unitite, Unitite Compact, and Strong SW CM. All implants are threaded cylindrical root-form designs. The Unitite provided with an acid-etched and HA surface, the Strong SW CM is provided with an acid-etched surface, Each product line has abutments available in multiple designs (temporary, cementable, angled, UCLA, ball, multi-unit). Subject device abutments are straight only.
Unitite implants are available in six implant body diameters (2.9. 3.5. 4.0. 4.3. 5.0 and 6.0 mm) and eight lengths (5, 6, 7, 8.5, 10, 11.5, 13, and 15 mm). Strong SW CM implants are available in four implant diameters (3.5, 3.8, 4.5.5.0 mm) and five lengths (8.5. 10. 11.5. 13. and 15 mm). Unitite abutments are available in five prosthetic platform diameters (3.3, 3.5, 4.0, 4.5, and 4.8 mm). Strong SW CM abutments are available in four prosthetic platform diameters (3.3, 3.5, 4.5 and 4.8 mm). Subject Device components are made of commercially pure titanium, titanium alloy, cobalt-chromium, or polycarbonate.
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 testing data submitted or relied upon to demonstrate substantial equivalence included: radiation sterilization validation according to ISO 11137-1 and 11137-2 and steam sterilization according to ISO 17665-1 and ISO 17665-2, demonstrating a sterility assurance level (SAL) of 10 %; Limulus amebocyte lysate (LAL) testing according to AANSI/AAMI ST 72: Shelf life testing according to ASTM F1980. ASTM F1929. and ASTM F88/F88M; biocompatibility testing according to ISO 10993-3 (genotoxicity), ISO 10993-5 (cytotoxicity), ISO 10993-6 (implantation), ISO 10993-10 (sensitization and irritation), and ISO 10993-11 (systemic toxicity) demonstrating acceptable biocompatibility; surface area analysis showing substantial equivalence to a predicate; and performance testing for insertion to show substantial equivalence to the predicate.
No clinical data were included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K120414, K072570, K081653, K101225, K092035
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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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.
December 5, 2017
S.I.N. - Sistema de Implante Nacional S.A. Linda K. Schulz Regulatory Affairs PaxMed International, LLC 12264 El Camino Real. Suite 400 San Diego, California 92130
Re: K170392
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 2, 2017 Received: November 3, 2017
Dear Linda K. Schulz:
This letter corrects our substantially equivalent letter of December 1, 2017.
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. Implants with lengths less than 7 mm are intended for delayed loading only.
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) |
|---|---|
| --------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------ |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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3
510(k) Summary S.I.N. - Sistema de Implante Nacional S.A. S.I.N. Dental Implant System K170392 December 1, 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, 21 CFR 872.3630, Class II |
| Product Code | DZE, NHA |
| Classification Panel | Dental Products Panel |
| Reviewing Branch | Dental Devices Branch |
PREDICATE DEVICE INFORMATION
| Primary Predicate | ||
|---|---|---|
| K051859 | Sistema de Implante Nacional Dental Implant System | Sistema de Implante Nacional, Ltda. |
| Reference Predicates | ||
| K120414 | OsseoSpeedTM Plus | Astra Tech AB |
| K072570 | NobelActive Multi Unit Abutment | Nobel Biocare AB |
| K081653 | MDI MII 2.9 mm Implants | IMTEC Corporation |
| K101225 | Promimic Dental Implant | Promimic AB |
| K092035 | Bicon Implants with a 2.5mm Internal Connection | Bicon, L.L.C |
4
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. Implants with lengths less than 7 mm are intended for delayed loading only.
DEVICE DESCRIPTION
The subject device consists of four Morse taper connection product lines: Unitite, Unitite Compact, and Strong SW CM. All implants are threaded cylindrical root-form designs. The Unitite provided with an acid-etched and HA surface, the Strong SW CM is provided with an acid-etched surface, Each product line has abutments available in multiple designs (temporary, cementable, angled, UCLA, ball, multi-unit). Subject device abutments are straight only.
