(59 days)
Color and Multilayer-SHT are intended for the manufacturing of partial and single crowns, full arch occlusally screwed bridges, inlays, onlays, and veneers, full contour restorations as well as reduced structures in combination with veneering ceramics. The products are categorized into class 5 according to ISO 6872.
Multilayer-3D is intended for the manufacturing of partial and single crowns, max. 3-unit bridges, inlays, onlays and veneers, full contour restorations as well as for reduced structures in combination with veneering ceramics and implant superstructures for 3-unit restorations in the anterior and posterior tooth region. The products are categorized into class 4 according to ISO 6872.
The products are suitable for all milling machines which are able to process presintered zirconia and which have the proper clamping device for the corresponding block.
Dental Zirconia Pre-shaded Block is composed of yttria-stabilized zirconia. It contains ZrO2+HfO2+Y2O3+Al2O3 and very small amount of additional inorganic pigments (Fe2O3+Er2O3+Mn2O3). The inorganic pigments generate the color on the restorations, after sintering at dental labs, that matches natural color of patient's teeth.
Dental Zirconia Pre-shaded Block has two color representations (i.e. monolayer and multilayer), corresponding to the categories of Color and Multilayer. The Multilayer also divided into two subcategories (Multilayer-SHT and Multilayer-3D) according to the consistency of the translucency across the zirconium block. And it offers various shapes and dimensions suitable for different milling systems.
The proposed device is processed into the dental restorations such as crowns, bridges, veneers, inlays and onlays based on the anatomical rendering of the patient's teeth using CAD/CAM (computer aided design / computer aided manufacturing) method or manual milling method.
The performance of the proposed device conforms to ISO 6872:2015 Dentistry: Ceramic Materials. It is a single-use device, and provided non-sterile.
This document is a 510(k) summary for a medical device called "Dental Zirconia Pre-shaded Block". The 510(k) process is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. This process does not involve the type of acceptance criteria and study design typically associated with AI/ML-driven diagnostic devices that assess patient conditions or make clinical recommendations.
Because this document is about a material used in dentistry (zirconia blocks for crowns and bridges), the "acceptance criteria" and "study" are related to material properties and biocompatibility as per relevant international standards (ISO), rather than diagnostic performance metrics like sensitivity, specificity, or AUC, which are common for AI/ML devices.
Therefore, many of the requested elements for describing AI/ML device acceptance criteria and studies (e.g., sample size for test set, data provenance, expert ground truth, MRMC studies, standalone performance, training set details) are not applicable to this type of medical device submission.
However, I can extract information related to the performance testing of the material, which serves as its "acceptance criteria" in the context of material science.
Acceptance Criteria and Device Performance for "Dental Zirconia Pre-shaded Block"
The acceptance criteria for this dental material are based on the international standard ISO 6872:2015 Dentistry - Ceramic materials. The study proving the device meets these criteria involved non-clinical performance testing and biocompatibility testing.
1. Table of Acceptance Criteria and Reported Device Performance
The requirements are defined by ISO 6872:2015. The device's performance is reported for two categories: "Multilayer-3D" and "Color, Multilayer-SHT".
