(72 days)
Not Found
No
The summary describes a standard dental implant system with mechanical components and surgical instruments. There is no mention of software, image processing, AI, or ML.
No
The device aids in restoring chewing function through surgical and restorative applications, which is a supportive role rather than directly treating a disease or condition. While it improves a bodily function, it's categorized more as a prosthetic support system than a therapeutic device in the medical device context.
No
Explanation: The device description and intended use focus on surgical and restorative applications for supporting prosthetic devices, restoring chewing function. There is no mention of diagnosing conditions or diseases.
No
The device description explicitly lists hardware components such as implants, cover screws, healing caps, abutment systems, suprastructures, and surgical instruments.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the MIS Dental Implant System is a physical device (implants, screws, abutments, instruments) intended for surgical placement in the bone of the jaw to support prosthetic devices. This is a surgical and restorative procedure performed directly on the patient's body, not a test performed on a sample outside the body.
The information provided aligns with a medical device used for surgical intervention and restoration, not for diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
The MIS 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.
Product codes
DZE, NHA
Device Description
The MIS Dental Implant System consists of one and two stage implants, internal and external hexagonal; cover screw and healing caps; abutment systems and suprastructures; surgical instruments.
Implants: One- or two-stage dental implant devices, both internal hexagonal and external hexagonal, including self-tapping implants of different dimensions. All implants are manufactured from medical grade 4 (GD-4) pure titanium, which meets requirements of standard ASTM F67-95.
Cover screw and healing caps: The implants are supplied together with cover screws and healing caps. manufactured from titanium grade 4. The cover screws and healing cups are placed in the implant during the integration period between the implant and the bone. They completely occlude the internal surface, keeping it free from ingrowth of bone and debris. The parts are supplied sterile together with the implant in the same individual package.
Abutment systems and suprastructures: Anatomic abutments are used in conjunction with the two-stage implants for screw retained reconstruction. The selection of the abutments is made at the beginning of the prosthetic procedure and is based on measurement of the gingival thickness. The abutments fit in/on the hexagonal part of the implant and deliver maximum stability with the use of the screw. Direct systems for screw retained construction and for cemented reconstruction are included in the system. Cerasthetic abutments manufactured from ceramic and titanium, as well as goldplastic cylinder abutments manufactured from burn-out plastic and gold are also available in the submitted system. Additional suprastructures include ball attachment system and bar and screw attachment system. Those systems are manufactured from titanium, gold, stainless steel or burn-out plastic.
Surgical instruments: The range of instruments made available as part of the MIS Dental Implant System includes drills, adapters, ratchet wrench and depth and direction indicators. The instruments are manufactured from titanium or stainless steel and supplied in kits specially designed kit packages.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
JUN - 9 2004
SUN 9 2007
mis
KC40807
510(k) Summary
- Company Name -MIS - Implant Technologies Ltd. POB 110 Shlomi Industrial Zone Shlomi 22832 ISRAEL
Telephone: +972-4-980-9966 +972-4-980-9944 Fax:
| Contact Name: | Sophie Goldman |
|---|---|
| QA Manager | |
| Telephone: +972-4-980-9966 | |
| Fax: | +972-4-980-9944 |
| E-mail: | sophie@mis-implants.com |
- Motti Weisman VP Marketing US Agent: MIS Implants Technologies Inc. 278 Broadway Elmwood Park, NJ 07407 Phone: (201) 797-9144 Fax: (201) 797-9145 E-mail: mis.service@verizon.net
Date prepared: March 15, 2004
2. Device Name -
Proprietary name: MIS Dental Implant System Common / Usual Name: Endosseous Dental Implant Trade Name: MIS Dental Implant System
The device has been classified in Class III under the following classification:
| Classification name | Product Code | Regulation No. | Panel Identification |
|---|---|---|---|
| Endosseous implant | DZE | 872.3640 | DentalDevices Pane |
1
3. Predicate Devices -
- 3i Dental Implant System from Implant Innovations Ltd, Palm Beach Gardens, FL. cleared under 510(k) no. K022009 (for two stage implants)
- 3i Dental Implant Accessories from Implant Innovations Ltd, Palm Beach ﮯ Gardens, FL, cleared under 510(k) no. K022113 (for accessories)
- ITI Dental Implant System from Straumann USA, Waltham, MA, cleared under 510(k) no. K030007 (for one stage implants)
4. Description of the Device -
The MIS Dental Implant System consists of one and two stage implants, internal and external hexagonal; cover screw and healing caps; abutment systems and suprastructures; surgical instruments.
