(522 days)
No
The description focuses on the material properties and dispensing mechanism of a self-curing composite, with no mention of AI or ML technologies.
No
The device is used for fabrication of temporary and long-lasting temporary dental restorations, such as crowns, bridges, inlays, onlays, and veneers. This falls under the definition of restoration or replacement, which is not considered a therapeutic action in the context of medical devices.
No.
The device is a self-curing composite used for the fabrication and rebasing of temporary dental restorations. Its intended use is to create physical dental pieces, not to diagnose medical conditions or analyze patient data for diagnostic purposes.
No
The device description clearly states it is a "Self-curing composite" consisting of "a base paste and a catalyzing paste stored in a cartridge and in a double-body syringe". This describes a physical material and dispensing system, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the fabrication of temporary dental restorations (crowns, bridges, inlays, onlays, veneers). This is a direct application within the patient's mouth or for creating devices that will be placed in the mouth.
- Device Description: The device is a self-curing composite material used for creating these temporary restorations. It's a material used in a dental procedure, not a test performed on a biological sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to create a physical restoration for dental purposes.
N/A
Intended Use / Indications for Use
- Fabrication of temporary crowns, bridges, inlays, onlays and veneers;
- Fabrication of long-lasting temporary restorations;
- Rebasing of prefabricated temporary crowns made of composite, polycarbonate or metal.
Product codes (comma separated list FDA assigned to the subject device)
EBG, POW
Device Description
Self-curing composite that is highly efficient for the production of temporary pieces for indirect dental procedures such as inlays, onlays, crowns, veneers and bridges. The product consists of a base paste and a catalyzing paste stored in a cartridge and in a double-body syringe, from where they are automatically dispensed in the correct proportion (1:1), providing practical clinical procedures with reduced chances of errors or incorporated bubbles.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Oral, teeth
Indicated Patient Age Range
All the groups
Intended User / Care Setting
Dental prosthetics and authorized laboratories and clinics.
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)
Non-clinical tests were performed:
- Setting time and heat released: Product was evaluated using the Differential Scanning Calorimetry Test (DSC) and presented results according to the design input.
- Viscosity: The test was done using the Brooksfield digital viscosimeter and the results were within the defined limits.
- Surface Finish: It was observed that the surface of the specimen was reflective, so this material is considered to be in accordance with the specifications of the ISO 10477 standard.
- Shade consistency and color stability: Only a small color difference (acceptable according to ISO 4049) was attested, when comparing Sample 3 (color A3) with Bisacrilic Technical Profile FGM. In the other analyzes, no changes were identified.
- Radiopacity: The FGM Bisacrylic resin, presented results above that specified by ISO 4049.
- Flexing Resistance: The FGM Bisacrylic type resin presented all the results within the values specified in the ISO 10477 standard, therefore, the material meets the requirements determined in terms of 3-point Flexural Strength.
- Water sorption and solubility: All results below are within the specified limit, therefore the material is considered to conform.
- Working time: The results show that the product has a working time of more than 60 seconds.
- Accelerated Stability Studies: The FGM Bisacrylic Resin product did not show significant changes in terms of its physical-chemical properties during the accelerated stability process (225 days).
- Evaluation of Report Long-Term Stability (Shelf): We don't have any conclusive data about shelf life yet. At the moment we are using the estimated shelf life in 2 years in the storage condition of 25°C, based on no accelerated stability test.
- Michohardness Vickers: All results are within the specified limit, so the material is considered as conform.
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.
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
§ 872.3770 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 logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 26, 2024
DentsCare LTDA % Rodrigo Abreu Regulatory Specialist United Regulatory LLC 2950 West Cypress Creek Rd. Ste 110 Fort Lauderdale, Florida 33309
Re: K231859
Trade/Device Name: PrimmaArt Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown And Bridge Resin Regulatory Class: Class II Product Code: EBG, POW Dated: September 27, 2024 Received: September 27, 2024
Dear Rodrigo Abreu:
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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory
2
assistance/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,
MICHAEL E. ADJODHA -S
Michael E. Adjodha, MChE, RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K231859
Device Name PrimmaArt
Indications for Use (Describe)
- Fabrication of temporary crowns, bridges, inlays, onlays and veneers;
- Fabrication of long-lasting temporary restorations;
- Rebasing of prefabricated temporary crowns made of composite, polycarbonate or metal.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ---------------------------------------------------------------------------------------------------------- | ----------------------------------------------- |
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Image /page/4/Picture/0 description: The image contains the logo and contact information for DentsCare LTDA. The logo features a stylized letter 'D' with wave-like lines inside. The text includes the company name, address (AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL), and phone number (Ph: 55 - 47 - 3441-6131).