| Test Item | Acceptance Criteria (from ISO 6872:2015) | Reported Device Performance (Multilayer-3D) | Reported Device Performance (Color, Multilayer-SHT) | Judgment |
|---|---|---|---|---|
| Physical Properties | ||||
| Uniformity | Uniform (as per standard) | Uniform | Uniform | Pass |
| Freedom from extraneous materials | Free from extraneous materials | Free from extraneous materials | Free from extraneous materials | Pass |
| Radioactivity | ≤ 1.0 Bq·g⁻¹ | 0.019 Bq·g⁻¹ | 0.019 Bq·g⁻¹ | Pass |
| Flexural strength | Multilayer-3D: ≥ 500 MPa | 1172.2 MPa | 1110.9 MPa | Pass |
| Color, Multilayer-SHT: ≥ 800 MPa | (N/A for Multilayer-3D) | (N/A for Color, Multilayer-SHT) | ||
| Linear thermal expansion coefficient | (10.5 ± 0.5) × 10⁻⁶ K⁻¹ (as per standard) | 10.8 × 10⁻⁶ K⁻¹ | 10.9 × 10⁻⁶ K⁻¹ | Pass |
| Chemical solubility | < 100 µg/cm² | 53.4 µg/cm² | 52.6 µg/cm² | Pass |
| Shrinkage factor | Not explicitly defined numerically in comparison, but inherent to material processing | 1.255 | 1.259 | Pass |
| Fracture Toughness | Multilayer-3D: ≥ 3.5 MPa·m¹/² | 18.24 MPa·m¹/² | 17.88 MPa·m¹/² | Pass |
| Color, Multilayer-SHT: ≥ 5.0 MPa·m¹/² | (N/A For Multilayer-3D) | (N/A for Color, Multilayer-SHT) | ||
| Biocompatibility | ||||
| Cytotoxicity | No cytotoxicity | No cytotoxicity | No cytotoxicity | Pass |
| Skin Sensitization | No skin sensitization | No skin sensitization | No skin sensitization | Pass |
| Oral Mucosa Irritation | No oral mucosa irritation | No oral mucosa irritation | No oral mucosa irritation | Pass |
| Acute Systemic Toxicity | No acute systemic toxicity | No acute systemic toxicity | No acute systemic toxicity | Pass |
| Subchronic Systemic Toxicity | No subchronic systemic toxicity | No subchronic systemic toxicity | No subchronic systemic toxicity | Pass |
| Genotoxicity | No genotoxicity | No genotoxicity | No genotoxicity | Pass |
| Implantation | No local effects | No local effects | No local effects | Pass |
(Note: "N/A" indicates that the specific performance metric threshold applies to a different product category/class within the device, or the value is directly given without a specific numeric range from the predicate comparison, but judged against the ISO standard.)
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample sizes (number of material samples, or human subjects for biocompatibility) used for each individual test. The tests were performed "according to ISO 6872:2015" and "ISO 7405:2018", which would imply the use of sample sizes consistent with these material science standards.
- Data Provenance: The tests are non-clinical (laboratory-based material testing) and performed by the manufacturer, Shenzhen Yurucheng Dental Materials Co., Ltd. The country of origin of the data is implicitly China, where the manufacturer is located. The nature of the data is prospective in the sense that these tests were conducted specifically for this 510(k) submission to demonstrate compliance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable. For material testing, "ground truth" is established by the physical and chemical properties measured according to standardized methods (e.g., universal testing machines for flexural strength, chemical analysis for composition, standardized biological assays for biocompatibility). It does not involve human expert consensus or clinical interpretation typical of imaging or diagnostic AI. The "experts" are likely the qualified laboratory personnel conducting the tests.
4. Adjudication Method for the Test Set
- Not Applicable. Material property measurements do not typically involve adjudication in the clinical sense. Results are quantitative values obtained via standardized test methods.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness study was done
- No. This type of study (MRMC) is relevant for AI/ML diagnostic interpretation where human readers' performance with and without AI assistance is evaluated. This is a material science device, so MRMC studies are not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical dental material; there is no "algorithm" to evaluate in a standalone manner. The performance refers to the intrinsic properties of the material itself.
7. The Type of Ground Truth Used
- The "ground truth" for this device's performance is based on standardized laboratory measurements of physical, chemical, and biological properties as defined by the ISO 6872:2015 (Dental Ceramic Materials) and ISO 7405:2018 (Biological Evaluation of Medical Devices Used in Dentistry) series of standards. This includes mechanical properties (flexural strength, fracture toughness), chemical properties (solubility, composition), physical properties (radioactivity, uniformity, thermal expansion, shrinkage factor), and biocompatibility endpoints (cytotoxicity, sensitization, systemic toxicity).
8. The Sample Size for the Training Set
- Not Applicable. This is a manufactured material, not an AI/ML model that undergoes "training" on a dataset. The consistent manufacturing process and material formulation are what ensure its properties.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As there is no "training set," there is no ground truth established in this context. The manufacturing process of the zirconia block is controlled to meet the desired material specifications.
