(178 days)
No
The document describes a physical dental implant system and its components, with no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is described as providing support for prosthetic devices to restore masticatory function, which is a structural and functional restoration rather than a therapeutic treatment of a disease or condition.
No
This device is a dental implant system used for restoring masticatory function by providing support for prosthetic devices (artificial teeth), not for diagnosing conditions.
No
The device description clearly details physical hardware components made of titanium, including implants and abutments, and mentions surgical placement. There is no indication of any software component being the primary or sole medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a dental implant system intended to be surgically placed in the bone to support prosthetic devices and restore masticatory function. This is a surgical implant, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details the physical characteristics, materials, and components of a dental implant and its associated abutments. It does not describe any reagents, instruments, or systems used for in vitro testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on these samples, or providing diagnostic information based on such analysis.
Therefore, the MIS V3 Conical Connection Dental Implant System falls under the category of a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
MIS V3 Conical Connection Dental Implant System 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 masticatory function. When a one-stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and the occlusal load is appropriate.
Narrow implants (Ø3.3mm) are indicated for use in surgical and restorative applications for placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
The MIS V3 Conical Connection implants are manufactured from titanium (Ti-6Al-4V ELI complying with standard ASTM F136-13 - Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant). The cylinder screw type implants are designed for both two-stage and single stage procedures, with one internal thread for screwed abutment. They have an internal conical connection with an anti-rotation index of six directions for Standard Platform Implants and three directions for Narrow Platform Implants.
The implants are self-tapping, root-form with tapered threads. They feature a tri-surface crestal contact, built-in platform switching and a flat apex enabling grip into bone.
The MIS V3 Conical Connection Implants are provided in 3.3, 3.9, 4.3 and 5.0 mm diameters and with the following lengths:
- 3.3 mm diameter: 10mm, 11.5mm, 13mm and 16mm
-
- 9mm diameter: 8mm, 10mm, 11.5mm, 13mm and 16mm
- . 4.3mm diameter: 8mm, 10mm, 11.5mm, 13mm and 16mm
- 5.0mm diameter: 8mm, 10mm, 11.5mm, 13mm and 16mm
The implants surface is sand blasted and acid etched.
The MIS V3 Conical Connection Dental Implant System is to be used in combination with a wide range of abutments provided in order to aid in the prosthetic rehabilitation.
For a quick identification of the diameters and to ensure the adequate abutments (cover screws, healing caps, cement- retained abutments, gold abutments, OT-Equators & ball attachments, Multi unit abutments and Temporary Ti and Peek Abutments), the internal part of the implant is anodized for coloring purposes as follows:
- "Narrow Platform" (NP) – 3.3mm diameter: blue
- "Standard Platform"(SP) - 3.9mm, 4.3mm and 5.0 diameters: purple
The MIS V3 Conical Connection Implant package comes with a sterile, single-use final drill (packaged in a sterile pouch).
Components:
The MIS V3 Conical Connection Dental Implant is to be used in combination with a variety of conical connection abutments (cover screws, healing caps, cement-retained abutments, gold abutments, OT-equators & ball attachments, multi unit abutments, and temporary Ti and PEEK abutments). These abutments are manufactured with a conical connection, ensuring compatibility to the conical connection implants.
Cover screws and healing caps are premanufactured prosthetic components directly connected to the endosseous dental implants and are indicated as temporary components to allow healing of the soft tissue. They are made of Ti-6Al-4V ELI, and supplied sterile to the user, for single use.
Cement- Retained Abutments are premanufactured dental implant abutments directly connected to the endosseous dental implant by a prosthetic screw, which is supplied with the abutments. Later on, the crown is cemented to the abutment. Cement retained abutments are available straight or angulated, in different heights and diameters to accommodate specific needs according to the patient. The angulated abutments allow a maximum angulation of 25º. The straight abutments are intended for 0º angulation and straight implantation only. They are made of Ti6Al-4V ELI, and supplied non sterile, to be steam sterilized by the user according to the labeling, intended for single use.
CPK abutments are premanufactured abutments directly connected to the endosseous dental implant by a prosthetic screw, which is supplied with the abutments. They are intended to be used in temporary and permanent prosthetic rehabilitation. CPK abutments are intended for 0° angulation and straight implantation only. They are cement retained, meaning the crown is cemented to the abutment. They are sold either on their own, or with additional components for impression taking and prosthetic fabrication. The abutments and prosthetic screw are made of T-6AI-4V ELI, while their additional components are made of POM. They are supplied non sterilized by the user according to the labeling, and intended for single use.
Gold Plastic abutments are pre-manufactured prosthetic abutments directly connected to the endosseous dental implant intended for permanent restoration, for either single or multiple tooth screw retained restorations. The lower part of the abutment which connects directly to the implant is made of gold AU, and the upper part is made of plastic (POM). The plastic part is dissolved once the casting is done. The abutment is connected to the implant by a prosthetic screw, supplied with the abutment, and made of TI 6AL 4V ELI. Gold abutments are intended for 0º angulation and straight implantation only. The abutments are supplied non sterile, to be steam sterilized by the user according to the labeling, and intended for single use.
Multi-Unit abutments are premanufactured dental implant abutments directly connected to the endosseous dental implant. They are indicated for multiple unit reconstructions when screw retained prosthetics is preferred. Multi-unit abutments allow either direct screw of the multiunit abutment or connection to a fixed overdenture bar. Multi-units are available both straight and angulated, with a maximum of 30º angulation. The straight multi units' lower part is threaded and tightened directly to the implant, while the angulated multi-unit is connected to the implant by a prosthetic screw, supplied with the multi-unit and made of Ti-6Al-4V ELI. The overdenture is connected to the multi-unit by a screw. All multi units are made of Ti-6Al-4V ELI. They are supplied sterile and intended for single use.
