BARI-KAD PACKING DEVICE

K050318 · Bioenvelop Agro, Inc. · EIE · Mar 4, 2005 · Dental

Device Facts

• Record ID: K050318
• Device Name: BARI-KAD PACKING DEVICE
• Applicant: Bioenvelop Agro, Inc.
• Product Code: EIE · Dental
• Decision Date: Mar 4, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6300
• Device Class: Class 1

Intended Use

Bari-Kad™ is a device intended to protect soft tissue and isolate a tooth or a series of teeth from paste in the mouth during dental procedures, such as teeth whitening.

Device Story

Bari-Kad™ is a dental accessory used to protect soft oral tissues and isolate teeth during procedures like teeth whitening. It acts as a physical barrier to prevent contact between dental pastes and surrounding soft tissue. Used in a clinical dental setting by a dentist or dental professional. The device provides a protective shield, reducing the risk of tissue irritation or chemical exposure from dental materials during treatment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical barrier device for dental isolation. Materials and specific dimensions not detailed in the provided text. Non-powered, manual device.

Indications for Use

Indicated for patients undergoing dental procedures, such as teeth whitening, requiring soft tissue protection and isolation of teeth from dental pastes.

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)

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol of an eagle or bird with three curved lines representing the wings and a wavy line representing the body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 4 - 2005

BioEnvelop Agro, Incorporated C/O Robert Schiff, PhD President Schiff & Company 1129 Bloomfield Avenue West Caldwell, New Jersey 07006

Re: K050318

Trade/Device Name: Bari-Kad™ Packing Device Regulation Number: 21 CFR 872.6300 Regulation Name: Rubber Dam and Accessories Regulatory Class: I Product Code: EIE Dated: February 08, 2005 Received: February 11, 2005

Dear Dr. Schiff:

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 Eederal Register.

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

## Page 2 - Robert Schiff, PhD

Please be advised that FDA's issuance of a substantial equivalence determination does not mean 1 lease be advised that 1 271 b seian that your device complies with other requirements of the Act or that I Drin has mude a acceministered by other Federal agencies. You must comply with all 1 cacial success and regulading, but not limited to: registration and listing (21 CFR Part 807); an the Ave requirements) ; good manufacturing practice requirements as set forth in the quality labeling (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) I mis letter will and my your e FDA finding of substantial equivalence of your device to a legally prematicated notified on " 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 n you attire office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small general informational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chiu S. Liu, Ph.D.

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

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

2050318

## INDICATIONS FOR USE STATEMENT

510(k) Number (if known): Device Name:

Not yet assigned. Packing Device

Indications for Use:

Bari-Kad™ is a device intended to protect soft tissue and isolate a tooth or a series of teeth from paste in the mouth during dental procedures, such as teeth whitening.

Prescription Use_X

Over-The-Counter Use

(Per 21 CFR 801 Subpart D)

(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)

Susan Pearce

Mision Sign-Off) asion of Anesthesiology, General Hospital, rection Control, Dental Devices

Number: K050318