(290 days)
No
The device description and performance studies focus solely on the physical components, materials, and mechanical testing of dental implants and related hardware. There is no mention of software, algorithms, or any computational processing that would suggest the use of AI or ML.
No.
The device is a dental implant system used to provide support for prosthetic devices to restore chewing function. It does not treat or cure a disease or condition.
No
Explanation: The device description and intended use clearly state that the Surgikor Dental Implant System is designed for surgical and restorative applications to provide support for prosthetic devices (artificial teeth) and restore chewing function. It outlines components like implants, abutments, and screws, all of which are used for physical implantation and support, not for diagnosing medical conditions or diseases.
No
The device description clearly outlines various physical components made of materials like Ti6ALAV ELI and gold, including implants, abutments, screws, and caps. This indicates a hardware-based medical device, not a software-only one.
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 surgical and restorative applications within the bone of the jaw to support prosthetic devices and restore chewing function. This is a direct medical intervention on the patient's body.
- Device Description: The device consists of implants, abutments, screws, and other components designed to be physically implanted and used within the mouth.
- 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 compatibility testing.
IVD devices are used in vitro (outside the body) to analyze samples and provide diagnostic information. This device is used in vivo (inside the body) for structural support and restoration.
N/A
Intended Use / Indications for Use
Surgikor's Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The Dental Implant System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading. The 7mm implants are intended to be used in the molar region.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
The Surgikor Dental Implant System consists of two stage endosseous form dental implants, hexagonal and conical implants and hexagonal and conical abutments; cover screws and healing caps; abutment systems including multi-unit abutments. Implants are made from Ti6ALAV ELI.
The Surgikor Dental Implant System includes:
Versatile model is a platform switched, tapered implant designed for use in any bone type and is offered with a Morse tapered hex connection. The regular hex platform comes in diameters of 3.5, 3.75, 4.2, 4.5, 5.0 and 6.0mm. Lengths of 8, 10, 11.5, 13 and 16 are available with 18 and 20 mm lengths available in the 4.2 diameter only.
Immediate model is a platform switched root-form implant design. The Immediate suitable for both immediate load applications and insertion into fresh extraction sockets and is offered with a Morse tapered hex connection in regular platform. It is available in 3.75, 4.2, 4.5, 5.0, 6.0, and 7.0 mm diameter. The hex is regular platform and comes in lengths of 7 (4.5, 5, 6.and 7mm only), 8, 10, 11.5, 13, 16 (7.0mm diameter not in 11.5,13 or 16 mm length).
Fixation model is a root form implant is appropriate for both immediate load applications and insertion into fresh extraction sockets. The Fixation is offered with a conical connection in narrow, regular and wide platforms. The 3.0 diameter implant is available in narrow platform and lengths of 10, 11.5, 13 and 15mm. The Fixation regular platform implant is available in 3.5 and 3.9 mm diameter and has available lengths of 8.5, 10, 11.5, 15, and 18 mm. Wide platform is available in 4.3 and 5.0 mm diameter with lengths of 8.5, 10, 11.5, 13, 15 and 18mm.
Solution model is equipped with a specially designed, narrow, deep, conical connection and is designed for use in narrow bone volumes. The Solution5 is available in narrow platform with a diameter of 3.25mm and lengths of 10, 11.5, 13, 15 mm. The regular platform is available in 3.5, and 4.0 diameter in lengths of 7.0 (4.0 diameter only), 8.5, 10. 11.5, 13, 15mm. The wide platform is available in diameters of 4.5. 5.0. 5.5 and 6.0mm. These diameters come in lengths of 7.0. 8.5. 10. 11.5. 13. and 15mm. The Solution2 is available with lengths of 10. 11.5. 13. and 16 mm in a diameter of 3.25 mm. The Solution5 and Solution2 differ in that the Solution5 implants have an outer thread like the Versatile model, while the Solution2 have an outer thread like the Immediate model.