Unitite implants are available in six implant body diameters (2.9. 3.5. 4.0. 4.3. 5.0 and 6.0 mm) and eight lengths (5, 6, 7, 8.5, 10, 11.5, 13, and 15 mm). Strong SW CM implants are available in four implant diameters (3.5, 3.8, 4.5.5.0 mm) and five lengths (8.5. 10. 11.5. 13. and 15 mm). Unitite abutments are available in five prosthetic platform diameters (3.3, 3.5, 4.0, 4.5, and 4.8 mm). Strong SW CM abutments are available in four prosthetic platform diameters (3.3, 3.5, 4.5 and 4.8 mm). Subject Device components are made of commercially pure titanium, titanium alloy, cobalt-chromium, or polycarbonate.
| IMPLANT | Body
Diameter
mm | Platform
Diameter
mm | Length
mm |
|-----------------|------------------------|----------------------------|-----------------------|
| Unitite Slim | 2.9 | 2.9 | 10, 11.5, 13 |
| Unitite | 3.5 | 3.5 | 8.5, 10, 11.5, 13, 15 |
| | 4.3 | 4.3 | 8.5, 10, 11.5, 13, 15 |
| | 5.0 | 5.0 | 8.5, 10, 11.5, 13, 15 |
| Unitite Compact | 4.0 | 4.0 | 5, 6, 7 |
| | 5.0 | 5.0 | 5, 6, 7 |
| | 6.0 | 6.0 | 5, 6, 7 |
| Strong SW CM | 3.5 | 3.5 | 8.5, 10, 11.5, 13, 15 |
| | 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 |
PERFORMANCE DATA
Non-clinical testing data submitted or relied upon to demonstrate substantial equivalence included: radiation sterilization validation according to ISO 11137-1 and 11137-2 and steam sterilization according to ISO 17665-1 and ISO 17665-2, demonstrating a sterility assurance level (SAL) of 10 %; Limulus amebocyte lysate (LAL) testing according to AANSI/AAMI ST 72: Shelf life testing according to ASTM F1980. ASTM F1929. and ASTM F88/F88M; biocompatibility testing according to ISO 10993-3 (genotoxicity), ISO 10993-5 (cytotoxicity), ISO 10993-6 (implantation), ISO 10993-10 (sensitization and irritation), and ISO 10993-11 (systemic toxicity) demonstrating acceptable biocompatibility; surface area analysis showing substantial equivalence to a predicate; and performance testing for insertion to show substantial equivalence to the 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.
5
Comparison of Indications for Use Statements
| Subject Device | |
|---|---|
| K170392 | |
| 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. Implants with lengths less than 7 mm are 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 | |
| OsseoSpeed™ 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 OsseoSpeed™ 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 Atlantis™ 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 Atlantis™ 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. | |
| K081653 | |
| MDI MII 2.9 mm Implants | |
| IMTEC Corporation | The MII Implant is intended to support single or multi-unit restorations in both long-term and temporary |
| applications throughout the maxillary and mandibular arches. The MII implant is indicated for immediate loading | |
| when good primary stability is achieved. Additionally, this device will permit stability and long term fixation of | |
| upper and lower dentures in edentulous cases. | |
| K101225 | |
| Promimic Dental Implant | |
| Promimic AB | The Promimic AB, Promimic Dental Implant is intended for surgical placement into the bone of upper/lower jaw |
| arches as a permanent anchorage for prosthetic devices and to restore chewing function. The Promimic Dental | |
| Implant can be immediately loaded only with good primary stability and appropriate occlusal loading. The | |
| Promimic Dental Implants are only to be used with straight abutments. | |
| K092035 | |
| Bicon Implants with a 2.5mm | |
| Internal Connection | |
| Bicon, L.L.C. | The Bicon implant is designed for use in edentulous sites in the mandible or maxilla for support of a complete |
| denture prosthesis, a final or intermediate abutment for fixed bridgework or for partial dentures, or as a single | |
| tooth replacement. |
6
