(115 days)
IDODENTINE MULTILAYER, IDODENTINE TRANSPA, IDODENTINE TRASPA, IDODENTINE TRANSPARENT
No
The 510(k) summary describes polymer blanks used in dental CAD/CAM milling systems. The description focuses on the material composition, physical properties, and intended use for fabricating temporary dental restorations. There is no mention of any software, algorithms, image processing, or AI/ML capabilities within the device description or performance studies. The testing described is related to material properties and biocompatibility, not algorithmic performance.
No.
The device is used to manufacture temporary dental crowns and bridges, which are restorative rather than therapeutic.
No
The device is described as polymethylmethacrylate and polycarbonate discs used to manufacture temporary crowns and bridges. It is a fabrication material, not a tool for diagnosis.
No
The device is described as polymethylmethacrylate and polycarbonate discs, which are physical materials used in dental CAD/CAM milling systems. There is no mention of software as the primary component or function of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The described devices are resin discs used to manufacture temporary dental crowns and bridges. These are physical structures placed in the mouth.
- Intended Use: The intended use is to create temporary dental prosthetics, not to analyze biological samples for diagnostic purposes.
- Testing Performed: The testing described (flexural strength, water absorption, water solubility, biocompatibility) relates to the physical and biological properties of the material for use in the oral cavity, not to the diagnostic performance of a test.
The device is a dental prosthetic material, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The resin discs TEMP PREMIUM FLEXIBLE, MULTISTRATUM FLEXIBLE and THERAPON are polymethylmethacrylate and polycarbonate discs indicated to manufacture temporary anterior and posterior crowns and bridges, with up to two adjacent pontics, that can be kept in the mouth for up to 12 months.
TEMP BASIC are PMMA discs intended for the fabrication of temporary anterior crowns and bridges, with up to one adjacent pontic, with a maximum recommended usage time of 12 months.
TRY-IN, BURNOUT and TRY-IN & BURNOUT are PMMA discs intended for the fabrication of temporary crowns and bridges that can be kept in the mouth for up to 24 hours as for TRY-IN, and up to 60 minutes as for BURNOUT and TRY-IN &BURNOUT.
Product codes
EBG, POW
Device Description
Intended use: polymer blanks used in dental CAD/CAM milling systems by professional dental technicians to manufacture dental crowns and bridges
The subject devices are composed of polymethylmethacrylate (PMMA) or polycarbonates (PC) and pigments. They are available in different models that differ in basic material, form and color. The materials used for the submitted devices have a long history of safe use for same or equivalent indications.
The blanks are available in different forms (the diameter of the block can be 95 mm or 98 mm, with step or without step) and heights (from 8 to 30mm) for different milling systems.
The usage period of the subject devices is limited: TEMP PREMIUM, TEMP PREMIUM FLEXIBLE, MULTISTRATUM FLEXIBLE and THERAPON discs can be kept in the oral cavity for up to 12 months; TRY-IN can be kept in the oral cavity for up to 24 hours, while BURNOUT and TRY-IN & BURNOUT devices can remain in the mouth for a maximum of 60 minutes.
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
The subject devices were tested according to ISO 10477:2004 to determine their flexural strength, water absorption and water solubility. All tested samples correspond with the requirements of the standard.
In consideration of the International Standard ISO 10993-1, Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing, the subject devices were tested to evaluate: In-vitro cytotoxicity, Skin sensitization, Irritation, Mutagenicity. Biocompatibility testing demonstrated that no issue of biocompatibility arises.
The results of nonclinical tests demonstrate that the devices are equivalent to the predicate devices.
Key Metrics
- Flexural Strength:
- TEMP BASIC: 64 MPa
- TEMP PREMIUM: 106 MPa
- TEMP PREMIUM FLEXIBLE: 110 MPa
- MULTISTRATUM FLEXIBLE: 120 MPa
- THERAPON: 115 MPa
- TRY-IN: 65.32 MPa
- BURNOUT: 53.66 MPa
- TRY-IN & BURNOUT: 57.34 MPa
- Predicate IDODENTINE MULTILAYER: 83 MPa
- Predicate IDODENTINE TRANSPA: 94 MPa
- Water Absorption:
- TEMP BASIC: 20.46 µg/mm³
- TEMP PREMIUM: 19.36 µg/mm³
- TEMP PREMIUM FLEXIBLE: 3.97 µg/mm³
- MULTISTRATUM FLEXIBLE: 2.90 µg/mm³
- THERAPON: 14.1 µg/mm³
- TRY-IN: 20.47 µg/mm³
- BURNOUT: 20.10 µg/mm³
- TRY-IN & BURNOUT: 19.68 µg/mm³
- Predicate IDODENTINE MULTILAYER: 22.3 µg/mm³
- Predicate IDODENTINE TRASPA: 25.8 µg/mm³
- Water Solubility:
- TEMP BASIC: 0 µg/mm³
- TEMP PREMIUM:
§ 872.3770 Temporary crown and bridge resin.
