RENEW, universal hybrid composite, is a highly filled (74% w/w), light-cured radiopaque hybrid composite. Its physical/mechanical properties are similar to the predicate device and uses are identical. Like the predicate device, RENEW is barium glass and silica filled dimethacrylate composite. It hardens by light cure polymerization mechanism employing light activated initiators. Both devices are designed to be used with high quality dentin/ enamel adhesive systems.

AI/ML Overview

The acceptance criteria for the RENEW™ composite restorative material are primarily based on achieving physical and mechanical properties similar to its legally marketed predicate device, AELITEFIL™, and meeting the standards set forth in ISO 4049 and American Dental Association §27 for dental resin-based filling materials. The device also needs to demonstrate biocompatibility.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Physical/Mechanical Properties (General)	"RENEW... physical/mechanical properties are similar to the predicate device and uses are identical." and "The chemical compositions of AELITEFIL and RENEW are quite similar. Both are barium glass and silled methacrylate hybrid composites. Both are light cured, and radiopaque for easy radiographic identification and evaluation."
Handling Characteristics (Pre-Cure)	"AELITEFIL and RENEW have been designed to achieve ‘Non-Sticky’ handling before cured..." "The Bis-GMA and UDMA monomers of AELITEFIL are balanced to achieve 'Non-Sticky' handling. RENEW is based on the the ethoxylated version of Bis-GMA resulting in reduction of 'stickiness' even more." (This suggests RENEW meets and potentially exceeds this criterion compared to the predicate).
Handling Characteristics (Post-Cure)	"...as well as high polishability and strength when cured." "The hybrid blend of ultra fine primary filler (averaging 0.7 µm with tightly controlled distribution) barium glass, and silica results in high strength and polishability of cured AELITEFIL and RENEW."
Radiopacity	Both AELITEFIL and RENEW are described as "radiopaque."
Diametral Tensile Strength (DTS)	AELITEFIL: 45 MPa, RENEW: 50 MPa. (RENEW meets and exceeds the predicate's performance).
Biocompatibility (Cytotoxicity)	"RENEW... was found to be non-toxic" (tested in conformance with EN 45001 (ISO 10993-5)).
Compliance with ISO 4049 and ADA §27 (Dental resin based filling materials)	"The non-clinical tests used for this submission are similar to those specified in ISO 4049 and American Dental Association §27..." While specific values for all parameters are not given, the statement implies compliance through the use of similar testing methods and the overall claim of substantial equivalence.
Substantial Equivalence to Predicate Device (AELITEFIL™)	"Side by side comparisons of RENEW to the predicate device provided in this submission clearly demonstrated that the applicant device, RENEW, is substantially equivalent to the legally marketed predicate device, AELITEFIL, in terms of effectiveness or suitability to the intended uses."

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

The provided documentation does not specify numerical sample sizes for the individual tests (e.g., DTS, cytotoxicity). It refers to "non-clinical tests" and "side by side comparisons."

Sample Size: Not explicitly stated as a number of samples or cases for each test.
Data Provenance: The tests were conducted internally by BISCO, Inc. (as indicated by references to "Bisco, Inc. Quality Control Testing Procedure") and by a commercial testing laboratory (NAMSA) for biocompatibility. The documentation does not specify the country of origin of the data beyond these entities. It is a retrospective report of non-clinical device testing.

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

This information is not applicable in the context of this submission. The "ground truth" for material properties is established by recognized international and national standards (ISO 4049, ADA §27) and objective physical/chemical testing, not by expert consensus on specific cases.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving interpretation by multiple human readers (e.g., imaging studies) to resolve discrepancies in diagnoses or assessments. For a material properties and biocompatibility study, objective measurements are taken, and results are compared against defined standards or predicate device performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

This is not applicable. This submission concerns a dental composite restorative material, not an AI-powered diagnostic or assistive device for human readers. Therefore, an MRMC study or AI assistance is irrelevant to this product.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable. The device is a physical material (composite restorative), not an algorithm or software. Standalone performance refers to the performance of an algorithm without human intervention, which doesn't apply here.

7. The Type of Ground Truth Used

The ground truth used for evaluating the RENEW™ device is based on:

Established Standards: ISO 4049:1988/Cor. 1:1992 (E) for Resin Based Filling Materials and American Dental Association §27.
Predicate Device Performance: Direct comparison of physical and mechanical properties (e.g., DTS) and chemical composition to the AELITEFIL™ device.
Laboratory Testing: Objective measurements from physical tests (e.g., DTS, flexural modulus) and biological tests (cytotoxicity).

8. The Sample Size for the Training Set

This is not applicable. The RENEW™ device is not an AI algorithm or a device that undergoes machine learning training. Therefore, there is no "training set."

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

This is not applicable for the same reason as point 8.

