FASTDAM

K972775 · Interdent, Inc. · EIE · Feb 27, 1998 · Dental

Device Facts

• Record ID: K972775
• Device Name: FASTDAM
• Applicant: Interdent, Inc.
• Product Code: EIE · Dental
• Decision Date: Feb 27, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6300
• Device Class: Class 1

Intended Use

SOFT TISSUE ISOLATION MOISTURE PREVENTION

Device Story

FastDam is a dental device used for soft tissue isolation and moisture control during clinical dental procedures. It functions as a barrier to protect oral tissues and maintain a dry field for the practitioner. Used by dental professionals in a clinical setting. The device aids in procedural efficiency and patient comfort by preventing moisture contamination during restorative or surgical dental work.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Dental isolation barrier; form factor designed for intraoral soft tissue protection. No specific materials or software described.

Indications for Use

Indicated for soft tissue isolation and moisture prevention 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)

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

Image /page/0/Picture/1 description: The image shows a logo with a stylized eagle design on the left. The eagle is composed of several curved lines, creating a sense of movement. To the right of the logo is the word "D" in a large, bold font. The logo is associated with the U.S. Department of Health and Human Services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 7 1998

Mr. William Grondin Director of Sales & Marketing Interdent Incorporated 2230 South Barrington Los Angeles, California 90064

K972775 Re: FastDam Trade Name: Regulatory Class: I Product Code: EIE February 16, 1998 Dated:

February 18, 1998

Dear Mr. Grondin:

Received:

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, Drug, 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes_compliance with_ the current Good Manufacturing Practice requirement, as set forth in the Ouality 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 regulation 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

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

Page 2 - Mr. Grondin

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 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.qov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

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

Enclosure

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

DFT

ー

Page of

| 510(k) Number (if known): | K972775 |
|---------------------------|----------|
| Device Name: | FAST DAM |

Indications For Use:
SOFT TISSUE ISOLATION22 MOISTURE PREVENTION 2

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sueerluser

..............................................................................................................................................................................

(Division Sign-Off) Division of Demal, I n Control and General Hospi 510(k) Number ..

Prescription Use_ (Pcr 21 CFR 801.109) OR

Over-The-Counter Use_

(Optional Formal 1-2-96)