OPALDAM

K971284 · Ultradent Products, Inc. · EIG · Jun 3, 1997 · Dental

Device Facts

• Record ID: K971284
• Device Name: OPALDAM
• Applicant: Ultradent Products, Inc.
• Product Code: EIG · Dental
• Decision Date: Jun 3, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4565
• Device Class: Class 1

Intended Use

OpalDam resin is used to protect soft tissue adjacent to the teeth during in-office bleaching. OpalDam is used with Opalescence Xtra (35% hydrogen peroxide) "power" bleaching agent.

Device Story

OpalDam is a resin-based material applied by dental professionals to gingival tissue during in-office tooth whitening procedures. It acts as a physical barrier to protect soft tissue from contact with high-concentration (35%) hydrogen peroxide bleaching agents. The material is applied directly to the tissue, providing isolation during the bleaching process, and is removed by the clinician following treatment. It serves to prevent chemical irritation or burns to the gingiva.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Resin-based material; light-cured or chemically cured barrier; supplied in syringe form for manual application; intended for single-use in a clinical dental setting.

Indications for Use

Indicated for protection of soft tissue adjacent to teeth during in-office bleaching procedures using 35% hydrogen peroxide bleaching agents. For prescription use only.

Regulatory Classification

Identification

A dental hand instrument is a hand-held device intended to perform various tasks in general dentistry and oral surgery procedures. The device includes the operative burnisher, operative amalgam carrier, operative dental amalgam carver, surgical bone chisel, operative amalgam and foil condenser, endodontic curette, operative curette, periodontic curette, surgical curette, dental surgical elevator, operative dental excavator, operative explorer surgical bone file, operative margin finishing file, periodontic file, periodontic probe, surgical rongeur forceps, surgical tooth extractor forceps, surgical hemostat, periodontic hoe, operative matrix contouring instrument, operative cutting instrument, operative margin finishing periodontic knife, periodontic marker, operative pliers, endodontic root canal plugger, endodontic root canal preparer, surgical biopsy punch, endodontic pulp canal reamer, crown remover, periodontic scaler, collar and crown scissors, endodontic pulp canal filling material spreader, surgical osteotome chisel, endodontic broach, dental wax carver, endodontic pulp canal file, hand instrument for calculus removal, dental depth gauge instrument, plastic dental filling instrument, dental instrument handle, surgical tissue scissors, mouth mirror, orthodontic band driver, orthodontic band pusher, orthodontic band setter, orthodontic bracket aligner, orthodontic pliers, orthodontic ligature tucking instrument, forceps, for articulation paper, forceps for dental dressing, dental matrix band, matrix retainer, dental retractor, dental retractor accessories, periodontic or endodontic irrigating syringe, and restorative or impression material syringe.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

JUN - 3 1997

Mr. Chester McCoy
Regulatory Affairs & Quality Assurance Manager
Ultradent Products, Incorporated
505 West 10200 South
South Jordan, Utah 84065

Re: K971284
Trade Name: Opaldam
Regulatory Class: I
Product Code: EIG
Dated: April 5, 1997
Received: April 7, 1997

Dear Mr. McCoy:

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 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 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 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. McCoy

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 at [phone].

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

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Page 1 of 1

510(k) Number (if known): Unknown K971284

Device Name: OpalDam

Indications For Use:

OpalDam resin is used to protect soft tissue adjacent to the teeth during in-office bleaching. OpalDam is used with Opalescence Xtra (35% hydrogen peroxide) "power" bleaching agent.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runne

(Division Sign-Off)

Division of Dental, Infection Control.

and General Hospital Devices

510(k) Number K971284

Prescription Use: ☑ (Per 21 CFR 801.109)

OR

Over-The-Counter Use: ☐ (Optional Format 1-2-96)