(292 days)
No
The device description and performance studies focus on the material properties and biocompatibility of a PMMA disc used in dental milling, with no mention of AI or ML.
No.
The device is used for the fabrication of dentures, which are prosthetic devices, not therapeutic.
No
The device is used for the fabrication of dentures, not for diagnosing any medical condition. Its performance characteristics relate to material properties and biocompatibility, not diagnostic accuracy.
No
The device description clearly states it is a physical disc made of PMMA and pigments, used in milling machines. It is a hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Fabrication of dentures." This is a mechanical process for creating a medical device (a denture) that is placed in the body.
- Device Description: The device is a material (PMMA disc) used in a manufacturing process (milling) to create a denture.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. IVDs are typically used to test blood, urine, tissue, etc., to detect diseases, conditions, or measure substances.
The device is a material used in the manufacturing of a medical device (a denture), not a diagnostic tool.
N/A
Intended Use / Indications for Use
- Fabrication of dentures.
Product codes
EBI
Device Description
PINK CAD/CAM disc are blanks used in different milling machines (dental CAD-CAM systems) by professional dental technicians.
They are composed of hot cured polymethyl methacrylate (PMMA) and pigments. Device is available in different pink shades. Discs of all shades are available in different dimensions (diameter, thickness and profile margin).
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
professional dental technicians
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)
The test results of E-modulus and flexural strength have been obtained with PINK CAD/CAM disc. The requirements of standard EN ISO 20795-1:2008: Dentistry-Base polymers –Part 1: Denture base polymers are that the required E-modulus of Type 1 material must be minimum 2000 MPa and required fluxural strength minimum 65 MPa. Both devices- PINK CAD/CAM disc and M-PM-Disc (Pink) comply with the requirements of standard EN ISO 20795-1 regarding the required flexural properties. The residual methyl methacrylate content of disc polymerised by Polident PMMA CAD/CAM disc material has been determined with regard to standard EN ISO 20795-1:2008: Dentistry- Base polymers -Part 1: Denture base polymers. The measured value is 1,02 wt-%. The requirement of residual monomer content with regard to EN ISO 20795-1 for Type 1 material is 2,2 wt-%. So PINK CAD/CAM disc complies the requirement of residual menthyl methacrylate content. In the literature company Merz Dental, the producer of predicate device M-PM-Disc (Pink), published that the amount of residual monomer in M-PM-Disc is 1,14 wt-%.
Therefore also cytotoxicity, sensitization and irritation testing was conducted on reference device PMMA CAD/CAM disc composed of Polident PMMA CAD/CAM disc material. The test results are that PMMA CAD/CAM disc material used for fabrication of reference device PMMA CAD/CAM disc and proposed device PINK CAD/CAM disc complies with the requirements of standard EN ISO 10993 regarding cytoxicity, irritation and sensitization properties. The Certificate of Compliance with ISO 10993: Biological Evaluation of Medical Devices for PMMA CAD/CAM disc has been issued.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- E-modulus (MPa) /EN ISO 20795-1/: 3040
- Fluxural strenght(MPa) /EN ISO 20795-1/: 115,8
- Residual methyl methacrylate (%): 1,02
- Biocompatibility: cytotoxicity test /EN ISO 10993-5/: Met the requirements of EN ISO 10993-5
- Biocompatibility: irritation test /EN ISO 10993-10/: Met the requirements of EN ISO 10993-10
- Biocompatibility: sensitization test /EN ISO 10993-10/: Met the requirements of EN ISO 10993-10
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of three human profiles facing right, layered on top of each other. These profiles are connected to three flowing shapes below, resembling fabric or ribbons. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 28, 2016
Polident D.O.O., Dental Products Industry Janja Lipuscek Head of Organic Programme Volcja Draga 42 Volcja Draga, 5293 SI
Re: K153546
Trade/Device Name: Pink Cad/cam Disc Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, Or Rebasing Resin Regulatory Class: Class II Product Code: EBI, Dated: June 24, 2016 Received: July 7, 2016
Dear Janja Lipuscek:
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.
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 devicerelated 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Susan Runno DDS, MA
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K153546
Device Name PINK CAD/CAM disc
Indications for Use (Describe)
- Fabrication of dentures.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
PoliDent
ച്ച
Polident d.o.o. Dental Products Industry Volčja Draga 42 5293 Volčja Draga Telephone: 00386 5 3304840, Fax: 00386 5 3304870 SLOVENIJA
Title 5: 510(k) Summary
| 510(k) owner`s name: | Polident d.o.o. Dental Products Industry Volčja Draga 42 5293 Volčja Draga Slovenija Phone: 00386-53304840 Fax: 00386-53304870 |
|---|---|
| Contact person: | mag. Janja Lipušček Phone: 00386-53304859 e-mail: janja.lipuscek@polident.si |
| Date of summary: | 21st September, 2016 |
| Trade name: | PINK CAD/CAM DISC |
| Classification name: | Denture relining, repairing, or rebasing resin |
| Product codes: | EBI |
| Regulation number: | 21 CFR 872.3760 |
| Device class: | II |
| Predicate device: | M-PM-Disc (Pink) Producer: Merz Dental GmbH 510 (k) Number: K140758 |
| Reference device: | PMMA CAD/CAM disc Producer: Polident d.o.o. 510 (k) Number: K112967 |
4
Device description:
PINK CAD/CAM disc are blanks used in different milling machines (dental CAD-CAM systems) by professional dental technicians.
