(107 days)
Zirconia Blocks are intended for use for the production of artificial teeth in fixed or removable dentures, for jacket facing, veneers. All Blocks are processed through dental laboratories or by dental professionals.
Zirconia ceramic block is made of ceramic materials (e.g., zirconium oxide) intended to be used to manufacture a final dental appliance/prosthesis (e.g., removable dentures, for jacket facing, veneers) for patient use. It is used to removable restorations using manual or computer-aided design/computer-aided manufacturing (CAD/CAM) technology. After application, this material cannot be reused for fabrication.
The provided document, K233125, is a 510(k) premarket notification for a medical device called "Zirconia Block." This device is a ceramic material intended for use in manufacturing dental prosthetics. The document primarily focuses on demonstrating the substantial equivalence of the Zirconia Block to a legally marketed predicate device (K192262, "Dental Zirconia Blocks") through non-clinical testing.
However, the provided text does not describe any study that proves an AI/ML-driven device meets acceptance criteria. The described tests are for a physical material (Zirconia Block) and assess its physical, chemical, and biological properties, not the performance of a software or AI/ML algorithm.
Therefore, I cannot provide details on:
- A table of acceptance criteria and reported device performance for an AI/ML device. The table provided is for a physical material.
- Sample size used for the test set and data provenance for an AI/ML device.
- Number of experts used to establish ground truth or their qualifications for an AI/ML device.
- Adjudication method for an AI/ML device.
- MRMC comparative effectiveness study or human reader improvement with AI assistance.
- Stand-alone algorithm performance.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI/ML device.
- Sample size for the training set for an AI/ML device.
- How the ground truth for the training set was established for an AI/ML device.
The provided document is about a material, not an AI/ML medical device.
If you are interested in the acceptance criteria and performance for the Zirconia Block material itself based on the provided document, here is the information:
Acceptance Criteria and Device Performance for Zirconia Block (a physical material):
1. Table of Acceptance Criteria and the Reported Device Performance:
| ID# | Test | Acceptance Criteria (Method) | Reported Device Performance (Conclusion) |
|---|---|---|---|
| 1.1 | Chemical Composition | Y2O3+Zr(Hf)O2 > 99.5% | 99.9% for all 10 samples |
| 1.2 | Flexural Strength | ≥ 800 Mpa (as per Table VI, but not explicitly stated as acceptance criteria in Table VII-1 for this row, instead it seems the number shown is the result of another chemical composition test row) | 912Mpa, 914Mpa, 910Mpa, 912Mpa, 915Mpa, 916Mpa, 906Mpa, 913Mpa, 913Mpa, 916Mpa (These values are presented as results for "Chemical Composition" in the table, which seems to be a mislabeling in the original document, these are typical flexural strength results) |
| 1.3 | Pre-sintering Density (first row) | ≥ 2.75 g/cm³ (Product technical requirements) | 3.1 g/cm³ for all 10 samples (e.g., 3.1 and 6.07g/cm³ indicates both pre- and post-sintering results for one sample) |
| 1.3 | Post-sintering Density (second row) | ≥ 6.00 g/cm³ (Product technical requirements) | 6.06 g/cm³ or 6.07 g/cm³ for all 10 samples |
| 1.4 | Sintering Shrinkage Rate | 19% - 22% | 20.46% - 20.55% for all 10 samples |
| 1.5 | Pre-sintering Solubility (first row) | ≤ 2000 µg/cm² | 0 µg/cm² for all 10 samples |
| 1.5 | Post-sintering Solubility (second row) | ≤ 100 µg/cm² | 0 µg/cm² for all 10 samples |
| 1.6 | Linear thermal expansion-coefficient | (10.5 ± 0.5) × 10⁻⁶ K⁻¹ | 10.3 to 10.6 × 10⁻⁶ K⁻¹ for all 10 samples |
| 1.7 & 1.8 | Scale out rate | The scaling factor falls within the range in between 1.210 and 1.260, and the deviation of the actual value from the nominal value should not be greater than 0.005. | 1.238 to 1.250 for all 10 samples (as listed) |