OT-Equators & Ball Attachments are premanufactured dental implant abutments directly connected to the endosseous dental implant by their lower threaded part, and are used in completely edentulous jaws for anchoring an overdenture to allow its insertion and removal. OT-Equators and Ball attachments allow a maximum of 15º angulation. Ball attachments have a higher profile and ball shaped head, while the OT equators have a lower profile and a truncated head. Both are made from Ti6Al-4V ELI, feature a Titanium Nitride (TiN) coating and are supplied with small-scale metal housing and replaceable nylon caps, offering various retention levels. The abutments are supplied non sterile, to be steam sterilized by the user according to the labeling and intended for single use.
Temporary abutments are premanufactured dental implant abutments directly connected to the endosseous dental implant, intended for use as an aid in temporary prosthetic rehabilitation, for a maximum of 180 days. They are available in Ti-6Al-4V ELI and in natural PEEK. Both are attached to the implant by a prosthetic screw made from Ti-6Al-4V ELI, supplied with the abutments, and are intended to be used for up to 6 months, and then replaced by permanent abutments. The post height is adjusted by the doctor to the appropriate height according to the intended restoration. Free rotation temporary abutments allow a maximum of 15º angulation. Anti-rotation temporary abutments are intended for 0º angulation and straight implantation only. Directions and limitations for modifications are given in the instructions for use supplied with the abutments are supplied non sterile, to be steam sterilized by the user according to the labeling and intended for single use.
For a quick and simple identification of the diameters and in order to ensure the use of the proper abutment with the right implant, the components are colored by anodizing as follows:
- "Narrow Platform"(NP) – 3.3mm diameter, blue
- . "Standard Platform"(SP) - 3.9mm, 4.3mm and 5.0 diameters: purple
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Upper or lower jaw arches
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)
- Biocompatibility: The subject device is manufactured using identical manufacturing methods, in the same manufacturing facility, and using the same raw material as the previously cleared predicate, K112162. The subject device is sterilized and packaged using identical materials and processing as the predicate, K112162. Finally the subject device has the same intended use, patient contact duration and type as the predicate, K112162. For these reasons, biocompatibility testing was not required to support the substantial equivalence of the subject device.
- Fatigue Testing: Mechanical testing of MIS V3 implants and abutments in accordance to ISO 14801:2007 was conducted. The test articles were able to withstand 5,000,000 cycles without failure at a substantially equivalent load to the cited predicates.
- Sterilization Testing: Sterilization tests were conducted in compliance with ANSI/AAMI/ISO 11137-1:06 and EN ISO 11137-2:12 for the MIS V3 Conical Connection Dental Implant System. Test results have demonstrated that the SAL of 10-6 was achieved and all testing requirements were met. Steam sterilization parameters were validated for 2 methods: gravity displacement and pre-vacuum sterilization. The studies were conducted in accordance with ISO 17665-1:2006 and demonstrated a SAL of 10 °.
- Shelf Life Testing: Shelf life testing of real-time aged implants to validate the integrity of the final package was completed by an independent testing laboratory. Test results were successful and consisted of a sterility testing of product which had been aged real-time for at least five years. No growth was determined for the samples provided for this testing. Additional burst testing had been completed by contract packager.
- Risk Analysis: Risk analysis for MIS implants was conducted in accordance with ISO 14971, Medical Devices: Application of Risk Analysis, for medical devices. It was determined by MIS that all risks associated with MIS implants were acceptable and as low as reasonably possible.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K112162, K140347, K071370, K102467, K061477
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it, overlaid on three human profiles facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 26, 2017
MIS Implants Technologies Ltd. Arbel Shezaf RA Coordinator P.O. Box 7, Bar Lev Industrial Park Bar Lev Industrial Park, 2015600 ISRAEL
Re: K163349
Trade/Device Name: MIS V3 Conical Connection Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: May 18, 2017 Received: May 18, 2017
Dear Arbel Shezaf:
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.
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Lori A. Wiggins -S6
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
510(k) Number (if known)
Device Name
MIS V3 Conical Connection Dental Implant System
Indications for Use (Describe)
MIS V3 Conical Connection Dental Implant System 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 masticatory function. When a one-stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and the occlusal load is appropriate.
Narrow implants (Ø3.3mm) are indicated for use in surgical and restorative applications for placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another.
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)
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EF
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
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Image /page/3/Picture/0 description: The image shows the logo for MIS Implants Technologies Ltd. The logo consists of the letters "MIS" in blue, with the "I" having a vertical line extending above the other letters. To the right of the logo is the text "Implants Technologies Ltd." in a smaller font size.
K163349 510(k) Summary
1. Submitter
MIS Implants Technologies Ltd. P.O. Box 7, Bar Lev Industrial Park 2015600 ISRAEL Telephone: +972-4-9016800 Fax: +972-4-9918623
Contact: Arbel Shezaf +972-4-9016802 arbel@mis-implants.com
Date Prepared: May 23, 2017
2. US Agent: Motti Weisman - VP Marketing
MIS Implants Technologies Inc. 18-00 Fair Lawn Ave Fair Lawn NJ 07410 Phone: (201) 797-9144 Fax: (201) 797-9145
3. Device Identification
| Trade/Proprietary Name: | MIS V3 Conical Connection Dental Implant System |
|---|---|
| Common/Usual Name: | Dental Implant |
| Classification Name: | Endosseous dental implant |
| Regulation Number: | 872.3640; |
| Product Code: | DZE, NHA |
| Device Class: | Class II |
| Classification Panel: | Dental Devices Panel |
4. Predicate Device(s)
Primary predicate device:
-
ASTRA TECH OsseoSpeed TX S from Astra Tech AB cleared under 510(k) K101732
Reference devices: -
MIS Conical Connection Implants from MIS Implants Technologies cleared under 510(k) K112162.