Healing caps are available in 3 platform sizes: normal, narrow and wide. The conical connection models are available in narrow, regular and wide platforms with lengths of 2, 3, 4, 5, 6, 7 mm and diameters of 3.0, 3.5 and 4.3 mm. There is also a wide platform conical connection healing cap for both narrow emergence and wide emergence. These are 4.3 mm diameter in lengths of 2, 3, 4, 5, 6 and 7 mm. The hex connection models are available in narrow emergence, regular platform with lengths of 2. 3. 4. 5. 6. 7 mm and a diameter of 3.75 mm and standard & wide emergence regular platform with lengths of 2,3, 4, 5, and 6 mm and a diameter of 3.75 mm. There is also a healing cap for the multiunit abutment which comes in one size. Healing caps with marks for scanning are available in 2mm length for regular hex, narrow conical, regular conical and wide conical platforms.
Temporary abutment is for immediate loading if appropriate. The Temporary abutment is available with a conical connection in narrow, regular and wide platforms all with lengths of 1, 2, 3, 4, 5, 6 and 7 mm and diameters of 3.0, 3.5 and 4.3 mm. It is also available with a hex connection regular platform with lengths of 1, 2, 3, 4, 5, 6, 7 mm and a diameter of 3.75 mm.
Non-shouldered abutments are straight titanium abutments with hex designed for permanent restoration. The abutments are supplied as regular non-shouldered straight abutments with lengths of 5, 7, 9, 12 and 15 (not in narrow conical) mm with a narrow conical platform of 3.0 mm width, a regular conical platform of 3.5 mm width, a wide conical platform of 4.3mm and with a regular hex platform of 3.75 mm width. Also available is a wide emergence non-shouldered straight abutment with lengths of 5, 7, 9, 12 and 15 mm with a wide conical platform of 4.3 mm. The 5mm height nonshouldered abutments are intended for multiple unit restorations only.
15° and 25° angular non-shouldered abutments: 15° abutments are supplied in lengths of 9, 11 and 13 mm with either a hex connection (3.75mm) or a conical connection in narrow (3.0mm), regular (3.5mm) or wide (4.3mm) platform. 25° abutments are supplied in lengths of 9, 11 and 13 mm with a hex connection, a conical connection regular platform or a conical connection wide platform. 15° and 25° narrow emergence abutments are supplied as a hex connection regular platform with a width of 3.75 mm. 15° and 25° wide emergence abutments are supplied as a wide platform conical connection with a width of 4.3 mm and lengths of 9, 11, and 13mm.
Anatomic Straight Shouldered Abutments All have a length of 7.5mm and shoulder heights of 1, 2 and 3 mm. They are available in the following configurations: conical connection, narrow, regular or wide platform or hex connection regular platform. Wide emergence versions are available in wide conical connection and regular hex connection.
15°, and 25° Angled Anatomic Abutment with Shoulder, all have a length of 7.5 mm and shoulder heights of 1, 2 and 3 mm. They are available in conical connection, narrow (available in 15° only), regular and wide platform and hex connection regular platform. Wide emergence version are available in wide conical.
Ball Attachment Abutments are provided with lengths of 1, 2, 3, 4, 5, and 6 mm and in the following configurations: Conical connection, narrow platform 3.0 mm diameter, Conical connection, regular platform 3.5 mm diameter, Conical connection, wide platform 4.3 mm diameter , Hex connection, regular platform 3.75 mm diameter. Ball attachment abutments are intended for multiple unit restorations only.
Multi-Unit Abutment are supplied with lengths of 1, 2, 3 and 4 mm. They are available in narrow regular and wide conical platforms and in hex regular platform. An angled multi-unit of either 18° or 30° is available for conical connections of narrow, regular and wide platform. A plastic sleeve for casting an extension for using multi-units in single units is included in the 510k. Multi-unit abutments are intended for multiple unit restorations only.
Standard Locator Abutments are supplied in shoulder heights of 1, 2, 3, 4, 5, and 6mm. Locators are intended for multiple unit restorations only.
Castable abutments are available in hexed and non-hexed in hex or conical connection (all three platforms). They are available in Ti alloy and gold. A plastic sleeve is available for use with the castable abutments. They are intended for casting straight abutments taller than 4mm.
Abutment Screws are available for hex connection and for all three platforms of conical connection.
