(124 days)
Not Found
No
The device is a physical material (zirconia blanks) used in dental prosthetics. While the manufacturing process involves CAD/CAM, which is computer-aided, there is no mention or indication of AI or ML being used in the design, manufacturing, or intended use of the blanks themselves. The performance studies focus on material properties and mechanical testing.
No.
The device is a material for creating prostheses (dentures, crowns, and bridges), which are restorative devices, not therapeutic devices.
No
This device is described as dental porcelain zirconia blanks used to create prostheses like dentures, crowns, and bridges, which are restorative rather than diagnostic.
No
The device is a physical material (zirconia blanks) used in the creation of dental prostheses, not a software application. The description details the material composition and physical properties, and the performance studies involve bench testing of the sintered material. While the blanks are used in a CAD/CAM process, the device itself is the physical blank, not the software used for design or milling.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to create dental prostheses (dentures, crowns, and bridges) for use in the mouth. This is a restorative dental application, not a diagnostic test performed on biological samples in vitro.
- Device Description: The device is a material (zirconia blanks) that is processed and used to create a physical restoration for the patient's mouth. It does not interact with biological samples for the purpose of diagnosis.
- Lack of Diagnostic Function: There is no mention of the device being used to detect, measure, or analyze any biological substance or condition for diagnostic purposes.
- Performance Studies: The performance studies focus on the material properties and mechanical strength of the sintered zirconia, which are relevant to its use as a dental restoration material, not as a diagnostic tool.
IVD devices are specifically designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
1Derful™ Zirconia blanks are indicated for use in prosthetic dentistry to create porcelain (ceramic) prostheses (dentures, crowns and bridges) in the anterior applications and not used solely as an implant. 1Derful™ Zirconia blanks are intended to be milled and fully sintered by Dental Professional or Dental Laboratory before use.
Product codes (comma separated list FDA assigned to the subject device)
EIH
Device Description
1Derful™ Zirconia are disc shaped dental porcelain zirconia oxide blanks that come in various sizes that are used in custom restorations by the dental laboratory. The dental laboratory will further process the blank by milling the blank based upon the anatomically rendering of the patient's teeth (done at the dental office) through "Computer Aided Drafting/ Computer Aided Machining (CAD/CAM). Once the custom rendered blank is milled the product is fully sintered and colored (if required) and fitted to the patient's teeth as dentures, crowns or bridges.
1Derful™ Zirconia blanks are composed of zirconia ceramics (ZrO2) based on yttriastabilized tetragonal zirconia (Y-TZP). Shading oxide will also be used to create the need shade in the disc. These three oxide materials are Fe2O3, ErO3, Co3O4 & Er2O3. All the oxide materials have been tested as an additive for physical strengths as well as solubility and are biocompatible according to ISO 10993-1: 2009 "Biological Evaluation of medical devices – Part 1: Evaluation and testing within a risk management process".
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior/posterior applications (prosthetic dentistry / teeth)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dental Professional or Dental Laboratory
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)
Nonclinical Testing: 1Derful, Inc performed a series of tests to assess whether the device is safe and effective to use. Sintered tests coupled with mechanical bench testing confirmed that the device meets specifications including established international standards and guidance documents. Density, bending strength, fracture toughness, chemical solubility and material characterization/composition of finished product was conducted to confirm that the product is safe and effective, while meeting performance goals established by standards. 1Derful™ Zirconia blanks comply with ISO 6872:2015, "Dentistry – Ceramic materials" and ISO 13356: 2008, "Implants for surgery, Ceramic materials based on yttria- stabilized tetragonal chemical solubility and material characterization/composition of finished product was conducted to confirm that the product is safe and effective, while meeting performance goals established by standards. 1Derful™ Zirconia blanks comply with ISO 6872:2015, "Dentistry – Ceramic materials" and ISO 13356: 2008, "Implants for surgery, Ceramic materials based on yttria- stabilized tetragonal zirconia (Y-TZP)".
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Flexural Strength Test per ISO 6872:2015 Section 7.3 Requirement minimum(mean) 800 MPa for class 6 fixed prostheses, lowest value: > 1000. mpa (Pass)
- Freedom from extraneous materials per ISO 6872:2015 Section 5.2 active conc. of not more than 1.0 Bq g-1 of Uranium238:
§ 872.6660 Porcelain powder for clinical use.
(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(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 and 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.
July 27, 2021
1Derful, Inc % Robin Carden Consultant RAC Dental Technologies 27134 Paseo Espada, B201 San Juan Capistrano, California 92675
Re: K210884
Trade/Device Name: 1Derful HS, 1Derful HT Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: Class II Product Code: EIH Dated: April 30, 2021 Received: May 6, 2021
Dear Robin Carden:
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 mediation-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,
Michael E. Adjodha, M.ChE. Assistant Director Restorative and Surgical Dental Devices Team DHT 1B: 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
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Indications for Use
510(k) Number (if known) K210884
Device Name 1DERFUL™ HS & 1DERFUL™ HT Zirconia
Indications for Use (Describe)
1Derful™ Zirconia blanks are indicated for use in prosthetic dentistry to create porcelain (ceramic) prostheses (dentures, crowns and bridges) in the anterior applications and not used solely as an implant. 1Derful™ Zirconia blanks are intended to be milled and fully sintered by Dental Professional or Dental Laboratory before use.
