DYRACT® FLOW RESTORATIVE is used for: Filling of defects and undercuts in crowns, inlays; 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 restorative Class I restorations; and Margin correction/adjustment of composite crowns for indirect laboratory use.

Device Description

DYRACT® FLOW RESTORATIVE is a one-component, moderately filled, visible light cured dental composite restorative material. DYRACT® FLOW RESTORATIVE 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.

AI/ML Overview

The document is a 510(k) summary for the DENTSPLY DYRACT® FLOW RESTORATIVE, a dental composite material. The device's acceptance criteria and the study proving it meets these criteria are outlined in section:

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria	Reported Device Performance
ISO Standard 4049 compliance	Meets ISO Standard 4049.

2. Sample size used for the test set and the data provenance:

The document does not provide details on the sample size used for testing or the data provenance specifically for the DYRACT® FLOW RESTORATIVE. It states that the physical properties meet ISO Standard 4049.

3. Number of experts used to establish the ground truth for the test set and their qualifications:

This information is not provided in the supplied text. The evaluation is based on meeting an international standard (ISO 4049), which implies standardized testing procedures rather than expert ground truth establishment in a clinical context.

4. Adjudication method for the test set:

This information is not provided in the supplied text.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:

No MRMC comparative effectiveness study is mentioned in the document. The submission focuses on the material's physical properties meeting an ISO standard and its components being used in predicate devices.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This question is not applicable as the device is a dental restorative material, not an AI or software device.

7. The type of ground truth used:

The ground truth used for proving the device meets its acceptance criteria is compliance with ISO Standard 4049 for physical properties. This is a technical standard, not a clinical ground truth like pathology or outcomes data.

8. The sample size for the training set:

This information is not applicable as the device is a dental restorative material, not an AI or software device requiring a training set in that context. The "training" in this context would refer to the development and formulation of the material.

9. How the ground truth for the training set was established:

This information is not applicable in the context of an AI training set. The development of the dental restorative material would have involved material science and chemical engineering principles, with "ground truth" being established through iterative testing and formulation to achieve desired physical and chemical properties and biocompatibility. The document notes that "All of the components found in DYRACT® FLOW RESTORATIVE have either been used in predicate dental devices or have been found safe for dental use," and that "prior use of the components... performance data, and the biocompatibility data provided support the safety and effectiveness." This suggests that previous research and testing on individual components contributed to the "ground truth" for developing the final device.

Summary

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AUG 18 1998

K982395

510(k) SUMMARY

DENTSPLY

NAME & ADDRESS:

DENTSPLY International

570 West College Avenue P.O. Box 872 York, PA 17405-0872 (717) 845-7511 Fax 17171 854-2343

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

P. Jeffery Lehn CONTACT:

JUL 0 8 1998 DATE PREPARED:

TRADE OR PROPRIETARY NAME:DYRACT® FLOW RESTORATIVE

COMMON OR USUAL NAME: Dental restorative material

CLASSIFICATION NAME:	Tooth shade resin material	872.3690
PREDICATE DEVICE:	Dyract® AP™ RestorativeAeliteflo Composite	K973235 K955292

DEVICE DESCRIPTION: DYRACT® FLOW RESTORATIVE is a one-component, moderately filled, visible light cured dental composite restorative material.

DYRACT® FLOW RESTORATIVE 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 DYRACT® FLOW RESTORATIVE meet ISO Standard 4049. 117 2017

INTENDED USE: DYRACT® FLOW RESTORATIVE is used for: Filling of defects and undercuts in crowns, inlays; 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 restorative Class I restorations; and Margin correction/adjustment of composite crowns for indirect laboratory use.

TECHNOLOGICAL CHARACTERISTICS: All of the components found in DYRACT® FLOW RESTORATIVE 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 DYRACT® FLOW RESTORATIVE in legally marketed predicate devices, the performance data, and the biocompatibility data provided support the safety and effectiveness of DYRACT® FLOW RESTORATIVE for the indicated uses.

000015

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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 features a stylized depiction of an eagle or bird in flight, composed of three curved lines that suggest feathers or wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 8 1998

Mr. P. Jeffrey Lehn Director, Corporate Compliance and Regulatory Affairs DENTSPLY International 570 West College Avenue P.O. Box 872 York, Pennsylvania 17405-0872

Re: K982395 Trade Name: Dyract® Flow Restorative Requlatory Class: II Product Code: EBF Dated: July 8, 1998 Received: July 9, 1998

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, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labelinq, 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. ਚੇ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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 described in your 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 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 the Office of 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,

S. Putman for

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:

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Device Name:

DYRACT® FLOW RESTORATIVE

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)

Prescription Use _____________________________________________________________________________________________________________________________________________________________

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

Surya Raoor

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

000007

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.