(301 days)
Not Found
No
The device description details a mechanical device for bone widening and does not mention any software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is used to widen the alveolar crest by creating new bone through Distraction Osteogenesis, which is a therapeutic intervention to prepare the ridge for implantation.
No
The device description indicates that the MIS Crest Widener is a surgical tool used to physically widen the alveolar crest, facilitating implant placement. It is an active mechanical device for tissue modification, not for obtaining or analyzing data about a patient's condition or disease.
No
The device description clearly details a physical medical device made of titanium alloy with mechanical components (arms, guiding pins, activating screw) used for a surgical procedure. It is not software.
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 Function: The MIS Crest Widener is a surgical instrument used to physically manipulate bone tissue (widen the alveolar crest) within the patient's body. It is a mechanical device used for a surgical procedure.
- Lack of Diagnostic Purpose: The device's intended use is to prepare the alveolar crest for implantation, not to diagnose any condition or analyze biological samples.
The description clearly indicates a surgical tool used in vivo (within the living body) for a structural modification, not a test performed in vitro (outside the living body) for diagnostic purposes.
N/A
Intended Use / Indications for Use
The MIS Crest Widener is intended to: - Preparing the narrow alveolar crest for implantation as an alternative to bone augmentation. The device is used temporary and is removed after the treatment has been completed. The device is for single use only.
Product codes (comma separated list FDA assigned to the subject device)
MQN
Device Description
The MIS crest widener is used to widen a narrow alveolar crest which has sufficient height so as to prepare the ridge for implantation. With this technique. bone augmentation is avoided and the implant is placed in the correct lateral position . The Crest widener is made of medical grade 5 Titanium alloy complying with the standard ASTM F136-02. The device consists of 4 arms, 2 on each side, connected with guiding pins and an activating screw. The Crest Widener is inserted after cutting 3 mucoperiosteal incisions (without stripping the bone) cutting and splitting the narrow alveolar crest. By rotating the activating screw, each pair of arms moves apart from the other 2 arms, thus pushing the buccal cortical bone apart. The device is supplied with a fine Titanium ligature for attachment to a neighbor tooth during the treatment period. Activating starts 5 - 7 days (latency period) after the insertion of the device. By separating the cortical plates, new bone is created in between (Distraction Osteogenesis) .. The device is not provided sterile and should be sterilized before use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
alveolar crest
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): 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
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.
0
DEC 1 7 2008
510(k) Summary:
MIS Crest Widener
Company Name -
MIS - Implants Technologies Ltd. POB 110 Shlomi Industrial Zone Shlomi 22832 ISRAEL Telephone: +972-4-980-9966 Fax: +972-4-980-9944
Establishment Registration Number: 3004203816
Contact Name: Iman Khorshid Quality Manager Telephone: +972-4-980-9966 Fax: +972-4-980-9944 E-mail: iman@mis-implants.com
US Agent: Motti Weisman - VP Marketing MIS Implants Technologies Inc. 278 Broadway Elmwood Park, NJ 07407 Phone: (201) 797-9144 Fax: (201) 797-9145 E-mail: motti(@misimplants.com
Date prepared: February 10, 2008
Trade Name: MIS Crest Widener
Classification name: External mandibular fixator and/or distractor
Common/usual name: MIS Crest Widener
Product Code: MQN
Regulation No.: 872.4760
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Mis
Class: II
Panel identification: Dental Devices Panel
Predicate Device:
-
- Alveolar Ridge Distractor from SYNTHES (USA). P.O.Box 1766, 1690 russell road , paoli, PA 19301 1222 cleared under 510(k) no. K043555.
-
- TRACK 1.0 & 1.5 MM SYSTEMS-TISSUE REGENERATION BY CALLUS DISTRACTION from KLS-Martin, L.P. 3234 ella ln., new port richey, FL 34655, cleared under 510(k) no. K002152
- ORAL OSTEODISTRACTION ROD APPLIANCE (ROD 5) from ORAL 3. OSTEODISTRACTION L.P., 962 allegro ln. apollo beach, FL 33572, cleared under 510(k) no. K042278.
Description of the device:
The MIS crest widener is used to widen a narrow alveolar crest which has sufficient height so as to prepare the ridge for implantation. With this technique. bone augmentation is avoided and the implant is placed in the correct lateral position .
The Crest widener is made of medical grade 5 Titanium alloy complying with the standard ASTM F136-02.
The device consists of 4 arms, 2 on each side, connected with guiding pins and an activating screw. The Crest Widener is inserted after cutting 3 mucoperiosteal incisions (without stripping the bone) cutting and splitting the narrow alveolar crest. By rotating the activating screw, each pair of arms moves apart from the other 2 arms, thus pushing the buccal cortical bone apart. The device is supplied with a fine Titanium ligature for attachment to a neighbor tooth during the treatment period.
Activating starts 5 - 7 days (latency period) after the insertion of the device. By separating the cortical plates, new bone is created in between (Distraction Osteogenesis) ..
The device is not provided sterile and should be sterilized before use.
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Indications for Use:
The MIS Crest Widener is intended to:
- Preparing the narrow alveolar crest for implantation as an alternative to bone augmentation.
The device is used temporary and is removed after the treatment has been completed.
Substantial Equivalence:
The MIS Crest Widener has the same intended use as its predicate devices:
-
- Alveolar Ridge Distractor from SYNTHES (USA). P.O.Box 1766, 1690 russell road , paoli, PA 19301 1222 cleared under 510(k) no. K043555.
-
- TRACK 1.0 & 1.5 MM SYSTEMS-TISSUE REGENERATION BY CALLUS DISTRACTION from KLS-Martin, L.P. 3234 ella ln., new port richey, FL 34655, cleared under 510(k) no. K002152
-
- ORAL OSTEODISTRACTION ROD APPLIANCE (ROD 5) from ORAL OSTEODISTRACTION L.P., 962 allegro ln. apollo beach, FL 33572, cleared under 510(k) no. K042278.
The MIS Crest Widener show equivalent performance capabilities comparing to its predicate devices. The predicate devices are made either of Titanium or stainless steel and used to distract the mandible and / or the maxilla. The devices have the same distraction concept. The use of a screwdriver for activation is similar for all the devices. The devices remain in the body similar period of time until they are removed.
The MIS Crest Widener is therefore substantially equivalent to the predicate devices.
Conclusion -
The evaluation of the MIS Crest Widener does not raise any additional concerns regarding safety and effectiveness and may therefore be considered substantially equivalent to the predicate devices.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or feathers. The bird is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
DEC 1 7 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Iman Khorshid Regulatory Affairs and Quality Assurance Manager MIS - Implants Technologies Limited P. O. Box 110, Shlomi Industrial Zone Shlomi ISRAEL 22832
Re: K080458
Trade/Device Name: MIS Crest Widener Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: MQN Dated: December 7, 2008 Received: December 9, 2008
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.
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 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.
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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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sudite Y. Mrchiond
Chiu S. Lin. Ph. D Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number (if known):
Device Name:
MIS Crest Widener
Indications for Use:
The MIS Crest Widener is intended to:
- . Preparing the narrow alveolar crest for implantation as an alternative to bone augmentation.
The device is used temporary and is removed after the treatment has been completed. The device is for single use only.
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 Punser
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K080452
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