(518 days)
LUXEN Zr is indicated for the production of all-ceramic inlays, multi-units bridges, onlays, and veneers without zirconium dioxide frameworks. LUXEN Smile is indicated for the production of full ceramic crowns, onlays, 3bridges and inlay bridges (anterior and molar).
LUXEN Zr and LUXEN Smile are used for custom made dental restorations using a CAD/CAM system. The LUXEN Zr and LUXEN Smile are provided in 4 different shapes - block, disk, Wieland and D-95. The LUXEN Zr is composed of 3 mol% TZP. LUXEN Smile is composed of 5 mol% TZP. The weight of yttria is classified in accordance with ISO 6872:2015 Type2, class 5 for 3Y-TZP Zirconia, and ISO 6872:2015 Type2, class 4b for 5Y-TZP Zirconia, respectively.
The provided text describes the non-clinical performance testing of two dental devices, LUXEN Zr and LUXEN Smile, to demonstrate their substantial equivalence to predicate devices. However, the document does not contain information about an AI/ML device. Therefore, I cannot fulfill the request for information on acceptance criteria, a study proving device meeting acceptance criteria, sample sizes, data provenance, number of experts for ground truth, adjudication method, MRMC comparative effectiveness study, standalone performance, type of ground truth, or training set details as these are specific to AI/ML device evaluations.
The document focuses on the physical properties and biocompatibility of dental materials.
Here's a breakdown of what the document does provide regarding the non-clinical performance and acceptance criteria for these dental materials:
1. A table of acceptance criteria and the reported device performance
The document provides comparative tables for LUXEN Zr vs. DD Bio ZX2 and LUXEN Smile vs. DD cube X2. These tables list various characteristics (such as flexural strength, chemical composition, thermal expansion coefficient, chemical solubility, etc.) and compare the subject device's performance against the predicate device or a relevant ISO standard. The acceptance criteria are implicitly defined by meeting or being similar to the predicate device's performance or exceeding minimum ISO standards.
LUXEN Zr (for 3Y-TZP Zirconia, ISO 6872:2015 Type2, Class 5)
| Characteristic | Acceptance Criteria (Predicate/Standard) | Reported Device Performance (LUXEN Zr) | Outcome |
|---|---|---|---|
| Classification Name | Porcelain powder for clinical use | Porcelain powder for clinical use | Similar |
| Product Code | EIH | EIH | Similar |
| Device Class | II | II | Similar |
| Blank configuration | Block, Disk, Wieland, D-95 type | Block, Disk, Wieland, D-95 type | Similar |
| Thicknesses | 10 mm to 25 mm | 10 mm to 25 mm | Similar |
| Crystal Morphology | 3Y-TZP | 3Y-TZP | Similar |
| Color | VITA shade guide met | VITA shade guide met | Similar |
| Sintering temperature | 1450 °C (predicate) | LUXEN Zr ST: 1580 °C, Others: 1500 °C | Similar (optimized for translucency) |
| Types, Class (ISO6872:2015) | Type II Class 5 | Type II Class 5 | Similar |
| Chemical composition (wt.%) | Meet ISO 13356 (e.g., Al2O3 ≤ 0.5%) | Meets ISO 13356 | Similar |
| Flexural strength (MPa) | 1250 (predicate) / >800 MPa (ISO) | 1038 ± 135 | Similar (higher than ISO) |
| Thermal expansion coeff. | 10 X 10-6 K-1 | 10.7 X 10-6 K-1 | Similar |
| **Chemical solubility (µg/cm²) ** | Not listed (predicate) | 0 | - |
| Biocompatibility | ISO 10993 and ISO 7405 | Biocompatible per ISO 10993-1 | Similar |
| Sterile | Non-sterile | Non-sterile | Similar |
LUXEN Smile (for 5Y-TZP Zirconia, ISO 6872:2015 Type2, Class 4b)
| Characteristic | Acceptance Criteria (Predicate/Standard) | Reported Device Performance (LUXEN Smile) | Outcome |
|---|---|---|---|
| Classification Name | Porcelain powder for clinical use | Porcelain powder for clinical use | Similar |
| Product Code | EIH | EIH | Similar |
| Device Class | II | II | Similar |
| Blank configuration | Disk, Wieland type | Block, Disk, Wieland, D-95 type | Similar |
| Thicknesses | 10 mm to 25 mm | 10 mm to 25 mm | Similar |
| Crystal Morphology | 5Y-TZP | 5Y-TZP | Similar |
| Color | VITA shade guide met | VITA shade guide met | Similar |
| Sintering temperature | 1450 °C | 1450 °C | Similar |
| Types, Class (ISO6872:2015) | Type II Class 4 (predicate, ISO 6872:2008) | Type II Class 4b (ISO 6872:2015) | Similar |
