POWER BLOCK

K983227 · Kreativ, Inc. · EIE · Dec 11, 1998 · Dental

Device Facts

• Record ID: K983227
• Device Name: POWER BLOCK
• Applicant: Kreativ, Inc.
• Product Code: EIE · Dental
• Decision Date: Dec 11, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6300
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

PowerBlock is a white, light reflective, paint on dam which, when light cured, will form a semi-plastic barrier which protects gingival tissue.

Device Story

PowerBlock is a light-curable, white, light-reflective material applied as a paint-on dam. Used by dental professionals to create a semi-plastic barrier over gingival tissue. The barrier protects the gingiva from potential irritation or damage during dental procedures. The device is applied manually and cured using a dental light source.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Light-curable, white, light-reflective paint-on material. Forms a semi-plastic barrier upon curing. Intended for dental application.

Indications for Use

Indicated for use as a protective barrier for gingival tissue during dental procedures.

Regulatory Classification

Identification

A rubber dam and accessories is a device composed of a thin sheet of latex with a hole in the center intended to isolate a tooth from fluids in the mouth during dental procedures, such as filling a cavity preparation. The device is stretched around a tooth by inserting a tooth through a hole in the center. The device includes the rubber dam, rubber dam clamp, rubber dam frame, and forceps for a rubber dam clamp. This classification does not include devices intended for use in preventing transmission of sexually transmitted diseases through oral sex; those devices are classified as condoms in § 884.5300 of this chapter.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

nFC 1 1 1998

Mr. Joseph M. Forehand Vice President and General Manager Kreativ, Incorporated 9025 Balboa Avenue 92123-1509 San Diego, California

K983227 Re: Power Block Trade Name: Requlatory Class: II EIE Product Code: Dated: November 18, 1998 November 23, 1998 Received:

Dear Mr. Forehand:

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 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. 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

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Page 2 - Mr. Forehand

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin 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 requlation (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" (21CFR 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/dsma/dsmamain.html".

Sincerely yours,

Patricia Cucinitto

Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications Statement

510(k) Number: K983227

Device Name:

PowerBlock

Indication for Use:

PowerBlock is a white, light reflective, paint on dam which, when light cured, will form a semi-plastic barrier which protects gingival tissue.

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Concurrence of (;DRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over the Counter Use_

Optional Format 1-2-96

Sandra L. Elvire, DMD for MSR
(Division Sign Off)

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

OR