FLOWABLE COMPOSITE is used for: Filling of defects and undercuts in crowns, inlays and onlays; As a liner under direct restorative materials and under inlay restorations-Class II box liner; Tunnel preparations; Pit and fissure sealants; Amalgam* margin repair; Improving margins of acrylic temporaries; Small class IV repairs; Intraoral porcelain repair; Cementing porcelain veneers, crowns, inlays/onlays; Refacing acrylic temporaries; Blockouts: Covering incisal edge stains; Repair of small enamel defects; Provisional occlusal changes; Class III and V restorations; Conservative Class 1 restorations; and Marqin correction/adjustment of composite crowns for indirect laboratory use.

Device Description

FLOWABLE COMPOSITE is a one-component, moderately filled, visible light cured dental composite restorative material. FLOWABLE COMPOSITE is a low viscosity, esthetic material for use as a composite restorative. It is a moderately filled, radiopaque, fluoride-releasing composite, primarily designed for restoration of shallow defects such as incipient Class V lesions. The physical properties of FLOWABLE COMPOSITE meet ISO Standard 4049.

AI/ML Overview

The provided text is a 510(k) summary for a dental device called "FLOWABLE COMPOSITE." It states that the device's physical properties meet ISO Standard 4049. However, it does not contain any information about acceptance criteria, specific device performance metrics, sample sizes for testing, ground truth establishment, expert qualifications, adjudication methods, or comparative effectiveness studies.

Therefore, I cannot populate the requested table or answer the specific questions about the study that proves the device meets acceptance criteria. The document explicitly states: "The physical properties of FLOWABLE COMPOSITE meet ISO Standard 4049." This is the only "acceptance criteria" mentioned, and the document claims the device meets it, but provides no further details on how this was proven.

Summary

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JUL 10 1998

510(k) SUMMARY

NAME & ADDRESS:

DENTSPLY International 570 West College Avenue P.O. Box 872 York, PA 17405-0872 (717) 845-7511 × (717) 851-2342

Ka8 lalos

P. J. Lehn Telefax (717) 849-4343

الموالي المتحدة المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنت P. Jefferv Lehn CONTACT:

June 3.1998 DATE PREPARED:

TRADE OR PROPRIETARY NAME: FLOWABLE COMPOSITE

COMMON OR USUAL NAME: Dental restorative material 872.3690 CLASSIFICATION NAME: Tooth shade resin material

K940459 PREDICATE DEVICE: Enforce® with Fluoride Cement K955292 Aeliteflo

DEVICE DESCRIPTION: FLOWABLE COMPOSITE is a one-component, moderately filled, visible light cured dental composite restorative material.

FLOWABLE COMPOSITE is a low viscosity, esthetic material for use as a composite restorative. It is a moderately filled, radiopaque, fluoride-releasing composite, primarily designed for restoration of shallow defects such as incipient Class V lesions.

The physical properties of FLOWABLE COMPOSITE meet ISO Standard 4049.

INTENDED USE: FLOWABLE COMPOSITE is used for: Filling of defects and undercuts in crowns, inlays and onlays; As a liner under direct restorative materials and under inlay restorations-Class II box liner; Tunnel preparations; Pit and fissure sealants; Amalgam* margin repair; Improving margins of acrylic temporaries; Small class IV repairs; Intraoral porcelain repair; Cementing porcelain veneers, crowns, inlays/onlays; Refacing acrylic temporaries; Blockouts: Covering incisal edge stains; Repair of small enamel defects; Provisional occlusal changes; Class III and V restorations; Conservative Class 1 restorations; and Marqin correction/adjustment of composite crowns for indirect laboratory use.

TECHNOLOGICAL CHARACTERISTICS: All of the components found in FLOWABLE COMPOSITE have either been used in predicate dental devices or have been found safe for dental use.

We believe that the prior use of the components of FLOWABLE COMPOSITE in legally marketed predicate devices and the performance data provided support the safety and effectiveness of FLOWABLE COMPOSITE for the indicated uses.

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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 eagle or bird-like symbol with three curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1998

Mr. P. Jeffrey Lehn ·Associate Director Corporate Compliance DENTSPLY International 570 West College Avenue P.O. Box 872 York, Pennsylvania 17404

K981965 Re : Flowable Composite Trade Name: Requlatory Class: II Product Code: EMA Dated: June 3, 1997 Received: June 4, 1997

Dear Mr. Lehn:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can-be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਕੇ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Lehn

This letter will allow you to begin marketing your device as Inis lecter will arrow you comment notification. The FDA debeing of substantial equivalence of your device to a legally marketed predicate device results in a classification for your marketed produce and thus, your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact one pionologi and Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda,gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Director

Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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PREMARKET NOTIFICATION

INDICATIONS FOR USE STATEMENT

(As Required by 21 CFR 801.109)

510(K) Number:

K981965

Device Name:

FLOWABLE COMPOSITE

Filling of defects and undercuts in crowns, inlays and onlays;
Liner under direct restorative materials and under inlay restorations-Class II box liner;
Tunnel preparations;
Pit and fissure sealants;
Amalgam margin repair; Improving margins of acrylic temporaries;
Small class IV repairs;
Intraoral porcelain repair;
Cementing porcelain veneers, crowns, inlays/onlays;
Refacing acrylic temporaries;
Blockouts;
Covering incisal edge stains;
Repair of small enamel defects;
Provisional occlusal changes;
Class III, V restorations;
Conservative Class I restorations;
Margin correction/adjustment of composite crowns for indirect laboratory use

Concurrence of CDRH, Office of Device Evaluation (ODE)

000007

Prescription Use

Over-The-Counter Use

(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number 198965

Regulation Number and Section

§ 872.3275 Dental cement.

(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.