-
. ANKYLOS C/X Dental Implant System from Dentsply International cleared under 510(k) K140347.
-
NobelActive Internal Connection Implants from Nobel BioCare cleared under 510(k) K071370.
-
. UTA and UHA cleared under 510(k) K102467.
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Image /page/4/Picture/0 description: The image shows the logo for MIS Implants Technologies Ltd. The logo consists of the letters "MIS" in blue, with the "M" and "I" connected and the "S" slightly offset to the right. To the right of the letters, there is a vertical line, followed by the text "Implants Technologies Ltd." in a smaller font size.
- Multi-Unit Abutments for AstraTech, Camlog and Ankylos Implant Systems from Nobel BioCare cleared under 510(k) K061477.
5. Device Description
The MIS V3 Conical Connection implants are manufactured from titanium (Ti-6Al-4V ELI complying with standard ASTM F136-13 - Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant). The cylinder screw type implants are designed for both two-stage and single stage procedures, with one internal thread for screwed abutment. They have an internal conical connection with an anti-rotation index of six directions for Standard Platform Implants and three directions for Narrow Platform Implants.
The implants are self-tapping, root-form with tapered threads. They feature a tri-surface crestal contact, built-in platform switching and a flat apex enabling grip into bone.
The MIS V3 Conical Connection Implants are provided in 3.3, 3.9, 4.3 and 5.0 mm diameters and with the following lengths:
- 3.3 mm diameter: 10mm, 11.5mm, 13mm and 16mm
-
- 9mm diameter: 8mm, 10mm, 11.5mm, 13mm and 16mm
- . 4.3mm diameter: 8mm, 10mm, 11.5mm, 13mm and 16mm
- 5.0mm diameter: 8mm, 10mm, 11.5mm, 13mm and 16mm
The implants surface is sand blasted and acid etched.
The MIS V3 Conical Connection Dental Implant System is to be used in combination with a wide range of abutments provided in order to aid in the prosthetic rehabilitation.
For a quick identification of the diameters and to ensure the adequate abutments (cover screws, healing caps, cement- retained abutments, gold abutments, OT-Equators & ball attachments, Multi unit abutments and Temporary Ti and Peek Abutments), the internal part of the implant is anodized for coloring purposes as follows:
- "Narrow Platform" (NP) – 3.3mm diameter: blue
- "Standard Platform"(SP) - 3.9mm, 4.3mm and 5.0 diameters: purple
The MIS V3 Conical Connection Implant package comes with a sterile, single-use final drill (packaged in a sterile pouch).
Components:
The MIS V3 Conical Connection Dental Implant is to be used in combination with a variety of conical connection abutments (cover screws, healing caps, cement-retained abutments, gold abutments, OT-equators & ball attachments, multi unit abutments, and temporary Ti and PEEK abutments). These abutments are manufactured with a conical connection, ensuring compatibility to the conical connection implants.
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Image /page/5/Picture/0 description: The image shows the logo for MIS Implants Technologies Ltd. The logo consists of the letters "mis" in blue, with the "i" having a dot above it. To the right of the letters is a vertical line, followed by the words "Implants Technologies Ltd." in a smaller font.
Cover screws and healing caps are premanufactured prosthetic components directly connected to the endosseous dental implants and are indicated as temporary components to allow healing of the soft tissue. They are made of Ti-6Al-4V ELI, and supplied sterile to the user, for single use.
Cement- Retained Abutments are premanufactured dental implant abutments directly connected to the endosseous dental implant by a prosthetic screw, which is supplied with the abutments. Later on, the crown is cemented to the abutment. Cement retained abutments are available straight or angulated, in different heights and diameters to accommodate specific needs according to the patient. The angulated abutments allow a maximum angulation of 25º. The straight abutments are intended for 0º angulation and straight implantation only. They are made of Ti6Al-4V ELI, and supplied non sterile, to be steam sterilized by the user according to the labeling, intended for single use.
CPK abutments are premanufactured abutments directly connected to the endosseous dental implant by a prosthetic screw, which is supplied with the abutments. They are intended to be used in temporary and permanent prosthetic rehabilitation. CPK abutments are intended for 0° angulation and straight implantation only. They are cement retained, meaning the crown is cemented to the abutment. They are sold either on their own, or with additional components for impression taking and prosthetic fabrication. The abutments and prosthetic screw are made of T-6AI-4V ELI, while their additional components are made of POM. They are supplied non sterilized by the user according to the labeling, and intended for single use.
Gold Plastic abutments are pre-manufactured prosthetic abutments directly connected to the endosseous dental implant intended for permanent restoration, for either single or multiple tooth screw retained restorations. The lower part of the abutment which connects directly to the implant is made of gold AU, and the upper part is made of plastic (POM). The plastic part is dissolved once the casting is done. The abutment is connected to the implant by a prosthetic screw, supplied with the abutment, and made of TI 6AL 4V ELI. Gold abutments are intended for 0º angulation and straight implantation only. The abutments are supplied non sterile, to be steam sterilized by the user according to the labeling, and intended for single use.
