Bluephase PowerCure

K190272 · Ivoclar Vivadent, AG · EBZ · Jul 3, 2019 · Dental

Device Facts

• Record ID: K190272
• Device Name: Bluephase PowerCure
• Applicant: Ivoclar Vivadent, AG
• Product Code: EBZ · Dental
• Decision Date: Jul 3, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6070
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

With its "Polywave" LED with broadband spectrum, Bluephase PowerCure is suitable for the polymerization of all lightcuring 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.

Device Story

Bluephase PowerCure is a pen-shaped, battery-powered LED curing light used by dentists or dental assistants in clinical settings. It utilizes a 'Polywave' LED to emit broadband blue light (385-515 nm) to polymerize dental materials. The device features four operational modes (3s Cure, Turbo, High Power, PreCure) with irradiance up to 3,050 mW/cm². The operator selects the program and time; the device automatically terminates the cycle upon completion. It is intended for use in dental practices or hospitals to harden restorative materials, adhesives, and luting agents directly in the oral cavity. The device benefits patients by enabling rapid polymerization of dental materials, potentially reducing chair time.

Clinical Evidence

No clinical data. Bench testing only. Device performance validated through electrical safety testing (IEC 60601-1:2012, IEC 60601-1-2:2007) and sterilization validation per ISO 14937.

Technological Characteristics

Handheld pen-style LED curing light; Polywave LED source; Li-ion battery power; 4 curing modes; irradiance up to 3,050 mW/cm²; wavelength 385-515 nm. Tested to IEC 60601-1:2012 and IEC 60601-1-2:2007. Non-sterile; light probe requires sterilization per ISO 14937.

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 for dental patients.

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 Style 20i (K163613)

Reference Devices

• VALO Grand Corded (K190627)

Submission Summary (Full Text)

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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. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 3, 2019

Ivoclar Vivadent, AG % Lori Aleshin Director of Quality & Regulatory Affairs Ivoclar Vivadent, Inc. 175 Pineview Drive Amherst. New York 14228

Re: K190272

Trade/Device Name: Bluephase PowerCure Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator For Polymerization Regulatory Class: Class II Product Code: EBZ Dated: June 11, 2019 Received: June 13, 2019

Dear Lori Aleshin:

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 medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Srinivas Nandkumar, Ph.D. Acting Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known)

K190272

Device Name Bluephase® PowerCure

Indications for Use (Describe)

With its "Polywave" LED with broadband spectrum, Bluephase PowerCure is suitable for the polymerization of all lightcuring 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.

Type of Use (Select one or both, as applicable)

| <span style="font-family: Arial;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
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| <span style="font-family: Arial;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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## 510(K) SUMMARY

Image /page/3/Picture/1 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 green and "Vivadent" in blue. Below the name is the tagline "passion vision innovation" in a smaller font. Above the company name is a series of green and blue dots and squares.

### K190272

| Contact: | Lori Aleshin, Director of Quality and Regulatory Affairs<br>Ivoclar Vivadent, Inc.<br>175 Pineview Drive<br>Amherst, New York 14228<br>716-264-2045<br>[e-mail] |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company: | Ivoclar Vivadent, AG<br>Bendererstrasse 2, Schaan, FL-9494, Liechtenstein<br>[phone] |
| Date Prepared: | June 6, 2019 |
| Proprietary Name: | Bluephase® PowerCure |
| Classification Name: | Activator, Ultraviolet, For Polymerization (872.6070)<br>(Classification Code EBZ) |
| Predicate Device: | Bluephase Style 20i (K163613) by Ivoclar Vivadent, AG |

Bluephase® PowerCure is an LED curing light that produces blue Device Description: light. It is used for the polymerization of light-curing dental materials immediately in the oral cavity of patients. The intended place of application is in the dental practice, medical practice or in the hospital by the dentist or dental assistant. The curing light must only be operated by trained dental personnel.

- The handpiece has the shape of a pen
- Operational notes: 4 programs (3s, Turbo, High, PreCure)
- Light source: Polywave LED ●
- . Power Source: Li-lons batterv

Indications for Use: With its "Polywave" LED with broadband spectrum, Bluephase PowerCure 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, 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: The primary predicate devices to which Bluephase® PowerCure has been compared is Ivoclar Vivadent, AG Bluephase Style 20i (K163613). The new device Bluephase PowerCure composite materials can be cured within 3 seconds, the new device is able to emit light with an irradiance of 3.050 mW/cm² in contrast to the predicate and has 4 curing modes in contrast to 2 programs of the predicate. To enable the higher light irradiance the power supply has a higher output.

Reference Device: VALO Grand Corded manufactured by Ultradent Products Inc. (K190627)

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# 510(K) SUMMARY

Image /page/4/Picture/1 description: The image shows the logo for Ivoclar Vivadent, a dental company. The logo is blue and green, and it features the company's name in a stylized font. Below the name is the company's slogan, "passion vision innovation." The number 2 is in the upper right corner of the image.

