(100 days)
Not Found
No
The device is a traditional dental impression material, and the description focuses on its physical and chemical properties, not any computational or analytical capabilities.
No
The device is an impression material used to create molds of teeth and alveolar ridges, which is a diagnostic or measurement function, not a therapeutic one.
No
The device is an impression material used to record the shape of teeth and alveolar ridges, which is a physical modeling process, not for diagnosing medical conditions.
No
The device description clearly states it is a "Polyvinylsiloxane Impression Material" supplied in cartridges with mixing tips, which are physical components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- Device Function: The MD-flex Heavy Body is an impression material used to create a physical mold of a patient's teeth and alveolar ridges. This mold is then used to create a gypsum model.
- Purpose: The purpose of this device is to physically capture the shape of anatomical structures for the creation of a model, not to analyze biological specimens to provide diagnostic information about a patient's health status.
The device is a dental impression material, which falls under the category of dental devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
MD-flex Heavy Body is used to record the shape of the patient's teeth and alveolar ridges.
Product codes
ELW
Device Description
MD-flex Heavy body is hydrophilic Polyvinylsiloxane Impression Material with thixotropic property, dimensional accuracy and excellent recovery from deformation. It complies with the requirements of ISO 4823:2000 Type 1 for dental elastomeric impression materials. It is supplied as a two-part base/catalyst formulation preloaded in a dual-barrel cartridge.
The MD Flex Heavy Body package includes two dual-barrel 50 ml cartridges, and six mixing tips that allows for easy mixing of the base and catalyst. The device (cartridge) and accessories (mixing tip) are to be sold non-sterile. Testing demonstrates that MD-Flex has a shelf life 2 years from the manufacturing date.
MD-Flex can be used to make a mold of a patient teeth and alveolar ridges. The mold can be used to generate Gypsum model within 30 minutes of removal of the mold from patient's mouth. The Gypsum model will be effectively reproduced without transformation due to an excellent reproducibility and volume stability of MD Flex.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth and alveolar ridges
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
§ 872.3660 Impression material.
(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).
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510(k) Summary
Summary of safety and effectiveness of MD Flex Heavy body Impression material
- 510(k) Submitter:
Metabiomed, Inc.V 110 Gibraltar Road, suite 106 Horsham, PA 19044 USA Ph: 267-282-5893 267-282-5899 Fax: Email: metabiomed@gmail.com
-
Company Contact: · Title:
-
Date of Submission
-
510(k) Preparer:
12/02/2013
Sales Director
lan Yun
Blix Winston Co ACMD Consulting, LLC. 2600 Mullinix Mill Road Mt. Airy, MD 21771 USA Ph: 301-607-9185 Email: fblixwinston@aol.com
- Device Name and Classification:
| Trade name | MD-Flex Heavy Body |
|---|---|
| Common name | Hydrophilic polyvinylsiloxane Impression |
| material | |
| Classification name | Material, Impression |
| Regulation number | 872.3660 |
| Class | II |
| Product Code | ELW |
-
- Predicate Devices:
| Manufacturer | Discus Dental, Inc. |
|---|---|
| Device | Precision VPS Impression Material |
| 510(k) Number | K040053 |
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7. Device Description:
MD-flex Heavy body is hydrophilic Polyvinylsiloxane Impression Material with thixotropic property, dimensional accuracy and excellent recovery from deformation. It complies with the requirements of ISO 4823:2000 Type 1 for dental elastomeric impression materials. It is supplied as a two-part base/catalyst formulation preloaded in a dual-barrel cartridge.
The MD Flex Heavy Body package includes two dual-barrel 50 ml cartridges, and six mixing tips that allows for easy mixing of the base and catalyst. The device (cartridge) and accessories (mixing tip) are to be sold non-sterile. Testing demonstrates that MD-Flex has a shelf life 2 years from the manufacturing date.
MD-Flex can be used to make a mold of a patient teeth and alveolar ridges. The mold can be used to generate Gypsum model within 30 minutes of removal of the mold from patient's mouth. The Gypsum model will be effectively reproduced without transformation due to an excellent reproducibility and volume stability of MD Flex.
-
- Intended Use:
MD-flex Heavy Body is used to record the shape of the patient's teeth and alveolar ridges.
- Intended Use:
-
- Biocompatibility:
Based on the contact duration listed in Appendix A of the Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" the following three biocompatibility tests Cytotoxicity. Irritation and Sensitizations test were conducted in compliance with ISO 10993. The test results included in section 10 demonstrate that MD-Flex Heavy Body is biocompatible.
- Biocompatibility:
- Substantial Equivalence
Based on the fact that: MD Flex has nearly identical intended use and indications for use as the predicate, and; MD Flex demonstrates similar physical and chemical properties and performance characteristics as the predicates, Metabiomed Inc., concludes that MD-Flex Heavy Body is substantially equivalent to the predicate devices.
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11. Conclusion
.
Based on performance testing and product description Metabiomed Inc. concludes that MD Flex Heavy Body is substantially equivalent to Precision VPS impression material and Flextime Xtreme 2.
·
ﺜﺒﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﻮﻗﻒ ﺍﻟﻤﺘﻮﻗﻒ ﺍﻟﻤﺘﻮﻗﻒ ﺍﻟﻤﺘﻮﻗﻒ ﺍﻟﻤﺘﻮﻗﻒ ﺍﻟﻤﺘﻮﻗﻒ
.
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Image /page/3/Picture/1 description: The image contains a logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a symbol. The symbol consists of a stylized representation of an eagle or bird-like figure with three curved lines forming its body and wings.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002
April 9, 2014
Metabiomed, Incorporated C/O Mr. Blix Winston Correspondent ACMD Consulting, LLC 2600 Mullinix Mill Road Mt. Airy, MD 21771
Re: K134008
Trade/Device Name: MD-Flex Heavy Body Regulation Number: 21 CFR 872.3660 Regulation Name: Impression material Regulatory Class: II Product Code: ELW Dated: January 16, 2014 Received: January 17, 2014
Dear Mr. Winston:
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, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Winston
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 contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mary S, Runner -S
Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section 3: Indications for Use Statements
Indications Statement for MD-Flex Heavy Body is included in this 510(k) application.
Indications for Use
| 510(k) Number (if known): | K134008 |
|---|---|
| --------------------------- | --------- |
Device Name: MD-Flex Heavy Body
Indications for Use:
MD-flex Heavy Body is used to record the shape of the patient's teeth and alveolar ridges.
Prescription Use ____ V ___ AND/OR
Over-The- Counter Use
(Part 21 CFR 810 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THUS LINE-CONTINUE ON
ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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