The provided 510(k) summary (K102874) details the substantial equivalence of New Stetic Acrylics to a predicate device, Myerson's Economy Denture Base Material (K970522). The "study" that proves the device meets acceptance criteria is a series of non-clinical performance tests conducted by New Stetic, aligning with specific international standards.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the New Stetic Acrylics are based on ANSI/ADA Specification No. 12:2002/ISO 1567:1999 (and 2008 for heat-polymerized acrylics) for Denture Base Polymers. The reported performance for both heat-polymerized and self-polymerized acrylics (which include New Stetic Acrylics) shows that they meet or exceed these requirements.

Heat-Polymerized Acrylics (e.g., Opti-cryl, Veracil, Novacryl, Poti-cryl Pour and EZ-cryl)

Parameters	Acceptance Criteria (ANSI/ADA SPEC. N° 12:2002/ISO 1567:2008)	Reported Device Performance	Meets Criteria?
Absorption	Not higher than 32 µg/mm³	18.10 µg/mm³	Yes
Solubility	Not higher than 1.6 µg/mm³	0.8 µg/mm³	Yes
Flexure Strength	65 MPa Minimum	70.8 MPa	Yes
Flexural Modulus	2000 MPa Minimum	5300 MPa	Yes
Residual Monomer Content	2.2% Maximum (In weight)	0.98%	Yes

Self-Polymerized Acrylics (e.g., Duracryl, O-cryl and Fidelity)

Parameters	Acceptance Criteria (ANSI/ADA SPEC. N° 12:2002/ISO 1567:2008)	Reported Device Performance	Meets Criteria?
Absorption	Not higher than 32 µg/mm³	19.50 µg/mm³	Yes
Solubility	Not higher than 8.0 µg/mm³	5 µg/mm³	Yes
Flexure Strength	60 MPa Minimum	65.4 MPa	Yes
Flexural Modulus	1500 MPa Minimum	3700 MPa	Yes
Residual Monomer Content	4.5% Maximum (In weight)	1.45%	Yes

Qualitative Properties:

Parameters	Acceptance Criteria	Reported Device Performance	Meets Criteria?
Color	Within accepted limits	Within accepted limits	Yes
Polishing Capacity	Within accepted limits	Within accepted limits	Yes
Translucency	Within accepted limits	Within accepted limits	Yes
Porosity	Free from imperfections and porosity	Free from imperfections and porosity	Yes

2. Sample Size and Data Provenance

Sample Size for Test Set: The document does not explicitly state the numerical sample size (e.g., number of specimens tested) for each physical property. It only mentions that "All testing that is required has been performed" and presents the experimental results.
Data Provenance: The testing was conducted in New Stetic's Quality Control Laboratory. New Stetic is located in Guarne, Antioquia, Colombia. Therefore, the data provenance is Colombia and the data is retrospective as it was collected for the purpose of the 510(k) submission based on existing testing protocols.

3. Number of Experts and Qualifications for Ground Truth

This submission pertains to the physical and chemical properties of a dental material, not a diagnostic device requiring expert interpretation of images or other subjective data. Therefore, the concept of "experts used to establish the ground truth" in the traditional sense (e.g., radiologists, pathologists) is not applicable. The "ground truth" here is defined by the technical specifications of the ANSI/ADA and ISO standards, and the measurements are performed using calibrated laboratory equipment.

4. Adjudication Method

Not applicable. As described above, this is a non-clinical performance evaluation against established objective standards using laboratory equipment, not a subjective assessment requiring human adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. A MRMC comparative effectiveness study is typically conducted for diagnostic imaging devices to assess human reader performance with and without AI assistance. This submission describes the testing of a dental material's physical properties.

6. Standalone Performance

Yes, in a sense. The reported performance data represents the standalone (algorithm-only, if considering the testing methodology as an "algorithm") performance of the New Stetic Acrylics samples as measured by laboratory equipment against predefined standards. There is no human-in-the-loop component in determining these physical properties.

7. Type of Ground Truth

The type of ground truth used is expert consensus/established standards. Specifically, the ground truth is defined by the requirements outlined in ANSI/ADA Specification No. 12:2002/ISO 1567:1999 (and 2008) for Denture Base Polymers. These standards are developed by industry experts and regulatory bodies to ensure the safety and effectiveness of dental materials.