They are composed of hot cured polymethyl methacrylate (PMMA) and pigments. Device is available in different pink shades. Discs of all shades are available in different dimensions (diameter, thickness and profile margin).
Indications for use:
- Fabrication of dentures -
Summary of the technological characteristics compared to the predicate devices:
| | Device:
PINK CAD/CAM disc | Predicate device:
M-PM-Disc (Pink) | Reference device:
PMMA CAD/CAM disc |
|--------------------------------------------------------------|------------------------------------------------------|--------------------------------------------------------------------|--------------------------------------------------------------------|
| Form | Solid disc | Solid disc
(the same) | Solid disc
(the same) |
| Shades | Denture base coloured
shade | Denture base coloured
shade
(the same) | Tooth coloured shade |
| Composition | Hot cured cross-linked
polymethyl
methacrylate | Hot cured cross-linked
polymethyl
methacrylate
(the same) | Hot cured cross-linked
polymethyl
methacrylate
(the same) |
| Material used | Polident PMMA
CAD/CAM disc
material | OMP-N PMMA
material | Polident PMMA
CAD/CAM disc
material
(the same) |
| Manufacturer's
technological process
used | Polident PMMA
CAD/CAM disc
process | Merz Dental process | Polident PMMA
CAD/CAM disc
process
(the same) |
| Fabrication | CAD/CAM technique | CAD/CAM technique
(the same) | CAD/CAM technique
(the same) |
| Indications for use | Fabrication of dentures | Fabrication of dentures
(the same) | Fabrication of
temporary crowns and
bridges |
| E-modulus (MPa)
/EN ISO 20795-1/ | 3040 | 2678
(the same) | 2771
(the same) |
| Fluxural strenght(MPa)
/EN ISO 20795-1/ | 115,8 | 90
(the same) | 114
(the same) |
| Residual methyl
methacrylate (%)
/EN ISO 20795-1/ | 1,02 | 1,14
(the same) | 1,02
(the same) |
| Biocompatibility:
cytotoxicity test
/EN ISO 10993-5/ | Met the requirements
of EN ISO 10993-5 | Met the requirements
of EN ISO 10993-5
(the same) | Met the requirements
of EN ISO 10993-5
(the same) |
| Biocompatibility:
irritation test
/EN ISO 10993-10/ | Met the requirements
of EN ISO 10993-10 | Test has not been
performed | Met the requirements
of EN ISO 10993-10
(the same) |
| Biocompatibility:
sensitization test
/EN ISO 10993-10/ | Met the requirements
of EN ISO 10993-10 | Met the requirements
of EN ISO 10993-10
(the same) | Met the requirements
of EN ISO 10993-10
(the same) |
5
Substantial equivalence:
The proposed device PINK CAD/CAM disc, predicate device M-PM-Disc (Pink) and reference device PMMA CAD/CAM disc are composed of polymethyl methacrylate hot cured polymer. All three devices have the same aesthetic function and are intended to fabricate the final products by CAD/CAM technique and have similar physical and chemical properties. The polymerization grade of all devices is high.
The proposed device and predicate device M-PM-Disc (Pink) have the same indication for use and are available in pink shades.
The proposed device and reference device PMMA CAD/CAM disc are composed of the same material type and are manufactured under the same technological process with the same raw material used. The material is called Polident PMMA CAD/CAM disc material. As is evident from the table, some tests have been performed with Polident PMMA CAD/CAM disc material used for fabrication of proposed device PINK CAD/CAM disc and reference device PMMA CAD/CAM disc. The performance characteristics have been determinated with PINK CAD/CAM disc. The same tests have been performed also with OMP-N PMMA material used for predicate device M-PM-Disc (Pink).
The test results of E-modulus and flexural strength have been obtained with PINK CAD/CAM disc. The requirements of standard EN ISO 20795-1:2008: Dentistry-Base polymers –Part 1: Denture base polymers are that the required E-modulus of Type 1 material must be minimum 2000 MPa and required fluxural strength minimum 65 MPa. Both devices- PINK CAD/CAM disc and M-PM-Disc (Pink) comply with the requirements of standard EN ISO 20795-1 regarding the required flexural properties. The residual methyl methacrylate content of disc polymerised by Polident PMMA CAD/CAM disc material has been determined with regard to standard EN ISO 20795-1:2008: Dentistry- Base polymers -Part 1: Denture base polymers. The measured value is 1,02 wt-%. The requirement of residual monomer content with regard to EN ISO 20795-1 for Type 1 material is 2,2 wt-%. So PINK CAD/CAM disc complies the requirement of residual menthyl methacrylate content. In the literature company Merz Dental, the producer of predicate device M-PM-Disc (Pink), published that the amount of residual monomer in M-PM-Disc is 1,14 wt-%.
Therefore also cytotoxicity, sensitization and irritation testing was conducted on reference device PMMA CAD/CAM disc composed of Polident PMMA CAD/CAM disc material. The test results are that PMMA CAD/CAM disc material used for fabrication of reference device PMMA CAD/CAM disc and proposed device PINK CAD/CAM disc complies with the requirements of standard EN ISO 10993 regarding cytoxicity, irritation and sensitization properties. The Certificate of Compliance with ISO 10993: Biological Evaluation of Medical Devices for PMMA CAD/CAM disc has been issued.
We can conclude that the proposed device PINK CAD/CAM DISC has comparible technological characteristics to the predicate device. The device beeing considered to be substantially equivalent in safety and effectiveness to the predicate device.
Conclusion:
We are claimed substantial equivalence of PINK CAD/CAM DISC to the predicate device.