(71 days)
Not Found
Not Found
No
The 510(k) summary describes a dental composite material and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device is a composite material used for dental restorations, which is a structural and aesthetic function, not a therapeutic one.
No
The device description states it is a light-curing, radiopaque microfilled composite for posterior restorations, which is a restorative material used in treatment, not for diagnosis.
No
The device description clearly states it is a "light-curing, radiopaque microfilled composite," which is a physical material used in dental restorations, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description clearly states that Heliomolar HB is a "light-curing, radiopaque microfilled composite specifically designed for posterior restorations." This indicates a material used in the body for restorative purposes, not a test performed on samples taken from the body to diagnose or monitor a condition.
- Device Description: The description reiterates its use as a composite for restorations.
- Lack of IVD characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information.
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. Heliomolar HB does not fit this definition.
N/A
Intended Use / Indications for Use
Heliomolar HB is a light-curing, radiopaque microfilled composite specifically designed. Heliomolar HB Translucent shades are to be used as a top lor the restoration to further enhance the esthetic appearance.
Product codes (comma separated list FDA assigned to the subject device)
EBF
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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
§ 872.3690 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 seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, which is a common symbol of the United States.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 0 7 2002
Ms. Donna M. Hartnett Assistant Corporate Counsel Ivoclar Vivadent, Incorporated 175 Pineview Drive Amherst, New York 14228
Re: K013929
Trade/Device Name: Heliomolar HB Translucent Shades Regulation Number: 872.3690 Regulation Name: Dental Composite Filling Material Regulatory Class: II Product Code: EBF Dated: November 20, 2001 Received: November 28 ,2001
Dear Ms. Hartnett:
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.
1
Page 2 - Ms. Hartnett
You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 es rear is the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product 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 11ms lection will and it you're cogne 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 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 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and the rior may of stance at its 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.
Timč A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
2
| 510(k) Number (if known): | Pending K013929 |
|---|---|
| --------------------------- | ----------------- |
Device Name:
HELIOMOLAR HB TRANSLUCENT SHADES
Indications For Use:
Heliomolar HB is a light-curing, radiopaque microfilled composite specifically designed riollomoral THE is a light outing, rather the Translucent shades are to be used as a top lor the restoration to further enhance the esthetic appearance.
(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
| Prescription Use
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use | |
|---|---|---|---|
| ------------------------------------------ | -- | ---- | ---------------------- |
Signature
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
| 510(k) Number | Number (Optional Format 1-2-96) |
|---|---|
| --------------- | ---------------------------------------- |