(393 days)
No
The 510(k) summary describes a standard dental implant system made of titanium alloy, focusing on mechanical properties, materials, and sterilization. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies are focused on physical and material properties, not algorithmic performance.
Yes
The device is described as restoring the patient's chewing function by providing support for prosthetic devices (artificial teeth), which is a therapeutic outcome.
No
This device is a dental implant system used for surgical and restorative applications to provide support for prosthetic devices, not to diagnose a condition.
No
The device description clearly details physical components made of Ti6AL4V ELI, including implants, abutments, cover screws, and healing caps, and describes physical testing and sterilization validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for surgical and restorative applications within the bone of the jaw to support prosthetic devices. This is a direct medical intervention on the patient's body.
- Device Description: The description details a physical implant made of titanium, designed to be surgically placed. It describes its physical characteristics and components used in the surgical and restorative process.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, or urine) to provide information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies focus on mechanical properties (fatigue testing), material properties, sterilization, and packaging integrity – all relevant to a surgically implanted device, not an IVD.
IVD devices are used in vitro (outside the body) to analyze samples and provide diagnostic information. This device is used in vivo (inside the body) as a physical implant.
N/A
Intended Use / Indications for Use
MSDI 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 or prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function.
It is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
MSDI Dental Implants System implants are self-tapping, root-form, two piece screw type dental implants, indicated for use in surgical and restorative applications for placement in the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function.
The MSDI's dental implant is a two stage screw type device that can equally well be used as one stage, surgically placed in the upper or lower jaw to provide support for prosthetic devices in partially or completely edentulous patients. The MSDI's implant is a two piece device to be used in combination with several different abutments and superstructures provided in order to aid in the prosthetic rehabilitation.
MSDI dental implants System is an internal hex implant system which provided in 3.3, 3.75, 4.2, 5.0 and 6.0 mm diameter for lengths of 8, 10, 11.5, 13 and 16mm. (There is no 6.0 mm diameter for the 16 mm length).
The MSDI Dental Implants are to be used in combination with cover screws, healing caps and abutments according to commonly used protocol in the dental implantation field.
The MSDI Dental Implants are made of Ti6AL4V ELI complying with standard ASTM F 136-13 - Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant.
The implants are grit blasted and acid etched surface. The system includes standard abutments, standard narrow abutments, standard shoulder abutments, standard wide shoulder abutments, multi- unit abutments, ball attachments, healing caps and standard 15° and 25° abutments are included in the system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone of the upper or lower jaw
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Dynamic fatigue testing according to ISO 14801 was conducted to determine the abutments are strong enough for their intended use. Predicate device comparative testing was also provided. Surface analysis according to the FDA guidance document was done including SEM and EDS. Sterilization validation according to ISO 11137-1 and 11137-2 was conducted on the implants. Abutment steam sterilization validation was done according to ISO 17665-1 and ISO 17665-2. Package integrity testing according to ASTM F1929-12 and accelerated aging according to ASTM F1980-07 was conducted. Materials used in the product meet ASTM F136 and the biocompatibility was demonstrated by testing the cytotoxicity according to ISO 10993-5. Endotoxin testing according to USP 161 was conducted. Cleanliness of implants was tested according to ISO 19227.
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.
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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June 26, 2020
Medical Systems and Devices International Ltd. % Iman Khorshid CEO, Founder ORS Industrial Park Tefen Tefen 2495900 ISRAEL
Re: K191443
Trade/Device Name: MSDI Dental Implants System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: June 21, 2020 Received: June 25, 2020
Dear Iman Khorshid:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Srinivas Nandkumar, Ph.D. for Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K191443
Device Name MSDI Dental Implants System
Indications for Use (Describe)
MSDI 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 or prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function.
It is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
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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510(k) Summary K191443
MSDI Dental Implants System
- Applicant Name: Medical Systems and Devices International Ltd. St. Ba'alei Malacha 26, P.O. Box 25414 Haifa. 3223020 ISRAEL Tel: 972-54-932-0515
Establishment Registration Number: 3013167159
- Contact Name: Iman Khorshid - QA/RA Manager Mobile: +972-54-3023043 Fax: +972-4-6860006 Email: iman@qrs-global.com
- US Agent: MID-LINK INTERNATIONAL Co., Ltd 2219 Rimlang Drive, Suite 301, Bellingham-Barkley Village, WA, 98226 Tel: 360-325-7028 Email: us.agent@mid-link.net
Date prepared: June 26, 2020
Trade Name: MSDI Dental Implants System Classification name: Endosseous Dental Implant Common/usual name: Dental Implant Product Code: DZE, NHA Regulation No.: 872.3640 Class: II Panel identification: Dental Devices Panel
510 (k) MSDI Dental Implants System Section E - Page 1 of 8
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Image /page/4/Picture/0 description: The image shows the logo for Medical Systems & Devices International (MSDI). The logo features the letters "MSDI" in a stylized font, with the "MS" in blue, the "D" in green, and the "I" in blue. Above the "DI" are dashed lines. Below the letters is the full name of the company, "Medical Systems & Devices International", in a smaller font.
