(124 days)
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.
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 yttria- stabilized 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.
The provided text describes the non-clinical testing performed for the 1DERFUL™ HS & 1DERFUL™ HT Zirconia blanks. It does not mention any clinical studies, multi-reader multi-case studies, or human-in-the-loop performance. Therefore, information regarding those aspects cannot be extracted.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Property | Acceptance Criteria (Standard Requirement) | Reported Device Performance (1DERFUL™ HS & 1DERFUL™ HT) | Outcome |
|---|---|---|---|
| Flexural Strength Test per ISO 6872:2015 Section 7.3 | 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 | < 1.0 Bq g-1 of Uranium238 | < 0.03 | Pass |
| Chemical solubility per ISO 6872:2015 Section 7.6 | Maximum 100 µg/cm² | 5.257 µg/cm² (from table on page 5) AND 18.1 µg/cm² (from table on page 8) | Pass |
| Fracture Toughness per ISO 6872:2015 Section Annex A | 5.0 MPa m^0.5 (min.) for Class 5 | 5.0 MPa m^0.5 | Pass |
| Sintered density (in-house calculated d=m/v) | ≥ 6.09 g/cm³ (from page 6) | 6.08 g/cm³ (from table on page 5) AND 6.08 g/cm³ (from table on page 6) | Pass |
| Grain Size determined per ISO 13356:2008 | (Not explicitly stated in "Acceptance Criteria" column, but the standard mandates the determination) | 0.41 µm | Pass |
| Amount of monoclinic phase (X-ray diffraction, ASTM F1873-98) | (Not explicitly stated in "Acceptance Criteria" column, but the standard mandates the determination, and the predicate has Tetragonal 98.5%, Monoclinic 1.5% max) | ZrO2– Zirconium Oxide Tetragonal P42/mmc 98.5%ZrO2– Baddeleyite Monoclinic P21/a 1.5% (max) | Pass |
| Linear Thermal Expansion Coefficient per ISO 6872:2015 | (Not explicitly stated as a minimum/maximum, but the standard requires the test) | 10.1 µm/m°C | Pass |
| Fe2O3 content | (Not explicitly stated in "Acceptance Criteria" column, but is tested as a component with a limit of ≤0.01%) | ≤0.01 | Pass |
Note: There are two different "Chemical solubility" values reported for the 1DERFUL™ device. One is 5.257 µg/cm² in the comparison table on page 5, and another is 18.1 µg/cm² in the detailed testing results table on page 8. Both are below the 100 µg/cm² limit.
Also, the Sintered Density acceptance criteria on page 6 states "≥ 6.09 g cm3", while the reported performance is 6.08 g/cm³ on both page 5 and 6, and it's marked as "Pass". This might indicate a slight discrepancy or that the "≥" means "at least" and 6.08 is considered acceptable based on the standard.
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified for individual tests. The text only says "1Derful, Inc performed a series of tests".
- Data Provenance: Not explicitly stated. The tests were performed by "1Derful, Inc" and are non-clinical, likely internal laboratory testing rather than data from a country of origin or retrospective/prospective studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This was non-clinical laboratory testing, not a study involving experts establishing ground truth for diagnostic accuracy.
4. Adjudication method for the test set
Not applicable. See point 3.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. The document explicitly states: "Clinical tests have not been performed." Therefore, no MRMC study (which typically involves human readers assessing cases) was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical material (zirconia blanks) for dental prostheses, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical testing was established by adherence to recognized international standards and guidance documents, such as ISO 6872:2015 and ISO 13356:2008. The performance metrics (e.g., flexural strength, chemical solubility, fracture toughness) were measured and compared against the limits specified in these standards.
8. The sample size for the training set
Not applicable. This is a physical device, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. See point 8.