| Chemical composition | Meet ISO 13356 (e.g., Al2O3 ≤ 0.5%) | Meets ISO 13356 | Similar |
| Flexural strength | > 750-800 MPa (predicate) / >500 MPa (ISO) | 770 ± 66 MPa | Similar (higher than ISO) |
| Thermal expansion coeff. | 10 X 10-6 K-1 | 10.3 X 10-6 K-1 | Similar |
| Chemical solubility | 15 μg/cm² (predicate) / >2000 μg/cm² (ISO) | 0 μg/cm² | Similar (better than predicate and ISO) |
| Biocompatibility | EN ISO 10993-1, -5 | Biocompatible per ISO 10993-1 | Similar |
| Sterile | Non-sterile | Non-sterile | Similar |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes for each non-clinical test (e.g., number of specimens for flexural strength, chemical solubility). It also does not mention the country of origin of the data or whether the tests were retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable as the study involves physical and biocompatibility testing of dental materials, not an AI/ML device requiring expert ground truth for interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for non-clinical material testing.
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
This is not applicable. This document is not about an AI device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. This document is not about an AI device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the non-clinical tests, the "ground truth" is established by the measurement outcomes of validated physical and chemical tests, and comparison against international standards (e.g., ISO 6872:2015, ISO 13356) and the characteristics of predicate devices. Biocompatibility uses established ISO 10993 series standards as the "ground truth" for safe biological interaction.
8. The sample size for the training set
This is not applicable as the document describes non-clinical testing of a dental material, not an AI/ML algorithm.
9. How the ground truth for the training set was established
This is not applicable as the document describes non-clinical testing of a dental material, not an AI/ML algorithm.
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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 & 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.
DENTALMAX Co., Ltd Jindong Kim President 50-7, Pungsesandan 2-ro Pungse-myeon, Dongnam-gu, Cheonan-si Chungcheongnam-do, 31217 Kr
Re: K171585
Trade/Device Name: LUXEN Zr, LUXEN Smile Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: September 25, 2018 Received: October 2, 2018
Dear Jindong Kim:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
October 31, 2018
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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Digitally signed by Mary Mary S. Date: 2018.10.31 Runner -S3/ 08:38:16 -04'00' For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K180718
Device Name ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES
Indications for Use (Describe) ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES are indicated for orthodontic movement of natural teeth.
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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510(K) SUMMARY
LUXEN Zr, LUXEN Smile
Date: October 29, 2018
I. SUBMITTER
DENTALMAX Co., Ltd 50-7, Pungsesandan 2-ro, Pungse-myeon, Dongnam-gu, Cheonan-si, Chungcheongnam-do, 31217, Republic of Korea TEL : +82-41-523-3580 FAX : +82-41-523-3581 Contact Name: Kim, Jindong Email: jdkim@hedent.co.kr
II. DEVICE NAME
| Name of Device: | LUXEN Zr, LUXEN Smile |
|---|---|
| Regulation Name: | Powder, Porcelain |
| Classification Name: | Porcelain powder for clinical use |
| Classification regulation: | 872.6660 |
| Regulatory Class: | 2 |
| Product Code: | EIH |
III. PREDICATE DEVICE
K142987, DD Bio ZX2, Dental Direkt of Amerika UG K142987, DD cube X2, Dental Direkt of Amerika UG
IV. DEVICE DESCRIPTION
LUXEN Zr and LUXEN Smile are used for custom made dental restorations using a CAD/CAM system. The LUXEN Zr and LUXEN Smile are provided in 4 different shapes - block, disk, Wieland and D-95. The LUXEN Zr is composed of 3 mol% TZP. LUXEN Smile is composed of 5 mol% TZP. The weight of yttria is classified in accordance with ISO 6872:2015 Type2, class 5 for 3Y-TZP Zirconia, and ISO 6872:2015 Type2, class 4b for 5Y-TZP Zirconia, respectively.
