The FUSION Curing Light is a dental curing light that is intended for photopolymerization of dental resins, restorative composite materials, and orthodontic brackets, bonding, and sealing that are photo-polymerized in the 440 – 480 nm wavelength range.

Device Description

The DentLight's FUSION Curing Light is a battery-powered cordless unit designed for curing VLC materials whose initiator systems are sensitive to light in the 440-480nm wavelength range of the visible spectrum. The unit is based on blue LED (light emitting diode) technology for light generation in the desired wavelength and Li-Ion rechargeable batteries.

The FUSION Curing Light includes:

A handpiece with a focusing lens focusing light emitted from a single LED probe tip and controlled by built-in control electronics
· A detachable rechargeable battery unit
· A base unit that plugs into main power as the handpiece stand
· An eye shield and disposable cap at probe tip
· Disposable disinfectant barrier sleeves on the probe tube

AI/ML Overview

The provided text describes the 510(k) summary for the FUSION Curing Light, which is a dental curing light. It discusses its intended use, technological characteristics, and performance testing. However, it does not contain specific acceptance criteria or detailed study results that would allow for a table of acceptance criteria versus reported device performance, or many of the other requested details for an AI/device study.

The document is a regulatory submission for a physical medical device, not an AI/ML-based device. Therefore, a significant portion of the requested information (e.g., sample size for AI, ground truth establishment, MRMC studies, standalone algorithm performance) is not applicable or present.

Here's what can be extracted based on the provided text, and where the requested information is not available:

Acceptance Criteria and Study Information for FUSION Curing Light

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific numerical acceptance criteria for performance tests. It lists the types of tests conducted but does not provide the threshold values for success or the quantitative results achieved. Therefore, a complete table cannot be generated.

Performance Characteristic	Acceptance Criteria	Reported Device Performance
Optical Power	Not specified	Testing was conducted. (Specific values not provided)
Resin Curing Time	Not specified	Testing was conducted. (Specific values not provided)
Curing Range	Not specified	Testing was conducted. (Specific values not provided)
Optical Wavelength	440-480nm range	Designed for 440-480nm range; testing was conducted. (Specific confirmation values not provided)
Electrical Safety	Compliance with IEC 60601	Designed to comply; will comply. (Specific test results not provided)
Electromagnetic Compatibility	Compliance with IEC 60601-1-2	Designed to comply; will comply. (Specific test results not provided)
Software and Hardware Verification and Validation	Not specified	Testing was conducted. (Details not provided)

Notes:

The document states that the "major difference between the proposed FUSION Curing Light and the predicate curing lights is the intensity of the light power delivered, the longer range of curing distance, size and weight." It also notes that "The increased light intensity of the proposed FUSION Curing Light allows the resin curing and tooth whitening agent activation to be conducted at faster speed. The longer range of curing distance enables more flexibility for operators." This implies performance benefits in these areas compared to predicates, but without quantitative acceptance criteria or results.

2. Sample Size for the Test Set and Data Provenance

Sample Size for Test Set: Not specified. The document states "The following testing was conducted to evaluate the functionality performance..." but does not detail the number of units tested or specific samples used for each test.
Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not specified.

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

Not Applicable. This device is a physical dental curing light, not an AI/ML diagnostic or prognostic tool that requires expert-established ground truth for a test set.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not Applicable. As per point 3.

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

No. This is not an AI-assisted device. MRMC studies are not relevant to this type of regulatory submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This is a physical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not Applicable. For a physical curing light, "ground truth" would relate to measurable physical properties (e.g., light spectrum, power output, curing depth/hardness of resin), which are evaluated through standard industrial test methods. The document does not specify the exact methods or comparator "ground truth" materials/standards used for the resin curing tests, but it would be based on recognized dental material testing protocols.

8. The Sample Size for the Training Set

Not Applicable. This device does not involve a "training set" in the context of AI/ML.

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

Not Applicable. As per point 8.

Summary

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K052593

510(k) Summary for FUSION Curing Light

1. SPONSOR

DentLight Inc. 4404 Breckinridge Blvd. Suite 500 Richardson, TX 75082

Contact Person: Richard Liu Tel: 972-889-8857

Date Prepared: September 9, 2005

2. DEVICE NAME

Proprietary Name: FUSION curing light Common/Usual Name: dental curing light Classification Name: ultraviolet activator for polymerization (872.6070)

3. PREDICATE DEVICES

Dentsply SmartLite PS Pen-Style LED curing light (K041372) Southern Dental Industries Radii (K030568)

4. DEVICE DESCRIPTION

The FUSION Curing Light includes:

A handpiece with a focusing lens focusing light emitted from a single LED probe tip and controlled by built-in control electronics
· A detachable rechargeable battery unit
· A base unit that plugs into main power as the handpiece stand
· An eye shield and disposable cap at probe tip
· Disposable disinfectant barrier sleeves on the probe tube

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5. INTENDED USE

The FUSION LED curing light is indicated for curing camphorquinone-based visible light cured (VLC) dental materials.

