Amber Mill Series and Amber Press Series
Device Facts
| Record ID | K160102 |
|---|---|
| Device Name | Amber Mill Series and Amber Press Series |
| Applicant | Hass Corp. |
| Product Code | EIH · Dental |
| Decision Date | Jul 14, 2016 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.6660 |
| Device Class | Class 2 |
Indications for Use
Amber Mill Series are indicated for fabricating glass ceramic restorations such as single-unit anterior and posterior crowns, veneers, inlays/onlays, and anterior 3-unit bridges using CAD/CAM System. Amber Press Series are indicated for fabricating glass ceramic restorations such as single-unit anterior and posterior crowns, veneers, inlays/onlays, and anterior 3-unit bridges using hot press technique.
Device Story
Lithium silicate glass ceramic material supplied as ingots or blocks; used for dental restorations (crowns, veneers, inlays/onlays, bridges). Amber Mill series processed via CAD/CAM milling; Amber Press series processed via hot press technique. Used in dental clinics/labs by dental professionals. Material provides aesthetic tooth-colored restorations. Benefits include restoration of tooth form and function. No software or electronic components; purely material-based device.
Clinical Evidence
Bench testing only. Compliance with ISO 6872 (uniformity, solubility, flexural strength, radioactivity, thermal expansion, glass transition) and ISO 10993 (genotoxicity, cytotoxicity, sensitization, irritation, systemic toxicity) demonstrated. All tests passed.
Technological Characteristics
Lithium silicate glass ceramic composed of SiO2, Li2O, K2O, P2O5, Al2O3, and inorganic pigments. Flexural strength >300MPa; chemical solubility <100 µg/cm²; Tg 553°C. Supplied as blocks (CAD/CAM) or ingots (hot press). Complies with ISO 6872 (Class 3 monolithic ceramic).
Indications for Use
Indicated for patients requiring glass ceramic dental restorations including single-unit anterior/posterior crowns, veneers, inlays/onlays, and anterior 3-unit bridges.
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
Submission Summary (Full Text)
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 14, 2016
Hass Corp. Ms. Priscilla Chung Regulatory Affairs Consultant Lk Consulting Group Usa, Inc. 2651 E Chapman Ave Ste 110 Fullerton, California 92831
Re: K160102
Trade/Device Name: Amber Mill Series And Amber Press Series Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: January 12, 2016 Received: January 19, 2016
Dear Priscilla Chung:
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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
# Michael J. Ryan -S
for Erin I. Keith, M.S. 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) K160102
Device Name
Amber Mill Series and Amber Press Series
### Indications for Use (Describe)
Amber Mill Series are indicated for fabricating glass ceramic restorations such as single-unit anterior and posterior crowns, veneers, inlays/onlays, and anterior 3-unit bridges using CAD/CAM System.
Amber Press Series are indicated for fabricating glass ceramic restorations such as single-unit anterior and posterior crowns, veneers, inlays/onlays, and anterior 3-unit bridges using hot press technique.
| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"><span style="font-size:20px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;"><span style="font-size:20px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C)</div> |
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# 510(k) Summary (K160102)
This summary of 510(k)-safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: ___ July 12, 2016_____
#### 1. Applicant / Submitter:
HASS CORP. 77-14, Gwahakdanji-ro Gangneung-si, Gangwon-do, Republic of Korea, 210-340
Tel: +82-70-7712-1300 Fax: +82-33-644-1231
#### Submission Correspondent: 2.
Priscilla Chung LK Consulting Group USA, Inc. 2651 E Chapman Ave Ste 110, Fullerton, CA 92831 Phone: 714-202-5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com
#### 3. Device:
| Proprietary Name: | Amber Mill Series and Amber Press Series |
|------------------------------|--------------------------------------------|
| Common Name: | Dental Frame Material for Dental Prosthesi |
| Classification Name: | Porcelain Powder for Clinical Use |
| Classification: | Class II, 21 CFR 872.6660 |
| Classification Product Code: | EIH |
#### 4. Predicate Device:
Obsidian™ Milling Blocks by Prismatik Dentalcraft, Inc. (K141788) Obsidian™ Press(All-Ceramic and POM) by Prismatik Dentalcraft, Inc. (K141887)
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#### 5. Device Description:
Amber Mill Series and Amber Press Series are a lithium silicate ceramic to be supplied in the form of Ingots & Blocks. Amber Mill can be fabricated using CAD/CAM technologies and Amber Press can be fabricated using hot press technique.
