(57 days)
Not Found
Not Found
No
The summary describes a resin used for soft tissue protection during bleaching and contains no mention of AI or ML.
No
The device, OpalDam resin, is used for protection during a cosmetic procedure (teeth bleaching) and does not treat or prevent any specific disease, injury, or medical condition.
No
Explanation: The device, OpalDam resin, is used to protect soft tissue during in-office bleaching procedures. Its function is protective and not involved in identifying or diagnosing a condition, disease, or its severity.
No
The device description explicitly states "OpalDam resin," indicating a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "protect soft tissue adjacent to the teeth during in-office bleaching." This is a direct application to the patient's body (soft tissue) for a therapeutic/protective purpose during a dental procedure.
- IVD Definition: In vitro diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Lack of Specimen Analysis: The description of OpalDam resin does not involve the analysis of any specimen taken from the patient. It is a barrier material applied directly to the soft tissue.
Therefore, OpalDam resin, as described, falls under the category of a dental device used for protection during a procedure, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
EIG
Device Description
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Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue adjacent to the teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
in-office
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.4565 Dental hand instrument.
(a)
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.(b)
Classification. Class I (general controls). If the device is made of the same materials that were used in the device before May 28, 1976, it is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/2 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUM SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 3 1997
Mr. Chester McCoy Regulatory Affairs & Quality Assurance Manger Ultradent Products, Incorporated 505 West 10200 South South Jordan, Utah 84065
Re : K971284 Trade Name: Opaldam Requlatory 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 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 requlations 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 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 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 (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638/2041 or at (301) 443-6597.
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
Page_1_of_1_
510(k) Number (if known): . _Unknown _ K 9 71284
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)
Euser Punpa
(Division Sign-Off) Division of Dantal, Infection Control. and General Houpl 510(k) Number
Prescription Use Yes
(Per 21 CFR 801.109)
OR
Over-The-Counter Use$\mu\nu$
(Optional Format 1-2-96)