The VL-7 is a dental curing light manufactured by J. MORITA MFG. CORP. The VL-7 is to be used at the dental treatment of curing polymer cement by the dentist. The VL-7 delivers an optimum wavelength of between 420 and 480nm by using blue LED. Its powerful light beam is directly irradiated on polymer material. There are three characteristics. 1. The irradiated beam is almost the same as parallel. Therefore, the percentage of reducing light intensity is lower. 2. The cordless handpiece can be easily positioned at molars. 3. The head part of the handpiece is able to be rotated around the axis of handpiece.

AI/ML Overview

The provided text is a 510(k) summary for the J. Morita USA Inc.'s Pencure VL-7, a dental curing light. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed de novo clinical study with explicit acceptance criteria and performance data. Therefore, many of the requested elements regarding specific study design, sample sizes, expert involvement, and ground truth establishment are not typically included in this type of regulatory document.

However, based on the information provided, here's an analysis:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics against those criteria. Instead, it relies on a comparison of characteristics to predicate devices to establish substantial equivalence. The "Performance" characteristic listed in the comparison table is simply marked as "Similar," implying that the device's performance is expected to be comparable to the predicate devices without providing numerical targets or measured results.

Category	Acceptance Criteria (Not Explicitly Stated)	Reported Device Performance
Indication for Use	Same as predicate devices	Similar to predicate devices: "polymerize (set) resinous dental pit and fissure sealants or dental restorative materials by light from head."
Target Population	Same as predicate devices	Identical to predicate devices
Design	Similar to predicate devices	Similar to predicate devices
Materials	Presumed similar to predicate devices	Presumed similar to predicate devices
Performance	Comparable to predicate devices	Similar to predicate devices
Sterility	Similar to predicate devices	Similar to predicate devices
Biocompatibility	Presumed similar to predicate devices	Presumed similar to predicate devices
Mechanical safety	Similar to predicate devices	Similar to predicate devices
Chemical safety	Similar to predicate devices	Similar to predicate devices
Anatomical sites	Same as predicate devices	Identical to predicate devices
Human factors	Same as predicate devices	Identical to predicate devices
Energy used and/or delivered	Similar to predicate devices	Similar to predicate devices (delivers optimum wavelength between 420 and 480nm)
Compatibility with environment and other devices	Similar to predicate devices	Similar to predicate devices
Where used	Same as predicate devices	Identical to predicate devices
Standards met	Presumed similar to predicate devices	Presumed similar to predicate devices
Electrical safety	Similar to predicate devices	Similar to predicate devices
Thermal safety	Presumed similar to predicate devices	Presumed similar to predicate devices
Radiation safety	Similar to predicate devices	Similar to predicate devices

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

The document does not describe a "test set" in the context of a formal clinical performance study that would involve a specific sample size. The evidence for substantial equivalence is based on comparing the characteristics of the Pencure VL-7 to existing predicate devices (JETLITE5000 and SmartLite™ PS Pen-Style LED Curing Light). No de novo data from a test set is presented.

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

Not applicable. The submission does not detail a study involving expert-established ground truth for a test set. This is a 510(k) submission, which primarily relies on comparison to known predicate devices for safety and effectiveness.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of an adjudication process for a test set in this 510(k) summary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

Not applicable. The document does not describe an MRMC comparative effectiveness study, nor does it discuss human reader performance or the effect of AI assistance. The device is a dental curing light, not an AI-powered diagnostic tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

Not applicable. The device is a physical dental curing light, not an algorithm.

7. The Type of Ground Truth Used

Not applicable in the context of a clinical performance study. The "ground truth" for this submission is effectively the established safety and effectiveness of the predicate devices. The new device is deemed "substantially equivalent" if it shares similar technological characteristics and intended uses, without raising new questions of safety or effectiveness.

8. The Sample Size for the Training Set

Not applicable. The device is a physical product and does not involve machine learning or a "training set."

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

Not applicable. As there is no training set for an algorithm, there is no ground truth to be established for it.

Summary

{0}------------------------------------------------

K063529

Attachment-6

510(k) SUMMARY J. Morita USA Inc.'s Pencure VL-7

JAN - 5 2007

1. Submitter Name and Address with Phone/Fax :

Registration No.	2081055
Initial Distributor:
J. Morita USA, Inc.
9 Mason
Irvine, CA 92618
USA
Telephone:	949-581-9600
Facsimile:	949-581-9688

2. Contact Person

Keith A. Barritt Fish & Richardson P.C. 1425 K Street, N.W. Suite 1100 Washington, DC 20005 Phone: (202) 783-5070 Facsimile: (202) 783-2331

Date summary prepared:

November 08, 2006

4. Device Name:

Common/Usual Name:	Dental curing light
Trade or Proprietary Name:	PENCURE
Product Model Name ;	VL-7
Regulation Number:	21 CFR § 872.6070
Regulation Name :	Ultra violet activator for polymerization
Regulatory Class :	II
Product Code:	EBZ
Classification Panel:	872 Dental.

