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, fissure sealants, temporaries, as well as luting materials for brackets and indirect restorations, such as ceramic inlays.

Device Description

Bluephase® PowerCure is an LED curing light that produces blue 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

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Ivoclar Vivadent Bluephase PowerCure, based on the provided FDA 510(k) summary:

This device is not an AI/ML device, therefore some of the requested information (like expert readers, stand-alone performance, MRMC studies, or training set details) are not applicable. The document focuses on demonstrating substantial equivalence to a predicate device primarily through technical specifications, safety standards, and functional equivalence for a non-AI medical device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria (Predicate)	Reported Device Performance (Bluephase PowerCure)
Indications for Use	Polymerization of all light-curing dental materials curing in the wavelength range of 385-515 nm, including restoratives, bonding agents/adhesives, bases, liners, fissure sealants, temporaries, as well as luting materials for brackets and indirect restorations, such as ceramic inlays.	Polymerization of all light-curing dental materials curing in the wavelength range of 385-515 nm, including restoratives, bonding agents/adhesives, bases, liners, fissure sealants, temporaries, as well as luting materials for brackets and indirect restorations, such as ceramic inlays.
Principles of Operation	Disinfect surfaces, check light irradiance, select curing program/time, start and automatic termination.	Disinfect surfaces, check light irradiance, select curing program/time, start and automatic termination.
Delivery Form Content	1 Charging base, 1 Handpiece, 1 Light probe 10>8 mm, 1 Anti-glare shield, 3 Anti-glare cones, 1 Pack of sleeves, 1 Instructions for use.	1 Charging base, 1 Handpiece, 1 Handpiece support, 1 Light guide 10>9 mm, 1 Anti-glare shield, 3 Anti-glare cones, 1 Instructions for Use. (Note: Sleeves in US delivery are typically separate, Handpiece support is new accessory, light guide diameter difference is non-significant).
Electrical Safety	Tested to IEC 60601-1:2005 and IEC 60601-1-2:2007.	Tested to IEC 60601-1:2012 and IEC 60601-1-2:2007. (Current version of standards met).
Operational Modes	2 programs: Turbo (2,000 mW/cm²), High Power Program (1,200 mW/cm²).	4 programs: 3s Cure Program (3,050 mW/cm²), Turbo program (2,100 mW/cm²), High power Program (1,200 mW/cm²), PreCure (preset to 2s)(950 mW/cm²). Key difference: Higher irradiance (3,050 mW/cm²) for shorter curing time. Comparable to Xtra Power Mode (3,200 mW/cm²) of reference device.
Storage Conditions	Temperature: -20 °C to + 60 °C /+4 °F to +140 °F; Relative humidity: 10% to 75%.	Temperature: -20 °C to + 60 °C /+4 °F to +140 °F; Relative humidity: 10% to 75%.
Infection Control	Recommended sterilization cycle for light probe in IFU; validated according to ISO 14937.	Recommended sterilization cycle for light probe in IFU; validated according to ISO 14937.
Biocompatibility	(Not explicitly stated for predicate in summary, but implied that direct contact with tissue is not intended, making ISO 10993-1 not applicable).	Direct contact with tissue is not intended; ISO 10993-1 not applicable. Toxicological statement of LED unit included.
Software Validation	(Not explicitly stated for predicate in summary, but assumed to meet similar standards).	Fully validated software/firmware meeting Design Specifications and following FDA Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."

Notes on "Reported Device Performance": For a 510(k) submission, "reported device performance" typically refers to how the new device matches or exceeds the performance characteristics of the predicate device, or meets relevant recognized standards. The summary indicates that the Bluephase PowerCure either has "no difference" or "conforms to the current version of the same standards" or offers an "innovation... with higher irradiance" but still achieves the same functional objective.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated for specific test sets in this summary document.
Data Provenance: The document does not specify country of origin for testing data. The "study" itself is a comparison to a predicate device and adherence to recognized standards. It's a regulatory submission, not a clinical trial with a "test set" in the traditional sense of patient data. The testing mentioned pertains to engineering, electrical safety, software, and sterilization validation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not Applicable. This is a dental curing light, not a diagnostic device requiring expert interpretation of results, nor does it involve a "ground truth" derived from expert consensus in a clinical context. The "truth" is established by adherence to technical specifications and recognized standards.

4. Adjudication Method for the Test Set

Not Applicable. See explanation above.

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

Not Applicable. This device is an LED polymerization light and does not involve AI or human readers for diagnostic interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not Applicable. This device does not use an algorithm for diagnostic purposes. Its standalone performance is demonstrated by its physical and electrical specifications (e.g., light irradiance, wavelength, safety standards).

