(132 days)
No
The summary describes a physical dental implant system and its components, with no mention of software, algorithms, or any technology that would typically incorporate AI/ML. The performance studies focus on mechanical, sterilization, and biocompatibility testing.
Yes
The device is described as a dental implant system intended to provide support for prosthetic devices to restore masticatory function and chewing function, which are therapeutic goals.
No
Explanation: The device is a dental implant system designed to support prosthetic devices and restore masticatory function, explicitly stating it is "surgically placed in the bone." It does not mention any diagnostic capabilities or functions.
No
The device description clearly states it is a dental implant system made of Ti-6AI-4V ELI, which is a hardware component. The summary also details mechanical testing and sterilization procedures for these physical implants and abutments.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for surgical placement in bone to support prosthetic devices and restore masticatory function. This is a direct surgical intervention and mechanical support, not a diagnostic test performed on samples from the body.
- Device Description: The description details a physical implant made of Ti-6AI-4V ELI, designed for surgical placement and connection to abutments. This aligns with a medical device for structural support, not a diagnostic tool.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples from the human body (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device is a dental implant system, which falls under the category of medical devices used for surgical and restorative purposes.
N/A
Intended Use / Indications for Use
MIS 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 & UNO) 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 C1 NP Conical Connection dental implants are manufactured from Ti-6AI-4V ELI. The conical root-shaped, screw-type implants are designed for both two-stage and single stage procedures, with one internal thread for screwed abutment. The implants are self-tapping, root-form with tapered threads. They have a 3.3 mm diameter and the following lengths: 10mm, 11.5mm, 13mm and 16mm. The internal part of the implant and the lower part of the abutment are anodized for coloring purposes for a quick identification of the diameter and to ensure the adequate abutments. The Implants are supplied sterile.
This submission also includes wide platform (WP) conical connection abutments which are compatible to the previously cleared (K112162) MIS conical connection wide platform implants.
Components:
The MIS C1 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. The abutments in this submission include NP abutments, compatible with the C1 NP implants also submitted here; and WP abutments compatible with previously cleared (K112162) MIS conical connection WP 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. Cement retained abutments are available straight or angulated, in different heights and diameters. The angulated abutments allow a maximum angulation of 25°. The straight abutments are intended for 0 degree 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 cement retained abutments intended to be used in temporary and permanent prosthetic rehabilitation. CPK abutments are intended for 00 angulation and straight implantation only. They are supplied non sterile, to be steam sterilized by the user according to the labeling, and intended for single use.
- Plastic healing caps are premanufactured abutments intended to cover the CPK abutment until the permanent restoration is ready. They are made from PEEK and intended to be used for up to 180 days. The plastic healing caps are delivered non sterile to the user, for single use, to be sterilized by steam sterilization. Different caps are available for use with narrow, standard, and wide platforms.
- Gold Plastic abutments are 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 alloy, and the upper part is made of plastic part is dissolved once the casting is done. Gold abutments are intended for 0° 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 indicated for multiple unit reconstructions when screw retained prosthetics is preferred. Multi-unit abutments allow either direct screw of the prosthesis into the multi-unit abutment or connection to a fixed overdenture bar. Multi-units are available in angulations between 17-309. The Multi units are made of Ti-6Al-4V ELI. They are supplied sterile and intended for single use.
- OT-Equators & Ball Attachments are screw retained dental implant abutments connected directly 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.
- 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, and in anti-rotation and free-rotation. The abutments are supplied non sterilized by the user according to the labeling and intended for single use.
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 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: No new testing required, as material, manufacturing, sterilization, packaging, intended use, patient contact duration, and type are identical to previously cleared predicate K163349.
- Fatigue Testing: Mechanical testing of MIS C1 implants in accordance to ISO 14801:2007 was conducted. The worst case narrow platform implant and abutment chosen for the test was the narrowest implant loaded with the abutment which has the greatest angulation. The test articles were able to withstand 5,000,000 cycles without failure at a substantially equivalent load to the cited predicates. Wide platform abutments were not tested for fatigue because they did not pose a new worst case compared to the cleared standard platform abutments in terms of raw material, diameter, wall thickness and moment arm.
- Sterilization Testing:
- Products supplied sterilized by gamma irradiation (implants, cover screws, healing caps, final drills, plastic cylinders, multi-units): Sterilization tests conducted per ANSI/AAMI/ISO 11137-1 and ANSI/AAMI/ISO 11137-2. Results demonstrated SAL of 10-6 was achieved and all testing requirements met.