K231859
Section 5
510(k) SUMMARY
A) Submitter's Name: DENTSCARE LTDA
Owner / Operator Registration Number: 3007210751
Manufacture Registration Number: 3007210751
B) Address: AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL
C) Phone and Fax Numbers
Phone: +55 (47) 34416131
D) Contact Person:
Roberta Uyara
Tel.: +55 (47) 99160-4500
E) Preparation Date: November 25, 2024
F) Classification Name: Crown And Bridge, Temporary, Resin
Common / Usual Name: Temporary crown and bridge resin
Proprietary Name: PrimmaArt
Product Code: EBG
Class: Class II
Regulation: 21 CFR 872.3770
G) Device Description
Self-curing composite that is highly efficient for the production of temporary pieces for indirect dental procedures such as inlays, onlays, crowns, veneers and bridges. The product consists of a base paste and a catalyzing paste stored in a cartridge and in a double-body syringe, from where they are automatically dispensed in the correct proportion (1:1), providing practical clinical procedures with reduced chances of errors or incorporated bubbles.
H) Substantial Equivalence (Predicates):
| Predicate
Type | Predicate
Description | 510(k) Number | Model | Company |
|-------------------|-------------------------------|---------------|------------------|-------------------|
| Predicate | Main Predicate | K120779 | Structur 3 | VOCO
GmbH |
| Reference | Biocompatibility
Reference | K191306 | Llis, Vittra APS | Dentscare
LTDA |
The PrimmaArt is equivalent with the following product:
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Image /page/5/Picture/0 description: The image contains the logo for DentsCare. The logo features a stylized letter "D" in a gray color, with three horizontal lines inside the upper part of the "D", resembling waves or airflow. Below the symbol is the text "DentsCare" in a sans-serif font, also in gray, with the first letter capitalized.
DENTSCARE LTDA BENTOGARE ETDA
AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA
CATARINA 89219-501 BRAZIL Ph: 55 - 47 - 3441-6131
| Reference | Biocompatibility
Reference | K201707 | Opallis, Opallis Flow | Dentscare
LTDA |
|-----------|-------------------------------|---------|-----------------------|-------------------|
| Reference | Biocompatibility
Reference | K183465 | Allcem, Allcem Core | Dentscare
LTDA |
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Image /page/6/Picture/0 description: The image shows the logo and contact information for DentsCare LTDA. The logo features a stylized letter 'D' with three horizontal lines inside it, and the name 'DentsCare' written below. The contact information includes the company name, address (AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL), and phone number (Ph: 55 - 47 - 3441-6131).
I) Indications for Use Statement:
- · Fabrication of temporary crowns, bridges, inlays, onlays and veneers;
- · Fabrication of long-lasting temporary restorations;
- · Rebasing of prefabricated temporary crowns made of composite, polycarbonate or metal.
| Indications for Use Comparison | |
|---|---|
| PrimmaArt | Structur 3 |
| - Fabrication of temporary crowns, bridges, inlays, onlays and veneers; | - Fabrication of temporary crowns, bridges, inlays, onlays, partial crowns, veneers and temporary posts. |
| - Fabrication of long-lasting temporary restorations; | - Fabrication of long-term temporary restorations |
| - Rebasing of prefabricated temporary crowns made of composite, polycarbonate or metal. | - Rebasing of prefabricated temporary crowns made of composite, polycarbonate or metal. |
Discussion:
The products are similar. Both devices are indicated to produce temporary pieces (crowns, bridges, inlays, onlays and veneers), long-term temporary restorations and rebasing of prefabricated temporary crowns made or metal.
J) Technological Characteristics Comparison:
The predicate device used to establish equivalence for the PrimmaArt device is outlined below. This section of this submission will provide a comparison of dechnical specifications of the PrimmaArt to the predicate device stratified by functional modality.
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Image /page/7/Picture/0 description: The image shows the logo and contact information for DentsCare LTDA. The logo features a stylized letter 'D' with three horizontal lines inside it, along with the name 'DentsCare' written below. The contact information includes the address 'AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL' and the phone number 'Ph: 55 - 47 - 3441-6131'.
| Device
Manufacturer
and
Common Name | PrimmaArt
Dentscare Ltda | Structur 3
VOCO GmbH |
|------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| 510k # | Not assigned yet | K120779 |
| Classification | Class II | Class II |
| Regulation # | 21 CFR 872.3770 | 21 CFR 872.3770 |
| Product Code | EBG | EBG |
| Classification Name | Temporary crown and bridge resin | Temporary crown and bridge resin |
| Patient Population | All the groups | All the groups |
| Prescription Use | RX only | RX only |
| Environment | Dental prosthetics and authorized laboratories
and clinics.
PrimmaArt must be stored in temperatures
between 5° to 25°C. | Dental prosthetics and authorized laboratories
and clinics.
