(378 days)
Not Found
No
The summary describes a physical dental implant and its materials, dimensions, and mechanical properties. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is intended to restore a patient's chewing function, which addresses a bodily dysfunction and provides therapeutic benefit.
No
Explanation: This device is an implantable medical device (dental implants) intended to provide support for prosthetic devices to restore chewing function, not to diagnose a medical condition.
No
The device description clearly describes physical dental implants made of Ti6AL4V ELI, which are hardware components. There is no mention of software as the primary or sole component of the device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The provided text describes a dental implant, which is a surgically implanted device used to support prosthetic teeth. It is a physical device placed within the body, not used to test samples outside the body.
- Intended Use: The intended use is to "be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices... in order to restore a patient's chewing function." This is a therapeutic and restorative function, not a diagnostic one.
The device is a medical device, but specifically a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DZE; NHA
Device Description
The conical connection dental 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 conical connection dental implants are provided in 3.75, 4.2 and 5.0 mm diameters and with the following lengths:
0 3.75mm diameter: 8mm, 10mm, 11.5mm, 13mm and 16mm
0 4.2mm diameter: 8mm, 10mm, 11.5mm, 13mm and 16mm
o 5.0mm diameter: 8mm, 10mm, 11.5mm, 13mm and 16mm
The implants surface is sand blasted and acid etched .
The conical connection dental implants are two piece devices whereas the implant is to be used in combination with cover screws, healing caps, abutments and superstructures.
The conical connection dental implants are made of Ti6AL4V ELI complying with standard ASTM F 136-08- Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant. The conical connection dental implants were modified to integrate a new type of connection, internal conical connection of 6 degrees with an anti-rotation index of six positions, ensuring a more definite seal and a more stable connection.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone of the upper or lower jaw 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)
- Non clinical tests: Fatigue test was performed on MIS conical connection implants and its results were found comparable to those of their predicate devices.
- Clinical tests: A preliminary clinical evaluation, based on case studies with six months follow up has been performed, showing good stability of the conical connection implant.
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.
Not Found
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 MIS Implants Technologies Ltd. The logo features the letters "MIS" in a stylized font, with the "S" being a curved line. 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.
AUG 8 2012
t.
510(k) Summary:
Conical Connection Dental Implants
Company Name: MIS Implants Technologies Ltd. P.O. Box 7, Bar Lev Industrial Park, 20156, ISRAEL Telephone: +972-4-9016800 Fax: +972-4-9918623
Establishment Registration Number: 3004203816
| Contact Name: | Iman Khorshid
VP QA & RA
Telephone: +972-4-9016800
Fax: +972-4-9918623 |
|---------------|---------------------------------------------------------------------------------|
| | E-mail: iman@mis-implants.com |
| US Agent: | Matti Weisman - VP Marketing |
US Agent:
Motti Weisman - VP Marketing MIS Implants Technologies Inc. 14-25 Plaza Rd. Suite S-3-5 Fair Lawn New Jersey; 07410 Phone: (201) 797-9144 (201) 797-9145 Fax: E-mail: service@misimplants.com
Date prepared: July 13, 2011
Trade Name: Conical Connection Implants
Classification name: Implants, Endosseous, Root Form
Common/usual name: Dental Implant
Product Code: DZE; NHA
Regulation No.: 872.3640
Class: II
Panel identification: Dental Devices Panel
510 (k) Conical Connection Implants Section E - Page 1 of 4
1
molams Technologies Ltd.
Predicate Device:
MIS Implants Technologies Ltd. dental implants Seven, Biocom and Lance, cleared under 510(k) K040807.
Description of the device:
The conical connection dental 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 conical connection dental implants are provided in 3.75, 4.2 and 5.0 mm diameters and with the following lengths:
0 3.75mm diameter: 8mm, 10mm, 11.5mm, 13mm and 16mm
0 4.2mm diameter: 8mm, 10mm, 11.5mm, 13mm and 16mm
o 5.0mm diameter: 8mm, 10mm, 11.5mm, 13mm and 16mm
The implants surface is sand blasted and acid etched .