Description of the device:
MSDI Dental Implants System implants are self-tapping, root-form, two piece screw type dental implants, indicated for use in surgical and restorative applications for placement in the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function.
The MSDI's dental implant is a two stage screw type device that can equally well be used as one stage, surgically placed in the upper or lower jaw to provide support for prosthetic devices in partially or completely edentulous patients. The MSDI's implant is a two piece device to be used in combination with several different abutments and superstructures provided in order to aid in the prosthetic rehabilitation.
MSDI dental implants System is an internal hex implant system which provided in 3.3, 3.75, 4.2, 5.0 and 6.0 mm diameter for lengths of 8, 10, 11.5, 13 and 16mm. (There is no 6.0 mm diameter for the 16 mm length).
The MSDI Dental Implants are to be used in combination with cover screws, healing caps and abutments according to commonly used protocol in the dental implantation field.
The MSDI Dental Implants are made of Ti6AL4V ELI complying with standard ASTM F 136-13 - Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant.
The implants are grit blasted and acid etched surface. The system includes standard abutments, standard narrow abutments, standard shoulder abutments, standard wide shoulder abutments, multi- unit abutments, ball attachments, healing caps and standard 15° and 25° abutments are included in the system.
Indications for Use:
MSDI 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 or
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Image /page/5/Picture/0 description: The image shows the logo for Medical Systems & Devices International. The logo consists of the letters "MSDI" in a stylized font, with the "M" and "DI" in blue and the "S" in green. The words "Medical Systems & Devices International" are written in a smaller font below the letters. The logo is simple and modern, and it effectively communicates the company's name and focus.
prosthetic devices, such as artificial teeth, in order to restore the patient's chewing
function.
It is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
510 (k) MSDI Dental Implants System Section E - Page 3 of 8
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Image /page/6/Picture/0 description: The image shows the logo for Medical Systems & Devices International. The logo is in blue and green, with the letters "MSDI" in a bold, sans-serif font. The words "Medical Systems & Devices International" are written in a smaller font below the logo. The "S" in MSDI is green, and the rest of the letters are blue. There are also some green dashed lines above the "S".
Testing Summary:
Dynamic fatigue testing according to ISO 14801 was conducted to determine the abutments are strong enough for their intended use. Predicate device comparative testing was also provided. Surface analysis according to the FDA guidance document was done including SEM and EDS. Sterilization validation according to ISO 11137-1 and 11137-2 was conducted on the implants. Abutment steam sterilization validation was done according to ISO 17665-1 and ISO 17665-2. Package integrity testing according to ASTM F1929-12 and accelerated aging according to ASTM F1980-07 was conducted. Materials used in the product meet ASTM F136 and the biocompatibility was demonstrated by testing the cytotoxicity according to ISO 10993-5. Endotoxin testing according to USP 161 was conducted. Cleanliness of implants was tested according to ISO 19227.
Primary Predicate Device:
Spiral Dental Implants manufactured by GP Implants Ltd. cleared under 510(k) K162299.
Reference Device:
Alpha-Bio Tec Dental Implant System K063364 DSI Dental Implant System K200188
510 (k) MSDI Dental Implants System Section E - Page 4 of 8
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Substantial Equivalence:
Technological Characteristics
The MSDI Dental Implants System have the same intended use and principles of operation as GP Implants' Spiral Dental Implants cleared under 510(k) K162299 and have equivalent performance characteristics. The material used for the MSDI Dental Implants System, as well as the manufacturing methods, manufacturing site and subcontractor are the same as the predicate device.
