Who is the manufacturer of 1Derful HS, 1Derful HT?

1derful, Inc. filed the 510(k) submission for 1Derful HS, 1Derful HT (K210884).

What is the FDA product code for 1Derful HS, 1Derful HT?

EIH. It is classified under 21 CFR 872.6660 as a Class 2 device in the Dental panel.

What is the regulatory pathway for 1Derful HS, 1Derful HT?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like 1Derful HS, 1Derful HT?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

1Derful HS, 1Derful HT

Q: What are the predicate devices for 1Derful HS, 1Derful HT?

NexxZr™ S / NexxZr™T (K130991).

K210884 · 1derful, Inc. · EIH · Jul 27, 2021 · Dental

Device Facts

Record ID	K210884
Device Name	1Derful HS, 1Derful HT
Applicant	1derful, Inc.
Product Code	EIH · Dental
Decision Date	Jul 27, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.6660
Device Class	Class 2
Attributes	Therapeutic

Intended 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.

Device Story

1Derful™ Zirconia blanks are disc-shaped yttria-stabilized tetragonal zirconia (Y-TZP) ceramic materials. Used by dental laboratories to fabricate custom dental restorations (dentures, crowns, bridges). Process involves CAD/CAM milling of the blank based on patient tooth anatomy, followed by sintering and optional coloring. Final restorations are fitted to the patient by a dental professional. Device provides a durable, biocompatible ceramic material for restorative dentistry, benefiting patients by restoring dental function and aesthetics.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via ISO 6872:2015 and ISO 13356:2008 standards, including flexural strength (>1000 MPa), fracture toughness (5.0 MPa m0.5), sintered density (6.08 g/cm3), chemical solubility, and grain size (0.41 µm).

Technological Characteristics

Yttria-stabilized tetragonal zirconia (Y-TZP) ceramic blanks. Composition: ZrO2 + HfO2 + Y2O3 (>99%), Al2O3 (≤0.1%), SiO2 (≤0.02%). Dimensions: 98.5 mm diameter, 10-30 mm thickness. Complies with ISO 6872:2015 (dentistry ceramic materials) and ISO 13356:2008 (implants for surgery).

Indications for Use

Indicated for use in prosthetic dentistry to create porcelain (ceramic) prostheses (dentures, crowns, and bridges) in anterior and posterior applications. Intended for use by dental professionals or laboratories. Not for use solely as an implant.

Regulatory Classification

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.

Predicate Devices

NexxZr™ S / NexxZr™T (K130991)

Related Devices

K191304 — EthanZir Zirconia · Besorah Dental Solutions NZ Limited · Nov 4, 2019
K212259 — Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank · Zirdent New Material Co., Ltd. · Nov 12, 2021
K221242 — Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank · Hunan Vsmile Biotechnology Co., Ltd. · Jul 29, 2022
K240882 — BruxZir® Esthetic · Prismatik Dentalcraft, Inc. · May 1, 2024
K240772 — Dental Zirconia Blank (HT-plus, ST-C, ST-ML, SHT-C, SHT-ML, UT-C, UT-ML, Pro- ML) · Hunan Ceramaster Material Technology Co., Ltd. · May 20, 2024

Submission Summary (Full Text)

{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 {2}------------------------------------------------ # 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) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 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: < 2 | HfO2: < 2 | | | | Y2O3: 5.2 | Y2O3: 5.2 | | | | Al2O3: ≤ 0.05 | Al2O3: ≤ 0.05 | | | | Other oxides: < 0.3 | Other oxides: < 0.3 | | | Freedom from extraneous materials per ISO 6872:2015 Section 5.2 active conc. of not more than 1.0 Bq g -1 of Uranium238 | <0.03 | Not available | | | Sintered Density g/cm-3 | 6.08 g/cm3 | 6.08 g/cm3 | same | | Coefficient of thermal expansion (CTE) | 10.1 μm/m °C | Not available | same | | Fracture toughness KIC | 5 MPa m0.5 | 5 MPa m0.5 | same | | Flexural strength per ISO 6872: 2008, Limit >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 | <0.03 | Pass | | Chemical solubility per ISO 6872:2015 Section 7.6 Requirement of max of 100 µg cm-2 | | Pass | | Fracture Toughness per ISO 6872:2015 Section Annex A Requirement for Class 5 of 5.0 MPa0.5 min. | 5.0 | Pass | | Sintered density in-house calculated (d=m/v) | 6.08 g/cm3 | Pass | | Grain Size determined per ISO 13356:2008, | 0.41 µm | Pass | | Amount of monoclinic phase shall be determined using X-ray diffraction methods in accordance with ASTM F1873-98 | 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 | 10.1 µm/m°C | Pass | {8}------------------------------------------------ | 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.