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February 18, 2022
Shenzhen Yurucheng Dental Materials Co., Ltd. % Grace Liu Consultant Shenzhen Joyantech Consulting Co. Ltd 1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan District Shenzhen, Guangdong 518000 CHINA
Re: K214003
Trade/Device Name: Dental Zirconia Pre-shaded Block Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: December 12, 2021 Received: December 21, 2021
Dear Grace Liu:
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.
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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 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 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
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Indications for Use
510(k) Number (if known) K214003
Device Name Dental Zirconia Pre-shaded Block
Indications for Use (Describe)
Color and Multilayer-SHT are intended for the manufacturing of partial and single crowns, full arch occlusally screwed bridges, inlays, onlays, and veneers, full contour restorations as well as reduced structures in combination with veneering ceramics. The products are categorized into class 5 according to ISO 6872.
Multilayer-3D is intended for the manufacturing of partial and single crowns, max. 3-unit bridges, inlays and veneers, full contour restorations as well as for reduced structures in combination with veneering ceramics and implant superstructures for 3-unit restorations in the anterior tooth region. The products are categorized into class 4 according to ISO 6872.
The products are suitable for all milling machines which are able to process presintered zirconia and which have the proper clamping device for the corresponding block.
| 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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Version: A/0
510(k) Summary - K214003
1. Contact Details
1.1 Applicant information
| Applicant Name | Shenzhen Yurucheng Dental Materials Co., Ltd. |
|---|---|
| Address | 101-201, Building 4, No.1 Branch of Zhongcheng Life Science Park, No. 14 Zhongxing Road, Xiuxin Community, Kengzi Street Office, Pingshan District, Shenzhen, China |
| Contact person | Fiya Liao |
| Phone No. | +86-17727849963 |
| ppk-jidcvcvmr@dingtalk.com | |
| Date Prepared | 2022-02-17 |
| 1.2 Submission Correspondent |
| Shenzhen Joyantech Consulting Co., Ltd | |
|---|---|
| 1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan District | |
| Shenzhen, Guangdong Province, China | |
| Phone No. | +86-755-86069197 |
| Contact person | Grace Liu; Field Fu; |
| Contact person's e-mail | grace@cefda.com; field@cefda.com |
| Website | http://www.cefda.com |
2. Device Information
| Trade name | Dental Zirconia Pre-shaded Block |
|---|---|
| Common name | Dental Zirconia Ceramics |
| Classification | II |
| Classification name | Porcelain powder for clinical use |
| Product code | EIH |
| Regulation No. | 21 CFR 872.6660 |
3. Legally Marketed Predicate Device
| Trade Name | PRETTAU®, ICE and Z-WHITE zirconia blanks |
|---|---|
| 510(k) Number | K183304 |
| Product Code | EIH |
| Manufacturer | ZIRKONZAHN SRL |
4. Device Description
Dental Zirconia Pre-shaded Block is composed of yttria-stabilized zirconia. It contains ZrO2+HfO2+Y2O3+Al2O3 and very small amount of additional inorganic pigments (Fe2O3+Er2O3+Mn2O3). The inorganic pigments generate the color on the restorations, after sintering at dental labs, that matches natural color of patient's teeth.
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Dental Zirconia Pre-shaded Block has two color representations (i.e. monolayer and multilayer), corresponding to the categories of Color and Multilayer. The Multilayer also divided into two subcategories (Multilayer-SHT and Multilayer-3D) according to the consistency of the translucency across the zirconium block. And it offers various shapes and dimensions suitable for different milling systems.
The proposed device is processed into the dental restorations such as crowns, bridges, veneers, inlays and onlays based on the anatomical rendering of the patient's teeth using CAD/CAM (computer aided design / computer aided manufacturing) method or manual milling method.
The performance of the proposed device conforms to ISO 6872:2015 Dentistry: Ceramic Materials. It is a single-use device, and provided non-sterile.
5. Intended Use/Indication for Use
Color and Multilayer-SHT are intended for the manufacturing of partial and single crowns, full arch occlusally screwed bridges, inlays, and veneers, full contour restorations as well as reduced structures in combination with veneering ceramics. The products are categorized into class 5 according to ISO 6872.