8. Sample Size for the Training Set

Not applicable. This submission describes the performance testing of a physical material, not an AI or machine learning model that requires a training set.

9. How Ground Truth for the Training Set Was Established

Not applicable, as no training set was used.

Summary

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K102874

510(k) SUMMARY (as required by 807.92(c))

Regulatory Correspondent: Regulatory and Marketing Services Inc 962 Allegro Lane Apollo Beach, FL, 334570 Arthur Ward award@ajwtech.com 813-645-2855 813-677-4787 Submitter of 510(k): New Stetic Carrera 33, No. 50-09 Guarne, Antioquia, Colombia Edna Cecilia Gil EcGil@newstetic.com Date of Summary: 9/1/2010 Trade/Proprietary Name: New Stetic Acrylics New Stetic Denture Base Resins Classification Name: Resin, Denture, Relining, Repairing, Rebasing Product Code: EBI Intended Use: The intended use of New Stetic® Acrylics is for the repair or fabrication of the denture base. Device Description: The product is a denture system consisting of monomer and polymer powder and liquid components. Predicate Device: K970522 - Myersons Economy Denture Base Material. . Substantial Equivalence: New Stetic claims the proposed devices to be substantially equivalent to the devices previously cleared by FDA in K970522. New Stetic claims this equivalence because the proposed devices have an

MAR 2 8 2011

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equivalent intended use, manufacturing materials, operating principles and physical operational specifications as compared to the predicate devices. The similarities and differences between the proposed and predicate devices have been identified and explained in the comparison matrix which has been included in Section 12 of this submission. These differences have no effect on safety and effectiveness.

Performance Testing:

All testing that is required has been performed. The New Stetic Acrylics have been found to fall within the required limits of the testing. The test results can be found in both the Biocompatibility Testing (Section 15) and the Performance Testing (Section 18) of this submission.

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SUMMARY OF TEHCNOLOGICAL CHARACTERISTICS

Following chart shows a comparison of the method of using and the properties declared with respect to the homologous Myerson's economy denture base

PRODUCT	Myerson's economy denturebase material.	New Stetic ®Acrylics, New Stetic ®Denture BaseResins.
510(K)NUMBER	K970522	Not yet assigned
PARAMETERS		SIMILARITIES	DIFFERENCES
Method of use	Curing is accomplished bymixing the powder and liquidcomponents at a prescribedratio (21 g powder/10 ml ofmonomer) yielding a dough-like material which is thepacked into a flask. The flaskis then placed in a water bathfor curing at:1. 90 minutes at165°F followed by30 minutes inboiling water, or2. Overnight at 165°Ffor at least 9hours.	Curing isaccomplished bymixing the powderand liquidcomponents at aprescribed ratio (2parts powder to 1part of monomer byweight) yielding adough-like materialwhich is the packedinto a flask. Theflask is then placed ina water bath forcuring at:90 minutes at165°F followed by30 minutes inboiling water.	The onlydifference is indetermining thepowder / liquidratio.This difference isrelated tocharacteristics ofpolymer particlesize, but not affectthe performanceof the medicaldevice aboutensuring safe use,which is supportedby the fulfilling ofparametersrequired bystandard ANSI /ADA SpecificationNo. 12:2002 / ISO1567:1999)
Experimentalresults
FlexureStrength.(65MPaMinimum)	74according to ANSI/ADASpecification No. 12:2002/ISO1567:1999)	70.8according to ANSI/ADASpecification No.12:2002/ISO1567:1999)	Withinspecification
FlexuralModulus2000 MPaMinimum	2459according to ANSI/ADASpecification No. 12:2002/ISO1567:1999)	5300according to ANSI/ADASpecification No.12:2002/ISO1567:1999)	Withinspecification

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CONCLUSION

According to previous information products Myerson's Economy Denture Base Material ( K970522) and New Stetic ® Acrylics, New Stetic ® Denture Base Resins are technically similar in terms of mechanical properties and specifications related to its use, since both meet the requirements of ANSI / ADA Specification No. 12:2002 / ISO 1567:1999 for Denture Base Polymers, which ensures that the product can be used safely.