Multi-Unit abutments are premanufactured dental implant abutments directly connected to the endosseous dental implant. They are indicated for multiple unit reconstructions when screw retained prosthetics is preferred. Multi-unit abutments allow either direct screw of the multiunit abutment or connection to a fixed overdenture bar. Multi-units are available both straight and angulated, with a maximum of 30º angulation. The straight multi units' lower part is threaded and tightened directly to the implant, while the angulated multi-unit is connected to the implant by a prosthetic screw, supplied with the multi-unit and made of Ti-6Al-4V ELI. The overdenture is connected to the multi-unit by a screw. All multi units are made of Ti-6Al-4V ELI. They are supplied sterile and intended for single use.
OT-Equators & Ball Attachments are premanufactured dental implant abutments directly connected to the endosseous dental implant by their lower threaded part, and are used in completely edentulous jaws for anchoring an overdenture to allow its insertion and removal. OT-Equators and Ball attachments
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Image /page/6/Picture/0 description: The image shows the logo for MIS Implants Technologies Ltd. The logo consists of the letters "MIS" in a stylized font, with the "I" having a dot above it. To the right of the letters is the text "Implants Technologies Ltd." in a smaller font. The logo is simple and modern, with a clean design.
allow a maximum of 15º angulation. Ball attachments have a higher profile and ball shaped head, while the OT equators have a lower profile and a truncated head. Both are made from Ti6Al-4V ELI, feature a Titanium Nitride (TiN) coating and are supplied with small-scale metal housing and replaceable nylon caps, offering various retention levels. The abutments are supplied non sterile, to be steam sterilized by the user according to the labeling and intended for single use.
Temporary abutments are premanufactured dental implant abutments directly connected to the endosseous dental implant, intended for use as an aid in temporary prosthetic rehabilitation, for a maximum of 180 days. They are available in Ti-6Al-4V ELI and in natural PEEK. Both are attached to the implant by a prosthetic screw made from Ti-6Al-4V ELI, supplied with the abutments, and are intended to be used for up to 6 months, and then replaced by permanent abutments. The post height is adjusted by the doctor to the appropriate height according to the intended restoration. Free rotation temporary abutments allow a maximum of 15º angulation. Anti-rotation temporary abutments are intended for 0º angulation and straight implantation only. Directions and limitations for modifications are given in the instructions for use supplied with the abutments are supplied non sterile, to be steam sterilized by the user according to the labeling and intended for single use.
For a quick and simple identification of the diameters and in order to ensure the use of the proper abutment with the right implant, the components are colored by anodizing as follows:
- "Narrow Platform"(NP) – 3.3mm diameter, blue
- . "Standard Platform"(SP) - 3.9mm, 4.3mm and 5.0 diameters: purple
6. Indications for Use
MIS V3 Conical Connection dental implant system 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 masticatory function.
When a one-stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and the occlusal load is appropriate.
Narrow implants (Ø3.3mm) are indicated for use in surgical and restorative applications for placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another.
7. Substantial Equivalence Discussion
The Indications for Use statement for the subject device is not identical to the predicate device; however, the differences do not alter the intended use of the device nor do they affect the safety and effectiveness of the device relative to the predicate. Both the subject and predicate devices are intended to be surgically placed in the bone of the upper or lower jaw arches for anchoring or supporting tooth replacement to restore chewing function, in partially or fully edentulous patients.
The main difference is in the subject device's indication for narrow platform implants, regarding the need for splinting mandibular central and lateral incisors when using two or more narrow implants
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Image /page/7/Picture/0 description: The image contains the logo for MIS Implants Technologies Ltd. The logo features the letters "MIS" in a stylized, blue font. To the right of the letters, there is a vertical line separating the logo from the company's name, "Implants Technologies Ltd.", which is written in a smaller, sans-serif font.
adjacent to one another. We believe this indication only improves the safety of the narrow implants as compared to the predicate device and does not alter the intended use.
The subject and predicate devices have the same intended use and similar indications for use. Their geometrical design is similar with minor differences which do not raise different safety or efficacy questions. The following tables compare the MIS V3 Conical Connection Dental Implant System to the predicate devices with respect to indications for use, principles of operation, technological characteristics and materials.
Under each table is a discussion of the differences and similarities.
Table 1 – Comparison of Endosseous Implant Characteristics – Narrow Platform
| Trade Name | MIS V3 Conical Connection Dental
Implant System, Narrow Platform | ASTRA TECH OsseoSpeed TX S |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | Subject | K101732 |
| Manufacturer | MIS Implants Technologies Ltd. | Astra Tech AB |
| Device Class | Class II | Class II |
| Product Code(s) | DZE | DZE |
| Regulation
Description | Endosseous dental implant | Endosseous dental implant |
| Regulation Number | 872.3640 | 872.3640 |
| Intended use: | Intended to be surgically placed in the
bone of the upper or lower jaw arches
for anchoring or supporting tooth
replacement to restore chewing
function. | Intended to be surgically placed in the
bone of the upper or lower jaw arches
for anchoring or supporting tooth
replacement to restore chewing
function. |
| Indications for use: | MIS V3 Conical Connection Dental
Implant System 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
masticatory function.
When a one-stage surgical procedure is
applied, the implant may be
immediately loaded when good primary
stability is achieved and the occlusal
load is appropriate.