Multilayer-3D is intended for the manufacturing of partial and single crowns, max. 3-unit bridges, inlays, onlays and veneers, full contour restorations as well as for reduced structures in combination with veneering ceramics and implant superstructures for 3-unit restorations in the anterior and posterior tooth region. The products are categorized into class 4 according to ISO 6872.
The products are suitable for all milling machines which are able to process presintered zirconia and which have the proper clamping device for the corresponding block.
6. Substantial Equivalence Comparison
| Comparisonitem | Proposed Device (K214003) | Predicate Device (K183304) | Comment |
|---|---|---|---|
| Manufacturer | Shenzhen Yurucheng DentalMaterials Co., Ltd. | ZIRKONZAHN SRL | None |
| Product Name | Dental Zirconia Pre-shaded Block | PRETTAU®, ICE and Z-WHITEzirconia blanks | None |
| Product Code | EIH | EIH | Same |
| RegulationNumber | 21 CFR § 872.6660 | 21 CFR § 872.6660 | Same |
| Classification | Class II | Class II | Same |
| PrescriptionUse | Yes | Yes | Same |
| Indications forUse | Color and Multilayer-SHT areintended for the manufacturing ofpartial and single crowns, fullarch occlusally screwed bridges,inlays, onlays, and veneers, fullcontour restorations as well asreduced structures incombination with veneeringceramics. The products arecategorized into class 5according to ISO 6872.Multilayer-3D is intended for themanufacturing of partial andsingle crowns, max. 3-unitbridges, inlays, onlays andveneers, full contour restorationsas well as for reduced structuresin combination with veneeringceramics and implantsuperstructures for 3-unitrestorations in the anterior andposterior tooth region. Theproducts are categorized intoclass 4 according to ISO 6872.The products are suitable for allmilling machines which are ableto process presintered zirconiaand which have the properclamping device for thecorresponding block. | Prettau®, Prettau® 2, Prettau® 2Coloured, Prettau® 2 Dispersive,ICE Translucent, ICE Premium,ICE Abutment, ICE TranslucentPlus, ICE Translucent PlusColoured, ICE Translucent PlusDispersive and Z-White areintended for the manufacturing ofmetal-free partial and singlecrowns, full arch occlusallyscrewed bridges, inlays, onlays,and veneers, full contourrestorations as well as reducedstructures in combination withveneering ceramics. Theproducts are categorized intoclass 5 according to ISO 6872.Prettau® 3, Prettau® 3 Coloured,Prettau® 3 Dispersive, Prettau® 4Anterior®, Prettau® 4 Anterior®Coloured and Prettau® 4Anterior® Dispersive are destinedfor the manufacturing ofmetal-free partial and singlecrowns, max. 3-unit bridges,inlays, onlays and veneers, fullcontour restorations as well as forreduced structures incombination with veneeringceramics and implantsuperstructures for 3-unitrestorations in the anterior andposterior tooth region. Theproducts have to be categorizedas class 4 according to ISO 6872.The products have beendeveloped for use with ColourLiquid, ICE Zirkon Ceramics, ICEZirkon Stains and ICE Zirkon | Similar |
| instructions of use when usingthese products. The blocks aresuitable for all milling units, whichare able to process presinteredzirconia and which have theproper clamping device for thecorresponding block. | |||
| Class(per ISO6872:2015) | Class 4Multilayer-3DClass 5Color, Multilayer-SHT | Class 4Prettau® 3, Prettau® 4 AnteriorClass 5Prettau®, Prettau® 2, ICE group,Z-White | Same |
| Composition | Based on yttria-stabilized zirconia | Based on yttria-stabilized zirconia | Similar |
| Color | Color | White, Color | Similar |
| Intended User | Professional dental technicians | Professional dental technicians | Same |
| Single Use | Yes | Yes | Same |
| Sterile | Non-sterile | Non-sterile | Same |
| PhysicalProperties | Conform to ISO 6872:2015 | Conform to ISO 6872:2015 | Same |
| Uniformity | Uniform | Uniform | Same |
| Freedom fromextraneousmaterials | Free from extraneous materials | Free from extraneous materials | Same |
| Radioactivity | ≤ 1.0 Bq.g-1 | ≤ 1.0 Bq.g-1 | Same |
| Flexuralstrength | Multilayer-3D:≥ 500 MPaColor, Multilayer-SHT:≥ 800 MPa | Prettau® 3, Prettau® 4 Anterior:600 MPaPrettau®, Prettau® 2, ICE group,Z-White:≥ 900 MPa | Similar |
| Chemicalsolubility | < 100 µg/cm² | < 100 µg/cm² | Same |
| Linear thermalexpansioncoefficient | $(10.5±0.5)×10-6 K-1$ | Not publicly available | Different |
| Shrinkagefactor | 1.257±0.002 | Not publicly available | Different |
| Fracture | Multilayer-3D: | Not publicly available | Different |
| Toughness | $≥ 3.5 MPa*m1/2$ | ||
| Color, Multilayer-SHT:$≥ 5.0 MPa*m1/2$ | |||
| Biocompatibility | Conform to ISO 7405:2018 | Conform to ISO 10993-1 | Similar |
| Labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | Same |
Table 1 Substantial Equivalence Comparison
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Version: A/0
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Version: A/0
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The proposed device has the similar indication for use as the predicate device as well as comparable technical and biocompatibility properties and characteristics, and the minor differences don't raise any additional questions for safety and effectiveness, therefore, the proposed device is substantially equivalent to the predicate device.