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) |
X Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary K210884
1. Submitter
1DERFUL, INC
Dr. Mohamad Alkassab
38345 Donigan Road, Brookshire, TX 77423
Phone: 346 331-9811
2. Device Name
Proprietary Name: 1DERFUL™ HS & 1DERFUL™ HT Zirconia Common/Usual Name: Powder. Porcelain Classification Name: Porcelain powder for clinical use
3. Predicate Device
NexxZr™ S / NexxZr™T - K130991
4. Indications for Use
1 DerfulTM Zirconia blanks are indicated for use in prosthetic dentistry to create porcelain (ceramic) prostheses (dentures, crowns and bridges) in the anterior/ posterior applications and not used solely as an implant. 1Derful™ Zirconia blanks are intended to be milled and fully sintered by Dental Professional or Dental Laboratory before use.
5. Device Description and Function
1Derful™ Zirconia are disc shaped dental porcelain zirconia oxide blanks that come in various sizes that are used in custom restorations by the dental laboratory. The dental laboratory will further process the blank by milling the blank based upon the anatomically rendering of the patient's teeth (done at the dental office) through "Computer Aided Drafting/ Computer Aided Machining (CAD/CAM). Once the custom rendered blank is milled the product is fully sintered and colored (if required) and fitted to the patient's teeth as dentures, crowns or bridges.
1Derful™ Zirconia blanks are composed of zirconia ceramics (ZrO2) based on yttriastabilized tetragonal zirconia (Y-TZP). Shading oxide will also be used to create the need shade in the disc. These three oxide materials are Fe2O3, ErO3, Co3O4 & Er2O3. All
38345 DONIGAN ROAD BROOKSHIRE, TEXAS 77423 USA
4
the oxide materials have been tested as an additive for physical strengths as well as solubility and are biocompatible according to ISO 10993-1: 2009 "Biological Evaluation of medical devices – Part 1: Evaluation and testing within a risk management process".
| | 1DERFUL™ HS & 1DERFUL™ HT
K210884 | NexxZr™ S
NexxZr™T
K130991 | Comparison |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Indications for use | 1DERFUL™ HS & 1DERFUL™
HT Zirconia blanks are indicated for use
in prosthetic dentistry to create porcelain
(ceramic) prostheses (dentures, crowns
and bridges). 1DERFUL™ HS &
1DERFUL™ HT Zirconia blanks are
intended to be milled and fully sintered
by a Dental Professional or Dental
Laboratory before use. Full contour
monolithic crowns and bridges in anterior
and posterior regions. Substructure
ceramic for prostheses involving four or
more units can be created. | NexxZr™ are intended for the
fabrication and preparation of
copings and full anatomical/full
contour crowns bridge, inlays
and onlays for anterior and
posterior segment
restorations. | Similar |
Substantial Equivalent Comparison 6.
5
| | 1DERFUL™ HS &
1DERFUL™ HT | NexxZS /
NexxZr™T | Comparison |
|-------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|---------------------------------------|------------|
| Material
Composition | Zirconia Powder:
ZrO2+HfO2 +Y2O3
99 | Zirconia Powder:
ZrO2+HfO2+Y2O3>99 | same |
| % wt. | HfO2: 900MPa | >1000 MPa | >1000MPa | same |
| | 1DERFUL TM HS &
1DERFULTM HT | NexxZrTM S /
NexxZrTMT | Comparison |
| Chemical solubility
per ISO 6872:2015
Limit 100 µg/cm² | 5.257 µg/cm² | Not available | |
| Blank sizes(mm) | Disc:
98.5 mm x 10-30mm | Disc:
98.5 x 10-30mm | same |
| Biocompatibility | Testing Per ISO
10993 | Testing Per ISO 10993 | same |
6
Physical Properties:
Tabulated chart of finished product "1Derful™ Zirconia" blanks
| Sintered Density | $\geq$ 6.09 g cm3 |
|---|---|
| Thermal Expansion coefficient (20-500°C) | 10.1 μm/m °C |
| Bending Strength | > 900 MPa |
| Grain size | 0.45 μm |
| Fracture toughness | 5 MPa m0.5 |
Chemical Properties:
| Component (chemical
| composition) | 1Derful™ Zirconia (percentage by wt.) |
|---|---|
| ZrO2 + HfO2 + Y2O3+ Al2O3 | > 99.9 |
| Y2O3 | 5.35 - 5.95 |
| Al2O3 | ≤0.1 |
| SiO2 | ≤0.02 |
7. Nonclinical Testing
1 Derful, Inc performed a series of tests to assess whether the device is safe and effective to use. Sintered tests coupled with mechanical bench testing confirmed that the device meets specifications including established international standards and guidance documents. Density, bending strength, fracture toughness, chemical
38345 DONIGAN ROAD BROOKSHIRE, TEXAS 77423 USA
7
solubility and material characterization/composition of finished product was conducted to confirm that the product is safe and effective, while meeting performance goals established by standards. 1Derful™ Zirconia blanks comply with ISO 6872:2015, "Dentistry – Ceramic materials" and ISO 13356: 2008, "Implants for surgery, Ceramic materials based on yttria- stabilized tetragonal chemical solubility and material characterization/composition of finished product was conducted to confirm that the product is safe and effective, while meeting performance goals established by standards. 1Derful™ Zirconia blanks comply with ISO 6872:2015, "Dentistry – Ceramic materials" and ISO 13356: 2008, "Implants for surgery, Ceramic materials based on yttria- stabilized tetragonal zirconia (Y-TZP)".
| Standard or Test Method Used | 1DERFUL™ HS &
1DERFUL™ HT | |
|--------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|------|
| Flexural Strength Test per ISO
6872:2015 Section 7.3 Requirement
minimum(mean) 800 MPa for class 6
fixed prostheses, lowest value | > 1000. mpa | Pass |
| Freedom from extraneous
materials per ISO 6872:2015
Section 5.2 active conc. of not
more than 1.0 Bq g-1 of Uranium238 |