Cover Screw are supplied with a conical connection as narrow, regular and wide and with a hex connection.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone of the upper or lower jaw
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)
Dynamic fatigue testing according to ISO 14801 was conducted to determine the abutments are strong enough for their intended use. Surface cleanliness analysis of the implants was done and all tests were passed. The gold used for UCLA abutments was shown to be biocompatible. The CoCr used for castable abutments was shown to be biocompatible. Sterilization according to ISO 11137-1 and 11137-2 was conducted on the implants. Abutment steam sterilization was done according to ISO 17665-1 and -2. Materials used in the product meet ASTM F136. Endotoxin testing according to USP 161 was conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K090709, K132125, K181381, K161604
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). 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.
July 8, 2019
Surgikor LLC % Angela Blackwell Senior Consultant Blackwell Device Consulting P.O. Box 718 Gresham, Oregon 97030-0172
Re: K182615
Trade/Device Name: Surgikor Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: April 3, 2019 Received: April 9, 2019
Dear Angela Blackwell:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Srinivas Nandkumar, Ph.D. Acting Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K182615
Device Name Surgikor Dental Implant System
Indications for Use (Describe)
Surgikor's Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The Dental Implant System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading. The 7mm implants are intended to be used in the molar region.
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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510k Summary K182615 July 8, 2019 Surgikor Dental Implant System
Name and address of Submitter: Surgikor LLC 1299 W Jefferson Blvd Los Angeles CA, 90007 Contact Person: Jeremy Barbanell Phone Number: +1 562-714-9732 Name of device: Surgikor Dental Implant System Classification Name: Endosseous dental implants CFR: 21 CFR 872.3640 Primary Product Code: DZE Secondary Product Code: NHA
Device Description: The Surgikor Dental Implant System consists of two stage endosseous form dental implants, hexagonal and conical implants and hexagonal and conical abutments; cover screws and healing caps; abutment systems including multi-unit abutments. Implants are made from Ti6ALAV ELI.
The Surgikor Dental Implant System includes:
Versatile model is a platform switched, tapered implant designed for use in any bone type and is offered with a Morse tapered hex connection. The regular hex platform comes in diameters of 3.5, 3.75, 4.2, 4.5, 5.0 and 6.0mm. Lengths of 8, 10, 11.5, 13 and 16 are available with 18 and 20 mm lengths available in the 4.2 diameter only.
Immediate model is a platform switched root-form implant design. The Immediate suitable for both immediate load applications and insertion into fresh extraction sockets and is offered with a Morse tapered hex connection in regular platform. It is available in 3.75, 4.2, 4.5, 5.0, 6.0, and 7.0 mm diameter. The hex is regular platform and comes in lengths of 7 (4.5, 5, 6.and 7mm only), 8, 10, 11.5, 13, 16 (7.0mm diameter not in 11.5,13 or 16 mm length).
Fixation model is a root form implant is appropriate for both immediate load applications and insertion into fresh extraction sockets. The Fixation is offered with a conical connection in narrow, regular and wide platforms. The 3.0 diameter implant is available in narrow platform and lengths of 10, 11.5, 13 and 15mm. The Fixation regular platform implant is available in 3.5 and 3.9 mm diameter and has available lengths of 8.5, 10, 11.5, 15, and 18 mm. Wide platform is available in 4.3 and 5.0 mm diameter with lengths of 8.5, 10, 11.5, 13, 15 and 18mm.
Solution model is equipped with a specially designed, narrow, deep, conical connection and is designed for use in narrow bone volumes. The Solution5 is available in narrow platform with a
4
diameter of 3.25mm and lengths of 10, 11.5, 13, 15 mm. The regular platform is available in 3.5, and 4.0 diameter in lengths of 7.0 (4.0 diameter only), 8.5, 10. 11.5, 13, 15mm. The wide platform is available in diameters of 4.5. 5.0. 5.5 and 6.0mm. These diameters come in lengths of 7.0. 8.5. 10. 11.5. 13. and 15mm. The Solution2 is available with lengths of 10. 11.5. 13. and 16 mm in a diameter of 3.25 mm. The Solution5 and Solution2 differ in that the Solution5 implants have an outer thread like the Versatile model, while the Solution2 have an outer thread like the Immediate model.