New Stetic ® Acrylics, New Stetic ® Denture Base Resins are equivalent to Myerson's Economy Denture Base Material

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SUMMARY OF NON-CLINICAL TESTING DATA

Physical properties of polymers are measured in New Stetic's Quality Control Laboratory by means of well-gauged high specialized equipment, according to ANSI/ADA Specification No. 12:2002/ISO 1567:1999 Polymers for Denture Bases.

The most relevant physical properties of Heat-polymerized and Self-polymerized polymers are showed in the following chart:

Heat-polymerized acrylics (Opti-cryl, Veracil, Novacryl, Poti-cryl Pour andEZ-cryl)

Parameters	RequirementsANSI/ADASPECIFICATION N°12:2002/ISO 1567:2008	Experimental results
Absorption	Not higher than 32 µg/mm³	18.10
Solubility in	Not higher than 1.6 µg/mm³	0.8
Flexure Strength	65 MPa Minimum	70.8
Flexural Modulus	2000 MPa Minimum	5300
Residual Monomer Content	2.2% Maximum (In weight)	0.98

Self-polymerized acrylics (Duracryl, O-cryl and Fidelity)

Parameters	Requirements	Experimental results
Absorption	Not higher than 32µg/mm³	19.50
Solubility in	Not higher than 8.0µg/mm³	5
Flexure Strength	60 MPa Minimum	65.4
Flexural Modulus	1500 MPa Minimum	3700
Residual MonomerContent	4.5% Maximum (In weight)	1.45

Other physical properties like color, polishing capacity, translucency, and porosity are evaluated qualitatively. These properties are inside accepted limits.

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QUALITY ASSURANCE OF THIS PRODUCT

Acrylic resins are made from the highest quality raw materials through a completely standardized production process which conforms to ISO Standard 9001:2008 and ISO 13485:2003.

Moreover, in its Quality Control Laboratory, New Stetic verifies the fulfilling of ANSI/ADA Specification No. 12:2002/ISO 1567:1999 concerning the quality requisites for the finished product, using specialized equipment.

The most representative machines used for quality control are the following

Water absorption and solubility: The amount of water that can be absorbed by acrylic resins or the amount of weight that they lose when submerged in water is accurately tested. Acrylic is not soluble in saliva or in any other oral fluid.
Porosity:The surface of processed acrylics is free from imperfections and porosity.
Flexural Strength and Flexural Modulus : The degree of distortion suffered by acrylic resins under the occlusion forces that are applied during the use is verified in an INSTRON Testing Machine. The force supported by a resin until its fracture is also measured. This aspect ensures the good clinical performance of resins.
Translucency: An object placed at the opposite side of the test tube containing acrylic resin must be visible.
Residual Monomer Content: The amount of monomer that remains after the making of a prosthesis must be minimum in order to avoid possible irritations of oral tissues.

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Image /page/6/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle image.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

New Stetic C/O Mr. Auther J. Ward Regulatory Correspondent Regulatory and Marketing Services, Incorporated 962 Allegro Lane Apollo Breach, Florida 33572

MAY 1 3 2011

Re: K102874 Trade/Device Name: New Stetic Acrylics Regulation Number: 21 CFR 272.3760 Regulation Name: Denture Relining Repairing or Rebasing Resin Regulatory Class: II Product Code: EBI, EBG Dated: March 14, 2011 Received: March 21, 2011

Dear Mr. Ward:

This letter corrects our substantially equivalent letter of March 28, 2011.

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 (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 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. Ward

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/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Susan Punner

/Anthony D. Watson, B.S., M.S., M.B.A. 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): K102874

Device Name: New Stetic Acryics

Indications for Use: The indication for use of the New Stetic® Acrtylics is for the repair or fabrication of the denture base.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Rurre
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

Page I of I

510(k) Number: K162874

Traditional 510k Submission - New Stetic Acrylics

2 of 626

Regulation Number and Section

§ 872.3760 Denture relining, repairing, or rebasing resin.

(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.