| 1.9 | Appearance (Surface) | Surface should be smooth and pore-free. | Yes (indicating compliance) for all 10 samples |
| 1.9 | Appearance (Color) | The color of zirconia porcelain block used for chip processing (initial sintering state) should be uniform, there should be no local pigment separation phenomenon, there should be no foreign body attached. | Yes (indicating compliance) for all 10 samples |
| 1.9 | Appearance (Size) | The size error should be less than ± 0.2mm. | +0.02mm to +0.03mm (indicating compliance) for all 10 samples |
| 1.10 | Packaging | The packing identification should be distinct, and the packing material should not have obvious changes. | No obvious changes (indicating compliance) for all 10 samples |
| 2.1 | Cytotoxicity | Non-Cytotoxicity (ISO 10993-5:2009) | Pass |
| 2.2 | Sensitization | Non-Sensitization (ISO 10993-10:2021) | Pass |
| 2.3 | Irritation or intracutaneous reactivity | Non-Irritation or intracutaneous reactivity (ISO 10993-23:2021) | Pass |
| 2.4 | Acute systemic toxicity | Non-Acute systemic toxicity (ISO 10993-11:2017) | Pass |
| 2.5 | Subacute toxicity | Non-Subacute toxicity (ISO 10993-11:2017) | Pass |
| 2.6 | Sub chronic toxicity | Non-Sub chronic toxicity (ISO 10993-11:2017) | Pass |
| 2.7 | Genotoxicity | Non-Genotoxicity (ISO 10993-3:2014) | Pass |
2. Sample Size for the Test Set and Data Provenance:
- For physical tests (1.1 to 1.10), 10 samples of the Zirconia Block were tested.
- The data provenance is not explicitly stated in terms of country of origin, but the manufacturer is Hangzhou IVISTA Medical Devices Co., Ltd. from China. The tests are non-clinical (bench testing) and thus are not retrospective or prospective in the same way clinical data would be.
3. Number of Experts used to establish the ground truth for the test set and their qualifications:
- This is not applicable as the tests performed are bench tests on a physical material (Zirconia Block). Ground truth is established by complying with specified ISO standards and technical requirements for material properties, not by expert consensus on interpretations.
4. Adjudication method for the test set:
- Not applicable as these are bench tests for material properties following established measurement methods in laboratory settings, not diagnostic interpretations requiring adjudication.
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, this study was for a physical dental material, not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, this study was for a physical dental material, not a standalone algorithm.
7. The type of ground truth used:
- For physical testing, the ground truth is based on objective measurements of the material's properties (e.g., chemical composition, density, flexural strength) as defined by recognized consensus standards (e.g., ISO 6872 mentioned in Table VI, although specific ISO standards are not fully detailed for each physical test in Table VII-1 beyond biocompatibility) and product technical requirements.
- For biocompatibility testing, ground truth is established by complying with the outcomes specified by relevant ISO 10993 series standards (e.g., Non-Cytotoxicity, Non-Sensitization).
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device, so there is no training set for an algorithm.
9. How the ground truth for the training set was established:
- Not applicable for the same reason as above.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 12, 2024
Hangzhou IVISTA Medical Devices Co., Ltd. Yao Cheng General Manager No. 7, Chunjiang Road, Qiaonan Development Zone Ningwei Town, Xiaoshan District Hangzhou, Zhejiang 311217 China
Re: K233125
Trade/Device Name: Zirconia Block Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: November 15, 2023 Received: November 16, 2023
Dear Yao Cheng:
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.
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"
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(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 OS 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.
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 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.