This dental material is glass type material used for aesthetic purposes of veneers, inlay/onlay, partial crowns, anterior crowns, posterior crowns. The ceramics material is composed of SiO2, Li20, K20, P205, Al2O3 and other oxides. It also contains inorganic pigments to provide different shades on the product surface.
The subject device offers 31 different size/shape series and each series offers 45 different shades. 31 different sizes are to be used with various equipments for CAD/CAM milling or hot press and to meet the needs of patients' various tooth shapes. 45 different shades are offered to meet the needs of different patients tooth colors.
#### 6. Principles of Operation:
Amber Mill Series and Amber Press Series are glass type dental material which can be fabricated using CAD/CAM technologies or hot press technique to make restorations such as single-unit anterior and posterior crowns, veneers, inlays/onlays, and anterior 3-unit bridges not involving molar restoration. These blanks correspond to ISO 6872, Dentistry: Ceramic Materials. The subject devices offer various sizes and shades to meet the needs of different patients' tooth shapes and colors.
| Material | Glass Ceramic |
|--------------------------------------|-----------------------------------------------------------------------------------------|
| Category | Dental Frame Material for Dental Prosthesis |
| Color | Various (High , Low translucencies and Medium Opacity): 16 A-D and<br>4 Bleach W shades |
| Odor | Odorless |
| Flexural strength | > 300MPa |
| Chemical solubility | < 100 ug / cm² |
| Glass Transition<br>Temperature (Tg) | 553 °C |
#### 7. Technological Characteristics Summary:
#### 8. Intended Use:
Amber Mill Series are indicated for fabricating glass ceramic restorations such as single-unit anterior and posterior crowns, veneers, inlays/onlays, and anterior 3-unit bridges using CAD/CAM System.
Amber Press Series are indicated for fabricating glass ceramic restorations such as single-unit anterior and posterior crowns, veneers, inlays/onlays, and anterior 3-unit bridges using hot press technique.
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#### 9. Performance Data(Non-Clinical):
The following properties were tested based on the referenced standards. All the test results support substantial equivalence to the predicate devices.
- ISO 6872 Uniformity, Foreign Body, Chemical Solubility, Flexural Strength, . Radioactivity, Linear Thermal Expansion, Glass Transition Temperature tests
- . ISO 10993-3 - Genotoxicity
- ISO 10993-5 Cytotoxicity י
- ISO 10993-10 Sensitization & Irritation .
- ISO 10993-11 Systemic Toxicity(oral) .