- Products supplied non-sterile and intended to be steam sterilized by the user (CPK kits and CPK abutments, cement retained abutments, gold abutments, temporary abutments, ball attachments and OT-equators): Steam sterilization parameters validated according to ANSI/AAMI/ISO 17665-1:2006 and ANSI/AAMI/ISO 17665-2:2009 for two methods: gravity displacement steam sterilization and pre vacuum steam sterilization.
- Endotoxin Testing: For products supplied sterile, a LAL test is conducted periodically to verify the endotoxin limit is within acceptance criteria according to USP 85, USP 161 and ANSI/AAMI/ ST72.
- Disinfection Validation: For Abutments supplied non-sterile and intended to be steam sterilized by the user, the disinfection procedure was validated in accordance with ANSI/AAMI/ISO 11737-1:2006 (R)2011, AAMI TIR 30:2011 and AAMI TIR 12:2010 by demonstrating a reduction of at least 106 of the microbiological challenge.
- Shelf Life Testing: For products supplied sterile, shelf life studies completed by an independent testing laboratory in accordance with ISO 11607-1. Test results successful and supported a 5 year shelf life of the sterilized products.
- Risk Analysis: Risk analysis conducted in accordance with ISO 14971, Medical Devices: Application of Risk Analysis. All risks determined to be acceptable and as low as reasonably possible.
- Clinical Performance Data: No human clinical testing required as indications for use are equivalent to the predicate device. Non-clinical testing supports substantial equivalence.
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.
K162482, K163349, K112162, K113410
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.
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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 and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
MIS Implants Technologies Ltd. % Randy Prebula Partner Hogan Lovells US LLP 555 13th Street, NW Washington, District of Columbia 20004 December 27, 2017
Re: K172505
Trade/Device Name: MIS C1 Narrow Platform Conical Connection Implant System MIS C1 Wide Platform Conical Connection Abutments Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: November 30, 2017 Received: November 30, 2017
Dear Randy Prebula:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Mary S. Runner -S
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K172505
Device Name
MIS C1 Narrow Platform Conical Connection Implant System MIS C1 Wide Platform Conical Connection Abutments
Indications for Use (Describe)
MIS 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 (03.3mm & UNO) 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)> Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for MIS Implants Technologies Ltd. The logo features the letters "MIS" in a stylized font, with the "M" and "I" connected and the "S" slightly offset. The text "Implants Technologies Ltd." is written in a smaller font to the right of the logo.
K172505 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: December 28, 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 C1 Narrow Platform Conical Connection Implant System MIS C1 Wide Platform Conical Connection Abutments Common/Usual Name: Dental Implant Classification Name: Endosseous dental implant Requlation Number: 872.3640; Product Code: DZE, NHA Device Class: Class II Classification Panel: Dental Devices Panel
4. Predicate Device(s)
Primary predicate device: ANKYLOS C/X Implant System cleared under 510(k) K140347. Reference devices:
- A.B. DENTAL DEVICES® Dental Implants System K162482 .
- MIS V3 Conical Connection Dental Implant System K163349 .
- MIS Conical Connection Implants K112162 ●
- Straumann NNC Protective Caps K113410 .
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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 a stylized font, 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.
5. Device Description
The MIS C1 NP Conical Connection dental implants are manufactured from Ti-6AI-4V ELI. The conical root-shaped, screw-type implants are designed for both two-stage and single stage procedures, with one internal thread for screwed abutment. The implants are self-tapping, root-form with tapered threads. They have a 3.3 mm diameter and the following lengths: 10mm, 11.5mm, 13mm and 16mm. The internal part of the implant and the lower part of the abutment are anodized for coloring purposes for a quick identification of the diameter and to ensure the adequate abutments. The Implants are supplied sterile.
This submission also includes wide platform (WP) conical connection abutments which are compatible to the previously cleared (K112162) MIS conical connection wide platform implants.
Components:
The MIS C1 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. The abutments in this submission include NP abutments, compatible with the C1 NP implants also submitted here; and WP abutments compatible with previously cleared (K112162) MIS conical connection WP implants.
- Cover screws and healing caps are premanufactured prosthetic components directly connected to ı 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. Cement retained abutments are available straight or angulated, in different heights and diameters. The angulated abutments allow a maximum anqulation of 25°. The straight abutments are intended for 0 degree 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 cement retained abutments intended to be used in temporary and permanent prosthetic rehabilitation. CPK abutments are intended for 00 angulation and straight implantation only. They are supplied non sterile, to be steam sterilized by the user according to the labeling, and intended for single use.
- Plastic healing caps are premanufactured abutments intended to cover the CPK abutment until the permanent restoration is ready. They are made from PEEK and intended to be used for up to 180 days. The plastic healing caps are delivered non sterile to the user, for single use, to be sterilized by steam sterilization. Different caps are available for use with narrow, standard, and wide platforms.