Healing caps are available in 3 platform sizes: normal, narrow and wide. The conical connection models are available in narrow, regular and wide platforms with lengths of 2, 3, 4, 5, 6, 7 mm and diameters of 3.0, 3.5 and 4.3 mm. There is also a wide platform conical connection healing cap for both narrow emergence and wide emergence. These are 4.3 mm diameter in lengths of 2, 3, 4, 5, 6 and 7 mm. The hex connection models are available in narrow emergence, regular platform with lengths of 2. 3. 4. 5. 6. 7 mm and a diameter of 3.75 mm and standard & wide emergence regular platform with lengths of 2,3, 4, 5, and 6 mm and a diameter of 3.75 mm. There is also a healing cap for the multiunit abutment which comes in one size. Healing caps with marks for scanning are available in 2mm length for regular hex, narrow conical, regular conical and wide conical platforms.
Temporary abutment is for immediate loading if appropriate. The Temporary abutment is available with a conical connection in narrow, regular and wide platforms all with lengths of 1, 2, 3, 4, 5, 6 and 7 mm and diameters of 3.0, 3.5 and 4.3 mm. It is also available with a hex connection regular platform with lengths of 1, 2, 3, 4, 5, 6, 7 mm and a diameter of 3.75 mm.
Non-shouldered abutments are straight titanium abutments with hex designed for permanent restoration. The abutments are supplied as regular non-shouldered straight abutments with lengths of 5, 7, 9, 12 and 15 (not in narrow conical) mm with a narrow conical platform of 3.0 mm width, a regular conical platform of 3.5 mm width, a wide conical platform of 4.3mm and with a regular hex platform of 3.75 mm width. Also available is a wide emergence non-shouldered straight abutment with lengths of 5, 7, 9, 12 and 15 mm with a wide conical platform of 4.3 mm. The 5mm height nonshouldered abutments are intended for multiple unit restorations only.
15° and 25° angular non-shouldered abutments: 15° abutments are supplied in lengths of 9, 11 and 13 mm with either a hex connection (3.75mm) or a conical connection in narrow (3.0mm), regular (3.5mm) or wide (4.3mm) platform. 25° abutments are supplied in lengths of 9, 11 and 13 mm with a hex connection, a conical connection regular platform or a conical connection wide platform. 15° and 25° narrow emergence abutments are supplied as a hex connection regular platform with a width of 3.75 mm. 15° and 25° wide emergence abutments are supplied as a wide platform conical connection with a width of 4.3 mm and lengths of 9, 11, and 13mm.
Anatomic Straight Shouldered Abutments All have a length of 7.5mm and shoulder heights of 1, 2 and 3 mm. They are available in the following configurations: conical connection, narrow, regular or wide platform or hex connection regular platform. Wide emergence versions are available in wide conical connection and regular hex connection.
15°, and 25° Angled Anatomic Abutment with Shoulder, all have a length of 7.5 mm and shoulder heights of 1, 2 and 3 mm. They are available in conical connection, narrow (available in 15° only),
5
regular and wide platform and hex connection regular platform. Wide emergence version are available in wide conical.
Ball Attachment Abutments are provided with lengths of 1, 2, 3, 4, 5, and 6 mm and in the following configurations: Conical connection, narrow platform 3.0 mm diameter, Conical connection, regular platform 3.5 mm diameter, Conical connection, wide platform 4.3 mm diameter , Hex connection, regular platform 3.75 mm diameter. Ball attachment abutments are intended for multiple unit restorations only.
Multi-Unit Abutment are supplied with lengths of 1, 2, 3 and 4 mm. They are available in narrow regular and wide conical platforms and in hex regular platform. An angled multi-unit of either 18° or 30° is available for conical connections of narrow, regular and wide platform. A plastic sleeve for casting an extension for using multi-units in single units is included in the 510k. Multi-unit abutments are intended for multiple unit restorations only.
Standard Locator Abutments are supplied in shoulder heights of 1, 2, 3, 4, 5, and 6mm. Locators are intended for multiple unit restorations only.
Castable abutments are available in hexed and non-hexed in hex or conical connection (all three platforms). They are available in Ti alloy and gold. A plastic sleeve is available for use with the castable abutments. They are intended for casting straight abutments taller than 4mm.
Abutment Screws are available for hex connection and for all three platforms of conical connection.
Cover Screw are supplied with a conical connection as narrow, regular and wide and with a hex connection.
Indications for Use: Surgikor's Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The Dental Implant System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading. The 7mm implants are intended to be used in the molar region.
