COMPOSITE 168 RESTORATIVE SYSTEM is to be used with Prime & Bond™ 2.1 Universal Light Cured Dental Adhesive System: • Indicated for cavity Classes I, II, III, IV, V, and VI in anterior and posterior teeth. •May be used as a direct restorative material ·May be used for fabrication of inlays and onlays

Device Description

COMPOSITE 168 RESTORATIVE is a visible light activated, radiopaque restorative material for anterior and posterior restorations of primary and permanent teeth. It is to be used with Prime & Bond 2.1 Universal Light Cured Dental Adhesive System. This one-component. VLC composite restorative is packaged in unit dose or svringes.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the "COMPOSITE 168 RESTORATIVE SYSTEM" based on the provided text.

This document describes a 510(k) premarket notification for a dental restorative material, which primarily relies on demonstrating substantial equivalence to a predicate device rather than presenting novel clinical study data for new performance claims. Therefore, some of the requested information (like MRMC studies, specific sample sizes for test sets, number of experts for ground truth, etc.) is not explicitly detailed in the provided summary as it's not typically required for a substantial equivalence determination based on physical properties and known biocompatibility.

Device Name: COMPOSITE 168 RESTORATIVE SYSTEM

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Set by Standard or Predicate Equivalence)	Reported Device Performance
Physical Properties: Meets ISO Standard 4049	Meets ISO Standard 4049
Biocompatibility: Negative Ames test results for main components and prior use of components in legally marketed devices (K863092 and K941899) supporting safety and effectiveness	Ames test results were negative. Prior use of components is asserted to support biocompatibility.
Intended Use: Equivalent to predicate device K941899 (SDI Composites) for Class I-VI restorations in anterior and posterior teeth, direct restorative, and fabrication of inlays/onlays.	Intended use stated to be substantially equivalent to K941899.
Technological Characteristics: Substantially equivalent in composition to predicate device K863092 (dental composite restorative).	Stated as substantially equivalent in composition.

2. Sample Size Used for the Test Set and Data Provenance

The 510(k) summary does not mention a specific "test set" in the context of clinical performance evaluation with human subjects.
The evaluation is centered on physical property testing according to ISO Standard 4049 and biocompatibility testing (Ames test). The sample sizes for these tests are not provided in the summary.
Data Provenance: The document implies in-house or contracted laboratory testing for physical properties and biocompatibility. There is no mention of country of origin for data or whether it was retrospective or prospective in a clinical sense.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not applicable or provided in the 510(k) summary. The ground truth for physical properties is defined by adherence to the ISO Standard 4049. Biocompatibility ground truth is established by standard laboratory tests (Ames test) and prior regulatory acceptance of component materials.

4. Adjudication Method for the Test Set

This information is not applicable or provided. The evaluation is based on objective measurements against a standard (ISO 4049) and laboratory test results.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done or required for this 510(k) submission. This type of study (comparing human readers with and without AI assistance) is for diagnostics and AI-powered decision support systems, not for dental restorative materials making claims about physical properties and substantial equivalence.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone algorithm performance study was not done. This device is a physical dental material, not an algorithm or AI system.

7. The Type of Ground Truth Used

For physical properties: Adherence to ISO Standard 4049 for dental resin-based filling materials.
For biocompatibility: Results of Ames testing (negative) and historical regulatory acceptance/prior use of the constituent components.
For intended use and technological characteristics: Substantial equivalence to predicate devices (K941899 for intended use, K863092 for composition) as determined by the FDA.

8. The Sample Size for the Training Set

This concept of a "training set" is not applicable as the device is a physical dental material evaluated against established standards and predicate devices, not an AI/ML algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable for the reasons stated in point 8.

