élan - 2 is a light-curable, dental restorative material containing a fluoride releasing agent which is designed to be used as a filling material for Class III and Class V restorations. Additional functions include: Repair of enamel defects, repair of porcelain restorations, minor occlusal build-ups in low-stress bearing areas, pit and fissure sealant, base/cavity liner and blockout of undercuts.

Device Description

The device is a light cured, radiopaque flowable compomer dental restorative combining the desirable properties of a flowable composite resin and a glass ionomer: good mechanical strength and wear resistance, excellent esthetics, easy handling and placement, and long-term fluoride release. This unique flowable compomer utilizes a special acidic aromatic resin containing multi-methacrylate functional groups, which, upon curing, results in an extremely strong and highly wear resistant crosslinked matrix system. It is reinforced with a reactive fluoroaluminosilicate filler (approximately 60%) and fumed silica to provide a flowable, non-slumping restorative material.

AI/ML Overview

The provided text is a 510(k) summary for a dental restorative material, not a description of a medical device that uses AI or sophisticated algorithms requiring acceptance criteria validation studies as typically conceived in a modern regulatory context. Therefore, much of the requested information cannot be extracted from this document.

The document discusses the substantial equivalence of a "light-curable dental restorative material" (élan-2) to existing legally marketed devices. It focuses on the physical and chemical properties and intended use of the material, not on a device that generates diagnostic output or relies on complex software performance.

Here's a breakdown of what can be inferred or directly stated from the provided text, and where gaps exist due to the nature of the device:

1. A table of acceptance criteria and the reported device performance

This document does not specify "acceptance criteria" in the context of a statistical performance study for an AI/algorithm-driven device. It discusses the device's properties in relation to substantial equivalence to a predicate device.

Acceptance Criteria (Not explicitly stated for performance, but implied for equivalence)	Reported Device Performance (Implied from description)
Functions in a manner similar to predicate device (Vivadent Ets., Compoglass Flow)	Light-cured, radiopaque, flowable compomer dental restorative.
Intended for the same use as predicate device	Restoration of Class III and Class V cavities, repair of enamel defects, repair of porcelain restorations, minor occlusal build-ups in low-stress bearing areas, lining cavities, sealing pits and fissures, block-out of undercuts.
Good mechanical strength and wear resistance (implied desirable properties)	Utilizes a special acidic aromatic resin containing multi-methacrylate functional groups, resulting in an extremely strong and highly wear-resistant crosslinked matrix system. Reinforced with reactive fluoroaluminosilicate filler and fumed silica.
Excellent esthetics (implied desirable properties)	Listed as a desirable property.
Easy handling and placement (implied desirable properties)	Listed as a desirable property.
Long-term fluoride release (implied desirable properties)	Listed as a desirable property.

2. Sample sized used for the test set and the data provenance

Not applicable. This device is a material, not a software/AI system that uses a test set of data.

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

Not applicable. No ground truth establishment by experts for a test set is described.

4. Adjudication method for the test set

Not applicable.

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

Not applicable. This is not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a dental material.

7. The type of ground truth used

Not applicable. The "ground truth" for a dental restorative material would be its physical, chemical, and biological properties, and clinical performance, evaluated through established ISO/ADA standards and clinical trials (which are not detailed here, as it's a 510(k) summary focused on substantial equivalence to a predicate).

8. The sample size for the training set

Not applicable. There is no training set for a machine learning model.

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

Not applicable.

Summary

{0}------------------------------------------------

OCT 2 8 1998

Image /page/0/Picture/1 description: The image shows the logo "sds" in a stylized font with a swoosh above it. To the right of the logo is the handwritten text "KA83091". The text appears to be a serial number or some other type of identification code. The image is in black and white.

SYBRON DENTAL SPECIA

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

Submitter:

Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 (714) 516-7484 - Phone (714) 516-7488 - Facsimile Colleen Boswell - Contact Person

Date Summary Prepared: September 1998

Device Name:

Trade Name élan 2 .
Common Name Light-Curable Dental Restorative Material .
Classification Name Tooth Shade Resin Material, per 21 CFR § 872.3690 ●

Devices for Which Substantial Equivalence is Claimed:

Vivadent Ets., Compoglass Flow .

Device Description:

Intended Use of the Device:

The intended use of élan - 2 is for the restoration of Class III and Class V cavities, repair of enamel defects, repair of porcelain restorations, minor occlusal build-ups in low-stress bearing areas, lining cavities, sealing pits and fissures and for block-out of undercuts.

Substantial Equivalence:

élan - 2 is substantially equivalent to other legally marketed devices in the United States. The compomer restorative material marketed by Vivadent Ets. functions in a manner similar to and is intended for the same use as the product manufactured by Kerr Dental Materials Center.

{1}------------------------------------------------

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the top. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.

OCT 28 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Kerr Dental Materials Center C/O Ms. Colleen Boswell Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867

Re : K983091 Trade Name: élan-2 Requlatory Class: II Product Code: EBF Dated: September 2, 1998 Received: September 3, 1998

Dear Ms. Boswell:

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, 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 Regulations, Title 21, Parts 800 to 895. A 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 requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in Please note: this response to your the Federal Register. 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.

{2}------------------------------------------------

Page 2 - Ms. Boswell

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA debtribut in four four 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,

Timothy A. Ulatowski

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

Enclosure

{3}------------------------------------------------

Section I - Indications for Use

510(k) Number: K983091

Device Name: élan - 2

Indications for Use:

Susan Runner

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

Prescription 11
(Per 21 CFR 801.109)

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.