- Gold Plastic abutments are 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 alloy, and the upper part is made of plastic part is dissolved once the casting is done. Gold abutments are intended for 0° angulation and straight implantation only. The
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Image /page/5/Picture/0 description: The image shows a logo with the letters 'mis' in blue. The 'm' and 's' are connected by a curved line at the bottom. To the right of the letters is the word 'Implementation' in a smaller font size. The logo is simple and modern.
Proponies | tri
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 indicated for multiple unit reconstructions when screw retained prosthetics is preferred. Multi-unit abutments allow either direct screw of the prosthesis into the multi-unit abutment or connection to a fixed overdenture bar. Multi-units are available in angulations between 17-309. The Multi units are made of Ti-6Al-4V ELI. They are supplied sterile and intended for single use.
- OT-Equators & Ball Attachments are screw retained dental implant abutments connected directly 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.
- -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, and in anti-rotation and free-rotation. The abutments are supplied non sterilized by the user according to the labeling and intended for single use.
6. Indications for Use
MIS 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 & UNO) are indicated for use in surqical 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
- a. Implants: The predicate device for the MIS C1 NP conical connection dental implants is the ANKYLOS C/X (K140347). Both devices have similar indications, although the predicate device states that implants 6.6 mm in length are for two-stage surgical procedures and cemented, removable or screw retained restorations. The subject device does not contain this limitation as its shortest device is 10 mm in length. The length range of the subject device is within the range of the predicate. Although the diameter of the subject device is somewhat smaller, 3.3 vs 3.5 mm, it possesses at least equivalent strength as compared to the predicate device. Their geometrical design is similar with minor differences which do not raise different safety or efficacy questions. Fatique testing per ISO 14801:2007 assessed the impact of these differences and demonstrates at least equivalent performance. The predicate device is indicated for all positions in the jaws, while the subject C1 NP implants are indicated for the mandibular central, lateral incisor and maxillary lateral incisor regions, and must be splinted if using two or more narrow implants adjacent to one another. 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. A reference device, A.B. DENTAL DEVICES® Dental Implants System (K162482) with the same 3.3mm diameter and similar indications for use as the subject device is also
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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, connected font, with the "i" having a dot above it. To the right of the logo is the text "Implants Technologies Ltd.", indicating the company's name and industry.
presented. A comparison of implant characteristics demonstrates substantial equivalence to the predicate device.
Table 1: Comparison of subject and predicate Implants
| Trade Name | MIS C1 NP Conical
Connection Dental
Implants | ANKYLOS C/X Implant
System | A.B. DENTAL DEVICES®
Dental Implants System |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K172505 | K140347 | K162482 |
| Manufacturer | MIS Implants Technologies Ltd. | DENTSPLY Implants | A.B. Dental Device Ltd. |
| 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 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 &
UNO) 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. | 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® 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. | A.B. DENTAL 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 System is indicated
also for immediate loading when
good primary stability is
achieved and with appropriate
occlusal loading.
Two Stage Implants: I22, I5, I55,
I10.
P4 and P14 angled abutments are
to be used only with standard
platform implants 3.5 mm in
diameter or larger. |
| | | Multiple tooth applications
may be splinted. | |
| Implant Material | Titanium 6Al-4V ELI per ASTM
F136 | CP Titanium grade 2 | Titanium 6Al-4V ELI |
| Surface Treatment | Anodized ,sand blasted and
acid etched | Sand blasted and acid etched | Sand blasted with CaP, except
for 0.5mm distal part of the neck
which is smooth. |
| Body design | Tapered design, threaded | Tapered design, threaded | Tapered design, threaded |
| Connection Type | Conical with indexes | Conical with indexes | Conical with internal hex |
| Type of implant | Bone level implant | Bone level implant | Bone level implant |
| Implant Diameters | 3.3 mm | 3.5 mm | Ø 3.3 mm |
| Implant Lengths | 10, 11.5, 13 and 16 mm | 6.6, 8, 9.5, 11, 14, 17 mm | 10, 11.5, 13 and 16 mm |
| Neck Design | Cylindrical | Cylindrical | Cylindrical |
| Apex | Domed apex | Domed apex | Flat apex |
| Thread | Dual | Dual | Dual |
| Sterilization
Method | Radiation | Radiation | Radiation |
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Image /page/7/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 vertical line extending above the other letters. To the right of the letters is the text "Implants Technologies Ltd." in a smaller font. The logo is simple and modern, and the text is clear and easy to read.