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's performance is established by:
- Technical Specifications: Measuring the irradiance, wavelength, and other physical properties to ensure they meet the design specifications and are suitable for the intended use (polymerization of dental materials).
- Compliance with Recognized Standards: Adherence to standards like IEC 60601-1 (Electrical Safety) and IEC 60601-1-2 (Electromagnetic Compatibility), and ISO 14937 (Sterilization).
- Functional Equivalence: Demonstrating that the device performs the same function as the legally marketed predicate device (Bluephase Style 20i) and reference device (VALO Grand Corded) in polymerizing dental materials.

8. The Sample Size for the Training Set

Not Applicable. This device is not an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. See explanation above.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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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 AffairsIvoclar Vivadent, Inc.175 Pineview DriveAmherst, New York 14228716-264-2045lori.aleshin@ivoclarvivadent.com
Company:	Ivoclar Vivadent, AGBendererstrasse 2, Schaan, FL-9494, Liechtenstein+423-235-3535
Date Prepared:	June 6, 2019
Proprietary Name:	Bluephase® PowerCure
Classification Name:	Activator, Ultraviolet, For Polymerization (872.6070)(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(K163613)	Ivoclar Vivadent: Bluephase®PowerCure
Indications for Use	With its "Polywave" broadbandspectrum, Bluephase Style 20i issuitable for the polymerization of all lightcuring dental materials curing in thewavelength range of 385-515 nm.These materials include restoratives,bonding agents/adhesives, bases,liners, fissure sealants, temporaries, aswell as luting materials for brackets andindirect restorations, such as ceramicinlays.	With its "Polywave" LED withbroadband spectrum, BluephasePowerCure is suitable for thepolymerization of all light-curing dentalmaterials curing in the wavelengthrange of 385 – 515 nm. Thesematerials include restoratives, bondingagents/adhesives, bases, liners,fissure sealants, temporaries, as wellas luting materials for brackets andindirect restorations, such as ceramicinlays.
Summary of Indications	The indications are the same as for the predicate therefore both devices aresubstantially equivalent.
Principles of operation	Step-by-step:1. Disinfect contaminated surfaces ofthe curing light as well as light probesand anti-glare cones beforeeach use.2. Make sure that the stipulated lightirradiance permits adequatepolymerization. For that purpose, checkthe light probe for contamination anddamage, as well as the light irradianceat regular intervals.3. Select curing program and time4. Start: Once the selected curing timehas elapsed,the curing program isautomatically terminated.	Step-by-step:1. Disinfect contaminated surfaces ofthe curing light as well as light guidesand anti-glare cones before each use.2. Make sure that the stipulated lightirradiance permits adequatepolymerization. For that purpose,check the light probe for contaminationand damage, as well as the lightirradiance at regular intervals.3. Select curing program and time4. Start: Once the selected curing timehas elapsed, the curing program isautomatically terminated.
Summary Principles ofoperation	No difference.
Delivery form content	1 Charging base with power cord andpower pack1 Handpiece1 Light probe 10>8 mm, black1 Anti-glare shield3 Anti-glare cones1 Pack of sleeves1 Instructions for use	1 Charging base with power cord andpower pack1 Handpiece1 Handpiece support1 Light guide 10>9 mm1 Anti-glare shield3 Anti-glare cones1 Instructions for Use
Summary of Deliveryform content	The US delivery form currently does not contain sleeves. Customers arerecommended to use an alternative product which is locally available in the US.The handpiece support is an accessory so that the dentist can lie the device downwithout putting it on the charging base or the working surface.The differences in the light guide diameter is non-significant.Therefore, delivery forms are basically the same for both devices.
Electrical Safety	This product has been tested to IEC60601-1:2005 and IEC 60601-1-2:2007	The new device has been tested toIEC 60601-1:2012 and IEC 60601-1-2:2007
Summary of ElectricalSafety	Bluephase PowerCure conforms to the current version of the same standards asthe predicate device.
Operational modes	2 programs:- Turbo (2,000 mW/cm²)- High Power Program (1,200 mW/cm²)	4 programs:- 3s Cure Program (3,050 mW/cm²)- Turbo program (2,100 mW/cm²)- High power Program (1,200 mW/cm²)- PreCure (preset to 2s)(950 mW/cm²)
Summary Operationalmodes	The innovation of the new device Bluephase PowerCure is that it is able to emitlight with 3,050mW/cm² in combination with a shorter curing time.
Storage Conditions	Temperature: -20 °C to + 60 °C /+4 °Fto +140 °FRelative humidity: 10% to 75%	Temperature: -20 °C to + 60 °C /+4 °Fto +140 °FRelative humidity: 10% to 75%
Summary of StorageConditions	No difference.
Device SpecificationSummary	The higher irradiance of Bluephase PowerCure (3,050mW/cm²) is comparable to the XtraPower 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.

Regulation Number and Section

§ 872.6070 Ultraviolet activator for polymerization.

(a)
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.(b)
Classification. Class II.