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There are various color and thickness for LUXEN Zr and LUXEN Smile; LUXEN Zr
- . Shade
- White, S1, S2, S3, E0, E1, E2, E3, E4, Multi-ivory
- . Thickness
- Block type: 10, 12, 14, 15, 16, 18, 20, 22, 25
- Disk type: 10, 12, 14, 16, 18, 20, 22, 25
- Wieland type / D95 type: 10, 12, 14, 16, 18, 20, 22, 25, 30
LUXEN Smile
- . Shade
- White, S1, S2, S3, E0, E1, E2, E3, E4, Multi-white, Multi-ivory
- . Thickness
- Block type: 16
- Disk type: 10, 12, 14, 16, 18, 20, 22, 25
- Wieland type / D95 type: 10, 12, 14, 16, 18, 20, 22, 25, 30
V. INDICATIONS FOR USE
LUXEN Zr is indicated for the production of all-ceramic inlays, multi-units bridges, onlays, and veneers without zirconium dioxide frameworks.
LUXEN Smile is indicated for the production of full ceramic crowns, onlays, 3bridges and inlay bridges (anterior and molar).
VI. COMPARISON TO PREDICATE DEVICE
LUXEN Zr
| Characteristics | Subject Device | Predicate Device | Summary |
|---|---|---|---|
| Device Name | LUXEN Zr | DD Bio ZX2 | - |
| Manufacturer | DENTALMAX CO., LTD. | Dental Direkt of AmerikaUG | - |
| 510(k) Number | K171585 | K142987 | - |
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| Classification Name | Porcelain powder for clinical use | Porcelain powder for clinical use | Both products are porcelain powder for clinical use. |
|---|---|---|---|
| Product Code | EIH | EIH | Both products are EIH. |
| Device Class | II | II | Both products are class II. |
| Indications for Use | LUXEN Zr is indicated for the production of all-ceramic inlays, multi-units bridges, onlays, and veneers without zirconium dioxide frameworks. | DD Bio Z-dental blanks are indicated for crowns, multi-unit bridges and inlay bridges. Applications include both anterior and posterior bridges. | Both products are indicated for dental restorations. |
| Blank configuration | Block typeDisk typeWieland typeD-95 type | Block typeDisk typeWieland typeD-95 type | Both products are block, disk, wieland and D-95 types. |
| Thicknesses | 10 mm to 25 mm | 10 mm to 25 mm | Both products are 10-25mm of thickness. |
| Crystal Morphology | 3Y-TZP | 3Y-TZP | Both products are 3Y-TZP. |
| Color | A0, A1, A2, A3, B1, B2, B3, B4, C4, B1-B2-B3-B4 LAYER | A0, A1, A2, A3, A3.5, A4, B1, B2, B3, B4, C1, C2, C3, C4, D2, D3, D4 | SimilarBoth product are met with VITA shade guide. Shade is an option that is selected according to patient's teeth color. Application of appropriate color that matches patient's teeth tone can be possible. |
| Sintering temperature | LUXEN Zr ST : 1580 °COthers : 1500 °C | 1450 °C | SimilarThe sintering temperature is not exactly same, but each product has provided the optimum temperature.LUXEN Zr is higher than predicate device, but it is confirmed that the temperature improves translucent for nature color shade. |
| Types,Class(ISO6872:2015) | Type II Class 5 | Type II Class 5 | Both products are type II Class 5. |
| Chemicalcomposition(wt.%) | Zirconia Powder ZpexZrO2+HfO2+Y2O3>99.8 | ZrO2+HfO2+ Y2O3 : ≥99Y2O3 : <6 | SimilarThe raw material of |
| Other oxides : <0.2 | Al2O3 : <<0.15Other oxides : <0.15 | LUXEN Zr (Zpex, Zpex Yellow, Zpex Pink / Manufacturer: Tosoh) is consisted of less amount of aluminium oxide than predicate device due to translucency. However, both products meet the requirement of ISO 13356 (Al2O3 ≤ 0.5%).Also, Zpex Yellow or Zpex Pink contain Fe2O3 or Er2O3, respectively, while predicate device contains Fe2O3, Er2O3 and MnO2. However, both products meet the requirement of ISO 13356 (other oxide < 0.5%). | |