Bobak Shirmohammadi -S
For Michael E. Adjodha, M. ChE., RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices
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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) K233125
Device Name Zirconia Block
Indications for Use (Describe)
Zirconia Blocks are intended for use for the production of artificial teeth in fixed or removable dentures, for jacket facing, veneers. All Blocks are processed through dental laboratories or by dental professionals.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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K233125 Section 3 510(k) Summary
l 510(k) Submitter
| Device Submitter: | Hangzhou IVISTA Medical Devices Co., Ltd.No. 7, Chunjiang Road, Qiaonan Development Zone, Ningwei TownXiaoshan District. Hangzhou City 311217, Zhejiang Province, China |
|---|---|
| ------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
Contact Person: Yao Cheng General Manager Phone: 86 13905009803 E-mail: cy2179@163.com
II Device
| Trade Name of Device: | Zirconia Block |
|---|---|
| Regulation Number: | 21 CFR 872.6660 |
| Classification Name: | Powder, Porcelain |
| Product Code: | EIH |
| Regulatory Class | II |
| Review Panel | Dental |
III Predicate Devices
| 510k Number | K192262 |
|---|---|
| Trade Name of Device: | Dental Zirconia Blocks |
| Regulation Number: | 21 CFR 872.6660 |
| Classification Name: | Powder, Porcelain |
| Regulatory Class | II |
| Product Code: | EIH |
IV Device Description
Zirconia ceramic block is made of ceramic materials (e.g., zirconium oxide) intended to be used to manufacture a final dental appliance/prosthesis (e.g., removable dentures, for jacket facing, veneers) for patient use. It is used to removable restorations using manual or computer-aided design/computer-aided manufacturing (CAD/CAM) technology. After application, this material cannot be reused for fabrication.
V Indications for use
Zirconia Blocks are intended for use for the production of artificial teeth in fixed or removable dentures,for jacket facing,veneers.All Blocks are processed through dental laboratories or by dental professionals.
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VI Technological Characteristics Comparison
| DeviceCharacteristic | Subject Device | Predicate Device(K192262) | Discussion |
|---|---|---|---|
| Trade name | Zirconia Block | Dental Zirconia Blocks | N/A |
| Regulation Number | 21 CFR 872.6660 | 21 CFR 872.6660 | Identical |
| Product Code | EIH | EIH | Identical |
| Manufacturer | Hangzhou IVISTA MedicalDevices Co., Ltd. | ARUMDENTISTRY Co., Ltd. | N/A |
| Device Classification | Powder, Porcelain | Powder, Porcelain | Identical |
| Intended Use | Zirconia Blocks are intended foruse for the production of artificialteeth in fixed or removabledentures,for jacketfacing,veneers.All Blocks areprocessed through dentallaboratories or by dentalprofessionals. | Dental Zirconia Blocks are intendedfor use for the production of artificialteeth in fixed or removabledentures,for jacket facing,veneers.AllBlocks are processed through dentallaboratories or by dentalprofessionals. | Identical |
| PrescriptionUse | Yes | Yes | Identical |
| Shapes | Blocks | Blocks, disc | DifferentComment 1 |
| Color | White and Colour | White and Colour | same |
| ChemicalComposition(Weight %) | ZrO2+HfO2+Y2O3 ≥99.0ZrO2 >90Y2O3 ≤9.5Fe2O3 ≤0.5Er2O3 ≤0.5Other oxide / | White zirconia:ZrO2+HfO2+Y2O3 ≥99.0Y2O3 4.5~6.0HfO2 ≤5Al2O3 ≤0.5Other oxide ≤0.5Color zirconia:ZrO2+HfO2+Y2O3 ≥98.0Fe2O3 <0.3Pr2O3 <0.2Er2O3 <1Other oxide ≤0.5 | DifferentComment 2 |