(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
June 28, 2018
Zirkonzahn GmbH Sandra Leitner Regulatory Affairs Responsible Gewerbegebiet - Zona Industriale an der Ahr 7 Gais, 39030 ITALY
Re: K180562
Trade/Device Name: TEMP BASIC, TEMP PREMIUM, TEMP PREMIUM FLEXIBLE, MULTISTRATUM FLEXIBLE, THERAPON, TRY-IN, BURNOUT, TRY-IN & BURNOUT Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: Class II Product Code: EBG, POW Dated: March 30. 2018 Received: April 3, 2018
Dear Sandra Leitner:
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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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 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.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Andrew I. Steen -S
for 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
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Indications for Use
510(k) Number (if known) K180562
Device Name
TEMP BASIC, TEMP PREMIUM FLEXIBLE, MULTISTRATUM FLEXIBLE, THERAPON, TRY-IN, BURNOUT, TRY-IN & BURNOUT
Indications for Use (Describe)
The resin discs TEMP PREMIUM FLEXIBLE, MULTISTRATUM FLEXIBLE and THERAPON are polymethylmethacrylate and polycarbonate discs indicated to manufacture temporary anterior and posterior crowns and bridges, with up to two adjacent pontics, that can be kept in the mouth for up to 12 months.
TEMP BASIC are PMMA discs intended for the fabrication of temporary anterior crowns and bridges, with up to one adjacent pontic, with a maximum recommended usage time of 12 months.
TRY-IN, BURNOUT and TRY-IN & BURNOUT are PMMA discs intended for the fabrication of temporary crowns and bridges that can be kept in the mouth for up to 24 hours as for TRY-IN, and up to 60 minutes as for BURNOUT and TRY-IN &BURNOUT.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Section 05 510(k) Summary
(k) SUMMARY 510
APPLICANT
ZIRKONZAHN GMBH Gewerbegebiet - Zona Industriale an der Ahr 7 Gais, ITALY 39030 Phone: +39 0474 066 660 Fax: +39 0474 066 661 E-mail: info@zirkonzahn.com
CONTACT PERSON
Sandra Leitner Regulatory Affairs ZIRKONZAHN GMBH Gewerbegebiet - Zona Industriale an der Ahr 7 Gais, ITALY 39030 Phone: +39 0474 066 784 Fax: +39 0474 066 661 E-mail: sandra.leitner@zirkonzahn.com
Date Summary Prepared: June 28, 2018
DEVICE IDENTIFICATION
| Trade/Proprietary Name: | TEMP BASIC, TEMP PREMIUM, TEMP PREMIUM FLEXIBLE,
MULTISTRATUM FLEXIBLE, THERAPON, TRY-IN, BURNOUT,
TRY-IN & BURNOUT |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Generic/ Common Name: | Dental polymer blanks (discs) |
| Classification name: | 21 CFR 872.3770,
CROWN AND BRIDGE, TEMPORARY, RESIN, |
| Class | II |
| Product Code: | EBG |
| Secondary Product Code: | POW |
| Panel: | Dental |
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LEGALLY MARKETED PREDICATE AND REFERENCE DEVICES
| Device Name | Company | 510(k) Number | |
|---|---|---|---|
| Predicate Device | IDODENTINE | Union Dental S. A. | K150432 |
| Reference Device | Polycarb | Inovativ, LLC | K022030 |
INDICATIONS FOR USE: The resin discs TEMP PREMIUM, TEMP PREMIUM FLEXIBLE, MULTISTRATUM FLEXIBLE and THERAPON are polymethylmethacrylate and polycarbonate discs indicated to manufacture temporary anterior and posterior crowns and bridges, with up to two adjacent pontics, that can be kept in the mouth for up to 12 months.
TEMP BASIC are PMMA discs intended for the fabrication of temporary anterior crowns and bridges, with up to one adjacent pontic, with a maximum recommended usage time of 12 months.