Narrow implants (Ø3.3mm) are
indicated for use in surgical and
restorative applications for placement
only in the mandibular central, lateral | The OsseoSpeed implants are intended
to be used:
• to replace missing teeth in single or
multiple unit applications within the
mandible or maxilla
• for immediate placement in extraction
sites and partially or completely healed
alveolar
ridge situations
•for both one- and two-stage surgical
procedures
• especially well in soft bone
applications where implants with other
implant surface
treatments may be less effective
• together with immediate loading |
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Image /page/8/Picture/0 description: The image shows the logo for MIS Implants. The logo is in blue and consists of the letters "mis" in a stylized font. To the right of the letters is a vertical line, followed by the word "Impla" in a smaller, sans-serif font. The overall design is clean and modern.
| | incisor and maxillary lateral incisor
regions of partially edentulous jaws, to
provide support for prosthetic devices
such as artificial teeth, in order to
restore the patient chewing function.
Mandibular central and lateral incisors
must be splinted if using two or more
narrow implants adjacent to one
another. | protocol in all indications, except in
single tooth situations in soft bone
(type IV) where implant stability may be
difficult to obtain and immediate
loading may not be appropriate
• together with immediate loading
protocol for single-tooth restorations
on implants 8 mm or longer
• with its 3.0 S product line for maxillary
lateral incisors and mandibular lateral
and central incisors. |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Endosseous Implant
Material(s) | Titanium 6Al-4V ELI per ASTM F136 | Titanium grade 4 |
| Surface Treatment | Anodized ,sand blasted and acid etched | TiO2-blasted fluoride-modified surface. |
| Body design | Tapered design, threaded | Cylindrical, threaded |
| Connection Type | Conical, 3 indexes, cone angulation 12° | Internal, double hex conical connection,
cone angulation 21° |
| Type of implant | Bone level implant | Bone level implant |
| Implant Diameters | Ø 3.3 mm | Ø 3.5 mm |
| Implant Lengths | 10, 11.5, 13 and 16 mm | 8, 9, 11, 13, 15 and 17 mm |
| Neck Design | Three-way cutaway longitude implant
axis at the cervical part of the implant | Cylindrical |
| Apex | Flat apex | Flat apex |
| Thread | Dual | Dual |
| Sterilization | Radiation | Radiation |
| Method | | |
The length range of the subject 3.3 mm MIS V3 is 10 -16 mm. which is within the range of the predicate (8 – 17 mm).
Although the diameter of the subject device is 3.3 mm, it possesses at least equivalent strength as tested and compared to the predicate device of larger diameter (3.5 mm), likely due to the use of Ti alloy (ASTM F136) which has a higher tensile strength compared to the predicate which uses C.P. Ti grade 4. Despite the difference in the connections provide a locking mechanism for a tight fit. Similarly, although there are minor differences in threading, body design (tapered vs. cylindrical), neck design and surface treatment, these differences do not raise different safety or efficacy Fatigue testing per ISO 14801:2007 assessed the impact of these differences and questions. demonstrates at least equivalent performance.
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Image /page/9/Picture/0 description: The image shows the logo for MIS Implants Technologies Ltd. The logo consists of the letters "MIS" in a stylized font, with the "I" having a dot above it. To the right of the logo is the text "Implants Technologies Ltd." in a smaller font. The logo is in blue and the text is in gray.
| Trade Name | MIS V3 Conical Connection
Dental Implant System
Standard Platform Ø3.9
and 4.3 mm | MIS Conical Connection
Implants Ø3.75 and
4.20mm | ASTRA TECH OsseoSpeed
TX S |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | Subject | K112162 | K101732 |
| Manufacturer | MIS Implants Technologies
Ltd. | MIS Implants Technologies
Ltd. | Astra Tech AB |
| Device Class | Class II | Class II | Class II |
| Product
Code(s) | DZE | DZE | DZE |
| Regulation
Description | Endosseous dental implant | Endosseous dental implant | Endosseous dental implant |
| Regulation
Number | 872.3640 | 872.3640 | 872.3640 |
| Intended use: | Intended to be surgically
placed in the bone of the
upper or lower jaw arches
for anchoring or supporting
tooth replacement to
restore chewing function. | Intended to be surgically
placed in the bone of the
upper or lower jaw arches
for anchoring or supporting
tooth replacement to
restore chewing function. | Intended to be surgically
placed in the bone of the
upper or lower jaw arches
for anchoring or supporting
tooth replacement to
restore chewing function. |
| Indications for
use: | MIS V3 Conical Connection
Dental Implant System 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 masticatory
function.
When a one-stage surgical
procedure is applied, the
implant may be
immediately loaded when
good primary stability is
achieved and the occlusal
load is appropriate.
Narrow implants (Ø3.3mm)
are indicated for use in
surgical and restorative
applications for placement
only in the mandibular
central, lateral incisor and | MIS Conical Connection
Implants are 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.
When a one stage surgical
procedure is applied, the
implant may be
immediately loaded when
good primary stability is
achieved and the occlusal
load is appropriate. | The OsseoSpeed implants
are intended to be used:
• to replace missing teeth
in single or multiple unit
applications within the
mandible or maxilla
• for immediate placement
in extraction sites and
partially or completely
healed alveolar
ridge situations
• for both one- and two-
stage surgical procedures
• especially well in soft
bone applications where
implants with other
implant surface
treatments may be less
effective
• together with immediate
loading protocol in all
indications, except in single
tooth situations in soft |
| Trade Name | MIS V3 Conical Connection
Dental Implant System
Standard Platform Ø3.9
and 4.3 mm | MIS Conical Connection
Implants Ø3.75 and
4.20mm | ASTRA TECH OsseoSpeed
TX S |
| | maxillary lateral incisor
regions of partially
edentulous jaws, to
provide support for
prosthetic devices such as
artificial teeth, in order to
restore the patient
chewing function.
