The device is a light cured resin based composite dental restorative designed for direct placement. By utilizing three types of fillers, Premise is designed to offer high polishability, high mechanical strength, and decreased polymerization shrinkage.

AI/ML Overview

This 510(k) summary (K032921) describes a dental composite restorative material called "Premise." It primarily focuses on demonstrating substantial equivalence to a predicate device ("Point 4 Modified") and does not contain detailed information about specific acceptance criteria and a study proving those criteria are met for the new device.

The document is a 510(k) premarket notification, which means the manufacturer is essentially stating that their new device is as safe and effective as a legally marketed predicate device. This process typically relies on demonstrating similar performance characteristics to the predicate device, rather than conducting new, extensive clinical trials to establish novel acceptance criteria or device performance.

Therefore, many of the requested details about acceptance criteria, specific study designs, sample sizes, and expert adjudication are not provided in this regulatory document.

However, I can extract the information that is present and highlight what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Acceptance Criteria (from predicate)	Reported Device Performance (Premise)
High Polishability	Similar to Point 4 Modified	Designed to offer high polishability
High Mechanical Strength	Similar to Point 4 Modified	Designed to offer high mechanical strength
Decreased Polymerization Shrinkage	Similar to Point 4 Modified	Designed to offer decreased polymerization shrinkage
Intended Use	For use in all classes of cavities (for predicate)	For use in all classes of cavities

Missing Information: Specific quantitative acceptance criteria (e.g., "Polishability score > X," "Flexural strength > Y MPa") are not provided. The document relies on qualitative claims of "similar to" or "designed to offer" in comparison to the predicate.

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

This information is not provided in the document. 510(k) summaries often do not include the raw data or detailed study designs for performance tests if the substantial equivalence is primarily based on material composition and intended use similarity to a well-established predicate.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided as there is no mention of a specific "test set" and "ground truth" establishment in the context of expert human review for a new device study. The document focuses on material properties and intended use.

4. Adjudication Method

This information is not provided.

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

This information is not provided. MRMC studies are typically for imaging or diagnostic devices where human interpretation is a key factor. This device is a dental restorative material.

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

This information is not applicable/not provided. This is a physical dental material, not an algorithm.

7. Type of Ground Truth Used

This information is not provided as no specific study in the context of establishing "ground truth" for a new device's performance is detailed. The substantial equivalence relies on comparison of material properties and intended use to an existing predicate. For material properties, "ground truth" would typically refer to laboratory measurements against established standards.

8. Sample Size for the Training Set

This information is not applicable/not provided. There is no "training set" in the context of an AI/ML algorithm for this physical dental material.

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

This information is not applicable/not provided.

Summary of the Study Discussed in the Document (Focus on Substantial Equivalence):

The document effectively describes the study for substantial equivalence. This "study" is the process of comparing the new device, "Premise," to a legally marketed predicate device, "Point 4 Modified."

Objective: To demonstrate that "Premise" is substantially equivalent to "Point 4 Modified" in terms of safety and effectiveness.
Methodology: The submission highlights that "Premise" "functions in a manner similar to and is intended for the same use as Point 4 Modified." This typically involves comparing:
- Intended Use: Both devices are for "use in all classes of cavities."
- Device Description/Technological Characteristics: Premise uses "three types of fillers" to offer "high polishability, high mechanical strength, and decreased polymerization shrinkage," implying these characteristics are comparable to or improved upon the predicate.
- Performance Data: While not explicitly detailed, in a 510(k) for a material, this would generally involve laboratory testing of properties like:
  - Flexural Strength
  - Compressive Strength
  - Radiopacity
  - Depth of Cure
  - Wear Resistance
  - Polymerization Shrinkage
  - Water Sorption/Solubility
  - Polishability retention
  - Biocompatibility (often by referencing components known to be biocompatible in other devices)

Conclusion from the Document: The FDA reviewed the 510(k) submission and determined that "Premise" is substantially equivalent to the predicate device, allowing it to be marketed. This determination is based on the information provided by the manufacturer, which presumably included data comparing the new device's characteristics to the predicate's established performance. The document itself does not present the detailed results of these comparative tests.

Summary

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K032921

Image /page/0/Picture/1 description: The image shows the text "K032921" in the upper left corner, followed by the logo for "sds" in the upper right. Below the logo is the text "SYBRON, DENTAL SPECIALTIES". The bottom of the image contains the text "Section III - 510(k) Summary of Safety and Effectiveness".

NOV 1 3 2003

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 2003

Device Name:

Trade Name Premise ●
Common Name - Dental Composite Restorative Material
Classification Name Tooth Shade Resin Material, per 21 CFR § 872.3690 ●

Devices for Which Substantial Equivalence is Claimed:

Kerr Dental Materials Center, Point 4 Modified ●

Device Description:

Intended Use of the Device:

The intended use of Premise is for use in all classes of cavities.

Substantial Equivalence:

Premise is substantially equivalent to other legally marketed devices in the United States. Premise functions in a manner similar to and is intended for the same use as Point 4 Modified that is currently marketed by Kerr Dental Materials Center.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 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 perimeter. Inside the circle is a stylized image of three human profiles facing right, with three wavy lines below them.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 3 2003

Ms. Colleen Boswell Director, Corporate Compliance Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867

Re: K032921

Trade/Device Name: Premise Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: September 15, 2003 Received: September 22, 2003

Dear Ms. Boswell:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Colleen Boswell

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. 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 Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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.

Oup

Chiu S. Lin, PhD Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):____K032921

Device Name: Premise

Indications For Use:

Premise is a dental composite restorative material intended to be used in all classes of cavites.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runser

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number ________________________________________________________________________________________________________________________________________________________________

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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.