Kerr VPS Impression Material is suitable for impressions in preparation of case study models, orthodontic models, opposing models, simple removable dentures, removable retainers and splints, provisional crown and bridge, and dental impressions.

Device Description

Kerr VPS impression material is an outstanding A-silicone impression material intended as an alternative to traditional alginate materials. Quick set time, excellent detail reproduction, compatibility with disinfection products, dimensional accuracy and stability make the best alternative. Available in 1:1 cartridges suitable for the Kerr Extruder and in Volume™ 5:1 362 mL foil packs for use in commercially available mixing machines.

AI/ML Overview

This document is a 510(k) premarket notification for a dental impression material named "Kerr VPS Impression Material." The purpose of a 510(k) submission is to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. This type of submission does not typically include detailed performance studies with acceptance criteria in the same way a PMA (Premarket Approval) would for novel, high-risk devices.

Therefore, the specific information requested in the prompt related to acceptance criteria, detailed study designs, sample sizes, ground truth establishment, expert adjudication, and MRMC studies is not present in this 510(k) summary.

Here's an analysis based on the provided text, explaining why the requested information is absent and what can be inferred:

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

Absent. This document does not provide a table of acceptance criteria or specific quantitative performance metrics for the Kerr VPS Impression Material.
Reason: For a 510(k) substantial equivalence submission, the primary focus is to show that the new device is as safe and effective as a predicate device. This is often done by demonstrating similar technological characteristics, materials, and intended use, rather than extensive de novo performance testing against pre-defined acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Absent. There is no mention of a "test set" or any specific study that would utilize a test set with a defined sample size.
Reason: The document focuses on demonstrating similarity to predicate devices rather than presenting novel clinical or performance study data that would typically involve a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Absent. Since no test set or related performance study is described, there's no mention of experts establishing ground truth.
Reason: Not applicable to a 510(k) summary of this nature.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Absent. No adjudication method is mentioned as there is no specific performance study outlined.
Reason: 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

Absent. No MRMC study is mentioned.
Reason: This device is a dental impression material, not an AI-powered diagnostic tool. MRMC studies are relevant for evaluating AI systems where human reader performance is a key metric.

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

Absent. "Standalone" performance is relevant for AI algorithms. This device is a physical material.
Reason: This question is not applicable to the device type.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Absent. No ground truth is discussed as no formal performance study against a definitive standard is presented.
Reason: Information not typically included in this type of 510(k) submission for a dental material.

8. The sample size for the training set

Absent. There is no mention of a "training set."
Reason: Training sets are relevant for machine learning algorithms. This device is a physical material.

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

Absent.
Reason: Not applicable for a physical dental impression material.

Summary of what is present and relevant to "proving" the device meets criteria for regulatory clearance:

Acceptance Criteria (Implied for 510(k)): The acceptance criterion for a 510(k) is substantial equivalence to predicate devices. This means the device must be shown to be as safe and effective as a legally marketed device and not raise different questions of safety and effectiveness.
Study Proving Acceptance: The "study" is the 510(k) submission itself, where Sybron Dental Specialties conducted a comparison of the Kerr VPS Impression Material to two predicate devices:
- 3M ESPE, Position Penta Quick
- DMG. Status Blue Mixstar
Mechanism of Proof: The submission aims to prove substantial equivalence by demonstrating that the Kerr VPS Impression Material:
- Has the same intended use: "impressions in preparation of case study models, orthodontic models, opposing models, simple removable dentures, removable retainers and splints, provisional crown and bridge, and dental impressions."
- Functions in a similar manner and has similar technological characteristics (A-silicone impression material, quick set time, excellent detail reproduction, compatibility with disinfection products, dimensional accuracy and stability).
- The FDA's letter states they "have determined the device is substantially equivalent... to legally marketed predicate devices."

In essence, for this 510(k), the "acceptance criteria" is a regulatory determination of substantial equivalence, and the "study" is the comparative analysis presented in the submission to satisfy that requirement, rather than a detailed performance study with explicit outcome measures and statistical analyses.

Summary

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K050604

sds

APR 1 5 2005

SYBRON DENTAL SPECIALTIES

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: March 2005

Device Name:

Trade Name -- Kert VPS Impression Material
Common Name Impression Material
Classification Name Impression Material, per 21 CFR § 872.3660

Devices for Which Substantial Equivalence is Claimed:

3M ESPE, Position Penta Quick
DMG. Status Blue Mixstar

Device Description:

Intended Use of the Device:

The intended use of Kerr VPS Impression Material is for impressions in preparation of case study models, orthodontic models, opposing models, simple removable dentures, removable retainers and splints, provisional crown and bridge, and dental impressions.

Substantial Equivalence:

Kerr VPS Impression Material is substantially equivalent to other legally marketed devices in the United States. Kerr VPS Impression Material functions in a manner similar to and is intended for the same use as Position Penta Quick and Status Blue Mixstar that are currently marketed by 3M ESPE and DMG, respectively.

1717 West Collins Avenue, Grange, CA 92867 800-537-7824 714-516-7400

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Public Health Service

APR 1 5 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K050604

Trade/Device Name: Kerr VPS Impression Material Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: March 08, 2005 Received: March 09, 2005

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 ass ontaled as 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 controle provise or cactice, 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 may of 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 Please be advised that FDA 's Issualice of a successfies with other requirements of the Act of that FDA has made a determination mar your con researces. You must comply with any Federal statules and regulations administered by onceess stration and listing (21 CFR Part 807);
all the Act's requirements, including, but not limited to: registration a all the Act's requirements, including, but not in increasing reguirements as set forth in the quality
labeling (21 CFR Part 801); good manufacturing proclassion product radia labeling (21 CFR Part 801), good manufacturing procession, the electronic product radiation
systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic produ systellis (QS) regulation (21-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 5 0 local This letter will anow you to begin marketing your antial equivalence of your device to a legally premarket notification. The PDA midnig of succeantal vice 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 If you desire specific advice for your do not of the regulation entitled, the regulation entitled, a contact the Office of Compliance at (2-10) 27-8 Part 807.97). You may obtain other
"Misbranding by reference to premarket notification" (21 CFR Part Bir in of Small "Misbranding of reference to premailer homics the Act from the Division of Small general information of your responsibilities and its toll-free number (800) 638-2041 or Manufacturers, International and Consulter Assistance as to research industry/support/index.html.

Sincerely yours,

Ques

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): {{050604

Device Name: Kerr VPS Impression Material

Indications For Use:

Kerr VPS Impression Material is suitable for impressions in preparation of case study Acr / 1 L 1 mproblem models, opposing models, simple removable dentures, removable models, orniousnats provisional crown and bridge, and dental impressions.

V 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)

	for K SM
(Division Sign-Off)
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number:	K050604

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Regulation Number and Section

§ 872.3660 Impression material.

(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).