(57 days)
Bonding of direct composite restorations (including Polyglas® and Compomer) .
Bonding of indirect restoration in combination with a light-curing luting cement . Porcelain, Polyglas®, and composite restorations (inlays, onlays, veneers, rowns).
Sealing hypersensitive areas of teeth. .
Not Found
I apologize, but the provided text from the FDA 510(k) clearance letter for the HKBond 2006 device does not contain the detailed information necessary to answer your request regarding acceptance criteria and a study proving the device meets those criteria.
The 510(k) letter primarily addresses:
- Substantial equivalence determination: It states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices. This implies that the new device performs as well as, or is as safe and effective as, existing devices for the stated indications.
- Regulatory information: It outlines the regulation number, regulation name, and product code.
- Indications for Use: It specifies how the device is intended to be used (bonding direct composite restorations, bonding indirect restorations, and sealing hypersensitive areas of teeth).
- Compliance requirements: It reminds the manufacturer of various regulatory requirements they must adhere to.
Missing Information:
The document does not include:
- A table of acceptance criteria and reported device performance: While the equivalence determination implies performance is comparable, specific metrics and targets are not given.
- Sample size and data provenance for a test set: There's no mention of a specific study or test set details.
- Number and qualifications of experts for ground truth: No information about expert involvement in a study.
- Adjudication method: Not discussed.
- MRMC comparative effectiveness study: No mention of such a study or effect size.
- Standalone performance study: Not explicitly detailed.
- Type of ground truth used: Not specified.
- Sample size for the training set: Not applicable for this type of medical device clearance, as it's not an AI/ML device that undergoes model training in the typical sense.
- How ground truth for the training set was established: See point 8.
For a medical device like HKBond 2006 (a resin tooth bonding agent), the "study" proving it meets acceptance criteria would typically involve bench testing (e.g., bond strength, fluoride release, cytotoxicity), material characterization, and potentially clinical evaluations (though often not full-scale trials for 510(k) clearance when substantial equivalence to a well-understood predicate is established). The acceptance criteria for these tests would be based on recognized standards and predicate device performance, but these details are not present in this FDA letter.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health and Human Services (USA). The logo features a stylized eagle with three curved lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES (USA)" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 1 2006
Ms. Cheryl V. Zimmerman Director, Regulatory Affairs Heraeus Kulzer, Incorporated 4315 South Lafayette Boulevard South Bend, Indiana 46614-2517
Re: K063062
Trade/Device Name: HKBond 2006 Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: September 28, 2006 Received: October 05, 2006
Dear Ms. Zimmerman:
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.
{1}------------------------------------------------
Page 2 - Ms. Cheryl V. Zimmerman
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. 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 requirements as set forth in 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 510(k) premarket notification. The 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Clare
Chiu S. Lin, PhD Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known):
Device Name:
Indications for Use:
Prescription Use
(Part 21 CFR 801 Subpart D)
- Bonding of direct composite restorations (including Polyglas® and Compomer) .
- Bonding of indirect restoration in combination with a light-curing luting cement . Porcelain, Polyglas®, and composite restorations (inlays, onlays, veneers, rowns).
- Sealing hypersensitive areas of teeth. .
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF
NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runyon
0-2-139 a of Anesthesiology, General M. on Control, Dental Devices
NC063062
Page 1 of _ 1
Image /page/2/Picture/16 description: The image shows the words "Heraeus Kulzer" stacked on top of each other. The text is in a bold, sans-serif font and is white in color. The background is dark and textured. The words are likely the name of a company or product.
§ 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.