Summary

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FEB - 9 1998

510(k) SUMMARY

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ﻣﺴﻴﺔ

NAME & ADDRESS:

K973221

DENTSPLY International

570 West College Avenue P.O. Box 872 York, PA 17405-0872 (717) 845-7511 ax 1777 854-2343

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

P. Jeffery Lehn CONTACT:

August 20 . 1997 DATE PREPARED:

COMPOSITE 168 RESTORATIVE SYSTEM TRADE OR PROPRIETARY NAME:

Dental restorative material COMMON OR USUAL NAME:

CLASSIFICATION NAME: Tooth resin shade material

K863092 Dental Composite Restorative PREDICATE DEVICE: SDI Composites K941899

DEVICE DESCRIPTION: COMPOSITE 168 RESTORATIVE is a visible light activated, radiopaque restorative material for anterior and posterior restorations of primary and permanent teeth. It is to be used with Prime & Bond 2.1 Universal Light Cured Dental Adhesive System. This one-component. VLC composite restorative is packaged in unit dose or svringes.

The physical properties of COMPOSITE 168 RESTORATIVE meet ISO Standard 4049.

INTENDED USE: COMPOSITE 168 RESTORATIVE SYSTEM is substantially equivalent in intended use to the predicate device, K941899 (SDI Composites). It is to be used with Prime & Bond™ 2.1 Universal Light Cured Dental Adhesive System and it:

a. Is indicated for cavity Classes I, II, III, IV, V, and VI in anterior and posterior teeth.

b. May be used as a direct restorative material and for fabrication of inlays and onlays
TECHNOLOGICAL CHARACTERISTICS: The new COMPOSITE 168 RESTORATIVE SYSTEM is substantially equivalent in composition to the predicate device, K863092 (dental composite restorative).

We believe that the prior use of the components found in COMPOSITE 168 RESTORATIVE SYSTEM in DENTSPLY legally marketed devices support our decision that additional biocompatibility studies with the final formulation are not necessary.

The results of Ames testing on the main components were negative.

We believe that the prior use of the components in the COMPOSITE 168 RESTORATIVE SYSTEM in predicate devices, the performance data provided, and the results of previous biocompatibility testing support the safety and effectiveness of COMPOSITE 168 RESTORATIVE SYSTEM for the intended 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 features a stylized image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

8 1398 FEB

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: K973221 Composite 168 Restorative System Trade Name: Requlatory Class: II Product Code: EBF Dated: January 28, 1998 Received: January 30, 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 reqistration, 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਖੇ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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

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Page 2 - Mr. Lehn

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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) 594-4618. 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,

the A. Tim Ulatowsk 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

|< 973221 510(K) Number:

Device Name:

COMPOSITE 168 RESTORATIVE SYSTEM

COMPOSITE 168 RESTORATIVE SYSTEM is to be used with Prime & Bond™ 2.1

Universal Light Cured Dental Adhesive System:

• Indicated for cavity Classes I, II, III, IV, V, and VI in anterior and posterior teeth.

•May be used as a direct restorative material

·May be used for fabrication of inlays and onlays

Susan Runser

n-Off Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sia Division of Dental, Infaction Contr and General Hospital D 5 1 O(k) Number OR Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use No

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a 1998 133

BISCO, INC., 1100 W. Irving Park Road, Schaumburg, IL 60193
510(k) submission for NTL-FLOW™

510(k) SUMMARY

As Required by the Safe Medical Devices Act of 1990

IDENTIFICATION OF THE LEGALLY MARKETED PREDICATE DEVICE

PREDICATE DEVICE AELITEFLO

AELITEFLO is a low viscosity, light-cure hybrid composite restorative material. It is a moderately filled (59% w/w), radiopague, flowable composite designed primarily for restoration of shallow defects such as incipient Class V lesions. It functions well as an anterior esthetic material to reshape and esthetically restore stained or otherwise developmentally compromised anterior teeth. AELITEFLO bonds micromechanically and chemically to dental primers/bonding resin adhesives through co-polymerization of the former's air inhibited layer. AELITEFLO is designed to be marketed as a stand alone product but can be made available in kit form including semi-gel etchant (K945604) and COMPOSITE PRIMER.