- b. Abutments: Healing caps, cover screws, cement retained abutments, CPK abutments, gold abutments, multi-units, temporary 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, manufactured in the same facility with the same manufacturing conditions and undergo the same surface treatments and were cleared under K163349. No new angulations were introduced. The subject worst case abutment was tested for fatigue limits 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.
Table 2 - Comparison of subject and predicate Abutments Characteristics
| Trade Name MIS C1 Conical Connection Abutments MIS V3 Conical Connection Abutments | ||
|---|---|---|
| 510(k) Number | Subject | K166349 |
| Manufacturer | MIS Implants Technologies Ltd. | MIS Implants Technologies Ltd. |
| Device Class | Class II | Class II |
| Product Code(s) | NHA | NHA |
| Regulation | ||
| Description | Endosseous dental implant abutment | Endosseous dental implant abutment |
| Regulation | ||
| Number | 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 | 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 |
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Prises Ltd
MIS C1 Conical Connection Abutments
MIS V3 Conical Connection Abutments
foundation for anchoring tooth replacements in either jaw. Restorations range from replacing one single tooth to fixed partial dentures using cementretained supra-constructions.
foundation for anchoring tooth replacements in either jaw. Restorations range from replacing one single tooth to fixed partial dentures using cementretained supra-constructions.
| Indications for
use: | MIS 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 & UNO) 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. | 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. | |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | | | |
| 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 and plastic healing
caps: 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 | |
| Surface
Treatment | Titanium: Polished and Anodized after machining | Titanium: Polished and Anodized after machining | |
| Angulation | NP: 0°, 10°, 20°
WP: 0°, 15°, 17°, 25°, 30° | NP 0°, 10°, 20°
SP: 0°, 15°, 17°, 25°, 30° | |
8. Non-Clinical Performance Data
As part of demonstrating the substantial equivalence of the C1 NP Conical Connection Dental Implant system and the MIS WP conical connection abutments to the predicate devices, MIS Implants Technologies completed a number of non-clinical performance tests:
- 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, K163349. The subject device is sterilized and packaged using identical materials and processing as the predicate. Finally the subject device has the same intended use, patient contact duration and type as the predicate. For these reasons, biocompatibility testing was not required to support the substantial equivalence of the subject device.
- . Fatigue Testing – Mechanical testing of MIS C1 implants in accordance to ISO 14801:2007 was conducted. The worst case narrow platform implant and abutment chosen for the
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mplants Technologies Ltd
test was the narrowest implant loaded with the abutment which has the greatest angulation. The test articles were able to withstand 5,000,000 cycles without failure at a substantially equivalent load to the cited predicates. Wide platform abutments were not tested for fatigue because they did not pose a new worst case compared to the cleared standard platform abutments in terms of raw material, diameter, wall thickness and moment arm.
- Sterilization Testing ●
- For products supplied sterilized by gamma irradiation (implants, cover screws, healing caps, O final drills, plastic cylinders, multi-units): Sterilization tests were conducted on each group of products in compliance with both ANSI/AAMI/ISO 11137-1 and ANSI/AAMI/ISO 11137-2. Test results have demonstrated that the SAL of 10-6 was achieved and all testing requirements were met.
- For products supplied non-sterile and intended to be steam sterilized by the user (CPK kits o and CPK abutments, cement retained abutments, gold abutments, temporary abutments, ball attachments and OT-equators): The steam sterilization parameters were validated according to ANSI/AAMI/ISO 17665-1:2006 and ANSI/AAMI/ISO 17665-2:2009 for two methods: gravity displacement steam sterilization and pre vacuum steam sterilization.
- . For products supplied sterile, a LAL test is conducted periodically to verify the endotoxin limit is within acceptance criteria according to USP 85, USP 161 and ANSI/AAMI/ ST72.
- . Disinfection Validation: for Abutments supplied non-sterile and intended to be steam sterilized by the user, the disinfection procedure was validated in accordance with ANSI/AAMI/ISO 11737-1:2006 (R)2011, AAMI TIR 30:2011 and AAMI TIR 12:2010 by demonstrating a reduction of at least 106 of the microbiological challenge.
- Shelf Life Testing - for the products which are supplied sterile, shelf life studies were completed by an independent testing laboratory in order to validate the integrity of the final package. The studies were conducted in accordance with ISO 11607-1. Test results were successful and supported a 5 year shelf life of the sterilized products.
- 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-dinical 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
The MIS C1 NP conical connection implant system and WP abutments have the same intended use, incorporate the same fundamental technology, and have similar indications for use as the predicate. Test data to verify the performance of the MIS C1 NP conical connection implant system and WP abutments has been provided including: dynamic fatigue, sterilization, shelf life, and the results of this testing, combined with the design and intended use comparison with the predicate device, support substantial equivalence.