| Density (presintering) | ≥2.75g/cm³ | ≥3.0g/cm³ | DifferentComment 3 |
| Density (postsintering) | ≥6.00g/cm³ | ≥6.02g/cm³ | |
| DeviceCharacteristic | Subject Device | Predicate Device(K192262) | Discussion |
| SinteringTemperature | $1500\pm100$ °C | 1400-1600 °C | Identical |
| Flexurastrength | ≥800Mpa | >800Mpa | Identical |
| Solubilit | ≤100µg/cm² | <100µg/cm² | Identical |
| Radioactive | ≤ 1.0 Bq / g | uranium-238concentration ≤ 1.0 Bq / g. | Identical |
| Single Use | Yes | Yes | Identical |
| Sterile | Non-sterile | Non-sterile | Identical |
| PerformanceTest | Including:AppearanceTest,Dimension Test,DensityTest,Product compositionFlexural strength,Linear thermalexpansion-coefficient,Chemicalsolubility Radioactivity of dentalof ceramic,thermalFracture toughness comply withISO 6872 | Including:AppearanceTest,Dimension Test,DensityTest,Product composition Flexuralstrength,Linear thermalexpansion-coefficient,Chemicalsolubility Radioactivity of dental ofceramic,thermalFracture toughness comply with ISO6872 | Identical |
| Biocompatibility | Comply ISO10993-1:2020 | Comply ISO10993-1:2018FDA Guidance, tests includedcytotoxicity, oral mucosa irritation,skin sensitization,pyrogenicity,acute systemic toxicity,subacute toxicity,subchronicsystemic toxicity,implantation effectand genotoxicity etc | DifferentComment 4 |
VI-1: Comparison of Zirconia Block
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Comment 1
Shapes in the subject device have been used in the predicate deviceThe form of the product is not the same but the composition and intended use are the same. Accordingly, it was concluded that the proposed device is substantially equivalent to the predicate device.
Comment 2
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All chemical ingredients in the proposed device have been used in thepredicate device and the reference device. Accordingly, it was concludedthat the proposed device is substantially equivalent in biocompatibility tothe predicate device and the reference device.
Comment 3
The pre sintering mainly affects the hardness of products which reflects theeasy degree of material machining operations. The pre sintering density ofthe proposed device is a little different with the predicated device and thereference device, but it has no obvious effect on the hardness, thisdifference does not affect substantial equivalence.
Comment 4
ISO10993-1:2018 Updated to ISO10993-1:2020, we do biocompatibility according to the latest standard and meet the requirements.
VII Summary of Non-clinical Testing (Bench)
The non-clinical testing for Zirconia Block was performed to demonstrate verification testing in conformance with the acceptance criteria of test methods and recognized consensus standards shown below.
| ID# | Test | Method | AcceptanceCriteria | Conclusion |
|---|---|---|---|---|
| 1 | Physical Testing of Dental Glass Ceramics | Test results of ten samples | ||
| 1.1 | ChemicalComposition | Y2O3+Zr(Hf)O2>99.5% | 99.9%,99.9%,99.9%,99.9%,99.9%,99.9%,99.9%,99.9%,99.9%,99.9% | |
| 1.2 | ChemicalComposition | Y2O3+Zr(Hf)O2>99.5% | 912Mpa, 914Mpa, 910Mpa, 912Mpa,915Mpa, 916Mpa, 906Mpa, 913Mpa,913Mpa, 916Mpa | |
| 1.3 | Pre-sintering | ≥2.75g/cm³ | Producttechnicalrequirements | 3.1 and 6.07g/cm³, 3.1 and 6.06g/cm³, 3.1 and 6.06g/cm³, 3.1 and6.07g/cm³, 3.1 and 6.06g/cm³, 3.1 and6.07g/cm³, 3.1 and 6.06g/cm³, 3.11and 6.07g/cm³, 3.1 and 6.06g/cm³,3.12 and 6.06g/cm³ |
