Bluephase Style 20i
Device Facts
| Record ID | K163613 |
|---|---|
| Device Name | Bluephase Style 20i |
| Applicant | Ivoclar Vivadent, AG |
| Product Code | EBZ · Dental |
| Decision Date | Apr 4, 2017 |
| Decision | SESE |
| Submission Type | Abbreviated |
| Regulation | 21 CFR 872.6070 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
With its "Polywave" broadband spectrum, Bluephase Style 20i is suitable for the polymerization of all light curing dental materials curing in the wavelength range of 385-515 nm. These materials include restoratives, bases, liners, fissure sealants, temporaries, as well as luting materials for brackets and indirect restorations, such as ceramic inlays.
Device Story
Bluephase Style 20i is a pen-shaped, LED-based dental polymerization light. It emits energy-rich blue light via a Polywave LED to cure dental materials (restoratives, adhesives, sealants, etc.) at the dental unit. Operated by dental professionals, the device features two user-selectable programs: Turbo (2,000 mW/cm²) and High Power (1,200 mW/cm²). The operator selects the program and time; the device automatically terminates the curing cycle once the time elapses. The device is powered by a Li-Po battery. By providing controlled light energy, it ensures proper polymerization of dental materials, facilitating restorative procedures and indirect restorations.
Clinical Evidence
Bench testing only. Testing included electrical safety (IEC 60601-1:2005, IEC 60601-1-2:2007), electromagnetic compatibility, and heat sink temperature switch-off verification. Biocompatibility was evaluated via comparison to the predicate. Sterilization validation was performed according to DIN EN 556-1 and ISO 17665-2:2009.
Technological Characteristics
LED polymerization light; Polywave LED source; wavelength 385-515 nm; Li-Po battery powered; pen-style form factor; two programs (Turbo: 2,000 mW/cm², High Power: 1,200 mW/cm²); tested to IEC 60601-1 and IEC 60601-1-2; non-sterile, autoclavable light probe.
Indications for Use
Indicated for polymerization of light-curing dental materials (restoratives, adhesives, bases, liners, sealants, temporaries, luting materials) in the 385-515 nm wavelength range.
Regulatory Classification
Identification
An ultraviolet activator for polymerization is a device that produces ultraviolet radiation intended to polymerize (set) resinous dental pit and fissure sealants or restorative materials by transmission of light through a rod.
Predicate Devices
- Bluephase 20i (K091020)
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 a stylized image of three human profiles facing right, stacked on top of each other, with a wing-like shape extending from the top profile.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 4, 2017
Ivoclar Vivadent, AG % Donna Hartnett Director QA/ Regulatory Affairs Ivoclar Vivadent, Inc 175 Pineview Drive Amherst, New York 14228
Re: K163613
Trade/Device Name: Bluephase Style 20i Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator For Polymerization Regulatory Class: Class II Product Code: EBZ Dated: January 4, 2017 Received: January 5, 2017
Dear Donna Hartnett:
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,
Susan Runner DDS, MA
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)
Device Name Bluephase® Style 20i
Indications for Use (Describe)
With its "Polywave" broadband spectrum, Bluephase Style 20i is suitable for the polymerization of all light curing dental materials curing in the wavelength range of 385-515 nm. These materials include restoratives, bases, liners, fissure sealants, temporaries, as well as luting materials for brackets and indirect restorations, such as ceramic inlays.
Type of Use (Select one or both, as applicable)
| <span style="font-family: DejaVu Sans, sans-serif;">✘</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|-----------------------------------------------------------------------------------------------------------|
| <span style="font-family: DejaVu Sans, sans-serif;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
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### Bluephase® Style 20i
Image /page/3/Picture/2 description: The image shows the logo for Ivoclar Vivadent, a dental company. The logo features the company name in a stylized font, with "Ivoclar" in a darker blue and "Vivadent" in a lighter blue. Above the company name is a series of green and blue dots, arranged in an arc. Below the company name is the company's slogan, "passion vision innovation", in a smaller, sans-serif font.
| Contact: | Donna Marie Hartnett |
|----------------------|--------------------------------------------------------------------------------------------|
| Company: | Ivoclar Vivadent, AG<br>Bendererstrasse 2, Schaan, FL-9494, Liechtenstein<br>+423-235-3535 |
| Date Prepared: | December 19, 2016 |
| Proprietary Name: | Bluephase® Style 20i |
| Classification Name: | Activator, Ultraviolet, for Poymerization 872.6070<br>(Classification Code EBZ) |
| Predicate Device: | Bluephase 20i - K091020 |
Device Description: Bluephase® Style 20i is an LED polymerization light that produces energy-rich blue plight. It is used for the polymerization of light-curing dental materials immediately at the dental unit. It consists of 1 Polywave LED in the probe.
- The handpiece has the shape of a pen
Operational notes: 2 programs (Turbo, High Power)
Light source: Polywave LED
Power source: Li-Po battery
Indications for Use:
With its "Polywave" broadband spectrum, Bluephase® Style 20i is suitable for the polymerization of all light-curing dental materials curing in the wavelength range of 385-515 nm. These materials include restoratives, bonding agents/adhesives, bases, liners, fissure sealants, temporaries, as well as luting materials for brackets and indirect restorations, such as ceramic inlays.
Comparison to Predicate: Both dental curing lights are indicated for light curing of dental restoratives including bonding agents/adhesives, liners, fissure sealants, temporaries, as well as luting materials for brackets and indirect restorations, such as ceramic inlays. In the case of Bluephase® Style 20i, the design has 2 programs (Turbo, High Power).