Testing Summary: Dynamic fatigue testing according to ISO 14801 was conducted to determine the abutments are strong enough for their intended use. Surface cleanliness analysis of the implants was done and all tests were passed. The gold used for UCLA abutments was shown to be biocompatible. The CoCr used for castable abutments was shown to be biocompatible. Sterilization according to ISO 11137-1 and 11137-2 was conducted on the implants. Abutment steam sterilization was done according to ISO 17665-1 and -2. Materials used in the product meet ASTM F136. Endotoxin testing according to USP 161 was conducted.
Primary Predicate: Cortex Dental Implants K163385 Reference Devices: Cortex Dental Implants K090709 AB Dental Implants K132125 & K181381 and Osstem K161604
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Substantial Equivalence:
Surgikor's Dental Implant System is substantially equivalent to Cortex Dental Implants in indications for use, materials, design, and fatigue performance. Slight differences in implant and angled abutment design between the subject devices and the predicate devices were addressed by showing both had adequate fatigue performance. Larger size implants and abutments as well as some abutment designs needed a reference device. The Osstem reference devices are used for demonstrating equivalence in device design and size for larger implants and abutments. The Osstem wider implants also have the indications limitation for only use in the molar region. The Cortex reference device is used for demonstrating equivalence to some designs and sizes which are not present in the later Cortex predicate submission. The AB Dental Implants reference devices are used to demonstrate equivalence in abutments designs and heights which are not in the predicate device submission.
| Company & Device Name | Surgikor's Dental Implant System | Cortex Dental Implants K090709 and K163385 | AB Dental Implants K132125 & K181381 | Osstem K161604 |
|---|---|---|---|---|
| Indications for Use | Surgikor's Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The Dental Implant System is indicated also for immediate loading when good primary stability is | Cortex Dental Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading for use in surgical (single-stage or two-stage procedures) and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic device such as artificial teeth and to restore the patient's chewing function. The system is intended to be used in either single teeth or | A.BDENTAL DEVICES® Dental Implants System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. A.B. DENTAL DEVICES® Dental Implants | The Osstem Implant is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. Ultra Wide Fixture System is intended to be used in the molar region. |
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| achieved and
with
appropriate
occlusal
loading. The
7mm implants
are intended
to be used in
the molar
region. | multiple teeth
applications. | System is
indicated also
for
immediate
loading when
good primary
stability is
achieved and
with
appropriate
occlusal
loading.
'Two Stage
Implants:
12,15,1661.
One Stage:
16, 16b,
16B.One
Stage & One-
Piece 3.0 mm
diameter
implants: 16,
168, 1681,
are intended
for placement
at
the
mandibular
central and
lateral
incisors and
maxillary and
lateral
incisors.
Indicated also
for denture
stabilization
using multiple
implants.
One stage &
One-Piece 2.4
mm diameter
implants for
temporary
use or long
term use: 16,
16b, permit
mmodinto |
| ------------------------------------------------------------------------------------------------------------------------------------------ | --------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
8
| | | | splint stability
and long term
fixation of
new or
existing
crown, bridge
and
prosthesis.
P14
Angulated
Abutment
Adapter is to
be used with
implant
diameter
4.2mm and
higher. | |
|----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Implant
Diameters | Versatile Hex
3.5, 3.75, 4.2,
4.5, 5.0,
6.0mm
Immediate
Hex 3.5,
3.75,4.2, 4.5,
5.0, 6.0,
7.0mm
Fixation
Narrow
Platform
3.0mm
Fixation
Regular
Platform 3.5,
3.9mm
Fixation Wide
Platform 4.3,
5.0mm
Solution5
Narrow
Platform
3.25mm
Solution5
Regular | Classix
3.3, 3.8, 4.2, 5.0,
6.0 Conical and Hex
Dynamix
3.0, 3.3, 3.8, 4.2,
5.0, 6.0
Conical and Hex
Saturn
3.8, 4.2 Hex
Magix
3.3, 3.8, 4.2 Conical | | Osstem Hex 3.2, 3.5, 3.75,
3.77, 4.2, 4.25, 4.4, 4.45,
4.6, 4.63, 4.65, 4.8, 4.9,
5.05, 5.08, 5.1, 5.25, 6.2,
7.1 mm |
| | Platform 3.5,
4.0mm
Solution5
Wide Platform
4.5, 5.0, 5.5,
6.0mm
Solution2
3.25mm | | | |
| Implant
Lengths | Versatile Hex
8, 10, 11.5, 13,
16, 18 (4.2
only), 20 (4.2
only)mm
Immediate
Hex 8 (no 3.5
diameter) 10,
11.5, 13,
16mm 7.00
diameter not
in 11.5, 13 or
16mm.