{1}------------------------------------------------

5. Substantial Equivalency is claimed against the following device:

The VL-7 covered by this submission is substantially equivalent to other legally marketed Ultraviolet activators.

1) Predicate device I

The VL-7 is substantially equivalent to the JETLITE5000 from J.MORITA USA.INC. , (K#051780). The VL-7 has similar general intended uses, similar principles of orare: on, and similar technological characteristics as the previously cleared predicate JETLITE5000.

2) Predicate device II

The VL-7 is substantially equivalent to the SmartLite™ PS Pen-Style LED Curing Light from DENTSPLY DeTrey GmbH (K#041372). The VL-7 has similar general intended uses, similar principles of operation, and similar technological characteristics as the previously cleared predicate SmartLite™ PS Pen-Style LED Curing Light .

Although there are minor differences in the characteristics of the VL-7and its predicate devices, these differences do not raise new questions of safety or effectiveness.

6. Description of the device

The VL-7 is a dental curing light manufactured by J. MORITA MFG. CORP. The VL-7 is to be used at the dental treatment of curing polymer cement by the dentist.

The VL-7 delivers an optimum wavelength of between 420 and 480nm by using blue LED. Its powerful light beam is directly irradiated on polymer material.

There are three characteristics.

1. The irradiated beam is almost the same as parallel. Therefore, the percentage of reducing light intensity is lower.
1. The cordless handpiece can be easily positioned at molars.
1. The head part of the handpiece is able to be rotated around the axis of handpiece.

7. Indications for use

The Pencure is intended to polymerize (set) resinous dental pit and fissure sealants or dental restorative materials by light from head.

{2}------------------------------------------------

8. Safety and effectiveness of the device

This device is safe and effective as the other predicate device cited above. This is better expressed in the tabulated comparison ( Paragraph 9 below).

Substantial Equivalent comparison table 9.

Model name of Predicate Device	JETLITE 5000	SmartLite™ PS Pen-StyleLED Curing Light
510(k) number of Predicate Device	K051780	K041372
TECHNOLOGICALCHARACTERISTICS	Comparison result	Comparison result
Indication for use	Similar	Similar
Target population	Identical	Identical
Design	Similar	Similar
Materials	Presumed similar	Presumed similar
Performance	Similar	Similar
Sterility	Similar	Similar
Biocompatibility	Presumed similar	Presumed similar
Mechanical safety	Similar	Presumed similar
Chemical safety	Similar	Presumed similar
Anatomical sites	Identical	Identical
Human factors	Identical	Identical
Energy used and/or delivered	Similar	Similar
Compatibility with environment andother devices	Similar	Similar
Where used	Identical	Identical
Standards met	Presumed similar	Presumed similar
Electrical safety	Similar	Presumed similar
Thermal safety	Presumed similar	Presumed similar
Radiation safety	Similar	Similar

FDA file reference number 510k number K051780 and K041372. Attachment inside notification submission file 510k FDA website print out

3 / 3

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized design that resembles an abstract representation of a human figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

J. Morita USA, Incorporated C/O Mr. Keith A. Barritt, Esq. Fish & Richardson P.C. 1425 K Street N.W., Suite 1100 Washington, District of Columbia 20005

Re: K063529

JAN 0 5 2007

Trade/Device Name: Pencure VL-7 Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ Dated: November 21, 2006 Received: November 24, 2006

Dear Mr. Barritt:

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.

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 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.

{4}------------------------------------------------

Page 2 – Mr. Keith A. Barritt, Esq.

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); good manufacturing practice requirements as set 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 legally marketed predicate 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours,

Susan Gunn

Chiu S. Lin, PhD Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Indications for Use

510(K) Number :

1 663529 anknown

Device Name: Pencure

Indications for Use:

The Pencure is intended to polymerize (set) resinous dental pit and fissure sealants or dental restorative materials by light from head.

AND/OR Prescription Use (Part2ICFR801 Subpart D)

Over-The-Counter Use (Part21CFR807 Subpart C)

(PLEASE) DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation(ODE)

Susan Crowe
(Division Sign-Off)

Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(K) Number

Number : KCC63529

Prescription Use (Part21CFR801.109)

Over-The-Counter Use (Optional Format 1-2-96)

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.