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.

AI/ML Overview

The provided text is a 510(k) summary for the MD-Flex Heavy Body dental impression material. This type of document focuses on demonstrating substantial equivalence to a predicate device, primarily through physical and chemical properties and intended use, rather than clinical study data involving human subjects or AI performance.

Therefore, many of the requested details related to clinical trials, AI performance, ground truth establishment for AI, and expert adjudication are not applicable to this submission.

Here's a breakdown of the information that can be extracted and how it relates to your request:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for MD-Flex Heavy Body are primarily based on its compliance with ISO 4823:2000 Type 1 for dental elastomeric impression materials. The summary states that the device "complies with the requirements of ISO 4823:2000 Type 1".

Acceptance Criteria (from ISO 4823:2000 Type 1)	Reported Device Performance
Physical properties for dental elastomeric impression materials. Specific values for dimensional accuracy, recovery from deformation, etc., as per ISO 4823:2000 Type 1.	Complies with the requirements of ISO 4823:2000 Type 1.
Thixotropic property.	Possesses thixotropic property.
Dimensional accuracy.	Possesses dimensional accuracy.
Excellent recovery from deformation.	Possesses excellent recovery from deformation.
Shelf life of 2 years.	Demonstrates a shelf life of 2 years from the manufacturing date.
Biocompatibility (Cytotoxicity, Irritation, Sensitization).	Biocompatible, as demonstrated by tests conducted in compliance with ISO 10993.

Study Information (Based on Available Text)

Sample size used for the test set and the data provenance: Not explicitly stated. The performance testing is based on compliance with ISO 4823:2000. It doesn't detail a "test set" in the context of clinical or AI performance. The data provenance is generally from laboratory testing of the material itself.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI or diagnostic studies (e.g., expert consensus on clinical images) is not relevant here. The "ground truth" for material properties is derived from standardized laboratory measurements.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. There is no expert adjudication for material property testing.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a dental impression material, not an AI-powered diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For material properties, the "ground truth" is established through standardized laboratory measurement methods as defined by ISO 4823:2000. For biocompatibility, it's based on biocompatibility testing results according to ISO 10993.
The sample size for the training set: Not applicable. This is not an AI device.
How the ground truth for the training set was established: Not applicable. This is not an AI device.

Summary of the "Study"

The device meets the acceptance criteria by demonstrating compliance with the ISO 4823:2000 Type 1 standard for dental elastomeric impression materials. This compliance is achieved through performance testing of the material's physical and chemical properties in a laboratory setting. Additionally, biocompatibility tests (Cytotoxicity, Irritation, Sensitization) conducted in compliance with ISO 10993 confirm its biological safety. These tests are the "study" that proves the device meets its acceptance criteria, showing it is substantially equivalent to predicate devices in its properties and intended use.

Summary

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K134008

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 Impressionmaterial
Classification name	Material, Impression
Regulation number	872.3660
Class	II
Product Code	ELW

1. Predicate Devices:

Manufacturer	Discus Dental, Inc.
Device	Precision VPS Impression Material
510(k) Number	K040053

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7. Device Description:

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.

1. Intended Use:
  MD-flex Heavy Body is used to record the shape of the patient's teeth and alveolar ridges.
1. 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.

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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Regulation Number and Section

§ 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).