Structur 3 must be stored in temperatures
between 4° to 23°C |
| Applicable Standards | ISO 7491; ISO 10477; ISO 10993; ISO 4049 | ISO 7491; ISO 10477; ISO 10993; ISO 4049 |
| Device Sterilization | Not Applicable | Not Applicable |
| Primary Package Container: | Syringe and cartridge | Syringe and cartridge |
| Shelf life | 2 years | Not disclosed by the manufacturer |
| Use the same materials or
substances in contact with
the same human tissues
or body fluids? | YES | YES |
| Is the product in compliance
to EN ISO 10993? | YES | YES |
| Tissues | Enamel and Dentin | Enamel and Dentin |
| Reusable | NO | NO |
| Duration | Temporary | Temporary |
| Part of body | Oral, teeth | Oral, teeth |
| it
used
for
the
ls
same
clinical condition? | yes | yes |
| Is it used at the same site in the body? | yes | yes |
| Is it used in a similar population? | yes | yes |
| Is it used for the same intended purpose? | yes | yes |
| Is not foreseen to deliver significantly different performances? | no | no |
| Is it similar conditions of use? | yes | yes |
| Is it similar specifications and properties | yes | yes |
| Is it similar principles of operation? | yes | yes |
| CLINICAL STEP | PrimmaArt (Dentscare) | Structur 3 (VOCO) |
| Two options: total isolation or
relative isolation | YES | YES |
| Application
according
to
adhesive technique | YES | YES |
| Require
finishing
and
polishing | YES | YES |
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Image /page/8/Picture/0 description: The image shows the logo for DentsCare. The logo features a stylized letter D with horizontal lines inside it, above the word "DentsCare" in a sans-serif font. The text "Dents" is also visible, but it is unclear what it refers to.
| Specification | PrimmaArt | Structur 3 |
|---|---|---|
| Shade consistency and color | ||
| stability ISO 4049 e 7491 | No more than a small color change | Not performed. Not disclosed by the |
| manufacturer. | ||
| Setting time and heat | ||
| released | ||
| ISO 4049 | Setting time: 2m48s | |
| Heat released: 0.30 mW/mg | Setting time: 3m02s | |
| Heat released: 0.31 mW/mg | ||
| Viscosity | Base Paste: 92733 mPa.s | |
| Catalyst paste: 90133 mPa.s | Not disclosed by the manufacturer | |
| Surface Finish ISO 10477 | According to ISO 10477, the polymerized | Not disclosed by the manufacturer |
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Image /page/9/Picture/0 description: The image shows the logo and contact information for DentsCare LTDA. The logo features a stylized letter D with three horizontal lines inside. The contact information includes the address: AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL, and the phone number: Ph: 55 - 47 - 3441-6131.
| composite has a shiny surface | ||
|---|---|---|
| Radio-opacity ISO 4049 | 1.68 mm | 1.0 mm, when |
| compared to the aluminum | ||
| scale, therefore, the value of | ||
| "X" obtained through the | ||
| equation of the line, must be > |
- | The FGM Bisacrylic resin, presented
results above that specified by ISO -
|
| Flexing
Resistance | According to ISO 10477, the
specified
flexural strength is
≥50MPa. | The FGM Bisacrylic
type
resin
presented all the results within the
values specified in the ISO
10477 standard,
therefore,
the
material
meets
the
requirements
determined
in |
| | | terms of 3-point Flexural Strength. |
| Water sorption
and solubility | According to ISO 4049, the
specified for sorption is a
maximum of 40 µg/mm³ and
for solubility a maximum of 7.5
µg/mm³. | All results below are within the
specified limit, therefore the
material is considered to conform. |
| Working time | According to EN ISO 4049, the
working time for cementation
materials must be at least 60
seconds. | The results show that the product
has a working time of more than
60 seconds. |
| Accelerated
Stability
Studies | Study created to accelerate the
possible chemical degradation
and/or physical changes of the
product in forced conditions of
storage. | The FGM Bisacrylic Resin product
did not show significant changes in
terms of its physical-chemical
properties during the accelerated
stability process (225 days). |
| Evaluation
of
Report
Long-Term
Stability
(Shelf) | Study designed to verify the
physical and chemical
characteristics of the product
during the expected shelf life.
The results are used to confirm
the expiration date and storage
conditions. | We don't have any conclusive data
about shelf life yet. At the moment
we are using the estimated shelf
life in 2 years in the storage
condition of 25°C, based on no
accelerated stability test. |
| Michohardness
Vickers | According to the Project Entry
Requirements, the Hardness
(HV) must be between 5 and
15 HV, and in the same way,
the results must be similar or
superior (justified) when
compared to the competitor
under study. | All results are within the specified
limit, so the material is considered
as conform. |
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Image /page/12/Picture/0 description: The image shows the logo for DentsCare. The logo features a stylized letter "D" in a muted blue-gray color, with three horizontal lines emanating from the left side of the "D", suggesting movement or flow. Below the symbol, the word "DentsCare" is written in a sans-serif font, also in the same muted blue-gray color, completing the branding for the dental care company.
Conclusion: Based on the performance test applied to this PrimmaArt and the predicate comparison (Structur 3), we conclude that the device in question is substantially equivalent with the predicate, as all products meet the same recognized standards.