The conical connection dental implants are two piece devices whereas the implant is to be used in combination with cover screws, healing caps, abutments and superstructures.
The conical connection dental implants are made of Ti6AL4V ELI complying with standard ASTM F 136-08- Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant. The conical connection dental implants were modified to integrate a new type of connection, internal conical connection of 6 degrees with an anti-rotation index of six positions, ensuring a more definite seal and a more stable connection.
510 (k) Conical Connection Implants Section E - Page 2 of 4
2
lmplants Technologies Ltd. Indications for Use:
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.
Substantial Equivalence:
- Technological characteristics comparative table: .
| | Conical Connection Implants from
MIS Implants Technologies Ltd. | Seven, Biocom and Lance
Implants from MIS Implants
Technologies Ltd. |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | K112162 | K040807 |
| Product Code | DZE/NHA | DZE/NHA |
| Indications For Use | 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. | MIS dental 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. |
| Supplied Sterile | Yes | Yes |
| Re-use | No | No |
| Material of Construction | Titanium Alloy - Ti6Al4V ELI | Titanium Alloy - Ti6Al4V ELI |
| Surface treatment | Sand blasted, acid etched and
anodized | Sand blasted and acid etched |
| Shape | Screw type | Screw type |
| Thread Diameter | 3.75, 4.2 and 5.0 mm | 3.75, 4.2 and 5.0 mm |
| Length | 8, 10, 11.5, 13 and 16 mm | 8, 10, 11.5, 13 and 16 mm |
| Internal Connection | Conical | Hexagonal |
| Abutments | Straight and up to 25° angled | Straight and up to 25° angled |
510 (k) Conical Connection Implants Section E - Page 3 of 4
3
| Implants Technologies Ltd. | ||
|---|---|---|
| Conical Connection Implants from | ||
| MIS Implants Technologies Ltd. | Seven, Biocom and Lance | |
| Implants from MIS Implants | ||
| Technologies Ltd. | ||
| Material of Construction of | ||
| Abutments | Titanium Alloy – Ti6Al4V ELI | Titanium Alloy – Ti6Al4V ELI |
| Surface treatment of | ||
| Abutments | Anodized | None |
| Abutments Connection | Conical | Hexagonal |
-
Non clinical tests: .
Fatigue test was performed on MIS conical connection implants and its results were found comparable to those of their predicate devices. -
Clinical tests: .
A preliminary clinical evaluation, based on case studies with six months follow up has been performed, showing good stability of the conical connection implant.
Conclusion:
The evaluation of the conical connection dental implants does not raise any additional concerns regarding safety and effectiveness and may therefore be considered substantially equivalent to its predicate device.
510 (k) Conical Connection Implants Section E - Page 4 of 4
4
Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
AUG · 8 2012
Ms. Iman Khorshid Vice President of Quality Assurance & Regulatory Affairs MIS Implants Technologies Limited P.O. Box 7, Bar Lev Industrial Park 20156. Israel
Re: K112162
Trade/Device Name: MIS Conical Connection Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: July 26, 2012 Received: July 27, 2012
Dear Ms. 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. The I ou may) ateres 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.
5
Page 2- Ms. Khorshid
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I hat 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 or any I vith 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set de rece related adverse overse) (2 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 n you accirc specific ad 1705 coutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
h for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Image /page/6/Picture/0 description: The image shows the word "mis" in a bold, sans-serif font. The letters are black against a white background. The "m" is stylized with sharp angles, the "i" is a simple vertical line with a dot above, and the "s" is curved. To the right of the word "mis" is the beginning of another word, "imp".
Implants Technologies Ltd.
INDICATIONS FOR USE
510(k) Number (if known):
Device Name:
Conical Connection Implants
Indications for Use:
MIS Conical Connection Implants are intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for mrule bone of the upper of artificial teeth, in order to restore a patient's chewing function.
When a one stage surgical procedure is applied, the implant may be when a one bago barge barge good primary stability is achieved and the occlusal load is appropriate.
OR X Prescription Use _ (Part 21 CFR 801 Subpart D)
Over the Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Surer Purre
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K112162
510 (k) Conical Connection Implants Section D- Page 1 of 1