DESCRIPTION OF APPLICANT DEVICE NTL-FLOW

NTL-FLOW is a dual-cure (light or heat and light) moderately filled (60%), radiopaque low modulus flowable composite. Its physical properties are similar to the predicate device and uses are identical. Like the predicate device, NTL-FLOW is a glass frit filled dimethacrylate composite. It hardens by a light or heat and light cure polymerization mechanism employing a light initiator, and a tertiary amine activator and peroxide initiator. Both devices are designed to be used with high quality dentin / enamel adhesive systems. The material can be used in a conventional fashion or it can be processed in a dedicated curing device that employs light, and a substantially oxygen free atmosphere created by flushing the device with an inert gas such as nitrogen. The heat is supplied by the lamp providing the light. The comparative low modulus facilitates the use of the material as a first increment liner that is intended to bond to the dental adhesive as well as the next increment composite.

INTENDED USES OF APPLICANT DEVICE NTL-FLOW

NTL-FLOW is indicated for: anterior esthetic restorative material for Class III and IV as well as conservative Class I restorations not involving opposing occlusal wear, direct esthetic veneer restorative for masking stains and developmental anomalies, pit and fissure sealant, core buildup material to replace missing tooth structure, dental cement/luting agent, composite repair, and a liner/base material.

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BISCO, INC., 1100 W. Irving Park Road, Schaumburg, IL 60193 510(k) submission for NTL-FLOW"

SCIENTIFIC CONCEPTS and SIGNIFICANT PERFORMANCE CHARACTERISTICS

AELITEFLO and Bisco NTL-FLOW are very similar with regard to chemical composition and AELT EF LO und Blood Nical properties. Significantly, AELITEFLO and NTL-FLOW, following curing, have been designed to be more flexible than conventional dental composites. Also, the flow characteristics or so-called syringability of these materials are superior to more thighly filled materials. The viscoelastic properties of conventional microfil composites are dependent on the interaction of submicron silica fillers and the design resin. Because of the enormous surface area of submicron silica, a much smaller amount of filler can be incorporated into a compared with a larger filler such as 0.7um barium glass as used in NTL-FLOW and AELITEFLO. The flowability of NTL-FLOW, therefore, is achieved by a careful balance of resin viscosities and filler loading. Submicron filler is also used in NTL-FLOW but to a much !esser extent than conventional microfil composites.

The flexibility of cured NTL-FLOW is achieved by an imaginative balance of polymerizable resins. These resins in concert with the fillers noted above achieve the properties described in this application, namely high service strength, flexibility, and ease of manipulation or svringability. Relative reduction of filler content typically reduces surface hardness of composites and that is evident with NTL-FLOW which has approximately 10% lower Barcol hardness than conventional composites.

The chemical composition of NTL-FLOW and AELITEFLO are quite similar. Both are silica and /or glass filled dimethacrylate light-cure composites. NTL-FLOW is based on the ethoxylated version of Bis-GMA whereas AELITEFLO is primarily a Bis-GMA triethyleneglycol dimethacrylate combination.

The non-clinical tests used for this submission are similar to those specified in ISO 4049 and American Dental Association Specification #27; both are for dental resin based filling materials. Diametral tensile testing (DTS) is an accepted method to characterize the tensile strength of brittle materials and the flexural modulus test addresses the strength in three point loading. DTS values are 41.3 and 39.0 MPa for NTL-FLOW and AELITEFLO respectively. Cytotoxicity of NTL-FLOW was performed by a commercial testing laboratory (NAMSA) and the product was found to be non-toxic.

Comparison of NTL-FLOW to the predicate device shows both are very similar with the major difference being the methods of final cure of the product. The proposed new product cures using visible light or heat (125°C) and light. The predicate device can cures using visible light exclusively.

Carme h. Sandik

James L. Sandrik, Ph.D. BISCO, Inc. Schaumburg, IL 60193 November 25, 1997

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BISCO, INC., 1100 W. Irving Park Road, Schaumburg, IL 60193 510(k) submission for NTL-FLOW™

REFERENCES

1. Craig, R. G. (ed), Restorative Dental Materials, eighth edition, C. V. Mosby Co., St. Louis, 1989, p 277.
1. International Standards Organization, ISO 4049:1988/Cor. 1:1992 (E), Resin Based Filling Materials, 1992.
1. Quality Control Procedures Manual, QC0003, Bisco, Inc., 1995.
1. ibid. QC0004
1. ibid. QC0006

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.