Fixation
Narrow
Platform 10,
11.5, 13,
15mm
Fixation
Regular
Platform 8.5,
10, 11.5, 13,
15, 18mm
Fixation Wide
Platform 8.5,
10, 11.5, 13,
15, 18mm
Solution5
Narrow
Platform
10,11.5, 13,
15mm
Solution5
Regular
Platform 7.0 | Classix 6,8,10,11.5,
13, 16 no 3.3 or 3.8
in 6, no 3.3 in 8, no
5 in 16 and no 6 in
13 or 16
Dynamix
6,8,10,11.5,13,16
no 3.0 3.3 or 3.8 in
6, no 3.3 or 3.8 in
8, no 13 in 6 and
no 5 or 6 in 16
Saturn
8,10,11.5,13,16
Magix
8,10,11.5,13 no 3.3
in 8 | Osstem
6.2,7.0,8.5,10,11.5,13,15,18 | |
| | only), 8.5, 10,
11.5, 13,
15mm
Solution5
Wide Platform
7.0, 8.5, 10,
11.5, 13,
15mm | | | |
| | Solution2 10,
11.5,13 16mm | | | |
| Material of
devices
included in the
submission | Ti-6AL-4V ELI | Ti-6AL-4V ELI | Ti-6AL-4V ELI | Ti-6AL-4V ELI |
| Type of | Pre-
manufactured
of no more
than 25° | Pre-manufactured
of no more than
25° | Pre-
manufactured
of no more
than 25 | Pre-manufactured of no
more than 25 |
| Interface
type/shape | Internal hex,
conical | Internal hex,
conical | Internal hex | Internal hex |
| ISO 14801
Fatigue Testing | Sufficient run
out load for
their intended
use | Sufficient run out
load for their
intended use | Sufficient run
out load for
their
intended use | Sufficient run out load for
their intended use |
| Surface
Treatment | HA blasted and
double acid
etched | Alumina blasted
and acid etched | HA blasted | Sand blasted and acid
etched |
| Post Surface
Treatment
Cleanliness
Demonstrated | Yes | Yes | Yes | Yes |
9
10
| Cover screw | Cover screw | Cover screw | ||
|---|---|---|---|---|
| Multi-Unit | ||||
| Abutments in Hex | ||||
| RP and Conical | ||||
| (NP,RP,WP) | Multi-unit | |||
| abutments in | ||||
| heights of 1,2,3 and | ||||
| 4 mm in conical | ||||
| diameters of 3.0, | ||||
| 3.5, and 4.3 plus | ||||
| hex diameter of | ||||
| 3.75 | Straight Multi-unit | |||
| Abutments in | ||||
| heights of 1,2,3,4 | ||||
| and 5 mm | ||||
| 18° and 30 °Angled | ||||
| Multi-Unit | Multi-unit | |||
| abutments in | ||||
| heights of 1,2,3 and | Angled Multi-Unit | |||
| Abutments 18° and | ||||
| Abutments in | ||||
| Conical (NP, RP, WP) | 4 mm in conical | |||
| diameters of 3.0, | ||||
| 3.5, and 4.3 | 30° in heights of | |||
| 1,2,34 and 5 mm | ||||
| Locator Abutments | ||||
| in Hex RP | Locator abutments | |||
| in heights of | ||||
| 1,2,3,4,5,and 6mm | Low Profile | |||
| Abutments 5.5mm | ||||
| and 7mm in height | ||||
| of 9mm | AB Dental | |||
| K132125 | ||||
| P25 AB Lock in | ||||
| heights of 0, | ||||
| 1,2,3,4 and 5 | ||||
| mm | ||||
| Ball attachments in | ||||
| Hex RP and Conical | ||||
| NP,RP.WP | Ball attachments in | |||
| heights of 1,2,3,4,5, | ||||
| and 6mm | Ball Attachment | |||
| System in heights of | ||||
| 1,2,3,4,5,6 and 7mm | ||||
| Healing Caps 4.5 | ||||
| diameter standard | Conical healing cap | |||
| in 2,3,4,5,6 and | ||||
| 7mm height | ||||
| Hex healing cap in | ||||
| 2,3,4,5,6mm height | Healing Cap | |||
| Abutments 4.6mm | ||||
| in 2,3,4,5,6and 7 | ||||
| mm | ||||
| Healing Caps 5.5 | ||||
| diameter wide | Conical healing cap | |||