7. Non-clinical Testing
> Performance Testing
The performance tests were performed according to ISO 6872:2015 Dentistry -Ceramic materials, and the test results showed that the proposed device meets the requirements specified in the standard (see Table 2).
| Test Results | |||
|---|---|---|---|
| Test Item | Multilayer-3D | Color, Multilayer-SHT | Judgment |
| Uniformity | Uniform | Uniform | Pass |
| Freedom fromextraneous materials | Free from extraneousmaterials | Free from extraneousmaterials | Pass |
| Radioactivity | $0.019$ Bq·g-1 | $0.019$ Bq·g-1 | Pass |
| Flexural strength | 1172.2 MPa | 1110.9 MPa | Pass |
| Linear thermalexpansion coefficient | $10.8 \times 10^{-6}$ K-1 | $10.9 \times 10^{-6}$ K-1 | Pass |
| Chemical solubility | 53.4 µg/cm² | 52.6 µg/cm² | Pass |
| Shrinkage factor | 1.255 | 1.259 | Pass |
| Fracture Toughness | 18.24 MPa*m1/2 | 17.88 MPa*m1/2 | Pass |
| Table 2 Summary of Performance Testing | ||
|---|---|---|
| ---------------------------------------- | -- | -- |
> Biocompatibility Testing
The biocompatibility tests were performed according to ISO 7405:2018 Dentistry -Evaluation of biocompatibility of medical devices used in dentistry (see Table 3), and the test results showed that the proposed device has no biocompatibility issues.
Table 3 Summary of Biocompatibility Testing
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Version: A/0
| Biological Endpoint | Reference | Test Result |
|---|---|---|
| Cytotoxicity | ISO 10993-5:2009 | No cytotoxicity under the conditionsof the study |
| Cytotoxicity | 6.2 of ISO 7405:2018 | No cytotoxicity under the conditionsof the study |
| Cytotoxicity | 6.3 of ISO 7405:2018 | No cytotoxicity under the conditionsof the study |
| Skin Sensitization | ISO 10993-10:2010 | No skin sensitization under theconditions of the study |
| Oral Mucosa Irritation | ISO 10993-10:2010 | No oral mucosa irritation under theconditions of the study |
| Acute Systemic Toxicity | ISO 10993-11:2017 | No acute systemic toxicity under theconditions of the study |
| Subchronic SystemicToxicity | ISO 10993-11:2017 | No subchronic systemic toxicityunder the conditions of the study |
| Genotoxicity | ISO 10993-3:2014 | No genotoxicity under the conditionsof the study |
| Implantation | ISO 10993-6:2016 | No local effects under the conditionsof the study |
The results of the non-clinical testing demonstrate that the proposed device is equivalent to the predicate device.
8. Clinical Testing
No clinical study is included in this submission.
9. Conclusions
The results of comparing the design specifications and non-clinical testing between the proposed device and the legally marketed predicate device (K183304) show that they are Substantially Equivalent (SE).
§ 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.