Comparison of Technological Characteristics
| | Subject Device | Primary
Predicate Device | | | Reference
Predicate Devices | | |
|-----------------------------------|--------------------------------------------------|----------------------------------------------------------|---------------------------------------------|------------------------------------|--------------------------------|-----------------------------------|-------------------------------------------------------|
| | | K051859 | K120414 | K072570 | K081653 | K101225 | K092035 |
| | S.I.N. Implant
System | Sistema de Implante
Nacional
Dental Implant System | OsseoSpeed™ Plus | NobelActive Multi
Unit Abutment | MDI MII 2.9 mm
Implants | Promimic
Dental Implant | Bicon Implants with
a 2.5mm Internal
Connection |
| | S.I.N. – Sistema de
Implante Nacional
S.A. | S.I.N. – Sistema de
Implante Nacional,
Ltda. | Astra Tech AB | Nobel Biocare AB | IMTEC Corporation | Promimic AB | Bicon, L.L.C. |
| DESIGN | | | | | | | |
| Prosthesis Attachment | Screw-retained
Cement-retained | Screw-retained
Cement-retained | Screw-retained
Cement-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 | One Piece | External | Internal |
| Implant Diameter, mm | 2.9 - 6.0 | 3.25 - 6.3 | 3.0 - 5.4 | NA | 2.9 | 3.75 | 4.0 - 4.5 |
| Implant Length, mm | 5.0 - 15 | 7.0 - 18 | 6.0 - 17 | NA | 10 - 18 | 8.5 - 15 | 5 - 11 |
| Abutment Platform
Diameter, mm | 3.3 - 4.8
(Prosthetic Ø) | 3.4 - 5.5
(Prosthetic Ø) | 3.0 - 5.4 | NP, RP | NA | 3.75 | 4.0 - 6.5 |
| Abutment Angle | 0° | 0° - 19° | 0° - 30° | 0° - 30° | 0° | 0° | 0° |
| MATERIAL | | | | | | | |
| Implant | CPTi Gr 4 | CPTi Gr 4 | CPTi Gr 4 | NA | Titanium Alloy | CPTi Gr 4 | Ti6Al4V |
| Surface | Acid-Etched
HA | Acid-Etched | OsseoSpeed™ | NA | Unknown | HA | HA, TPS, Integra Ti,
NanoTite™ |
| 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 | Titanium Alloy | Ti-6Al-4V |
| Abutment Screw | Ti-6Al-4V | Ti-6Al-4V | Ti-6Al-4V | Ti-6Al-4V | NA | Titanium Alloy | Ti-6Al-4V |
7
The subject device and predicate devices are substantially equivalent in intended use. Minor differences in language in the Indications for Use Statement between the subject device and the predicate devices do not change the intended use of implant placement and function. All are implant systems placed in the maxilla or mandible for single or multi-unit restorations with possible immediate loading for implants shorter than 7 mm is substantially equivalent to the statement in K120414 limiting immediate loading to implants 8 mm or greater.
Indications for Use Statements of the above predicates, K101225, K120414, and K081653 include an indication for immediate loading. The phrase, "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" in the primary predicate submission, K051859, has been replaced with the phrase, "S.I.N. Dental Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading" as seen for the reference predicate K101225. The phrase, crowns, bridges and overdentures has been replaced with the equivalent statement, "single-unit or multi-unit restorations." Minor changes in language to the Indications for Use Statement do not affect the safety, efficacy or substantial equivalence of the subject device.
Subject device implants are substantially equivalent to K051859 implants in body, connection design, material and acid-etched surface. The subject device implant HA surface is substantially equivalent to the K101225 surface treatment. The short implant is substantially equivalent to K092035 in size, surface area and function. Subject device abutments are substantially equivalent to K051859 and 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 similar materials. The subject device and predicate devices encompass the same range of physical dimensions, including diameter, length and angle of 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.