(71 days)
Heliomolar HB is a light-curing, radiopaque microfilled composite specifically designed for posterior restorations. The Translucent shades are to be used as a top lor the restoration to further enhance the esthetic appearance.
Heliomolar HB is a light-curing, radiopaque microfilled composite specifically designed for posterior restorations. The Translucent shades are to be used as a top lor the restoration to further enhance the esthetic appearance.
The provided text is a set of FDA correspondence letters and a form. It does not contain any information about acceptance criteria, study details, device performance, sample sizes, ground truth establishment, or expert qualifications for a medical device.
The document is a 510(k) premarket notification letter for a dental composite filling material, "Heliomolar HB Translucent Shades" (K013929). It confirms that the device is substantially equivalent to legally marketed predicate devices.
Therefore, I cannot fulfill your request for information regarding acceptance criteria and study details from the provided text.
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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.
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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
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| 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) |
|---|---|
| --------------- | ---------------------------------------- |
§ 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.