(60 days)
Not Found
Not Found
No
The summary does not mention AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The intended use and device description (though not found) point towards a dental restorative material.
Yes.
The device is intended for restoration, sealing, and adjustments of teeth, which are all methods of treating or mitigating a disease or injury.
No
The "Intended Use / Indications for Use" section describes the device's function as being for sealing, restoring, correcting, and lining teeth, which are all treatment and modification procedures, not diagnostic ones.
No
The 510(k) summary describes a material intended for dental restorations and procedures, which is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes procedures performed directly on the patient's teeth (sealing, restorations, splinting, etc.). IVDs are used to examine specimens taken from the body (like blood, urine, tissue) to diagnose or monitor conditions.
- Anatomical Site: The anatomical site is "teeth," which are part of the patient's body, not a specimen being tested in vitro.
- Lack of IVD Characteristics: The description lacks any mention of analyzing biological samples, using reagents, or providing diagnostic information based on laboratory testing.
Therefore, this device is a dental material used for direct application to teeth, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This material is intended for extended pit and fissure sealing; class V restoration, minimal invasive restorations of class I, II and III; slight form and shade corrections of enamel; splinting of teeth after traumatic impact; adjustments of congenital tooth defects (e.g. enamel hypoplasis); cavity lining in class I and II restorations.
Product codes
EBF
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle's head and neck, depicted with three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
7 1999 MAY
Ms. Cheryl V. Zimmerman Heraeus Kulzer, Incorporated Dental Products 4315 South Lafayette Boulevard South Bend, Indiana 46614-2517
Re : K990756 Flow Line Trade Name: Requlatory Class: II Product Code: EBF Dated: April 22, 1999 Received: April 26, 1999
Dear Ms. Zimmerman:
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 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). You may, therefore, market the device, subject to the general The general controls controls provisions of the Act. provisions of the Act include requirements for annual reqistration, 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. ਚੋ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (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 Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
1
Page 2 - Ms. Zimmerman
through 542 of the Act for devices under the Electronic through 542 of the Act 101 devices or other Federal laws or regulations.
This letter will allow you to begin marketing your device as Inis icceci will as a (k) premarket notification. The FDA described in your 510 (i) promatence of your device to a legally linding of substancial equivalence of polassification for your marketed prodically wours your device to proceed to the market.
If you desire specific advice for your device on our labeling II you debire bportunit 801 and additionally 809.10 for in regulacion (ar elevices), please contact the Office of Victo dragnobere at (301) 594-4692. Additionally, for questions on compriation 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" (21CFR 807.97). Other general premation on your responsibilities under the Act may be Information of Small Manufacturers Assistance obcarned from cho mumber (800) 638-2041 or (301) 443-6597 or at its internet address
"http://www.fda.gov/cdrh/dsma/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
499075
Page_1__of__1_
K990756 510(k) Number (if Known):
Device Name: Flow Line
Indications For Use:
This material is intended for extended pit and fissure sealing; class V restoration, minimal invasive restorations of class I, II and III; slight form and shade corrections of enamel; splinting of teeth after traumatic impact; adjustments of congenital tooth defects (e.g. enamel hypoplasis); cavity lining in class I and II restorations.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device evaluation (ODE)
| (Division Sign-Off) | |
| Division of Dental, Infection Control, | |
| and General Hospital Devices | |
| 510(k) Number | K990756 |
| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| --------------------------------------- | ---- | ---------------------- |
(Optional Format 1-2-96)