| ZrO2 : 83-92 | |||
| Y2O3 : 4-6 | |||
| HfO2 : <5 | |||
| Al2O3 : 0.03-0.07 | |||
| SiO2 : Max 0.02 | |||
| Fe2O3 : 0.12-0.18 | |||
| Zirconia Powder Zpex YellowZrO2+HfO2+Y2O3 : >99.8Other oxides : <0.2ZrO2 : 83-92Y2O3 : 4-6HfO2 : <5Al2O3 : 0.03-0.07SiO2 : Max 0.02Fe2O3 : 0.12-0.18 | |||
| Zirconia Powder Zpex PinkZrO2+HfO2+Y2O3 : >99.8Other oxides : <0.2ZrO2 : 79-92HfO2 : <5Er2O3 : 8-11Al2O3 : 0.03-0.07SiO2 : Max 0.02Fe2O3 : Max 0.01 | |||
| Flexural strength(MPa) | 1038 ± 135 | 1250 | Similar Flexural strength is slightly lower, but higher than required by ISO 6872 for Class 5 dental ceramics(>800 MPa). |
| Thermal expansion coefficient(20-500°C)Coefficient of thermal expansion | 10.7 X 10-6K-1 | 10 X 10-6K-1 | Both products are 10 X 10-6K-1. |
| Chemical solubility(µg/cm²) | 0 | Not listed | - |
| Biocompatibility | Device is biocompatible when used as directed by dental professionals per ISO 10993-1. | ISO 10993 and ISO 7405 | Both products are biocompatible. |
| Sterile | Non-sterile | Non-sterile | Both products are non-sterile. |
| Characteristics | Subject Device | Predicate Device | Summary |
| Device Name | LUXEN Smile | DD cube X2 | - |
| Manufacturer | DENTALMAX CO., Ltd. | Dental Direkt GmbH | - |
| 510(k) Number | K171585 | K150196 | - |
| Classification Name | Porcelain powderforclinical use | Porcelain powderforclinical use | Bothproductsareporcelain powderforclinical use. |
| Product Code | EIH | EIH | Both products are EIH. |
| Device Class | II | II | Both products are classII. |
| Indications for Use | LUXEN Smile is indicatedfor the production ofof full ceramic crowns,onlays, 3- bridges andinlay bridges(anteriorand molar). | Dental blanks madefrom DD cubeX2 areindicated for crowns,multi-unit bridges (up toa maximum of 3elements) and inlaybridges. Applicationsinclude both, anteriorand posterior bridges. | Bothproductsareindicated fordentalrestorations. |
| Blank configuration | Block typeDisk typeWieland typeD-95 type | Disk typeWieland type | Both products are Diskand Wieland type. |
| Thicknesses | 10 mm to 25 mm | 10 mm to 25 mm | Both products are 10-25mm of thickness. |
| Crystal Morphology | 5Y-TZP | 5Y-TZP | Both products are 5Y-TZP. |
| Color | A0, A1, A2, A3, B1, B2,B3, B4, C4, A1-A2-B3-B4LAYER,B1-B2-B3-B4LAYER | A0, A1, A2, A3, A3.5,B2, C2, D3 | SimilarBoth product are metwith VITA shade guide.Shade is an option that isselected according topatient's teeth color.Application ofappropriate color thatmatches patient's teethtone can be possible. |
| Sintering temperature | 1450 °C | 1450 °C | Both products are1450 °C. |
| Types,Class(ISO6872:2015) | Type II Class 4b | Type II Class 4 | The proposed deviceLUXEN Smile is a Type IIclass 4b device |
