(114 days)
No
The 510(k) summary describes blanks used in dental CAD/CAM milling systems. The description focuses on the material composition (PMMA) and physical properties of the blanks. There is no mention of AI, ML, image processing, or any software-based functionality that would suggest the use of these technologies. The performance studies are related to material properties and biocompatibility, not algorithmic performance.
Yes
The devices are used for the creation of bite splints, orthodontic splints, and occlusal splints for bruxism, which are therapeutic applications.
No
The devices described are blanks used for manufacturing dental restorations like crowns, bridges, denture teeth, and splints. Their intended use is for fabrication, not for diagnosing medical conditions.
No
The device description explicitly states the devices are "blanks used in dental CAD/CAM milling systems" and are "supplied in form of solid discs" made of Polymethylmethacrylate (PMMA). This indicates a physical, hardware-based device, not software.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the devices are used for manufacturing dental restorations (provisional crowns, bridge frameworks, denture teeth, denture bases, bite splints, orthodontic splints, occlusal splints). This is a manufacturing process for a medical device, not a diagnostic test performed on a sample taken from the human body.
- Device Description: The devices are described as solid discs of Polymethylmethacrylate (PMMA) used in dental CAD/CAM milling systems. This aligns with materials used for fabricating physical dental prosthetics.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze a biological sample (blood, urine, tissue, etc.) or to provide information about a patient's health status or condition.
- Performance Studies: The performance studies focus on the physical properties and biocompatibility of the material, which are relevant to its use as a dental prosthetic material, not as a diagnostic tool.
- Key Metrics: The key metrics listed (Flexural Strength, Water absorption, Water solubility, Residual monomer content) are all related to the material properties and safety for oral use, not diagnostic performance.
In summary, the device is a material used to create dental prosthetics, which are considered medical devices, but the material itself and its intended use do not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
PRIME is used for manufacturing provisional crowns and bridge frameworks with up to two adjacent pontics in the anterior and posterior tooth area.
ABRO 1 is intended for the fabrication of denture teeth; RESITON GINGIVA is intended for the fabrication of denture bases.
PRIME TRANSPA, ABRO 1 TRANSPA and THERAPON TRANSPA are designed for the creation of bite splints, orthodontic splints and occlusal splints for bruxism.
Product codes
EBG, EBI, MQC
Device Description
The subject devices are blanks used in dental CAD/CAM milling systems by professional dental technicians to manufacture dental restorations. The devices are supplied in form of solid discs.
All devices are composed of the same basic material, Polymethylmethacrylate (PMMA), and are available in various models that differ in color and dimension.
The materials used for the submitted devices have a long history of safe use for the same or equivalent indications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior and posterior tooth area
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
Zirkonzahn carried out performance testing on its devices according to ISO 10477:2018. All tested samples meet the requirements of the standard and show similar values as the predicate device.
Biocompatibility was established in consideration of the International Standard 10993-1:2010 'Biological Evaluation of Medical Devices' Part 1: Evaluation and Testing.
Key Metrics
Flexural Strength: >= 105 MPa
Water absorption:
§ 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 U.S. Department of Health and Human Services and the U.S. 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 is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
July 8, 2020
Zirkonzahn srl Sandra Leitner Regulatory Affairs Via An der Ahr 7 Gais. BZ 39030 Italy
Re: K200676
Trade/Device Name: ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPA Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown And Bridge Resin Regulatory Class: Class II Product Code: EBG. EBI. MOC Dated: April 7, 2020 Received: April 9, 2020
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K200676
Device Name
ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPA
Indications for Use (Describe)
PRIME is used for manufacturing provisional crowns and bridge frameworks with up to two adjacent pontics in the anterior and posterior tooth area.
ABRO 1 is intended for the fabrication of denture teeth; RESITON GINGIVA is intended for the fabrication of denture bases.