Hereby is a description of each of the components:
Implants:
One- or two-stage dental implant devices, both internal hexagonal and external hexagonal, including self-tapping implants of different dimensions. All implants are manufactured from medical grade 4 (GD-4) pure titanium, which meets requirements of standard ASTM F67-95.
Cover screw and healing caps:
The implants are supplied together with cover screws and healing caps. manufactured from titanium grade 4. The cover screws and healing cups are placed in the implant during the integration period between the implant and the bone. They completely occlude the internal surface, keeping it free from ingrowth of bone and debris. The parts are supplied sterile together with the implant in the same individual package.
Abutment systems and suprastructures:
Anatomic abutments are used in conjunction with the two-stage implants for screw retained reconstruction. The selection of the abutments is made at the beginning of the prosthetic procedure and is based on measurement of the gingival thickness. The abutments fit in/on the hexagonal part of the implant and deliver maximum stability with the use of the screw.
Direct systems for screw retained construction and for cemented reconstruction are included in the system.
Cerasthetic abutments manufactured from ceramic and titanium, as well as goldplastic cylinder abutments manufactured from burn-out plastic and gold are also available in the submitted system.
2
Additional suprastructures include ball attachment system and bar and screw attachment system. Those systems are manufactured from titanium, gold, stainless steel or burn-out plastic.
Surgical instruments:
The range of instruments made available as part of the MIS Dental Implant System includes drills, adapters, ratchet wrench and depth and direction indicators. The instruments are manufactured from titanium or stainless steel and supplied in kits specially designed kit packages.
న. Indications for Use -
The MIS 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.
6. Substantial Equivalence -
The MIS Dental Implant System has the same intended use as the 3i Dental Implants and 3i Dental Implant Accessories from Implant Innovations Ltd, Palm Beach Gardens, FL, cleared under 510(k) no. K022009 and K022113 and ITI Dental Implant System cleared under 510(k) no. K030007 and has equivalent performance characteristics. Those product systems contain implants, cover screws and healing cups, abutments and the applicable surgical instruments. All other technological characteristics are similar and both devices show equivalent performance capabilities.
7. Conclusion -
The evaluation of the MIS Dental Implant System does not raise any additional concerns regarding safety and effectivity and may therefore be considered substantially equivalent to the predicate devices.
3
Image /page/3/Picture/1 description: The image contains the words "Public Health Service" in bold, black font. The words are arranged on a single line. The text appears to be a title or heading.
Image /page/3/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized human figure.
JUN - 9 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MIS-Implant Technologies Limited C/O Mr. Motti Weisman Vice President Marketing MIS Implants Technologies, Incorporated 278 Broadway Elmwood Park, New Jersey 07407
Re: K040807
Trade/Device Name: MIS Dental Implant System Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE, NHA Dated: April 22, 2004 Received: April 27, 2004
Dear Mr. Weisman:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your end 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 mendments, or to devices that have been reclassified in accordance with the provisions of Amendinents, or to arrivatic Act (Act) that do not require approval of a premarket the rederal F 00d, Drag). You may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls providents or annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 wir), it may be subject to 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.
4
Page 2 - Mr. Weisman
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advisod that I Dr. 5 tbudines on that your device complies with other requirements mean that IDA nas made a dotentials administered by other Federal agencies. of the Act of ally i ederal statutes and enginements, including, but not limited to: registration You must comply with an the Hot Stog (21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 807), labeling (21 CFR Part 820); and if requirents as set form in the quality ajon control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begal mailing of substantial equivalence of your device to a premarket notheation. The PDF results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire specific advice for your de at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Ifray outain other general was and Consumer Assistance at its toll-free Dribber (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Ques
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K040807
Device Name: MIS Dental Implant System
Indications for Use: The MIS Dental Implant System is indicated for use in surgical and Thurcations for ose. The Mio Donal in the bone of the upper or lower jaw to provide restorative apprivations local as artificial teeth, in order to restore the patient's chewing function.
AND/OR Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Surin Rungs
(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number
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