Mandibular central and
lateral incisors must be
splinted if using two or
more narrow implants
adjacent to one another. | | bone (type IV) where
implant stability may be
difficult to obtain and
immediate loading may not
be appropriate
• together with immediate
loading protocol for single-
tooth restorations on
implants 8 mm or longer
• with its 3.0 S product line
for maxillary lateral incisors
and mandibular lateral and
central incisors. |
| Endosseous
Implant
Material(s) | Titanium 6Al-4V ELI per
ASTM F136 | Titanium 6Al-4V ELI per
ASTM F136 | Titanium grade 4 |
| Surface
Treatment | Anodized, sand blasted and
acid etched | Anodized, sand blasted and
acid etched | TiO2-blasted fluoride-
modified surface. |
| Body design | Tapered design, threaded | Tapered design, threaded | Cylindrical, threaded |
| Connection
Type | Conical - 6 indexes, cone
angulation 12° | Conical – 6 indexes, cone
angulation 12° | Internal, double hex conical
connection, cone
angulation 21° |
| Type of implant | Bone level implant | Bone level implant | Bone level implant |
| Implant
Diameters | Ø 3.90 and 4.30 mm | Ø 3.75 and 4.2 mm | Ø 3.5, 4.0 mm |
| Implant
Lengths | 8, 10, 11.5, 13 and 16 mm | 8, 10, 11.5, 13 and 16 mm | 3.5 mm: 8, 9, 11, 13, 15
and 17 mm
4.0 mm: 6-17 mm |
| Neck Design | Three-way cutaway
longitude implant axis at
the cervical part of the
implant | Cylindrical | Cylindrical |
| Apex | Flat apex | Domed apex | Flat apex |
| Thread | Dual | Dual | Dual |
| Sterilization
Method | Radiation | Radiation | Radiation |
| Trade Name | MIS V3 Conical Connection Dental
Implant System, Standard Platform
Ø5.0 mm | ANKYLOS C/X Implant System Ø5.5 mm | |
| 510(k) Number | Subject | K140347 | |
| Manufacturer | MIS Implants Technologies Ltd. | Dentsply International, Inc. | |
| Device Class | Class II | Class II | |
| Product Code(s) | DZE | DZE | |
| Regulation
Description | Endosseous dental implant | Endosseous dental implant | |
| Regulation
Number | 872.3640 | 872.3640 | |
| Intended use: | Intended to be surgically placed in the
bone of the upper or lower jaw arches
for anchoring or supporting tooth
replacement to restore chewing
function. | Intended to be surgically placed in the
bone of the upper or lower jaw arches for
anchoring or supporting tooth replacement
to restore chewing function. | |
| Indications for
use: | MIS V3 Conical Connection Dental
Implant System 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
masticatory function.
When a one-stage surgical procedure
is applied, the implant may be
immediately loaded when good
primary stability is achieved and the
occlusal load is appropriate.
Narrow implants (Ø3.3mm) are
indicated for use in surgical and
restorative applications for placement
only in the mandibular central, lateral | ANKYLOS® C/X Implants of 8 mm in length
or longer are for single-stage or two-stage
surgical procedures and cemented,
removable or screw retained restorations.
The ANKYLOS® C/X Implants may be used
for immediate placement and function on
single tooth and/or multiple tooth
applications when adequate primary
stability is achievable, with appropriate
occlusal loading, in order to restore
chewing function. Multiple tooth
applications may be splinted.
ANKYLOS® C/X Implants of 6.6 mm in
length are for two-stage surgical
procedures and cemented, removable or
screw retained restorations. The ANKYLOS® | |
Table 2 – Comparison of Endosseous Implant Characteristics – Standard Platform Ø3.9 and 4.3 mm
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The subject and predicate devices have similar indications. The length range of the subject 3.9 and 4.3 mm MIS V3 is 8 -16 mm which is the same range of the predicate C1, and within the range of the predicate ASTRA TECH OsseoSpeed (6 – 17 mm). Both subject device and predicate C1 have a tapered
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Image /page/11/Picture/0 description: The image contains the logo for MIS Implants Technologies Ltd. The logo features the letters "MIS" in a stylized, blue font. To the right of the letters, the words "Implants Technologies Ltd." are written in a smaller, sans-serif font. The logo is simple and modern, with a focus on the company's name.
body design, a similar conical connection with the same number of indexes, and undergo the same surface treatment. The ASTRA TECH predicate has a cylindrical body design, and an internal, double hex conical connection. The subject device and C1 predicate are both made from Ti-6Al-4V ELI while the ASTRA TECH OsseoSpeed TX S is made from CP Titanium grade 4. Although there are minor differences in diameter, threading, apex and neck design, these differences are common endosseous implants and do not raise different safety or efficacy questions. Fatigue testing per ISO 14801:2007 assessed the impact of these differences and demonstrates at least equivalent performance, as demonstrated in the performance testing for the subject V3 Conical Connection Implants and for the predicates C1 and ASTRA TECH OsseoSpeed TX S.