Summary

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SEP 15 1998

K982729

510(k) Submission for RENEW™M BISCO, INC., 1100 W. Irving Park Road Schaumburg, IL 60193

SH 22 of 25

As Required by 21

APPLICANT DEVICE Trade Name: RENEW™M Common Name: Composite Restorative Material Classification Name: Tooth Shade Resin Material, Class II, 21 CFR 872.3690

LEGALLY MARKETED PREDICATE DEVICE: AELITEFIL™

PREDICATE DEVICE AELITEFIL

AELITEFIL, universal hybrid composite, is a highly filled (75% by wt.), light cured hybrid composite restorative material is radiopaque and indicated for all types of cavity preparations. The hybrid blend of ultra fine primary filler (averaging 0.7 µm with tightly controlled distribution) and submicron silica results in superior optical qualities and physical/mechanical properties. The material bonds micromechanically and chemically to dental primers/bonding resin adhesives through co-polymerization of the former's air inhibited layer. AELITEFIL is designed to be marketed as a stand alone product.

DESCRIPTION OF APPLICANT DEVICE RENEW

INTENDED USES OF APPLICANT DEVICE RENEW

RENEW is indicated for: Class I, III, IV, V and VI restorations, direct aesthetic veneers for masking stains and developmental anomalies, core build ups to replace missing tooth structure and composite/ porcelain repairs.

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510(k) Submission for RENEW™M BISCO, INC., 1100 W. Irving Park Road Schaumburg, IL 60193

SH 23 of 25

510(k) SUMMARY (cont.)

SCIENTIFIC CONCEPTS and SIGNIFICANT PERFORMANCE CHARACTERISTICS

AELITEFIL and RENEW are very similar with regard to chemical composition and selected physical/mechanical properties. Significantly, AELITEFIL and RENEW have been designed to achieve 'Non-Sticky' handling before cured as well as high polishability and strength when cured. These properties are desired of restoratives to be indicated for all types of cavity preparations. The hybrid blend of ultra fine primary filler (averaging 0.7 µm with tightly controlled distribution) barium glass, and silica results in high strength and polishability of cured AELITEFIL and RENEW. The Bis-GMA and UDMA monomers of AELITEFIL are balanced to achieve 'Non-Sticky' handling. RENEW is based on the the ethoxylated version of Bis-GMA resulting in reduction of 'stickiness' even more.

The chemical compositions of AELITEFIL and RENEW are quite similar. Both are barium glass and silled methacrylate hybrid composites. Both are light cured, and radiopaque for easy radiographic identification and evaluation.

The non-clinical tests used for this submission are similar to those specified in ISO 4049 and American Dental Association $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 45 and 50 MPa for AELITEFIL and RENEW respectively.

Biocompatability of RENEW, Cytotoxicity, was tested in conformance with good laboratory practice and EN 45001 (ISO 10993-5) by a commercial testing laboratory (NAMSA) and the product was found to be non-toxic.

Side by side comparisons of RENEW to the predicate device provided in this submission clearly demonstrated that the applicant device, RENEW, is substantially equivalent to the legally marketed predicate device, AELITEFIL, in terms of effectiveness or suitability to the intended uses.

K. Joung
Dr. Joung, Ph.D.

Kathy Jour QA/QC Manager 1-800-BIS-DENT or 847-534-6106 Fax: 847-891-6865 August 3, 1998

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510(k) Submission for RENEW™ BISCO, INC., 1100 W. Irving Park Road Schaumburg, IL 60193

SH 24 of 25

REFERENCES

Craig, R. G. (ed), Restorative Dental Materials, eighth edition, C. V. 1. Mosby Co., St. Louis, 1989, p 277.
1. International Standards Organization, ISO 4049:1988/Cor. 1:1992 (E), Resin Based Filling Materials, 1992.
Bisco, Inc. Quality Control Testing Procedure, QC-0004, 1987. 3.
ibid. QC-003, 1998 4.
ibid. QC-006, 1997 5.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of three human profiles facing to the right, arranged in a stacked formation. The profiles are rendered in black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUM SERVICES USA" is arranged around the top and left side of the profile graphic.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 5 1998

Kathy Jounq, Ph.D. QA/QC Manager BISCO. Incorporated 1100 W. Irving Park Road Schaumburg, Illinois 60193

K982729 Re : RENEW™ Trade Name: Requlatory Class: II Product Code: EBF Dated: August 3, 1998 Received: Auqust 5, 1998

Dear Dr. Joung:

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 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). 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. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (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 requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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 - Dr. Joung

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

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" (21CFR 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/dsma/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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K982729

510(k) Submission for RENEW™ BISCO, INC., 1100 W. Irving Park Road Schaumburg, IL 60193

SH 10 of 25

INDICATIONS for USE

510(k) Number (if known):______ K982729

Device Name: _RENEW™

Indications for Use:

1. Class I, II, III, IV, V and VI restorations.
1. Direct aesthetic veneers for masking stains and developmental anomalies.
1. Core build ups to replace missing tooth structure.
1. Composite and porcelain repairs.

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

Concurrence of CDRL, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801.109) Over-The-Counter Use

(Optional Format 1-2-96)

(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K982729

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.