6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANDTIAL EQUIVALENCE

The FUSION LED Curing Light is substantially equivalent to K041372 and K030568 in intended use and operation.

FUSION Curing Light offers multiple curing programs for photopolymerization of dental resins and activation of bleaching materials. These program differ in the intensity of the light delivered and the length of the light exposure. The operational principles of the proposed and predicate devices are identical. The operator chooses the appropriate program by a selection of the push buttons.

The major difference between the proposed FUSION Curing Light and the predicate curing lights is the intensity of the light power delivered, the longer range of curing distance, size and weight. The increased light intensity of the proposed FUSION Curing Light allows the resin curing and tooth whitening agent activation to be conducted at faster speed. The longer range of curing distance enables. Horre flexibility for operators. The size and weight is a benefit to constant patient operations and counter space.

7. PERFORMANCE TESTING AND COMPLIANCE

The following testing was conducted to evaluate the functionality performance of the proposed FUSION Curing Light:

Optical Power Testing
Resin curing time .
Curing range .
Optical wavelength .
Software and hardware verification and validation .

The FUSION is designed to comply with electrical safety and electromagnetic compatibility and will comply with electrical safety requirement established.by IEC 60601 and 60601-1-2.

We believe the similarity of the FUSION LED Curing Light to the legally marketed predicate devices and the performance data provided support the safety and effectiveness of the FUSION LED Curing Light for the indicated use.

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Third Party Review Quality Assessment

Section 1 - Submission Information
------------------------------------

510(k) No.:	K052593
Third Party Organization:	Reg Tech Services, LLC
Third Party's Primary Reviewer(s):	Mark Job
ODE/OIVD Division:	DAGID
Branch/Team:	DEDB

Section 2 - 510(k) Decision
-----------------------------

Third party recommendation:	SE ✓ NSE ______ Other (specify): ______
ODE/OIVD final decision:	SE ✓ NSE ______ Other (specify): ______

Section 3 – Assessment of Third Party Review

Review Element	Rating (check one)
	Adequate	Minor Issue(s)	Major Issue(s)
a. Determination of device eligibility for third party review	✓
b. Extent of pre-submission consultation with ODE/OIVD division	✓
c. Organization and format of review documentation	✓
d. Determination of 510(k) administrative completeness (screening review)	✓
e. Summary of device characteristics, intended use, and performance (including accessories, if applicable) and reason for 510(k) submission	✓
f. Comparison to legally marketed devices—identification and analysis of key similarities and differences	✓
g. Rationale for conclusions and recommendation	✓
h. Use of guidance documents and standards	✓
i. Resolution of 510(k) deficiencies and FDA requests for additional information	✓
j. Scope of reviewer expertise and use of consulting reviewers	✓
k. Other (specify):

Comments (explanation of ratings/issues): ____________________________________________________________________________________________________________________________________ .

Section 4 - ODE/OLD Assessor Information

Assessed by: MSPR Date: 09/26/05. Tel. No.: 301-827-5253

.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Routing: Division -- Clip completed assessment (this page only) to inside front cover of 510(k). DMC-Forward this page only to Eric Rechen, POS/ODF, Rm. 120J, Corp. Blvd. (HFZ-402).

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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

SEP 2 8 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DentLight, Incorporated C/O Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Strect, NW Buffalo, Minnesota 55313

Re: K052593

Trade/Device Name: FUSION Curing Light Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ Dated: September 19, 2005 Received: September 21, 2005

Dcar Mr. Job:

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 approvisions of the Act. The general controls provisions of the Act include eequirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 Nr.), it may 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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Page 2 - Mr. Job

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. or mo ret of any with all the Act's requirements, including, but not limited to: registration r od listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and ifing (2) - 2011 forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a premiurket notification - 11 device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), n free contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Anthony D. Watson for CKL

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, 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): K052593

Device Name: FUSION Curing Light

Indications For Use.

X Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Colleen for MSR

(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital,
Division of Anesthesiology, General Devices Division of Anesthoolors of Device

Infection Control
510(k) Number. K0512593

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.