Two differences exist between the subject device and primary predicate device:
The healing caps heights range, MSDI's healing caps 4.5 diameter in heights of 3,4,5,6 and 7mm and GP's healing caps 4.5 diameter in 2 and 7mm height. MSDI's Implants system include three types of implants (Alef, TAF, KAF) and the predicate device include only one type of implant (SPI). The additional two types of implants (TAF and KAF) don't affect the intended use and indication for use since they are meant to be used the same way as the primary predicate device.
| | MSDI Dental
Implants System
from Medical
Systems and Devices
International Ltd. | Spiral Dental
Implants from GP
Implants Ltd. | Alpha-Bio Tec
Dental Implant
System | DSI Dental
Implant System
from DSI Dental
Solutions Ltd. |
|---------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | K191443 | K162299 | K063364 | K200188 |
| Product Code | DZE, NHA | DZE, NHA | DZE, NHA | DZE, NHA |
| Indications for
Use | MSDI 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 or prosthetic
devices, such as
artificial teeth, in
order to restore the
patient's chewing
function.
It is intended for
immediate loading
when good primary | The Spiral Dental
Implants is indicated
for use in surgical
and restorative
applications for
placement in the
bone of the upper or
lower jaw to provide
support or prosthetic
devices, such as
artificial teeth, in
order to restore the
patient's chewing
function.
It is intended for
immediate loading
when good primary
stability is achieved | The Alpha-Bio
Tec Dental
implant System is
indicated for use
in surgical and
restorative
applications for
placement in the
bone of the upper
or lower jaw to
provide support
for prosthetic
devices, such as
artificial teeth, in
order to restore the
patient's chewing
function.
Alpha-Bio Dental | DSI Dental Implants
are endosseous
implants intended to
be surgically placed
in the
upper or lower jaw
arches to provide
support for
prosthetic devices,
such as an artificial
tooth, in order
to restore patients
esthetics and
chewing function.
DSI implants are
intended for single
or multiple unit
restorations on |
| | MSDI Dental
Implants System
from Medical
Systems and Devices
International Ltd. | Spiral Dental
Implants from GP
Implants Ltd. | Alpha-Bio Tec
Dental Implant
System | DSI Dental
Implant System
from DSI Dental
Solutions Ltd. |
| | stability is achieved
and with appropriate
occlusal loading. | and with appropriate
occlusal loading. | Implant System is
indicated for
immediate loading
when good primary
stability is achieved
and with
appropriate
occlusal loading. | splinted or non-
splinted
applications.
Premium Spiral
implants are
intended for
immediate loading
when good primary
stability is achieved,
and with appropriate
occlusive loading.
These implants can
also be used for
loading after a
conventional
healing period. |
| Supplied Sterile | Yes | Yes | Yes | Yes |
| Re-use | No | No | No | No |
| Material of
Implants | Ti-6Al-4V, ELI | Ti-6Al-4V, ELI | Ti-6Al-4V, ELI | ASTM F136 Ti 6Al
4V ELI |
| Implants Shape | Screw type | Screw type | Screw type | Premium Spiral |
| Implants
Connection | Internal Hexagon | Internal Hexagon | Internal Hexagon | Internal Hexagon |
| Implants
Surface | Sand blasted and acid
etched | Sand blasted and
acid etched | Sand blasted and
acid etched | Sand blasted and
acid etched |
| Implants Length | 8, 10, 11.5, 13 and
16mm | 8, 10, 11.5, 13 and
16 mm | 8, 10, 11.5, 13 and
16 mm | 8, 10, 11.5, 13, 16
(6.0mm diameter not
in 13 or 16 length) |
| Implants
Diameter | 3.3, 3.7, 4.2, 5.0 and
6.0 mm | 3.3, 3.7, 4.2, 5.0, and 6.0 mm | 3.3, 3.7, 4.2, 5.0, and 6.0 mm | 3.5, 3.75, 4.2, 5.0,
6.0 mm |
| Abutments | Straight, 15° and 25° | Straight, 15° and 25° | Straight, 15° and
25° | Straight, 15° and 25° |
| Material of
abutments | Titanium Alloy -
Ti6Al4V ELI | Titanium Alloy -
Ti6Al4V ELI | Titanium Alloy -
Ti6Al4V ELI | Titanium Alloy -
Ti6Al4V ELI |
| Surface
treatment of
abutments | None | None | None | None |
| | MSDI Dental
Implants System
from Medical
Systems and Devices
International Ltd. | Spiral Dental
Implants from GP
Implants Ltd. | Alpha-Bio Tec
Dental Implant
System | DSI Dental
Implant System
from DSI Dental
Solutions Ltd. |
| Types of
abutments | Multi-unit
abutments in heights
of 1,2,3 and 4 mm | Multi-unit
abutments in heights
of 1,2,3 and 4 mm | AlphaLoc
Attachment in
heights of
0.5,1,2,3,4,5,6 and
7 mm | Multi-unit
abutments
in heights of 1,2,3
and 4 mm |
| | Ball attachments in
heights of 1,2,3,4,5,
and 6mm | Ball attachments in
heights of 1,2,3,4,5,
and 6mm | Ball attachments in
heights of
0.5,2,3,4,5, and
6mm | Ball attachments in
heights of 2,3,4,5,
and 6mm |
| | Healing Caps 4.5
diameter in heights of
3,4,5,6 and 7mm | Healing Caps 4.5
diameter in 2 and
7mm height | Standard Healing
Abutment in
heights of 2,3,4,5,6
and 7mm | Healing Cap 3.8 in
3,4,5,6,7mm height |
| | Wide Healing Cap
5.5 diameter in
heights 2,3,4,5,6 and
7mm | Healing Cap 5.5
diameter in heights
2,3,4,5,6 and 7mm | Wide healing
abutment in heights
of 3 and 5mm | Healing cap 4.6 and
5.5 in 2,3,4,5,6,
and 7mm height.
