Premise Flowable Modified is a nano-filled, light cure, resin dental restorative suitable for Class I - V restorations. Additional functions include: base/liner material, repair of enamel defects, repair of temporaries, repair of porcelain restorations, minor occlusal build-ups in non-stress bearing area, pit and fissure sealant, cement for ceramic/composite veneers, incisal abrasions and core build-ups.

Device Description

Premise Flowable Modified is a medium viscosity, light-cured, nano filled, resin restorative material, dispensed in a syringe with single-use tips. It is suitable for Class I - V restorations. This nano composite technology incorporates three different fillers resulting in a flowable, yet sculptable and non-slumping material.

AI/ML Overview

The provided text is a 510(k) summary for a dental restorative material. It does not contain information about acceptance criteria, device performance metrics, or any studies involving a test set, expert ground truth, or human-AI comparison.

The document discusses the device's name, description, intended use, and claims of substantial equivalence to a legally marketed predicate device (Premise Flowable by Kerr Corporation). It also includes the FDA's clearance letter.

Therefore, I cannot fulfill your request for the detailed information regarding acceptance criteria and a study proving the device meets them, as that information is not present in the provided text. This document is a regulatory submission summary, not a scientific study report.

Summary

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K093484

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

JAN 2 7 2010

Submitter:

Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 (714) 516-7484 - Phone (714) 516-7472 - Facsimile Wendy Garman - Contact Person

Date Summary Prepared: November 2009

Device Name:

Trade Name Premise Flowable Modified ●
� Common Name - Dental Composite Restorative Material
. Classification Name - Tooth Shade Resin Material, per 21 CFR § 872.3690

Devices for Which Substantial Equivalence is Claimed:

Kerr Dental Materials Center, Premise Flowable .

Device Description:

Intended Use of the Device:

The intended use of Premise Flowable Modified is for use as a resin dental restorative suitable for Class I - V restorations. Additional functions include: base/liner material, repair of enamel defects, repair of temporaries, repair of porcelain restorations, minor occlusal build-ups in non-stress bearing area, pit and fissure sealant, cement for ceramic/composite veneers, incisal abrasions and core build-ups.

Substantial Equivalence:

Premise Flowoble Modified is substantially equivalent to other legally marketed devices in the United States. Premise Flowable Modified functions in a manner similar to and is intended for the same use as Premise Flowable that is currently marketed by Kerr Corporation.

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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with healthcare, featuring a staff with a serpent entwined around it.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002

Kerr Corporation C/O Ms. Wendy German Sybron Dental Specialties, Incorporated Kerr Corporation 1717 West Collins Avenue Orange, California 92867

JAN 2 7 2010

Re: K093484

Trade/Device Name: Premise Flowable Modified Regulation Number: 21CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: November 6, 2009 Received: November 9, 2009

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Nh for

Anthony D. Watson, B.S., M.S., M.B.A. 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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Indications for Use

510(k) Number (if known):

K093484

Device Name: Premise Flowable Modified

Indications For Use:

Prescription Use (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)

Sotz, DO.

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

510(k) Number:

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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.