(40 days)
Not Found
No
The device is described as an orally applied gel and there is no mention of AI, ML, or any related concepts in the summary.
Yes
Brace Eze is intended to provide relief from discomfort and irritation, which aligns with the definition of a therapeutic device.
No
Explanation: The device is intended to provide relief from discomfort and irritation caused by orthodontic braces, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states that Brace Eze is an "orally applied gel," indicating it is a physical substance, not software.
Based on the provided information, Brace Eze is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Brace Eze's Function: Brace Eze is an orally applied gel that is applied to orthodontic brackets to provide physical relief from irritation. It does not analyze any biological samples from the body to diagnose or monitor a condition.
- Intended Use: The intended use is to provide relief from discomfort, not to diagnose or detect a disease or condition.
Therefore, Brace Eze falls outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of Brace Eze is as a setting gel, which provides relief of the discomfort and irritation caused by orthodontic braces to the inside of the cheek and lips.
Brace Eze is intended to provide relief from the discomfort and irritation to the inside of the cheek and lips caused by orthodontic brace.
Product codes (comma separated list FDA assigned to the subject device)
EGD
Device Description
Brace Eze is an orally applied gel that is applied to the brackets of orthodontic braces.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
inside of the cheek and lips
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.
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
§ 872.6890 Intraoral dental wax.
(a)
Identification. Intraoral dental wax is a device made of wax intended to construct patterns from which custom made metal dental prostheses, such as crowns and bridges, are cast. In orthodontic dentistry, the device is intended to make a pattern of a patient's bite to make study models of the teeth.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.
0
Image /page/0/Picture/0 description: The image shows a logo with the letters "UNT" in a stylized font. Below the logo, the words "Dentistry has a Homepage" are written in a smaller font. The logo and text are in black and white.
FEB 1 1 2002
UDENT, INC. P.O. Box 58 Chino Hills. CA 91709 Phone: (909) 623-0409 Fax: (909) 623-9915 Email: info@udent.com
KU20009
Chapter 8 - 510(k) Summary
Submitter:
UDENT, Inc. 676 Fairplex Drive Pomona, CA 91768 Phone: 909-623-0409 Fax: 909-623-9915 Contact: Manar M. Jamal, DDS Email: manar@udent.com
Date of Submission: December 28, 2001
Device Name:
Trade name: Common name: Classification name:
Brace Eze Orthodontic brace irritation relief Orthodontic: Appliance & Accessories (per 21 CFR section 880.6250)
Description of Device:
Brace Eze is an orally applied gel that is applied to the brackets of orthodontic braces.
The Intended Use of Device:
The intended use of Brace Eze is as a setting gel, which provides relief of the discomfort and irritation caused by orthodontic braces to the inside of the cheek and lips.
Device for Which Substantial Equivalence is Claimed:
Ortho Wax
Substantial Equivalence:
Brace Eze is substantial equivalent to other legally marketed devices in the United States. Brace Eze functions in a manner similar to and is intended for the same use as Ortho Wax cleared for marketing for Heraeus Kulzer, Inc (K924024).
1
Image /page/1/Picture/1 description: The image is a black and white circular seal. The seal contains the symbol of the United States Department of Health and Human Services, which is an abstract image of an eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 1 2002
Dr. Manar M. Jamal President UDENT, Incorpoated 676 Fairplex Drive Pomona, California 91768
Re: K020009
Trade/Device Name: Brace Eze Regulation Number: 872.6890 Regulation Name: Intraoral Dental Wax Regulatory Class: I Product Code: EGD Dated: December 28, 2001 Received: January 02, 2002
Dear Dr. Jamal:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
2
You must comply with all the Act's requirements, including, but not limited to: registration r od intest comply with and any labeling (21 CFR Part 801); good manufacturing practice and ilsuing (21 OF RT Lev (0)); in the quality systems (QS) regulation (21 CFR Part 820); and if requirences as bet form nroduct radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section I ins least will and w you to over and A 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 If you desire up 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and Office of Configitance are, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and the receint of to verailirs toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Timoth Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Chapter 15 - Indications For Use
510(k) Number: K020009
Device Name: Brace Eze
Indications For Use:
Brace Eze is intended to provide relief from the discomfort and irritation to the inside of the cheek and lips caused by orthodontic brace.
Over-the-Counter Use
Siver Russer
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices NOO 510(k) Number _