Healing Caps 6.3 in
2,3,4
and 5 mm height |
| | Standard Titanium
Abutment with
height of 7mm | Standard Titanium
Abutment with
height of 7mm | TLA with height of
8.5mm | 4.5mm Standard
Titanium Abutment
with heights of 7,9,
and
11 mm |
| | Standard narrow
abutment with
heights of 7,9, and
11mm | Standard narrow
abutment with
heights of 7,9, and
11mm | TLASP1 Height
8.9
TLASP2 Height
9.9
TLASP3 Height
10.9
TLASP4 Height
11.9 | 3.8mm Standard
narrow abutment
with
heights of 7,9 and 11
mm |
| | Standard shoulder
abutment in heights
of 1,2,3 and 4mm | Standard shoulder
abutment in heights
of 1,2,3 and 4mm | ETLASP1 height 1
ETLASP1 height 2
ETLASP1 height 3
ETLASP1 height 4 | 4.5mm Standard
shoulder abutment
in
heights of 1,2,3 and
4mm |
| | Standard Wide
Shoulder
Abutment with
heights of 1,2,3
and 4mm | Standard Wide
Shoulder Abutment
with heights of 1,2,3
and 4mm | TLA02 height of 2
mm
TLA04 height of 4
mm | 5.4mm Standard
Wide
Shoulder Abutment
with heights of 1,2,3
and 4mm |
| MSDI Dental
Implants System
from Medical
Systems and Devices
International Ltd. | Spiral Dental
Implants from GP
Implants Ltd. | Alpha-Bio Tec
Dental Implant
System | DSI Dental
Implant System
from DSI Dental
Solutions Ltd. | |
| Standard 15°
Abutment
with heights of 8, 12,
and 13mm | Standard 15°
Abutment
with heights of 8,
12, and 13mm | TLA15 height of
8.5mm
TLAL15 height of
11.5mm | Standard 15°
Abutment
with heights of 1,2,3 mm | |
| Standard 25°
Abutment with
heights of 9 and
12mm | Standard 25°
Abutment with
heights of 9 and
12mm | TLA25 height of
8.5mm
TLAL25 height of
11.5mm | Standard 25°
Abutment
with heights of 1,2,3 mm | |
510 (k) MSDI Dental Implants System Section E - Page 5 of 8
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510 (k) MSDI Dental Implants System
Section E - Page 6 of 8
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510 (k) MSDI Dental Implants System
Section E - Page 7 of 9
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Non-Clinical Performance Data
Fatigue test was performed according to ISO 14801 on the MSDI's dental implants and showed equivalence to the predicate devices.
The MSDI implants and abutments, as well as their predicate devices, are manufactured by the same sub-contractor "DAND" and manufactured in the same facility. Therefore, MSDI has adopted DAND's testing and validations in regard of all non- clinical DATA as it was adopted by the "GP Implants Ltd." the manufacturer of the predicate device.
Clinical Performance Data
No clinical performance data is provided in this submission.
Conclusion:
The evaluation of the MSDI's dental System is substantially equivalent to SPI Dental Implant System. They both have the same indications for use, are of the same material, have internal hex and connections. The abutments, healing caps, and angled abutments are offered in similar designs and heights. Performance testing demonstrates substantial equivalence to the identified predicate devices.
510 (k) MSDI Dental Implants System Section E - Page 8 of 8