SPECTRUM 800 CURING UNIT

K982318 · Dentsply Intl. · EBF · Sep 15, 1998 · Dental

Device Facts

• Record ID: K982318
• Device Name: SPECTRUM 800 CURING UNIT
• Applicant: Dentsply Intl.
• Product Code: EBF · Dental
• Decision Date: Sep 15, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2

Intended Use

The SPECTRUM™ 800 CURING UNIT provides visible light irradiation for the curing of dental VLC resin products.

Device Story

The SPECTRUM™ 800 CURING UNIT is a visible light-emitting photopolymerization device used in dental clinics to cure VLC resin materials. The device utilizes a light bulb to emit visible light, which is filtered to a specific wavelength range to initiate polymerization. Operators (dentists or dental staff) use the device to harden dental restorations. Key features include an adjustable light intensity dial, allowing the operator to match intensity to specific restoration requirements, and a built-in digital radiometer to monitor output performance. The device provides consistent light irradiation, ensuring quality curing of dental resins, which benefits the patient by facilitating the hardening of restorative materials.

Clinical Evidence

Bench testing only.

Technological Characteristics

Visible light photopolymerization unit. Features a light bulb, optical filter for wavelength control, and a built-in digital radiometer. Includes an intensity adjustment dial for output control. Operates via visible light irradiation.

Indications for Use

Indicated for the curing of dental visible light-cured (VLC) resin products in a clinical dental setting.

Regulatory Classification

Identification

Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.

Predicate Devices

• Spectrum™ Curing Light (K951425)

Submission Summary (Full Text)

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SEP 1 5 1998

DENTSPLY

## 510(k) SUMMARY

NAME & ADDRESS:

## DENTSPLY International

570 West College Avenue P.O. Box 872 York, PA 17405-0872 [phone] 777 8542343

P. J. Lehn Telefax [phone]

CONTACT: P. Jeffery Lehn

June 29, 1998 DATE PREPARED:

TRADE OR PROPRIETARY NAME: SPECTRUM™ 800 CURING UNIT

CLASSIFICATION NAME: Unclassified

Visible light activator for polymerization COMMON OR USUAL NAME:

Spectrum™ Curing Light K951425 PREDICATE DEVICES:

DEVICE DESCRIPTION: The SPECTRUM™ 800 CURING UNIT is a visible light emitting photopolymerization unit that produces light used to photoactivate dental resin products.

INTENDED USE: The SPECTRUM™ 800 CURING UNIT provides visible light irradiation for the curing of dental VLC resin products.

TECHNOLOGICAL CHARACTERISTICS: The SPECTRUM™ 800 CURING UNIT is identical to the Spectrum™ Curing Light (K951425) except for cosmetic changes to the appearance and operating features and an increased wattage light bulb. The same filter used for the Spectrum™ Curing Light is used for the SPECTRUM™ 800 CURING UNIT and controls the wavelength of light that is emitted by the unit. Both curing units feature a radiometer built into the base. However, the SPECTRUM™ 800 CURING UNIT radiometer is a digital type, whereas the Spectrum™ Curing Light radiometer is a red light/green light type.

An additional difference in the SPECTRUM™ 800 CURING UNIT from the Spectrum™ Curing Light is the intensity adjustment feature of the light. The operator can dial the intensity of the light. This feature will ensure the operator quality repeat output performance every time the light is used. This feature also allows the operator the ability to match the restoration type with the intensity required.

We believe that the similarity of the SPECTRUM™ 800 CURING UNIT to the predicate device and the performance and safety data provided support the safety and effectiveness of the SPECTRUM™ 800 CURING UNIT for the indicated use.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the logo is a stylized image of a caduceus, a symbol often associated with healthcare. The caduceus in the logo is composed of three intertwined lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 5 1998

Mr. P. Jeffrey Lehn Director, Corporate Compliance and Requlatory Affairs DENTSPLY International 570 West College Avenue P.O. Box 872 York, Pennsylvania 17405-0872

Re : K982318 Spectrum 800 Curing Unit Trade Name: Requlatory Class: II Product Code: EBF June 29, 1998 Dated: Received: July 2, 1998

Dear Mr. Lehn:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbrandinq and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ದ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Lehn

This letter will allow you to beqin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain:html".

Sincerely yours,

Timothy A. Ulatowski

Directbr Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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## PREMARKET NOTIFICATION

## INDICATIONS FOR USE STATEMENT

(As Required by 21 CFR 801.109)

510(K) Number:

Device Name:

SPECTRUM™ 800 CURING UNIT

ﺪ ﺍﻟﻤﺪﻳﻨﺔ ﺍﻟﻤﻨﺘﺠﺎﺕ ﺍﻟ

The SPECTRUM™ 800 CURING UNIT provides visible light irradiation for the curing of dental VLC resin products.

Concurrence of CDRH, Office of Device Evaluation (ODE)

ﻠﺴ Prescription Use

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

Susan Curry

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number .

00007