- Other bench testing Visual Inspection, Size, Package tests י
| Test Title | Test Standard | Requirement/Criteria | Test Result |
|-----------------------------------------|---------------|---------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
| Visual Inspection<br>Report | | There shall be no extraneous<br>materials, distributing at use<br>when assessed by visual<br>inspection. | There were no extraneous<br>materials, distributing at use<br>when assessed by visual<br>inspection. |
| Size Test Report | | The size tolerance should be<br>within +/- 2mm | PASS |
| Package Test Report | | There shall be no breakage, no<br>crack, no pollution of foreign<br>body and no problem of use in<br>product. | There was no breakage, no<br>crack, no pollution of foreign<br>body and no problem of use in<br>product. |
| Uniformity Test Report | ISO 6872 | Colorants shall be dispersed<br>uniformly on the block. | Colorants were dispersed<br>uniformly on the block. |
| Foreign Body Test<br>Report | ISO 6872 | It shall be free from<br>extraneous materials. | They were free from<br>extraneous materials. |
| Chemical Solubility<br>Test Report | ISO 6872 | less than 100 µg/cm² | PASS |
| Flexural Strength Test<br>Report | ISO 6872 | Over 300 MPa | PASS |
| Radioactivity Test<br>Report | ISO 6872 | U238: Less than 1.0 Bq/g | PASS |
| Linear Thermal<br>Expansion Test Report | ISO 6872 | 10.0+/- 0.5 10-6K-1 | PASS |
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| Glass Transition<br>Temperature Test<br>Report | ISO 6872 | 550+/- 20 °C | PASS |
|------------------------------------------------|--------------|--------------------------|------|
| Genotoxicity | ISO 10993-3 | < 2.0 | PASS |
| Cytotoxicity test | ISO 10993-5 | ≥ 70% | PASS |
| Irritation test | ISO 10993-10 | No mutation | PASS |
| Sensitization test | ISO 10993-10 | < 1.6 | PASS |
| Systemic toxicity(oral)<br>test | ISO 10993-11 | No abnormality and death | PASS |
#### 10. Substantial Equivalence
Amber Mill Series and Amber Press Series are substantially equivalent to the Obsidian™ Milling Blocks (K141788) and Obsidian™ Press (K141887). Two predicate devices are chosen for showing substantial equivalence to the predicate devices in the market in terms of milling methods employed for the materials which are CAD/CAM and pressing methods.
The following comparison table is presented to demonstrate substantial equivalence.
| | Proposed Device | Primary Predicate<br>Device | Reference Predicate<br>Device | Substantial<br>Equivalence |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K160102 | K141788 | K141887 | - |
| Manufacturer | HASS CORP. | Prismatik Dentalcraft,<br>Inc. | Prismatik Dentalcraft,<br>Inc. | - |
| Device Name | Amber Mill Series<br>Amber Press Series | Obsidian™ Milling<br>Blocks | Obsidian™ Press(All-<br>Ceramic and POM) | - |
| Common Name | Porcelain powder for<br>clinical use | Porcelain powder for<br>clinical use | Porcelain powder for<br>clinical use | Same |
| CFR Section | 21 CFR 872.6660 | 21 CFR 872.6660 | 21 CFR 872.6660 | Same |
| Product Code | EIH | EIH | EIH | Same |
| Type and class<br>according to ISO<br>6872 | Monolithic Ceramic<br>Class 3 | Monolithic Ceramic<br>Class 3 | Monolithic Ceramic<br>Class 3 | Same |
