(179 days)
Not Found
No
The 510(k) summary describes a material for fabricating dentures and does not mention any AI/ML components or image processing. The performance metrics are related to material properties, not algorithmic performance.
No
The device is described as a denture system used for the repair or fabrication of denture bases, which is a restoration rather than a therapeutic treatment for a disease or condition.
No
The device is indicated for the repair or fabrication of denture bases, which is a manufacturing or restorative process, not a diagnostic one.
No
The device description clearly states it is a denture system consisting of physical monomer and polymer components, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "repair or fabrication of the denture base." This is a mechanical and structural application, not a diagnostic test performed on a biological sample to determine the presence of a disease or condition.
- Device Description: The device is a "denture system consisting of monomer and polymer powder and liquid components." This describes materials used for creating a physical structure (a denture base), not reagents or instruments used for in vitro testing.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Testing biological samples (blood, urine, tissue, etc.)
- Detecting analytes (proteins, DNA, antibodies, etc.)
- Providing diagnostic information about a patient's health status
The device is clearly intended for use in dentistry to create or repair dentures, which is a medical device application, but not an in vitro diagnostic one.
N/A
Intended Use / Indications for Use
The intended use of New Stetic® Acrylics is for the repair or fabrication of the denture base. The indication for use of the New Stetic® Acrtylics is for the repair or fabrication of the denture base.
Product codes (comma separated list FDA assigned to the subject device)
EBI, EBG
Device Description
The product is a denture system consisting of monomer and polymer powder and liquid components.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
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.
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.
Heat-polymerized acrylics (Opti-cryl, Veracil, Novacryl, Poti-cryl Pour and EZ-cryl):
Absorption: 18.10 (Requirement: Not higher than 32 µg/mm³)
Solubility in: 0.8 (Requirement: Not higher than 1.6 µg/mm³)
Flexure Strength: 70.8 (Requirement: 65 MPa Minimum)
Flexural Modulus: 5300 (Requirement: 2000 MPa Minimum)
Residual Monomer Content: 0.98 (Requirement: 2.2% Maximum (In weight))
Self-polymerized acrylics (Duracryl, O-cryl and Fidelity):
Absorption: 19.50 (Requirement: Not higher than 32 µg/mm³)
Solubility in: 5 (Requirement: Not higher than 8.0 µg/mm³)
Flexure Strength: 65.4 (Requirement: 60 MPa Minimum)
Flexural Modulus: 3700 (Requirement: 1500 MPa Minimum)
Residual Monomer Content: 1.45 (Requirement: 4.5% Maximum (In weight))
Other physical properties like color, polishing capacity, translucency, and porosity are evaluated qualitatively. These properties are inside accepted limits.
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
§ 872.3760 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.
0
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
1
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.
2
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 denture
base material. | New Stetic ®
Acrylics, New Stetic ®
Denture Base
Resins. | |
|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K)
NUMBER | K970522 | Not yet assigned | |
| PARAMETERS | | SIMILARITIES | DIFFERENCES |
| Method of use | Curing is accomplished by
mixing the powder and liquid
components at a prescribed
ratio (21 g powder/10 ml of
monomer) yielding a dough-
like material which is the
packed into a flask. The flask
is then placed in a water bath
for curing at:
-
90 minutes at
165°F followed by
30 minutes in
boiling water, or -
Overnight at 165°F
for at least 9
hours. | Curing is
accomplished by
mixing the powder
and liquid
components at a
prescribed ratio (2
parts powder to 1
part of monomer by
weight) yielding a
dough-like material
which is the packed
into a flask. The
flask is then placed in
a water bath for
curing at:
90 minutes at
165°F followed by
30 minutes in
boiling water. | The only
difference is in
determining the
powder / liquid
ratio.
This difference is
related to
characteristics of
polymer particle
size, but not affect
the performance
of the medical
device about
ensuring safe use,
which is supported
by the fulfilling of
parameters
required by
standard ANSI /
ADA Specification
No. 12:2002 / ISO
1567:1999) |
| Experimental
results | | | |
| Flexure
Strength.
(65MPa
Minimum) | 74
according to ANSI/ADA
Specification No. 12:2002/ISO
1567:1999) | 70.8
according to ANSI/ADA
Specification No.
12:2002/ISO
1567:1999) | Within
specification |
| Flexural
Modulus
2000 MPa
Minimum | 2459
according to ANSI/ADA
Specification No. 12:2002/ISO
1567:1999) | 5300
according to ANSI/ADA
Specification No.
12:2002/ISO
1567:1999) | Within
specification |
3
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
4
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 | Requirements
ANSI/ADA
SPECIFICATION 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 32 | |
| µg/mm³ | 19.50 | |
| Solubility in | Not higher than 8.0 | |
| µg/mm³ | 5 | |
| Flexure Strength | 60 MPa Minimum | 65.4 |
| Flexural Modulus | 1500 MPa Minimum | 3700 |
| Residual Monomer | ||
| Content | 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.
5
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.
6
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.
7
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
8
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
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