PA GEL 35% IN BLUE AND PA GEL 10% IN GREEN OR BLUE

K993716 · Harry J. Bosworth Co. · EBF · Dec 21, 1999 · Dental

Device Facts

• Record ID: K993716
• Device Name: PA GEL 35% IN BLUE AND PA GEL 10% IN GREEN OR BLUE
• Applicant: Harry J. Bosworth Co.
• Product Code: EBF · Dental
• Decision Date: Dec 21, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2

Intended Use

PA GEL 35% AND PA GEL 10% are indicated for use when etching of tooth dentin or enamel is required before bonding to the tooth structure. Ten percent concentration is indicated for either tooth dentin or enamel etching. Thirty-five percent concentration is indicated only for tooth enamel etching.

Device Story

PA Gel 35% and 10% are phosphoric acid-based etching agents used in dental procedures. Applied by dental professionals to tooth surfaces to prepare dentin or enamel for bonding. The acid etchant modifies the tooth surface to facilitate adhesion of restorative materials. Used in clinical dental settings. Benefits include improved bond strength between tooth structure and restorative materials.

Clinical Evidence

Bench testing only.

Technological Characteristics

Phosphoric acid-based etching gel. Available in 35% and 10% concentrations. Formulated as a gel for topical application to tooth structure.

Indications for Use

Indicated for patients requiring tooth dentin or enamel etching prior to bonding procedures. 10% concentration for dentin or enamel; 35% concentration for enamel only.

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.

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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized symbol featuring three human profiles facing right, with flowing lines above them that resemble wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 1 1999

Ms. Mildred M. Goldstein, President Harry J. Bosworth 7227 North Hamlin Avenue Skokie, Illinois 60076

Re: K993716 PA Gel 35% in blue and PA Gel 10% in green Trade Name: or blue Regulatory Class: II Product Code: EBF October 27, 1999 Dated: Received: November 2, 1999

Dear Ms. Goldstein:

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 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A 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 requlation 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

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

Page 2 - Ms. Goldstein

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.

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 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

Timot Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Page 1 of 1

510(K) Number: K993716

Device Name: P A Gels 35% and 10%

## INDICATIONS FOR USE:

PA GEL 35% AND PA GEL 10% are indicated for use when etching of tooth dentin or enamel is required before bonding to the tooth structure. Ten percent concentration is indicated for either tooth dentin or enamel etching. Thirty-five percent concentration is indicated only for tooth enamel etching.

Image /page/2/Picture/5 description: The image shows the word "CONFIDENTIAL" in large, bold letters. The word is slightly tilted upwards from left to right. The letters are somewhat faded and have a textured appearance, giving the impression that the word has been stamped or printed onto a surface.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

是非常的不同可能量的是用品不可是在的点面是可用可用的出租用用用

| Prescription Use<br>(Per 21 CFR 801.109) | |
|------------------------------------------|--|
|------------------------------------------|--|

OR

| Over-the-Counter Use<br>(Optional Format 1/2/96) | |
|--------------------------------------------------|--|
|--------------------------------------------------|--|

(Division Sign-Off)

Division of Dental, Infection Control,
and General Hospital Devices

| 510(k) Number | KA93716 |
|---------------|---------|
|---------------|---------|