| Indication For<br>Use | Amber Mill Series are<br>indicated for fabricating<br>glass ceramic<br>restorations such as<br>single-unit anterior and<br>posterior crowns,<br>veneers, inlays/onlays,<br>and anterior 3-unit<br>bridges using<br>CAD/CAM System.<br>Amber Press Series are<br>indicated for fabricating<br>glass ceramic<br>restorations such as<br>single-unit anterior and<br>posterior crowns,<br>veneers, inlays/onlays,<br>and anterior 3-unit<br>bridges using hot press<br>technique. | The Obsidian™ Milling<br>Blocks is used to<br>fabricate ceramic dental<br>prostheses in the nature<br>of crowns and bridges<br>for posterior and anterior<br>applications using<br>CAD/CAM methods. | The Obsidian™ Press<br>ceramic is used to<br>fabricate Press Over<br>Metal dental prostheses<br>in<br>the nature of crowns and<br>bridges as well as<br>monolithic dental<br>prostheses in the nature<br>of crowns, partial<br>crowns, veneers, inlays,<br>and onlays for posterior<br>and anterior applications,<br>as well as 3-unit anterior<br>bridges (including pre-<br>molar region as terminal<br>abutment) using<br>pressing methods. | Same |
| Materials | SiO2, Li2O, K2O,<br>P2O5, Al2O3 and<br>other oxides | SiO2, Li2O, K2O,<br>P2O5, Al2O3 and other<br>oxides | SiO2, Li2O, K2O,<br>P2O5, Al2O3 and other<br>oxides | Similar<br>**The subject device and<br>the predicate devices<br>might have a slight<br>difference in<br>compositions but all the<br>devices have SiO2,<br>Li2O, K2O, P2O5, and<br>Al2O3 as major<br>components.<br>Despite this difference,<br>the test results per ISO<br>6872 shows that the<br>subject device is<br>substantially equivalent<br>to the predicate device in<br>physical and chemical<br>properties and meets the<br>necessary requirements. |
| Main chemical<br>compositions<br>(in %) | Silicon dioxide(SiO2)<br>71.45 ~ 78.07% | Silicon dioxide(SiO2)<br>(% not known) | Silicon dioxide(SiO2)<br>(% not known) | Similar |
| Summary of sizes<br>and shapes | Form of Blocks :<br>(12 × 5 × 15mm ~<br>15.2 × 15.2 × 40mm)<br>Form of Ingots :<br>(Ø12.7×7mm<br>~Ø12.7×20mm) | Form of Blocks:<br>(12 × 5 × 15 mm ~<br>15.2 × 15.2 × 40mm) | Form of Ingots :<br>(Ø12.7×7mm<br>~Ø12.7×20mm) | Similar |
| Shades | Various<br>(High, Low<br>translucencies and<br>Medium Opacity): 16<br>A-D and 4 Bleach W | Various<br>(A1, A2, A3, A3.5,<br>B1, B2, B3, B4,<br>C1, C2, C3, C4, BL1<br>and BL4) | Various<br>(A1, A2, A3, A3.5,<br>B1, B2, B3, B4,<br>C1, C2, C3, C4, BL1 and<br>BL4) | Similar<br>**The subject device and<br>the predicate devices<br>might have a slight |
| | shades | | | difference in shades.<br>Despite this difference,<br>the test results per ISO<br>6872 and 10993<br>standards show that the<br>subject device is<br>substantially equivalent<br>to the predicate device in<br>physical/chemical<br>properties and<br>biocompatibility, and<br>meet the necessary<br>requirements. |
| Principle of<br>Operation | Fabricating<br>restorations using hot<br>press technique or<br>CAD/CAM system | Fabricating restorations<br>using CAD/CAM<br>system | Fabricating restorations<br>using hot press technique | Same |
| Performance tests<br>performed | • ISO 6872 -<br>Uniformity, Foreign<br>Body, Chemical<br>Solubility, Flexural<br>Strength,<br>Radioactivity, Linear<br>Thermal Expansion,<br>Glass Transition<br>Temperature tests<br>• ISO 10993-3 -<br>Genotoxicity<br>• ISO 10993-5 -<br>Cytotoxicity<br>• ISO 10993-10 -<br>Sensitization &<br>Irritation<br>• ISO 10993-11 -<br>Systemic<br>Toxicity(oral)<br>• Other bench testing<br>- Visual Inspection,<br>Size, Package tests | • ISO 6872 – Foreign<br>Body, Chemical<br>Solubility, Flexural<br>Strength,<br>Radioactivity, Linear<br>Thermal Expansion<br>• ISO 10993-5 -<br>Cytotoxicity<br>• ISO 10993-10 -<br>Sensitization &<br>Irritation | • ISO 6872 - Foreign<br>Body, Chemical<br>Solubility, Flexural<br>Strength, Radioactivity,<br>Linear Thermal<br>Expansion<br>• ISO 10993-5 -<br>Cytotoxicity<br>• ISO 10993-10 -<br>Sensitization &<br>Irritation | Similar<br>** More performance<br>tests were done on the<br>subject devices. |