| 1.3 | Post-sintering | ≥6.00g/cm³ | 6.07g/cm³, 3.1 and 6.06g/cm³, 3.1 and6.07g/cm3, 3.1 and 6.06g/cm3, 3.11and 6.07g/cm³, 3.1 and 6.06g/cm³ | |
| 1.4 | SinteringShrinkage Rate | 19%-22% | 20.53%, 20.51%, 20.49%,20.51%,20.46%, 20.55%, 20.55%,20.51%,20.5%, 20.51% | |
| 1.5 | Pre-sintering | ≤2000µg/cm² | 0 and 0µg/cm², 0 and 0µg/cm², 0 and0µg/cm², 0 and 0µg/cm², 0 and 0µg/cm², 0 and 0µg/cm², 0 and 0µg/cm², 0 and 0µg/cm², 0 and 0µg/cm², 0 and 0µg/cm² | |
| 1.5 | Post-sintering | ≤100µg/cm² | 0 and 0µg/cm², 0 and 0µg/cm², 0 and0µg/cm², 0 and 0µg/cm², 0 and 0µg/cm², 0 and 0µg/cm², 0 and 0µg/cm², 0 and 0µg/cm², 0 and 0µg/cm², 0 and 0µg/cm² | |
| 1.6 | Linear thermalexpansion-coefficient | $(10.5±0.5) × 10-6 K-1$ | 10.5×10-6 K-1, 10.6 ×10-6 K-110.3×10-6 K-1, 10.4 ×10-6 K-110.6×10-6 K-1, 10.3 ×10-6 K-110.5×10-6 K-1, 10.4 ×10-6 K-110.4×10-6 K-1,10.5×10-6 K-1 | |
| 1.7 | Scale out rate | The scaling factor falls withinthe range in between 1.210and 1.260, and the deviationof the actural value from thenominal value should not begreater than 0.005. | 1.245, 1.250, 1.240, 1.242, 1.240,1.246, 1.240, 1.248, 1.238, 1.249 | |
| 1.8 | Scale out rate | The scaling factor falls withinthe range in between 1.210and 1.260, and the deviationof the actural value from thenominal value should not begreater than 0.005. | 1.245, 1.250, 1.240, 1.242, 1.240,1.246, 1.240, 1.248, 1.238, 1.249 | |
| 1.9 | Appearance | Surface: surface should besmooth and pore- free. | Yes, Yes, Yes, Yes, Yes, Yes, Yes, Yes,Yes, Yes, Yes | |
| The color of zirconiaporcelain block used forchip processing (initialsintering state) should beuniform, there should be nolocal pigment separationphenomenon, there shouldbe no foreign bodyattached. | Yes, Yes, Yes, Yes, Yes, Yes, Yes, Yes,Yes, Yes, Yes | |||
| Size: the size errorshould be less than ±0.2mm. | +0.03mm, +0.03mm, +0.03mm,+0.02mm, +0.02mm, +0.03mm,+0.02mm, +0.02mm, +0.02mm, | |||
| 1.10 | Packaging | The packing identificationshould be distinct, and thepacking material should nothave obvious changes. | No obvious changes, no obviouschanges, no obvious changes, noobvious changes, no obvious changes,no obvious changes, no obviouschanges, no obvious changes, noobvious changes, no obvious changes | |
| Biocompatibility Testing | ||||
| 2.1 | Cytotoxicity | ISO 10993-5:2009 | Non-Cytotoxicity | Pass |
| 2.2 | Sensitization | ISO 10993-10:2021 | Non-Sensitization | Pass |
| 2.3 | Irritation orintracutaneousreactivity | ISO 10993-23:2021 | Non-Irritation orintracutaneousreactivity | Pass |
| 2.4 | Acute systemictoxicity | ISO 10993-11:2017 | Non-Acute systemictoxicity | Pass |
| 2.5 | Subacute toxicity | ISO 10993-11:2017 | Non-Subacutetoxicity | Pass |
| 2.6 | Sub chronictoxicity | ISO 10993-11:2017 | Non-Sub chronictoxicity | Pass |
| 2.7 | Genotoxicity | ISO 10993-3:2014 | Non-Genotoxicity | Pass |
Table VII-1: Performance testing was conducted on the subject device
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VIII Clinical Test Conclusion
No clinical study is included in this submission.
IX Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the Zirconia Block is as safe as effective, and performs as well as or better than the legally marketed device.
X Copy Statement
The Copy is an exact duplicate of the paper copy.
Signature of the applicant:
花遥
date of the submission:2023.12.11
§ 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.