| Device | Ivoclar Vivadent AG: Bluephase Style 20i<br>(K163613) | Ivoclar Vivadent: Bluephase®<br>PowerCure |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | With its "Polywave" broadband<br>spectrum, Bluephase Style 20i is<br>suitable for the polymerization of all light<br>curing dental materials curing in the<br>wavelength range of 385-515 nm.<br>These materials include restoratives,<br>bonding agents/adhesives, bases,<br>liners, fissure sealants, temporaries, as<br>well as luting materials for brackets and<br>indirect restorations, such as ceramic<br>inlays. | With its "Polywave" LED with<br>broadband spectrum, Bluephase<br>PowerCure is suitable for the<br>polymerization of all light-curing dental<br>materials curing in the wavelength<br>range of 385 – 515 nm. These<br>materials include restoratives, bonding<br>agents/adhesives, bases, liners,<br>fissure sealants, temporaries, as well<br>as luting materials for brackets and<br>indirect restorations, such as ceramic<br>inlays. |
| Summary of Indications | The indications are the same as for the predicate therefore both devices are<br>substantially equivalent. | |
| Principles of operation | Step-by-step:<br>1. Disinfect contaminated surfaces of<br>the curing light as well as light probes<br>and anti-glare cones before<br>each use.<br>2. Make sure that the stipulated light<br>irradiance permits adequate<br>polymerization. For that purpose, check<br>the light probe for contamination and<br>damage, as well as the light irradiance<br>at regular intervals.<br>3. Select curing program and time<br>4. Start: Once the selected curing time<br>has elapsed,the curing program is<br>automatically terminated. | Step-by-step:<br>1. Disinfect contaminated surfaces of<br>the curing light as well as light guides<br>and anti-glare cones before each use.<br>2. Make sure that the stipulated light<br>irradiance permits adequate<br>polymerization. For that purpose,<br>check the light probe for contamination<br>and damage, as well as the light<br>irradiance at regular intervals.<br>3. Select curing program and time<br>4. Start: Once the selected curing time<br>has elapsed, the curing program is<br>automatically terminated. |
| Summary Principles of<br>operation | No difference. | |
| Delivery form content | 1 Charging base with power cord and<br>power pack<br>1 Handpiece<br>1 Light probe 10>8 mm, black<br>1 Anti-glare shield<br>3 Anti-glare cones<br>1 Pack of sleeves<br>1 Instructions for use | 1 Charging base with power cord and<br>power pack<br>1 Handpiece<br>1 Handpiece support<br>1 Light guide 10>9 mm<br>1 Anti-glare shield<br>3 Anti-glare cones<br>1 Instructions for Use |
| Summary of Delivery<br>form content | The US delivery form currently does not contain sleeves. Customers are<br>recommended to use an alternative product which is locally available in the US.<br>The handpiece support is an accessory so that the dentist can lie the device down<br>without putting it on the charging base or the working surface.<br>The differences in the light guide diameter is non-significant.<br>Therefore, delivery forms are basically the same for both devices. | |
| Electrical Safety | This product has been tested to IEC<br>60601-1:2005 and IEC 60601-1-2:2007 | The new device has been tested to<br>IEC 60601-1:2012 and IEC 60601-1-<br>2:2007 |
| Summary of Electrical<br>Safety | Bluephase PowerCure conforms to the current version of the same standards as<br>the predicate device. | |
| Operational modes | 2 programs:<br>- Turbo (2,000 mW/cm²)<br>- High Power Program (1,200 mW/cm²) | 4 programs:<br>- 3s Cure Program (3,050 mW/cm²)<br>- Turbo program (2,100 mW/cm²)<br>- High power Program (1,200 mW/cm²)<br>- PreCure (preset to 2s)(950 mW/cm²) |
| Summary Operational<br>modes | The innovation of the new device Bluephase PowerCure is that it is able to emit<br>light with 3,050mW/cm² in combination with a shorter curing time. | |
| Storage Conditions | Temperature: -20 °C to + 60 °C /+4 °F<br>to +140 °F<br>Relative humidity: 10% to 75% | Temperature: -20 °C to + 60 °C /+4 °F<br>to +140 °F<br>Relative humidity: 10% to 75% |
| Summary of Storage<br>Conditions | No difference. | |
| Device Specification<br>Summary | The higher irradiance of Bluephase PowerCure (3,050mW/cm²) is comparable to the Xtra<br>Power Mode (3,200 mW/cm²) | |

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## 510(K) SUMMARY

Image /page/5/Picture/1 description: The image shows the Ivoclar Vivadent logo. The logo is composed of the company name in blue, with the words "passion vision innovation" underneath. Above the company name, there is a series of green and blue dots and squares arranged in a semi-circular pattern. The number 3 is in the upper right corner of the image.

### 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 ISO 14937 Sterilization of health care products- General requirements for characterization of a sterilization agent and the development, validation and routine control of a sterilization process for medical devices.

### Biocompatibility:

Direct contact with tissue is not intended. Therefore ISO 10993-1 is not applicable. A Toxicological statement of the LED Unit Bluephase PowerCure has been included in this submission.

### Software Validation:

Bluephase PowerCure software/firmware has been fully validated and the device software meets its Design Specifications. FDA Guidance Document Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices has been followed in connection with the design of the device.

### Summary of Safety Testing:

The product has been tested to IEC 60601-1:2012 and IEC 60601-1-2:2007 and meets the requirements for Electrical Safety, including US National Deviations, and Electromagnetic Compatibility. The test reports are included in this submission.

### Conclusion:

Bluephase PowerCure is an LED polymerization light, which is used for the polymerization of light-curing dental materials. This is achieved by using the same operating principle and performance criteria as for Bluephase Style 20i.

Therefore, Bluephase PowerCure is substantially equivalent to its predicate device, Bluephase Style 20i.