Herculite Ultra is a light-cured, resin-based, dental restorative designed for direct placement. It is indicated for all cavity classes in anterior and posterior teeth.

AI/ML Overview

The provided text is a 510(k) summary for the Herculite Ultra dental composite restorative material. It serves as a regulatory document to demonstrate substantial equivalence to a predicate device and does not contain information about the acceptance criteria or a study proving the device meets those criteria in the way you've outlined.

Specifically, the document focuses on:

Device Name and Classification: Herculite Ultra, a dental composite restorative material (21 CFR § 872.3690).
Predicate Device: Herculite XRV, Kerr Corporation.
Device Description: Light-cured, resin-based, dental restorative for direct placement in all cavity classes.
Intended Use: Dental composite restorative material for all classes of cavities.
Substantial Equivalence Claim: Herculite Ultra functions similarly to the legally marketed Herculite XRV.
FDA Communication: Formal letter from the FDA indicating review of the 510(k) and a determination of substantial equivalence, allowing the device to be marketed.

Therefore, I cannot provide the requested information from the given text because:

Acceptance Criteria and Reported Device Performance: This document does not specify performance acceptance criteria or report specific performance metrics for Herculite Ultra that would be typically found in a clinical or performance study report.
Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set): The document is a regulatory submission summary for substantial equivalence, not a detailed study report. It does not contain information about specific test sets, ground truth establishment, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or training set details.

A 510(k) submission primarily relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device. This often involves comparing device characteristics (materials, physical properties, intended use) and, where applicable, non-clinical or limited clinical data to show equivalence, rather than establishing de novo performance against acceptance criteria in the way a new drug or novel high-risk device might.

Summary

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K682671

DEC 1 1 2008

Section III - 510(k) Summary of Safety and Effectiveness

Submitter:

Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 (714) 516-7602 - Phone (714) 516-7472 - Facsimile Wendy Garman - Contact Person

Date Summary Prepared: September 2008

Device Name:

· Trade Name Herculite Ultra
· Common Name Dental Composite Restorative Material
· Classification Name -- Tooth Shade Resin Material, per 21 CFR § 872.3690

Device for Which Substantial Equivalence is Claimed:

· Herculite XRV, Kerr Corporation

Device Description:

Herculite Ultra is a light-cured, resin-based, dental restorative designed for direct placement. It is indicated for all cavity classes in anterior and posterior teeth.

Intended Use of the Device:

Herculite Ultra is a dental composite restorative material intended to be used in all classes of cavities.

Substantial Equivalence:

Herculite Ultra is substantially equivalent to another legally marketed device in the United States. Herculite Ultra functions in a manner similar to Herculite XRV, which is currently marketed by Kerr Corporation.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 11 2008

Ms. Wendy Garman Director of Regulatory Affairs Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867

Re: K082671

Trade/Device Name: Herculite Ultra Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: September 12, 2008 Received: September 15, 2008

Dear Ms. Garman:

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.

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Page 2 - Ms. Garman

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 (OS) 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 vours.

Smitley. Michael DMD

Chiu S. Lin. Ph. D Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K08 2671

Indications før Use

510(k) Number (if known):

Device Name: Herculite Ultra

Indications For Use:

Herculite Ultra is a dental composite restorative material intended to be used in all classes of cavities.

Prescription Use Y (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shorl wose

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K950671

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Regulation Number and Section

§ 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.