TRY-IN, BURNOUT and TRY-IN & BURNOUT are PMMA discs intended for the fabrication of temporary crowns and bridges that can be kept in the mouth for up to 24 hours as for TRY-IN, and up to 60 minutes as for BURNOUT and TRY-IN &BURNOUT.
DEVICE DESCRIPTION
Intended use: polymer blanks used in dental CAD/CAM milling systems by professional dental technicians to manufacture dental crowns and bridges
The subject devices are composed of polymethylmethacrylate (PMMA) or polycarbonates (PC) and pigments. They are available in different models that differ in basic material, form and color. The materials used for the submitted devices have a long history of safe use for same or equivalent indications.
The blanks are available in different forms (the diameter of the block can be 95 mm or 98 mm, with step or without step) and heights (from 8 to 30mm) for different milling systems.
The usage period of the subject devices is limited: TEMP PREMIUM, TEMP PREMIUM FLEXIBLE, MULTISTRATUM FLEXIBLE and THERAPON discs can be kept in the oral cavity for up to 12 months; TRY-IN can be kept in the oral cavity for up to 24 hours, while BURNOUT and TRY-IN & BURNOUT devices can remain in the mouth for a maximum of 60 minutes.
5
DISCUSSION OF NON CLINICAL TESTS
The subject devices were tested according to ISO 10477:2004 to determine their flexural strength, water absorption and water solubility. All tested samples correspond with the requirements of the standard.
In consideration of the International Standard ISO 10993-1, Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing, the subject devices were tested to evaluate: In-vitro cytotoxicity, Skin sensitization, Irritation, Mutagenicity. Biocompatibility testing demonstrated that no issue of biocompatibility arises.
The results of nonclinical tests demonstrate that the devices are equivalent to the predicate devices.
SUBSTANTIAL EQUIVALENCE DISCUSSION
The table below provides a more detailed comparison of the submitted devices and the predicate devices.
Both, the submitted devices and the predicates are made of polymers that have a well- documented history for use in medical device applications and have been in use for many years.
The submitted devices and the predicates have similar indications for use as well as comparable technical, physical, chemical and biological properties and characteristics.
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| | TEMP BASIC, TEMP PREMIUM, TEMP
PREMIUM FLEXIBLE,
MULTISTRATUM FLEXIBLE,
THERAPON, TRY-IN, BURNOUT,
TRY-IN & BURNOUT | Predicate Device:
IDODENTINE blanks
K150432 | Reference Device:
POLY-CARB
K022030 | Comparison |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company | ZIRKONZAHN GMBH | UNION DENTAL S.A. | INOVATIV, LLC | |
| Regulation number | 872.3770 | 872.3770 | 872.3770 | Same |
| Product Code | EBG | EBG | EBG | Same |
| Classification name | Temporary crown and bridge resin. | Temporary crown and bridge
resin. | Temporary crown and
bridge resin. | Same |
| Indications for use | The resin discs TEMP PREMIUM, TEMP
PREMIUM FLEXIBLE, MULTISTRATUM
FLEXIBLE and THERAPON are
polymethylmethacrylate and polycarbonate
discs indicated to manufacture temporary
anterior and posterior crowns and bridges,
with up to two adjacent pontics, that can be
kept in the mouth for up to 12 months.
TEMP BASIC are PMMA discs intended for
the fabrication of temporary anterior crowns
and bridges, with up to one adjacent pontic,
with a maximum recommended usage time
of 12 months.
TRY-IN, BURNOUT and TRY-IN &
BURNOUT are PMMA discs intended for the | Temporary anterior and
posterior crowns Temporary
anterior and posterior bridges
with up to two adjacent pontics
Implant supported temporary
restorations Maximum
recommended usage period: 12
months
Removable structures for
dentures (dental bases)
Removable structures for
therapeutic restorations (bite
splints or occlusal splints) | The Polycarb is intended
for the fabrication of
temporary dental
prostheses like partial
denture clasps, temporary
crowns, and bridges using
the Inovativ, LLC Polycarb
resin. | Similar. The Zirkonzahn
devices are more limited in
their indications for use.
No new questions of safety
and effectiveness are arising
as the indications are not
expanded, but more
restricted. |
| | fabrication of temporary crowns and bridges that can be kept in the mouth for up to 24 hours as for TRY-IN, and up to 60 minutes as for BURNOUT and TRY-IN &BURNOUT. | | | |
| Components | PMMA or PC based resins with approx. 1% pigments | PMMA >99% wt.
Pigments