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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
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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
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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™ HTK210884 | NexxZr™ SNexxZr™TK130991 | Comparison | |
|---|---|---|---|
| Indications for use | 1DERFUL™ HS & 1DERFUL™HT Zirconia blanks are indicated for usein prosthetic dentistry to create porcelain(ceramic) prostheses (dentures, crownsand bridges). 1DERFUL™ HS &1DERFUL™ HT Zirconia blanks areintended to be milled and fully sinteredby a Dental Professional or DentalLaboratory before use. Full contourmonolithic crowns and bridges in anteriorand posterior regions. Substructureceramic for prostheses involving four ormore units can be created. | NexxZr™ are intended for thefabrication and preparation ofcopings and full anatomical/fullcontour crowns bridge, inlaysand onlays for anterior andposterior segmentrestorations. | Similar |
Substantial Equivalent Comparison 6.
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| 1DERFUL™ HS &1DERFUL™ HT | NexxZS /NexxZr™T | Comparison | |
|---|---|---|---|
| MaterialComposition | Zirconia Powder:ZrO2+HfO2 +Y2O3> 99 | Zirconia Powder:ZrO2+HfO2+Y2O3>99 | same |
| % wt. | HfO2: < 2 | HfO2: < 2 | |
| Y2O3: 5.2 | Y2O3: 5.2 | ||
| Al2O3: ≤ 0.05 | Al2O3: ≤ 0.05 | ||
| Other oxides: < 0.3 | Other oxides: < 0.3 | ||
| Freedom fromextraneous materialsper ISO 6872:2015Section 5.2 activeconc. of not morethan 1.0 Bq g -1 ofUranium238 | <0.03 | Not available | |
| Sintered Densityg/cm-3 | 6.08 g/cm3 | 6.08 g/cm3 | same |
| Coefficient ofthermal expansion(CTE) | 10.1 μm/m °C | Not available | same |
| Fracture toughnessKIC | 5 MPa m0.5 | 5 MPa m0.5 | same |
| Flexural strengthper ISO 6872:2008, Limit>900MPa | >1000 MPa | >1000MPa | same |
| 1DERFUL TM HS &1DERFULTM HT | NexxZrTM S /NexxZrTMT | Comparison | |
| Chemical solubilityper ISO 6872:2015Limit 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 ISO10993 | Testing Per ISO 10993 | same |
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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 (chemicalcomposition) | 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
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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 ISO6872:2015 Section 7.3 Requirementminimum(mean) 800 MPa for class 6fixed prostheses, lowest value | > 1000. mpa | Pass |
| Freedom from extraneousmaterials per ISO 6872:2015Section 5.2 active conc. of notmore than 1.0 Bq g-1 of Uranium238 | <0.03 | Pass |
| Chemical solubility per ISO 6872:2015Section 7.6 Requirement of max of 100µg cm-2 | Pass | |
| Fracture Toughness per ISO6872:2015 Section Annex ARequirement for Class 5 of 5.0 MPa0.5min. | 5.0 | Pass |
| Sintered density in-house calculated(d=m/v) | 6.08 g/cm3 | Pass |
| Grain Size determined per ISO13356:2008, | 0.41 µm | Pass |
| Amount of monoclinic phase shall bedetermined using X-ray diffractionmethods in accordance with ASTMF1873-98 | ZrO2– Zirconium OxideTetragonal P42/mmc98.5%ZrO2– BaddeleyiteMonoclinic P21/a1.5% (max) | Pass |
| Linear Thermal Expansion Coefficientper ISO 6872:2015 | 10.1 µm/m°C | Pass |
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| Fe2O3 | ≤0.01 | Pass |
|---|---|---|
| Chemical solubility | 18.1 µg/cm² | Pass |
8. Clinical Testing
Clinical tests have not been performed.
Conclusion: 9.
The conclusions drawn from the nonclinical and clinical tests that demonstrate that 1DERFUL™ HS & 1DERFUL™ HT Zirconia blanks are as safe, as effective, and performs as well as the legally marketed predicate device.
§ 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.