| Flexural strength | > 300MPa<br>(meeting the ISO6872<br>requirements) | > 300MPa<br>(meeting the ISO6872<br>requirements) | > 300MPa<br>(meeting the ISO6872<br>requirements) | Similar<br>** All devices meet ISO<br>6872 requirements. |
| Chemical<br>solubility | < 100 ug / cm2<br>(meeting the ISO6872<br>requirements) | < 100 ug / cm2<br>(meeting the ISO6872<br>requirements) | < 100 ug / cm2<br>(meeting the ISO6872<br>requirements) | Similar<br>** All devices meet ISO<br>6872 requirements. |
| Freedom from<br>Extraneous<br>Material | Shall be free from<br>extraneous materials<br>when assessed by visual<br>inspection ( meeting<br>ISO 6872 requirements) | Shall be free from<br>extraneous materials<br>when assessed by visual<br>inspection ( meeting ISO<br>6872 requirements) | Shall be free from<br>extraneous materials<br>when assessed by visual<br>inspection ( meeting ISO<br>6872 requirements) | Similar<br>** All devices meet ISO<br>6872 requirements. |
| Radioactivity | Activity<br>concentration of<br>uranium238 less<br>than 1.0Bq g-1 | Activity<br>concentration of<br>uranium238 less<br>than 1.0Bq g-1 | Activity<br>concentration of<br>uranium238 less<br>than 1.0Bq g-1 | Similar<br>** All devices meet ISO<br>6872 requirements. |
| | (meeting the ISO6872<br>requirements) | (meeting the ISO6872<br>requirements) | (meeting the ISO6872<br>requirements) | |
| Linear of thermal<br>expansion | $10.0\pm0.5 \times 10^{-6}/\degree C$<br>(meeting the ISO6872<br>requirements) | $12.0\pm0.5 \times 10^{-6}/\degree C$<br>(meeting the ISO6872<br>requirements) | $12.0\pm0.5 \times 10^{-6}/\degree C$<br>(meeting the ISO6872<br>requirements) | Similar<br>** All devices meet ISO<br>6872 requirements. |
| Glass Transition<br>Temperature | Activity<br>concentration of<br>uranium238 less<br>than 1.0Bq g-1<br>(meeting ISO 6872<br>requirements) | Activity<br>concentration of<br>uranium238 less<br>than 1.0Bq g-1<br>(meeting ISO 6872<br>requirements) | Activity<br>concentration of<br>uranium238 less<br>than 1.0Bq g-1<br>(meeting ISO 6872<br>requirements) | Similar<br>** All devices meet ISO<br>6872 requirements. |
| Biocompatibility | Non-toxic and<br>biocompatible<br>(Meeting the ISO<br>10993-3, 5, 10 and<br>10993-11<br>Requirements) | Non-toxic and<br>biocompatible<br>(Meeting the ISO<br>10993-5 and<br>10993-10<br>Requirements) | Non-toxic and<br>biocompatible<br>(Meeting the ISO<br>10993-5 and<br>10993-10<br>Requirements) | Similar<br>** All devices meet ISO<br>10993 requirements. |
| Shelf-life | Semi-permanent | Semi-permanent | Semi-permanent | Same |
| Labeling | Package labeling and<br>Instructions for Use | Package labeling and<br>Instructions for Use | Package labeling and<br>Instructions for Use | Same |
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# Substantial Equivalence Discussion
The subject device has the same intended use and the same principle of operation as the predicate devices. The subject device and the predicate devices might have a slight difference in compositions but all the devices have SiO2, Li2O, K2O, P2O5, and Al2O3 as major components. Despite this difference, the test results per ISO 6872 shows that the subject device is substantially equivalent to the predicate device in physical and chemical properties and meets the necessary requirements.
In addition, the subject device has been tested for Cytotoxicity (ISO 10993-5), Sensitization (ISO 10993-10), and Irritation (ISO 10993-10) to meet the biocompatibility requirements.
Based on the test results and the information provided in this submission, we conclude that the subject device is substantially equipment to the predicate devices.
#### 11. Conclusion:
Based on the testing results, HASS CORP. concludes that the Amber Mill Series and Amber Press Series are substantially equivalent to the predicate devices.