Table 3 – Comparison of Endosseous Implant Characteristics – Standard Platform Ø5.0 mm
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| Trade Name | MIS V3 Conical Connection Dental
Implant System, Standard Platform
Ø5.0 mm | ANKYLOS C/X Implant System Ø5.5 mm |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | incisor and maxillary lateral incisor
regions of partially edentulous jaws,
to provide support for prosthetic
devices such as artificial teeth, in
order to restore the patient chewing
function. Mandibular central and
lateral incisors must be splinted if
using two or more narrow implants
adjacent to one another. | C/X Implants may be used for immediate
placement on single tooth and/or multiple
tooth applications when adequate primary
stability is achievable, with appropriate
occlusal loading, in order to restore
chewing function. Multiple tooth
applications may be splinted. |
| Endosseous
Implant
Material(s) | Titanium 6Al-4V ELI per ASTM F136 | CP Titanium grade 2 |
| Surface Treatment | Anodized , sand blasted and acid
etched | Sand blasted and acid etched |
| Body design | Tapered design, threaded | Tapered design, threaded |
| Connection Type | Conical — 6 indexes
Cone angulation 12° | Conical: 6 indexes
Cone angulation 11° |
| Type of implant | Bone level implant | Bone level implant |
| Implant Diameters | Ø 5.0 mm | Ø5.5 mm |
| Implant Lengths | 8, 10, 11.5, 13 and 16 mm | 6.6, 8, 9.5, 11, 14 and 17 mm |
| Neck Design | Three-way cutaway longitude implant
axis at the cervical part of the implant | Cylindrical |
| Apex | Flat apex | Domed apex |
| Thread | Dual | Dual |
| Sterilization
Method | Radiation | Radiation |
nologies Ltd.
Both subject and predicate devices have similar indications, and while there are differences in wording, both are indicated for one or two stage surgical procedures, for either cement or screw retained restorations, with the purpose of restoring chewing function. The length range of the subject 5.0 mm MIS V3 is 8 -16 mm. which is within the range of the predicate ANKYLOS (6.6 - 17 mm). They share a tapered body design, similar conical connection with the same number of indexes, and undergo similar surface treatment with the exception of anodization treatment to internal part of the subject device's implant. Although the subject device's diameter of 5.0 mm is smaller than the predicate (5.5 mm), and there are minor differences in threading, apex and neck design, fatigue testing per ISO 14801:2007 assessed the impact of these differences and demonstrates at least equivalent performance. The difference in the materials between the subject and predicate devices, does not affect the safety and effectiveness of the subject device since Titanium-6Al-4V ELI alloy, has a higher tensile strength compared to the predicate's material, CP-Titanium grade 2.
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| Trade Name | MIS V3 Conical
Connection Abutments | C1 Conical Connection
Abutments | Nobel BioCare |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k)
Number | Subject | K112162 | K071370 |
| Manufacturer | MIS Implants
Technologies Ltd. | MIS Implants Technologies
Ltd. | NobelActive Internal
Connection Implants |
| Device Class | Class II | Class II | Class II |
| Product
Code(s) | NHA | NHA | NHA |
| Regulation
Description | Endosseous dental
implant abutment | Endosseous dental implant
abutment | Endosseous dental implant
abutment |
| Regulation
Number | 872.3630 | 872.3630 | 872.3630 |
| Intended use: | Dental implant abutments
are intended to be used in
the upper or lower jaw
used for supporting tooth
replacements to restore
chewing function.
The abutments in
combination with two-
stage endosseous
implants are intended to
be used as a foundation
for anchoring tooth
replacements in either
jaw. Restorations range
from replacing one single
tooth to fixed partial
dentures using cement-
retained supra-
constructions. | Dental implant abutments
are intended to be used in
the upper or lower jaw used
for supporting tooth
replacements to restore
chewing function.
The abutments in
combination with two-stage
endosseous implants are
intended to be used as a
foundation for anchoring
tooth replacements in either
jaw. Restorations range from
replacing one single tooth to
fixed partial dentures using
cement-retained supra-
constructions. | Dental implant abutments are
intended to be used in the
upper or lower jaw used for
supporting tooth
replacements to restore
chewing function.
The abutments in
combination with two-stage
endosseous implants are
intended to be used as a
foundation for anchoring
tooth replacements in either
jaw. Restorations range from
replacing one single tooth to
fixed partial dentures using
cement-retained supra-
constructions. |
| Indications
for use: | MIS V3 Conical
Connection Dental
Implant System 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 | MIS Conical Connection
dental implant system 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 masticatory function. | NobelActive Internal
Connection Implants are
threaded, root-form dental
implants intended for use in
the upper and/or lower jaw to
support prosthetic devices,
such as artificial teeth, in
order to restore patient
esthetics and chewing |
| Trade Name | MIS V3 Conical
Connection Abutments | C1 Conical Connection
Abutments | Nobel BioCare |
| | restore masticatory
function.
When a one-stage surgical
procedure is applied, the
implant may be
immediately loaded when
good primary stability is
achieved and the occlusal
load is appropriate.
Narrow implants
( $Ø$ 3.3mm) are indicated
for use in surgical and
restorative applications
for placement only in the
mandibular central, lateral
incisor and maxillary
lateral incisor regions of
partially edentulous jaws,
to provide support for
prosthetic devices such as
artificial teeth, in order to
restore the patient
chewing function.
Mandibular central and
lateral incisors must be
splinted if using two or
more narrow implants
adjacent to one another | When a one-stage surgical
procedure is applied, the
implant may be immediately
loaded when good primary
stability is achieved and the
occlusal load is appropriate. | function to partially or fully
edentulous patients.
Nobel Biocare's NobelActive
implants may be placed
immediately and put into
immediate function provided
that initial stability
requirements detailed in the
manual are satisfied.