| in 2,3,4,5,6 and | ||||
| 7mm height | Healing Cap | |||
| Abutments in | ||||
| 5.6mm in 2,3,4,5, | ||||
| and 6mm height | ||||
| Healing Caps 3.75 | ||||
| diameter narrow | Conical healing cap | |||
| in 2,3,4,5,6 and | ||||
| 7mm height | Healing Cap | |||
| Abutments in | ||||
| 3.8mm in | ||||
| 2,3,4,5,6,and 7 mm | ||||
| height | ||||
| Healing Cap narrow | ||||
| emergence conical | ||||
| WP and Hex RP | Narrow emergence | |||
| hex and wide | ||||
| conical healing cap | ||||
| in 2,3,4,5,6 and 7 | ||||
| mm height | AB Dental | |||
| K132125 | ||||
| PON narrow | ||||
| emergence | ||||
| healing cap in | ||||
| 3,4,5,6 and | ||||
| 7mm height | ||||
| Healing Cap wide | ||||
| emergence conical | ||||
| WP | Wide emergence | |||
| wide conical healing | ||||
| cap in 2,3,4,5,6 and | ||||
| 7 mm height | ||||
| Wide emergence | ||||
| Hex healing cap in | ||||
| 2,3,4,5,6mm height | Osstem | |||
| K161604 | ||||
| Healing Cap for | ||||
| ultra-wide | ||||
| fixtures | ||||
| Multi-Unit Healing | ||||
| Cap | Single size healing | |||
| cap for multi-unit | Single size healing | |||
| cap for multi-unit | ||||
| Standard Titanium | ||||
| Abutment Hex RP | ||||
| Conical RP and WP | Non-shouldered | |||
| Standard Titanium | ||||
| Abutment with | ||||
| heights of 5,7, 9, 12, | ||||
| and 15 mm in Hex | Titanium abutments | |||
| in 7.5 and 9mm | ||||
| height | AB Dental | |||
| Implants | ||||
| K132125 | ||||
| P3 and P3-5 | ||||
| Hex Standard | ||||
| RP, Conical RP and | ||||
| WP | Titanium | |||
| Abutment with | ||||
| height of 5,7, | ||||
| 9,11,12,15mm | ||||
| P3C Conical | ||||
| Standard | ||||
| Titanium | ||||
| Abutment | ||||
| height of 9mm | ||||
| Standard Narrow | ||||
| Abutment in | ||||
| Conical NP | Non-shouldered | |||
| Standard narrow | ||||
| abutment with | ||||
| heights of 5,7,9 and | ||||
| 12 mm in Conical | ||||
| NP | Ttianium abutments | |||
| in 7.5 and 9mm | ||||
| height | ||||
| Standard Wide | ||||
| Emergence | ||||
| Abutment in | ||||
| Conical WP | Non-shouldered | |||
| standard wide | ||||
| emergence | ||||
| abutment with | ||||
| heights of 5,7,9,12, | ||||
| and 15mm | Osstem | |||
| K161604 | ||||
| Abutment for | ||||
| ultra-wide | ||||
| fixtures | ||||
| Standard Shoulder | ||||
| Abutment | Standard shoulder | |||
| abutment in heights | ||||
| of 1,3 and 4mm | Straight Abutment | |||
| with collar in heights | ||||
| of 1,2,3 and 4mm | ||||
| Standard Wide | ||||
| Shoulder Abutment | Standard Wide | |||
| Shoulder Abutment | ||||
| with heights of | ||||
| 1,2,3,and 4mm | Standard Wide | |||
| Shoulder Abutment | ||||
| with heights of | ||||
| 1,2,3,and 4mm | ||||
| Standard 15° | ||||
| Abutment in Hex | ||||
| RP and Conical NP, | ||||
| RP, WP | Standard 15° | |||
| Abutment with | ||||
| lengths of | ||||
| 9,11,13mm | Angulated 15° | |||
| Abutment 9,12mm | AB Dental | |||
| K132125 | ||||
| Hex RP P4 15° | ||||
| Abutment with | ||||
| height of | ||||
| 8,9mm | ||||
| Hex RP P4L 15° | ||||
