PLASMACURE BXE

K033795 · Eele Laboratories, LLC · EBZ · Dec 19, 2003 · Dental

Device Facts

• Record ID: K033795
• Device Name: PLASMACURE BXE
• Applicant: Eele Laboratories, LLC
• Product Code: EBZ · Dental
• Decision Date: Dec 19, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6070
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The PlasmaCure BXe Curing Light is a source of illumination for curing dental restorative materials and is a source of illumination for tooth whitening activities performed in dentistry.

Device Story

PlasmaCure BXe is a dental curing light used by dental professionals in clinical settings. It consists of a base control unit and a corded handpiece. The handpiece houses the light source, optical filter assembly, and fiber optic tip, which emits blue light (385-495 nm) to polymerize dental materials. An external trigger on the handpiece activates the lamp. Intensity and exposure time are controlled via the base unit keypad and the specific eeleCoolTip™ inserted. The device includes a rotatable light shield for user protection. By providing high-intensity light, it enables rapid curing of restorative materials and facilitates tooth whitening, improving clinical efficiency compared to traditional halogen or LED curing methods.

Clinical Evidence

Bench testing only. Testing included biocompatibility, sterilization, packaging, and functionality. Performance testing demonstrated that the PlasmaCure BXe polymerized dental materials faster than the halogen, laser, and LED lights evaluated at the time. Safety testing included compliance with UL 2601-1, IEC 60601-1, CAN/CSA-C22.2, IEC 60601-1-4, EN50081-1, and FCC 15/EN55011 Class B emissions limits. Environmental and dynamic testing (temperature, humidity, shock, and vibration per Mil-Std-810-E) was also performed.

Technological Characteristics

Device consists of a molded plastic control unit and corded handpiece. Light source is located in the handpiece. Emits blue light (385-495 nm) via fiber optic tip. Includes optical filter assembly and rotatable light shield. Powered by mains electricity. Complies with IEC 60601-1, Mil-Std-810-E Method 514.4, and FCC 15/EN55011 Class B standards.

Indications for Use

Indicated for use by dental professionals as a light source for the polymerization of dental restorative materials and for tooth whitening procedures.

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

• Rmo Plasma Curing Light (K024374)
• Q-Lux Plasma 100 Light Cure Unit (K001719)
• Optilux 501 (K020091)

Submission Summary (Full Text)

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# eele Laboratories

eele Laboratories, LLC email: [e-mail] 1 [phone] 1 [phone] 50 Orville Drive, Bohemia NY 11716-2519

DEC 1 9 2003

### 8. 510 (k) Summary

K033795

This summary of 510 (k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR Part 807.87(h).

eele Laboratories, LLC 50 Orville Drive Bohemia, N.Y. 11716 Phone: [phone] Fax: [phone]

Name of Applicant/Contact: Signature of Applicant: Dated:

Robert Grasman (Phone extension; 106)

October 20, 2003

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### ele Laboratorie

#### Proposed Device

- Ultraviolet activator for polymerization 0 Device Classification Name:
Dental Curing Light

PlasmaCure BXe

21 CFR 872.6070

II

EBZ

- Device Common Name: 0
- Trade/Proprietary Name: 0
- Regulation Number:
- 0 Regulatory Class: O
- Product Code: O
- Review Advisory Committee: Dental 0

Substantial Equivalence

| Device<br>Name | Device/<br>Classification<br>Name | Owner/Operator<br>Applicant | 510 (k)<br>No. | Product<br>Code | Reg. # |
|----------------------------------------|--------------------------------------------------|--------------------------------|----------------|-----------------|----------|
| Rmo Plasma<br>Curing Light | Activator,<br>Ultraviolet, for<br>Polymerization | Lokki Lasers<br>Medicaux | K024374 | EBZ | 872.6070 |
| Q-Lux Plasma<br>100 Light Cure<br>Unit | Activator,<br>Ultraviolet, for<br>Polymerization | Rolence Enterprise<br>Co., LTD | K001719 | EBZ | 872.6070 |
| Optilux 501 | Activator,<br>Ultraviolet, for<br>Polymerization | Kerr Corporation<br>(Danbury) | K020091 | EBZ | 872.6070 |

The PlasmaCure BXe addressed in this premarket notification, is substantially equivalent to the following commercially dental curing lights:

#### Device Description

The PlasmaCure BXe is a device used for the polymerization of dental materials using blue light. It consists of a base unit and a cord connected hand piece. The molded plastic control unit (base unit) contains a power inlet receptacle for a detachable mains power cord, fuse holder and fuses, power supply & controller printed circuit board (control circuitry for lamp and cooling fan functions). The cord connected hand piece contains a printed circuit board, lamp reflector module assembly, optical filter assembly, fibertip insert and fiber optic tip that generates blue light energy having the wavelength range of approximately 385-495 nm. An external trigger switch (hand piece) activates the curing lamp. The emitted intensity and exposure time level depends on which type of eeleCoolTip™ is inserted in the hand piece and which key was last activated on the keypad of the base unit. The hand piece also has a removable and rotatable light shield that will protect the user when in operation.

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eele Laboratories

eele Laboratories, LLC email: [e-mail] 1 [phone] 1 [phone] 50 Orville Drive, Bohemia NY 11716-2519

Statement of Indications for Use

The PlasmaCure BXe Curing Light is a source of illumination for curing dental restorative materials and is a source of illumination for tooth whitening activities performed in dentistry.

Device Testing Results and Conclusion

Bench testing was performed, which included biocompatibility, sterilization, packaging, and functionality to confirm that the PlasmaCure BXe is equivalent to the predicate devices. All bench testing results met specified requirements.

Summary of Technological Characteristics to Predicate Devices

- The Optilux 501 utilizes a halogen light source that is located in the plastic O hand piece (handle) that also includes the optical filter assembly and fiber optic light guide. The light emanates from the light guide that is attached to the hand piece.
- The other comparable devices have their light source located in the control O unit (box) and the light travels through a light pipe (conduit) and then the light guide. These devices are listed to demonstrate the "Plasma Arc" technology using a Xenon Arc Lamp.
- 0 The PlasmaCure BXe has the light source (similar to Optilux 501) in the plastic hand piece (handle) as well as the optical filter assembly and fiber optic guide. Instead of having the light source in the control unit (box) as above, it is located in the hand piece.

Safety and Effectiveness Information Supporting the Substantial Equivalence

The PlasmaCure BXe complies with the following standards, practices, and guidance's:

- Effectiveness: Independent Testing Facility test results for equivalence (nonclinical performance data).
The PlasmaCure BXe performed similar to other plasma arc lights, & polymerized faster than the halogen, laser, & LED lights evaluated at that time.

- Safety: Pending Approval of UL 2601-1 including IEC 60601-1. CAN/CSA-C22.2 and evaluation to IEC 60601-1-4. In addition Immunity testing to EN50081-1 as well as Radiated and Conducted

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## ele Laboratories

emissions testing to FCC 15 and EN55011 Class B limits to 1 GHz.

Independent Testing Facilities:

- · Software development, verification, and validation process is also pending to ensure performance to specifications, Federal Regulations and user requirements.
- Environmental & Dynamic Testing including temperature, o humidity, Mil-Std-810-E Method 514.4 category 1 and shock testing.

#### Conclusion

The intended use and technological features of the PlasmaCure BXe do not differ from the legally marketed predicate device(s). Both the PlasmaCure BXe and the predicate device(s) have the same materials and product design. The PlasmaCure BXe performs as well as or better than the predicate devices. This conclusion is based upon the devices' similarities in functional design, materials, indications for use, and methods of construction. The subject device is substantially equivalent to the predicate devices with regard to intended use, indications, device characteristics, method of use, labeling, materials, and safety features.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its wings, positioned to the right of the text. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the left side of the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 9 2003

Eele Laboratories, LLC Mr. Neil E Devine Responsible Third Party Official Entela, Incorporated 3033 Madison Avenue, SE Grand Rapids, Michigan 49548

Re: K033795

Trade/Device Name: PlasmaCure Regulation Number: 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: Product Code: EBZ Dated: December 5, 2003 Received: December 5, 2003

Dear Mr. Devine:

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.

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Page 2 -Mr. Devine

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Chiu-Ling, Ph.D.

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

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#### 5. Statement of Indications for Use

1 of 1 Page

510(k) Number (if known): K033795

Device Name: PlasmaCure BXe

Indications For Use:

The PlasmaCure BXe Curing Light is a source of illumination for curing dental restorative materials and is a source of illumination for tooth whitening activities performed in dentistry.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Ruan

on of Anesthesiolog Infection Control, Dent

(Optional Format 3-10-98)

510(k) Number. K053245

**Prescription Use**
**(Per 21 CFR 801.109)**

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