The NobelActive 3.0 implant is
indicated for use in the
treatment of missing maxillary
lateral incisors or the
mandibular central and lateral
incisors to support prosthetic
devices, such as artificial
teeth, in order to restore
chewing function in partially
edentulous patients.
The NobelActive 3.0 implants
may be put into immediate
function provided that
stability requirements
detailed in the manual are
satisfied. |
Table 4 – Comparison of Endosseous Abutments Characteristics
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Image /page/15/Picture/0 description: The image shows the logo for MIS Implants Technologies LTD. The logo consists of the letters "mis" in blue, with the "m" and "i" connected in a stylized way. To the right of the letters, the words "Implants Technologies LTD" are written in a smaller font, also in blue. The logo is simple and modern, with a focus on the company's name and its area of expertise.
| Trade Name | MIS V3 Conical
Connection Abutments | C1 Conical Connection
Abutments | Nobel BioCare |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Material(s) | Healing caps, cover
screws, Prosthetic Screws,
Ball Attachment/Equators,
cement retained
abutments: TI 6Al-4V ELI
per ASTM F136
Gold plastic abutments:
Gold Alloy
Plastic cylinder:
Polyoxymethylene (POM)
Temporary plastic
abutments: PEEK | Healing caps, cover screws,
Prosthetic Screws, Ball
Attachment/Equators,
cement retained abutments:
TI 6Al-4V ELI per ASTM F136
Gold plastic abutments: Gold
Alloy
Plastic cylinder:
Polyoxymethylene (POM)
Temporary plastic
abutments: PEEK | Abutments: TI 6Al-4V ELI per
ASTM F136
Abutment screws: TI 6Al-4V
Temporary Plastic Abutments:
Polyetheretherketone (PEEK) |
| Surface
Treatment | Polished and Anodized
after machining | Polished and Anodized after
machining | Polished and Anodized after
machining |
| Angulation | NP 0°, 10°, 20°
SP 0°, 15°, 17°, 25°, 30° | SP: 0°,15°,25° | RP : 0°,17°,30° |
Healing caps, cover screws, cement retained abutments, gold abutments, OT-equators and ball attachments were compared to equivalent MIS conical connection abutments, which share the same indications, are made of the same materials, are manufactured in the same facility with the same manufacturing conditions and undergo the same surface treatments. The differences between the subject and predicate devices are additional platforms and diameters, with no new gingival heights or angulations. The new narrow platform abutments and differences in diameter were performance tested with their compatible implant and showed at least equivalent performance to the predicates and therefore did not raise new issues of safety and effectiveness.
Temporary abutments and multi-units were compared to Nobel Biocare's temporary abutments and multi-units. The temporary abutments share similar intended use, materials and angulations, and are both intended for up to 180 days of use. The multi units share similar intended use, materials and angulations. Both temporary abutments and multi units differ from their predicates in connection type but both of the connection types provide a locking mechanism for a tight fit. The subject multi-units were fatigue tested and met the pre-determined success criteria. The differences between subject and predicate devices did not alter the intended use and new issues of safety and effectiveness were not raised.
8. Non-Clinical Performance Data
As part of demonstrating the substantial equivalence of the V3 Conical Connection Dental Implant System to the predicate devices listed in this 510(k) submission, MIS Implants Technologies completed a
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number of non-clinical performance tests. The MIS V3 Conical Connection Dental Implant System was tested in accordance with internal requirements, national standards, and international standards shown below to support substantial equivalence of the subject device:
- . Biocompatibility - The subject device is manufactured using identical manufacturing methods, in the same manufacturing facility, and using the same raw material as the previously cleared predicate, K112162. The subject device is sterilized and packaged using identical materials and processing as the predicate, K112162. Finally the subject device has the same intended use, patient contact duration and type as the predicate, K112162. For these reasons, biocompatibility testing was not required to support the substantial equivalence of the subject device.
- . Fatigue Testing - Mechanical testing of MIS V3 implants and abutments in accordance to ISO 14801:2007 was conducted. The test articles were able to withstand 5,000,000 cycles without failure at a substantially equivalent load to the cited predicates.
- . Sterilization Testing - Sterilization tests were conducted in compliance with ANSI/AAMI/ISO 11137-1:06 and EN ISO 11137-2:12 for the MIS V3 Conical Connection Dental Implant System. Test results have demonstrated that the SAL of 10-6 was achieved and all testing requirements were met. Steam sterilization parameters were validated for 2 methods: gravity displacement and pre-vacuum sterilization. The studies were conducted in accordance with ISO 17665-1:2006 and demonstrated a SAL of 10 °.
- Shelf Life Testing - Shelf life testing of real-time aged implants to validate the integrity of the final package was completed by an independent testing laboratory. Test results were successful and consisted of a sterility testing of product which had been aged real-time for at least five years. No growth was determined for the samples provided for this testing. Additional burst testing had been completed by contract packager.
- . Risk Analysis - Risk analysis for MIS implants was conducted in accordance with ISO 14971, Medical Devices: Application of Risk Analysis, for medical devices. It was determined by MIS that all risks associated with MIS implants were acceptable and as low as reasonably possible.
9. Clinical Performance Data
There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.
10. Summary
The comparison between the subject device and the predicate devices has shown that the indications for use, principles of operation, technological characteristics and materials were similar, and that the differences did not raise new safety and effectiveness issues. Furthermore, performance testing showed that the predicate device is at least equivalent to the predicates by means of performance.
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11. Conclusions
Based on the comparison of the indications for use, the technological characteristics and the performance testing it was concluded that the MIS V3 Dental Implant System it substantially equivalent to the predicate devices.