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# Bluephase® Style 20i
Image /page/4/Picture/2 description: The image shows the logo for Ivoclar Vivadent. The logo is in blue and green, with the words "Ivoclar Vivadent" in a stylized font. Above the company name are a series of green and blue dots that form an arc. Below the company name are the words "passion vision innovation" in black.
| Indications for Use | Predicate device K091020 | Bluephase® Style 20i |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications | For light curing polymerization of light-<br>curing dental materials curing in the<br>wavelength range of 385–515 nm.<br>These materials include restoratives,<br>bonding agents/<br>adhesives, bases, liners, fissure<br>sealants, temporary<br>materials as well as luting materials for<br>brackets and<br>indirect restorations such as ceramic<br>inlays. | With its "Polywave"<br>broadband spectrum,<br>Bluephase Style 20i is<br>suitable for the polymerization<br>of all light-curing dental<br>materials curing in the<br>wavelength range of 385-515<br>nm. These materials include<br>restoratives, bonding<br>agents/adhesives, bases,<br>liners, fissure sealants,<br>temporaries, as well as luting<br>materials for brackets and<br>indirect restorations, such as<br>ceramic inlays. |
| Summary Indications | Bluephase® Style 20i is an LED polymerization light that produces<br>energy-rich blue light. It is used for the polymerization of light-curing<br>dental materials immediately at the dental unit. This is achieved using<br>the same technology as the predicate device Bluephase® 20i.<br>Furthermore, Bluephase® Style 20i features 2 programs instead of the 4<br>programs that are part of the predicates design.<br>Therefore, Bluephase® Style 20i is substantially equivalent to the<br>predicate device, Bluephase 20i® Plus. | |
| Working Principle | | |
| | Step-by-step:<br>1. Disinfect contaminated surfaces of<br>the curing light<br>as well as light probes and anti-glare<br>cones before<br>each use.<br>2. Make sure that the stipulated light<br>intensity permits adequate<br>polymerization. For that purpose,<br>check the light probe for contamination<br>and damage, as well as<br>the light intensity at regular intervals.<br>3. Select curing program and time<br>4. Start: Once the selected curing time<br>has elapsed,<br>the curing program is automatically<br>terminated. | Step-by-step:<br>1. Disinfect contaminated<br>surfaces of the curing light<br>as well as light probes and<br>anti-glare cones before<br>each use.<br>2. Make sure that the<br>stipulated light intensity<br>permits adequate<br>polymerization. For that<br>purpose, check the light probe<br>for contamination and<br>damage, as well as the light<br>intensity at regular intervals.<br>3. Select curing program and<br>time<br>4. Start: Once the selected<br>curing time has elapsed,<br>the curing program is<br>automatically terminated. |
| Summary Working<br>Principle | No difference. | |
| Summary Material<br>Composition | No difference | |
| Power Output | ☐650 mW/cm² (5 sec) then ramps to<br>1,200 mW/cm² (10, 15, or 20 sec)<br>☐ Low – 650 mW/cm² (10, 15, or<br>20 sec)<br>☐ High 1,200 mW/cm²(10, 15, or 20<br>sec)<br>☐Turbo 2,000 mW/cm² (5 sec) | ☐ High 1,200 mW/cm² (10, 15,<br>or 20 sec)<br>☐Turbo 2,000 mW/cm² (5<br>Sec) |
| Design styling | Wand Style | Gun style |
| Electrical Safety | The product has been tested to IEC<br>60601-1:2005 and IEC 60601-1-2:2007 | This product has been tested<br>to IEC 60601-1-: 2005 and<br>IEC 60601-1-2: 2007 |
| Summary of Electrical<br>Safety | Bluephase® Style 20i conforms to the current version of the same<br>standards as the predicate device. | |
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### Bluephase® Style 20i
Image /page/5/Picture/2 description: The image shows the logo for Ivoclar Vivadent. The logo is blue and green, with the words "ivoclar vivadent" in a stylized font. Above the words is a series of green and blue dots. Below the words is the tagline "passion vision innovation" in a smaller font.
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Bluephase® Style 20i
Image /page/6/Picture/2 description: The image is a logo for Ivoclar Vivadent. The words "Ivoclar Vivadent" are in blue, with "Ivoclar" on top of "Vivadent". Above the words are green and blue dots in an arc shape. Below the words is the phrase "passion vision innovation" in black.
### Summary of Safety Testing:
The product has been tested to IEC 60601-1:2005 and IEC 60601-1-2:2007 and meets the requirements for Electrical Safety, including US National Deviations, and Electromagnetic Compatibility. The Bluephase Style 20i was bench tested to assure the switch-off temperature of the heat sink functioned properly and found to meet the design specifications.
### Software Validation:
Bluephase Style 20i software/firmware has been fully validated and the device software meets its Design Specifications. FDA Guidance Document "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices (May 11, 2005) has been followed in connection with the design of this device.
#### Biocompatibility:
The Bluephase Style 20i has been evaluated for biocompatibility and compared to the predicate device. No new issues of biocompatibility are related to the subject device as the construction materials are substantially the same.
### Infection Control:
The device is sold in a non-sterile condition. Prior to use and after use sterilization of the light probe is recommended. The sterilization cycle recommended in the Instructions for Use have been validated according to DIN EN 556-1: Sterilization of a Medical Device and ISO 17665-2:2009. The curing light also is sold with plastic sleeves for infection control.
### Conclusion:
Bluephase® Style 20i is a LED polymerization light that is used for the polymerization of lightcuring dental materials. This is achieved using the same operating principle and performance as the one used in Bluephase® 20i. Furthermore, Bluephase® Style 20i comes in a new wand shape design. The working steps and indications for use are the same as with Bluephase® 20i.
Therefore, Bluephase® Style 20i is substantially equivalent to the predicate device, Bluephase® 20i.