PRIME TRANSPA, ABRO 1 TRANSPA and THERAPON TRANSPA are designed for the creation of bite splints, orthodontic splints and occlusal splints for bruxism.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Research Use (Part of SER-001; Subject, Plasma) | Core Tissue Use (Part of SER-001; Subject, Core Tissue) |
|---|---|
| ----------------------------------------------------------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------- |
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
510 (k) SUMMARY
510(k) number: K200676
APPLICANT
ZIRKONZAHN SRL Via 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 SRL Via An der Ahr 7 Gais, ITALY 39030 Phone: +39 0474 066 784 Fax: +39 0474 066 661 E-mail: sandra.leitner@zirkonzahn.com
DATE PREPARED 2020-06-29
DEVICE IDENTIFICATION
| Trade/Proprietary Name: | ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPA |
|---|---|
| Generic / Common Name: | Dental polymer blanks (discs) |
| Regulation Number: | 872.3770 |
| Classification Name: | Temporary crown and bridge resin |
| Class: | II |
| Primary Product Code: | EBG |
| Secondary Product Codes: | EBI, MQC |
| Panel: | Dental |
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LEGALLY MARKETED PRIMARY PREDICATE DEVICE
| Company: | UNION DENTAL S.A. |
|---|---|
| Device Name: | IDODENTINE blanks |
| Primary Product Code: | EBG |
| Secondary Product: | EBI, MQC |
| 510(k) Number: | K150432 |
LEGALLY MARKETED REFERENCE DEVICE
| Company: | ZIRKONZAHN SRL |
|---|---|
| Device Name: | THERAPON |
| Primary Product Code: | EBG |
| 510(k) Number: | K180562 |
INDICATIONS FOR USE
PRIME is used for manufacturing provisional crowns and bridge frameworks with up to two adjacent pontics in the anterior and posterior tooth area.
ABRO 1 is intended for the fabrication of denture teeth; RESITON GINGIVA is intended for the fabrication of denture bases.
PRIME TRANSPA, ABRO 1 TRANSPA and THERAPON TRANSPA are designed for the creation of bite splints, orthodontic splints and occlusal splints for bruxism.
DEVICE DESCRIPTION
The subject devices are blanks used in dental CAD/CAM milling systems by professional dental technicians to manufacture dental restorations. The devices are supplied in form of solid discs.
All devices are composed of the same basic material, Polymethylmethacrylate (PMMA), and are available in various models that differ in color and dimension.
The materials used for the submitted devices have a long history of safe use for the same or equivalent indications.
5
DISCUSSION OF NON CLINICAL TESTS
Zirkonzahn carried out performance testing on its devices according to ISO 10477:2018. All tested samples meet the requirements of the standard and show similar values as the predicate device.
Biocompatibility was established in consideration of the International Standard 10993-1:2010 'Biological Evaluation of Medical Devices' Part 1: Evaluation and Testing.
PREDICATE DEVICE COMPARISON TABLE
In the following comparison table, the most important aspects that support substantial equivalence to the primary predicate device are indicated.
| | New devices:
ABRO 1, RESITON
GINGIVA, PRIME and
THERAPON TRANSPA
(K200676) | Primary Predicate
Device:
IDODENTINE blanks
(K150432) | Comparison |
|------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| Company | Zirkonzahn srl | UNION DENTAL S.A. | N.A. |
| Product Code | EBG, EBI, MQC | EBG, EBI, MQC | Same |
| Regulation
Number | 872.3770 | 872.3770 | Same |
| Regulation
Name | Temporary
crown
and
bridge resin | Temporary
crown
and
bridge resin | Same |
| Indications for
use | PRIME is used for
manufacturing
provisional crowns and
bridge frameworks with
up to two adjacent
pontics in the anterior
and posterior tooth area.
ABRO 1 is intended for
the fabrication of denture
teeth; RESITON
GINGIVA is intended for
the fabrication of denture
bases.
PRIME TRANSPA,
ABRO 1 TRANSPA and
THERAPON TRANSPA
are designed for the
creation of bite splints,
orthodontic splints and
occlusal splints for
bruxism. | 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). | Similar
(see
discussion
hereunder) |
| Chemical
Composition | PMMA based with
approx. 1% pigments. | PMMA >99% wt.
Pigments