(142 days)
Not Found
Not Found
No
The provided 510(k) summary does not contain any mention of AI, ML, image processing, or any other indicators typically associated with AI/ML technology in medical devices. The device is described as a "Tooth Desensitizer," which is a common non-AI/ML medical device type.
Yes
The device is described as a "Tooth Desensitizer," which indicates it is intended to alleviate or reduce tooth sensitivity, thereby providing a therapeutic benefit.
No
The device is a "Tooth Desensitizer," which is used for treatment (desensitizing teeth) rather than for diagnosing a condition.
Unknown
The provided 510(k) summary lacks a "Device Description" section, which is crucial for determining if the device is software-only. Without this information, it's impossible to ascertain if the device includes hardware components or is solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is a "Tooth Desensitizer". This indicates a direct application to the tooth for a therapeutic purpose (reducing sensitivity).
- Anatomical Site: The anatomical site is the "Tooth". This is a part of the human body, not a sample taken from the body for analysis.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing information about a disease or condition based on sample analysis
- Using reagents or assays
IVDs are devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. A tooth desensitizer acts directly on the tooth itself.
N/A
Intended Use / Indications for Use
Tooth Desensitizer Indications For Use:
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Product codes
KLE
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.
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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 0 2004
Ms. Marlene Tietjen Senior Vice President, Scientific Affairs DEL Pharmaceuticals, Incorporated 178 EAB Plaza P.O. Box 9357 Uniondale, New York 11553-9357
Re: K041680
Trade/Device Name: Orajel (R) Advanced Tooth Desensitizer Regulation Number: 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: October 5, 2004 Received: October 6, 2004
Dear Ms. Tietjen:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed yoursed the device is substantially equivalent (for the relerenced above and have determined to tegally marketed predicate devices marketed in murcations for use sutted in May 28, 1976, the enactment date of the Medical Device mensiale commerce prior to they been reclassified in accordance with the provisions of Amendinents, or to do rough and the Act (Act) that do not require approval of a premarket the rederal I vod; Drug, and Ocemenay, therefore, market the device, subject to the general approvin application (fthe Act. The general controls provisions of the Act include controls provisions of the ristration, 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 IT your device is olabsitional controls. Existing major regulations affecting (1 Mrs), it may of subject to Basic of Federal Regulations, Title 21, Parts 800 to 898. In your device earl of found in the be announcements concerning your device in the Federal Register.
1
Page 2 - Ms. Tietjen
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA $ Issualice of a substances complies with other requirements
mean that FDA has made a determination that your device Federal agencies mean that FDA has made a decermination that Jour and inistered by other Federal agencies.
of the Act or any Federal statutes and regulations administered to: positration of the Act of any rederal statutes and registerents, including, but not limited to: registration
You must comply with all the Act's requirements and measuficaturing progrise Y ou must comply with an the Fec 3 requires (21 CFR Part 801); good manufacturing practices
and listing (21 CFR Part 807); labeling (21 CFR Part 801); gEP Rart 800); and i and listing (21 CFK Pat 807), laceling (21 OFF Crice as a sees), g
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the quality systems (SD) regions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your device to o This letter will anow you to begil maries. A 3 on a finding of your device to a premarket notification. The I Dr Imaing of cassification 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), If you desire specific advice for your de at (240) 276-0115. Also, please note the regulation in entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain other general mironmation on your and Consumer Assistance at its toll-free Division of 01 0 0 6 3 - 2041 or (301) 443-6597 or at its Internet address
Sincerely yours,
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Del Pharmaceuticals, Inc., 510(k) Notification, 6/18/04--Page 3a
Indications for Use
510(k) Number (if known): K041680
JTO(K) Nambar (Maran)
Device Name: Oraje1(R) Advanced Tooth Desensitizer
Tooth Desensitizer Indications For Use:
Prescription Use (Part 21 CFR 801 Subpart D) . AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Devices Evaluation (ODE)
Smar Ruppe
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number:
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