(331 days)
Not Found
No
The device description and intended use focus solely on the physical characteristics and function of dental implants, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as dental implants intended to restore a patient's chewing function, which is a therapeutic purpose.
No
Explanation: The device is a dental implant intended to restore chewing function, not to diagnose a condition.
No
The device description clearly states it is a physical dental implant made of Ti6AL4V ELI, a metal alloy, and is intended for surgical placement. It is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a dental implant intended for surgical placement in the jawbone to support prosthetic devices and restore chewing function. This is a direct therapeutic and restorative function within the body.
- Device Description: The description details the physical characteristics, materials, and components of a dental implant, which is a surgically implanted medical device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
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. 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 short implants are to be used only with straight abutments.
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
The MIS short 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 MIS short implants are provided in 6.0mm length and 4.2mm, 5.0 mm, and 6.0mm diameters, as follows: Seven internal hexagon 6.0mm length: diameter 4.20mm, 5.0 mm and 6.0mm Biocom internal hexagon 6.0mm length: diameter 4.20mm, 5.0 mm and 6.0mm Lance internal hexagon 6.0mm length: diameter 4.20mm, 5.0 mm and 6.0mm The implants surface is sand blasted and whereas the implant is to be used in combination with cover screws, healing caps, abutments and superstructures. The MIS short implants are made of Ti6ALAV ELI complying with standard ASTM F 136-08- Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant. The MIS short implants are two piece devices in combination with cover screws, healing caps, abutments and superstructures.
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 short implants and its results were found.
Clinical tests: A clinical evaluation, based on literature review and case studies with 30 months follow up, has been performed.
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
KI03089
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 shape. To the right of the logo is the text "Implants Technologies Ltd." in a smaller font.
510(k) Summary:
SEP 1 5 2011
MIS Short Implants
- MIS Implants Technologies Ltd. Company Name: MIS Implants Technology
P.O.Box 7, Bar Lev Industrial Park, 20156, ISRAEL 20150, 1510-4-9016800 Fax: +972-4-9918623
Establishment Registration Number: 3004203816
US Agent:
Motti Weisman - VP Marketing MIS Implants Technologies Inc. MIS Implants Technology
14-25 Plaza Rd. Suite S-3-5 Fair Lawn New Jersey; 07410 Phone: (201) 797-9144 (201) 797-9145 Fax: Fax: 2 (2 mail: service@misimplants.com
Date prepared: August 21st, 2011
Trade Name: MIS Short Implants
Classification name: Implants, Endosseous, Root Form
Common/usual name: Dental Implant
Product Code: DZE
Regulation No.: 872.3640
Class: II
Panel identification: Dental Devices Panel
510 (k) MIS Short Implants Section E - Page 1 of 5
1
hnologies Ltd.
Predicate Device:
Predicate Device:
4.5x6.0mm and 6.0x6.0mm dental implants cleared under 510(k) K050712 and 4.5x6.0mm and 6.0x6.0mm dental implants cleared and on the 501Arborway,
5.0x6.0mm cleared under 510(k) K042637, both from Bicon, Inc. 501Arborway, 1 Boston, Massachusetts, 02130;
Boston, Massachusetts, 02130;
OsseoSpeed 4.0S – 6 mm implant cleared under 510(k) K063779 from Astra Tech
OsseoSpeed 4.0S – 6 mm implant cleared under 510 kb care and 1245 OsseoSpeed 4.05 = 0 han = 1.
Inc., 890 Winter Street, Suite 310, Waltham, MA 02451 .
Inc., 890 Winter Street, Suite 310, Waltham, MA 02451 .
Description of the device:
Description of the device:
The MIS short implants are self tapping, root-form, two piece screw type dental The MIS short implants are self tapping, 1001-1011; the personations for placement in
implants, indicated for use in surgical and restorative applications for placement in implants, indicated for use in surgical and restoration of institution such as artificial
the upper or lower jaw to provide support for prosthetic devices such as artificial the upper or fower just to f
eeth, in order to restore the patient chewing for a form length
teeth, in order to restore the patient chewing ranetices.