| Abutment | ||||
| height of | ||||
| 13.4mm | ||||
| Conical RP 15° | ||||
| Abutment P4C | ||||
| height of 9mm | ||||
| Standard 25° | ||||
| Abutment in Hex | ||||
| RP and Conical RP, | ||||
| WP | Standard 25° | |||
| Abutment with | ||||
| lengths of | ||||
| 9,11,13mm | Angulated 25° | |||
| Abutment 9,12mm | AB Dental | |||
| K132125 | ||||
| Hex RP P4 25° | ||||
| Abutment with | ||||
| height of | ||||
| 8,9mm | ||||
| Hex RP P4L 25° | ||||
| Abutment | ||||
| height of | ||||
| 13.4mm | ||||
| Conical RP 25° | ||||
| Abutment P4C | ||||
| height of 9mm | ||||
| Narrow Emergence | ||||
| Standard 15° | ||||
| Abutment in Hex | ||||
| RP | Lengths of | |||
| 9,11,13mm | Angled 15° | |||
| Abutment Slim 9mm | AB Dental | |||
| K132125 | ||||
| Hex RP P4N 15° | ||||
| Narrow | ||||
| Abutment | ||||
| height 9mm | ||||
| Narrow Emergence | ||||
| Standard 25° | ||||
| Abutment in Hex | ||||
| RP | Lengths of | |||
| 9,11,13mm | Angled 25° | |||
| Abutment Slim 9mm | ||||
| Wide Emergence | ||||
| Standard 15° | ||||
| Abutment in | ||||
| Conical WP | Lengths of | |||
| 9,11,13mm | AB Dental | |||
| K132125 | ||||
| Hex RP P4ST | ||||
| 15° Abutment | ||||
| height of 9mm | ||||
| P4-5 15° | ||||
| Abutment | ||||
| height of | ||||
| 10.75, 11.1mm | ||||
| Wide Emergence | ||||
| Standard 25° | ||||
| Abutment in | ||||
| Conical WP | Lengths of | |||
| 9,11,13mm | AB Dental | |||
| K132125 | ||||
| Hex RP P4ST | ||||
| 25° Abutment | ||||
| height of 9mm | ||||
| P4-5 25° | ||||
| Abutment | ||||
| height of | ||||
| 10.75, 11.1mm | ||||
| Anatomic | ||||
| Shouldered | ||||
| Standard 15° | ||||
| Abutment | ||||
| Hex RP Conical | ||||
| NP.RP and WP | Heights of 1,2, or | |||
| 3mm | Anatomic 15° | |||
| Angulated | ||||
| Abutment with | ||||
| collar | ||||
| Heights of 1,2,3,4 | ||||
| mm | AB Dental | |||
| K132125 | ||||
| Hex RP 15° | ||||
| Shouldered | ||||
| Abutment of | ||||
| height 1,2 | ||||
| 3mm overall | ||||
| height of 7 | ||||
| Anatomic | ||||
| Shouldered | ||||
| Standard 25° | Heights of 1,2, or | |||
| 3mm | Anatomic Angulated | |||
| Abutment 25° with | ||||
| collar |
11
12
13
14
Conclusion:
Surgikor Dental Implant System is substantially equivalent to Cortex Dental Implant System. They both have the same indications for use, are of the same material, and have internal hex or conical connections. The predicate device system does not have 7mm implants so does not have the indications statement about them being used in the molar region. The 7mm implants have indications limitation as the reference devices from Osstem which are wider implants. The abutments, healing caps, and angled abutments are offered in similar designs and heights. Any abutment designs not found within the Cortex Dental Implant System were found in the reference devices which have the same materials, similar indications for use and same internal hex or conical connections as the Surgikor Dental Implant System. Performance testing demonstrates substantial equivalence to the identified predicate devices.