| Chemical composition | Zirconia Powder Zpex SmileZrO2+HfO2+Y2O3 : >99.8Other oxides : <0.2ZrO2 : 80-92Y2O3 : 8-10HfO2 : <5Al2O3 : 0.04-0.06SiO2 : Max 0.02Fe2O3 : <0.1Zirconia Powder Zpex YellowZrO2+HfO2+Y2O3 : >99.8Other oxides : <0.2ZrO2 : 83-92Y2O3 : 4-6HfO2 : <5Al2O3 : 0.03-0.07SiO2 : Max 0.02Fe2O3 : 0.12-0.18Zirconia Powder Zpex PinkZrO2+HfO2+Y2O3 : >99.8Other oxides : <0.2ZrO2 : 79-92HfO2 : <5Er2O3 : 8-11Al2O3 : 0.03-0.07SiO2 : Max 0.02Fe2O3 : Max 0.01 | ZrO2+HfO2+ Y2O3 : ≥99Y2O3 : <10HfO2 : ca.0.2Al2O3 : <0.1Other oxides : ≤0.05 | 6872:2015 standardwhile the predicate device DD cube X² is aType II class 4 (Catalog, Dental Direkt GmbH) in accordance with ISO 6872:2008 standard.SimilarThe raw material of LUXEN Smile (Zpex Smile, Zpex Yellow, Zpex Pink / Manufacturer: Tosoh) is consisted of less amount of aluminium oxide than predicate device due to translucency. However, both products meet the requirement of ISO 13356 (Al2O3 ≤ 0.5%).Also, Zpex Yellow or Zpex Pink contain Fe2O3 or Er2O3, respectively, while predicate device contains Fe2O3, Er2O3 and MnO2. However, both products meet the requirement of ISO 13356 (other oxide < 0.5%). |
| Flexural strength | 770 ± 66 MPa | > 750-800 MPa | SimilarFlexural strength is slightly lower, but higher than required by ISO 6872 for Class 4b dental ceramics(>500 MPa). |
| Thermal expansion coefficient(20-500°C)Coefficient of thermal expansion | $10.3 X 10^{-6}K^{-1}$ | $10 X 10^{-6}K^{-1}$ | Both products are $10 X 10^{-6}K^{-1}$ . |
| Chemical solubility | 0 μg/cm² | 15 μg/cm² | SimilarThe lower value of |
| chemical solubility hasmore stable, and bothresults of meet therequirement of ISO 6872for Class 4b dentalceramics(>2000 $\mu$ g/cm2).Therefore, it isequivalent. | |||
| Biocompatibility | Device is biocompatiblewhen used as directedby dental professionalsper ISO 10993-1. | EN ISO 10993-1, -5 | Both products arebiocompatible. |
| Sterile | Non-sterile | Non-sterile | Both products are non-sterile. |
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LUXEN SMILE
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VII. PERFORMANCE(NON-CLINICAL) TESTING
The subject devices, LUXEN Zr and LUXEN Smile, and the predicate devices, DD Bio ZX2 and DD cube X2 were tested for the non-clinical performance including uniformity, freedom from extraneous materials, radioactivity, chemical solubility, flexural strength and linear thermal expansion.
All of test results obtained from these tests indicated that the subject devices, LUXEN Zr and LUXEN Smile, is substantially equivalent to the predicate devices, DD Bio ZX2 and DD cube X2, in terms of physical properties and performance.
The biocompatibility evaluation for the subject devices, LUXEN Zr and LUXEN Smile, was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1:Evaluation and Testing" May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1 : Evaluation and Testing Within a Risk Management Process" as recognized by FDA. The device of testing included the following tests:
Contact classification:
- · External communicating devices: Dentin, Enamel, Oral mucosa
- · Categorization by duration of contact: C-Permanent(>30d)
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Standard:
- · ISO 10993-5:2009, Cytotoxicity(MTT),
- · ISO 10993-10:2010, Oral mucous Irritation,
- ISO 10993-10:2010, Sensitization(LLNA), .
- · ISO 10993-11:2006, Acute systemic toxicity
The results of test indicated that the subject devices, LUXEN Zr and LUXEN Smile, are considered to be biocompatible and therefore equivalent with its predicate devices, DD Bio ZX2 and DD cube X2 that considered biocompatibility per ISO 10993-1 and ISO 7405.
VIII. CONCLUSIONS
The indications for use and technological characteristics of the subject devices and predicate devices are substantially equivalent.
§ 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.