The MIS short implants are provided in 6.0mm length and 4.2mm, 5.0 mm, and
6.0mm diameters, as follows: 6.0mm diameters, as follows:
Seven internal hexagon 6.0mm length: diameter 4.20mm, 5.0 mm and 6.0mm
1.0mm internal hexagon 6.0mm the diameter 4.20mm, 5.0 mm and 6.0mm Seven internal hexagon 6.0mm length: diameter 4.20mm, 5.0 mm and 6.0mm
Biocom internal hexagon 6.0mm length: diameter 4.20mm, 5.0 mm and 6.0mm Biocom internal hexagon 6.0mm length: diameter 4.20mm, 5.0 mm and 6.0mm
Lance internal hexagon 6.0mm length: diameter 4.20mm, 5.0 mm and 6.0mm
Internal hexagon 6.0mm length a
Lance internal nexagon on The implants surface is sand blasted and actues whereas the implant is to be used in
The MIS short implants are two piece devices whereas the implant is and The MIS short implants are two piece academents and superstructures.
combination with cover screws, bealing caps, abutments and supers combination with cover screws, healing caps, abanieman and ASTM
The MIS short implants are made of Ti6ALAV ELI complying with standard ASTM
The MIS short implants are made of The MIS short implants are made of TibALAV LEI compose of the MIS short in the MIS short imm-4Vanadium ELI
F 136-08- Standard Specification for Wrought Titanium-6Aluminum-4Va F 136-08- Standard - 136-06- Surgical Implant.
(Extra Low Interstitial) Alloy for Surgical Implant.
Indications for Use:
Indications for Use:
MIS dental implants are intended to be surgically placed in the bone of the upper or MIS dental implants are intended to be surgically places and as artificial teeth, in
lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in
order jaw around a patient's chewing function. order to restore a patient's chewing function.
When a one stage surgical procedure is applied, the implant may be immediately When a one stage surgical procedure is applical list and the occlusal load is appropriate.
Ioaded when good primary stability is achieved and the occlusal load is appropriate
loaded when good primary stability is
MIS short implants are to be used only with straight abutments.
The short implants are to be used only with straight abutments.
510 (k) MIS Short Implants 310 (K) E - Page 2 of 5
2
Substantial Equivalence:
Substantial Equivalence:
The MIS short implants have the same intended use as the 4.5x6.0mm dental implans The MIS short implants have the same intentional as as as a manufactured to the mass cleared
6.0x6.0mm cleared under 510(k) KD50712 and 5.0x6.0mm 6.0x6.0mm cleared under 510(x) Ro371 ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... . . . . . . . . . . . . . . . . . . . . . . . . . . . under 510(k) K042637, both from Bicoll, the Street, Speed implant cleared under
Massachusetts, 02130, and the OsseoSpeed 4.0S – 6 mm implant cleared under Massachusetts, 02130, and the OsseoSpeca 4.05 = 6 mm. ........................................................................................................................ 510(k) K063779 from Astra Tech Inc., 690 w hise excepts to these products are
02451, and have equivalent performance characteristics. All these products are 02451, and have equivalent performance characteristics of the missteristics.
manufactured from the same Titanium alloy. All other technological characteristics manufactured from the same Titanum andy. The MIS short implants
are similar and show equivalent performance capabilities. The MIS short implants
are similar and show equival are similar and show equivalent posses.
are therefore substantially equivalent to their predicate devices.
Therefore substantially equivalent to their predicate devices.
Ther
cal characteristics – comparative table:
| Technological characteristics - compar... | ||||
|---|---|---|---|---|
| Indications | ||||
| For Use | MIS Short Implants | |||
| from MIS Implants | ||||
| Technologies Ltd. |
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.
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 | 4.5x6.0mm
6.0x6.0mm
Implants from
Bicon, Inc.
The 4.5x6.0 mm and
the 6.0mmx6.0mm
implants are designed
for use in edentulous
sites in the mandible
or maxilla for support
of a complete denture
prosthesis, a terminal
or intermediate
abutment for fixed
bridgework, partial
dentures, or a single
tooth replacement. | 5.0x6.0 mm Implant
from Bicon, Inc.
The 5.0x6.0 mm
implant is intended to
be surgically placed
in the maxilla or
mandible to provide
support for prosthetic
devices to restore the
patient's chewing
function. | OsseoSpeed from Astra
Tech Inc.
The OsseoSpeed™ 4.0S - 6
mm is intended to be used
to replace missing
masticatory functional units
(teeth) in single or multiple
unit applications within the
mandible or maxilla where
immediate implant stability
may be obtained. The
device may be used equally
well in a single-stage or
two-stage surgical
procedure. It is indicated
for immediate implantation
in extraction sited or
implantation in partially
healed or completely
healed alveolar ridge
situations. When a one-stage surgical approach is applied, the implant may be
immediately loaded after
implantation where
immediate implant stability |
| | MIS Short Implants
from MIS Implants
Technologies Ltd. | 4.5x6.0mm
6.0x6.0mm
Implants from
Bicon, Inc. | 5.0x6.0 mm Implant
from Bicon, Inc. | OsseoSpeed from Astra
Tech Inc. |
| | appropriate.
MIS short implants
are to be used only
with straight
abutments. | | | may be obtained.
The fluoride-modified
surface, though having a
fluoride ion level far below
that needed for caries
prevention in teeth,
provides a favorable
substrate for bone
attachment and
osseointegration.
OsseoSpeed 4.0S – 6 mm is
especially indicated for use
in soft bone applications
where implants with other
implant surface treatments
may be less effective.
Because initial stability
may be difficult to obtain in
Type IV bone, immediate
loading of single tooth
restorations may not be
appropriate in such
situations. |
| Supplied
Sterile | Yes | Yes | Yes | Yes |
| Re-use | No | No | No | No |
| Material of
Construction | Titanium Alloy | Titanium Alloy | Titanium Alloy | Titanium Alloy |
| Shape | Screw type | Screw type | Screw type | Screw type |
| Length | 6.0 mm | 6.0 mm | 6.0 mm | 4.0 |
| Thread
Diameter | 4.2, 5.0 and 6.0 mm | 4.5 and 6.0 mm | 5.0 mm | Straight and up to 20° |
| Abutment
Material of
Construction
of
Abutments | Straight
Titanium Alloy | Straight and up to 25°
Titanium Alloy | Straight and up to 25°
Titanium Alloy | Straight and up to 20°
Titanium Alloy |
| Surface | None | None | None | None |
510 (k) MIS Short Implants 310 (K) Mis Page 3 of 5
3
Image /page/3/Picture/0 description: The image shows the word "nis" in a stylized font. The letters are bold and connected, with the "s" resembling a backwards "u". To the right of the word "nis" is the word "Implan", which is likely the beginning of the word "Implant". The image appears to be a logo or part of a title.
510 (k) MIS Short Implants
Section E - Page 4 of 5
4
Image /page/4/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 "S" being a curved line. To the right of the logo is the text "Implants Technologies Ltd." in a smaller font. The text is slightly angled upwards.
Non – clinical tests:
Non – clinical tests:
Fatigue test was performed on MIS short implants and its results were found
ed the state was performed on Marts devices Fatigue test was F
Clinical tests:
A clinical evaluation, based on literature review and case studies with 30 months
. follow up, has been performed.
Conclusion:
Conclusion:
The evaluation of the MIS short implants does not raise any additional concerns
and the MIS short implants of the MIS short implants may therefore be The evaluation of the MIS short implants does not the may therefore be
regarding safety and effectiveness and the MIS short implants may therefore be regarding safety and effectiveness .
considered substantially equivalent to their predicate device
510 (k) MIS Short Implants Section E - Page 5 of 5
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird-like figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
Ms. Iman Khorshid V P. QA & RA MIS Implants Technologies, Limited P.O. Box 7 Bar Lev Industrial Park 20156. ISRAEL
Re: Ki03089
Trade/Device Name: MIS Short Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: September 11, 2011 Received: September 13, 2011
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 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, Paris 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
SEP 1 5 2011
6
Page 2 - Ms. Khorshid
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 (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm 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/Reportal/roblem/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.hum.
Sincerely vours.
Wh 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 Eyaluation Center for Devices and Radiological Health
Enclosure
7
Implants Technologies Ltd.
INDICATIONS FOR USE
| 510(k) Number: | K103089 |
|---|---|
| ---------------- | --------- |
Device Name: MIS Short Implants
Indications for Use: 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.
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 short implants are to be used only with straight abutments.
Prescription Use x OR (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)
Susan Runner
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
KID30599 510(k) Number:
510 (k) MIS Short Implants Section D- Page 1 of 1