The PRE-IMPRESSION CONDITIONING SOLUTION is indicated as a preparation conditioning solution for uniform surface wetting prior to elastomeric impression procedures.
Indications for Use: Preparation conditioning solution for uniform surface wetting prior to elastomeric impression procedures

Device Description

The PRE-IMPRESSION CONDITIONING Solution is a product to be used in the impressiontaking process. When applied to substrates such as sulcular tissue; tooth preparations; ceramic, composite, or metal core build-up material; or implant abutments or copings, it provides a uniform surface condition with reduced surface tension prior to the application of an elastomeric impression material. This standardized surface with reduced contact angle on all impressed substrates allows capture of fine preparation detail both supra and subgingiyally.

AI/ML Overview

This 510(k) summary provides limited information about the device's technical characteristics and studies. Based on the provided text, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific acceptance criteria or quantitative performance metrics for the PRE-IMPRESSION CONDITIONING SOLUTION. Instead, it relies on a comparison to legally marketed predicate devices and the safety of its components.

Acceptance Criteria	Reported Device Performance
Not explicitly stated in the document. The submission claims equivalency to predicate devices based on component safety and prior use.	Provides a "uniform surface condition with reduced surface tension prior to the application of an elastomeric impression material." This "standardized surface with reduced contact angle on all impressed substrates allows capture of fine preparation detail both supra and subgingiyally."

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

The document does not describe a specific "test set" for the PRE-IMPRESSION CONDITIONING SOLUTION. The basis for clearance appears to be:

The fact that "All of the components found in PRE-IMPRESSION CONDITIONING SOLUTION have been used in legally marketed devices and are safe for dental use."
"Prior use of the components of PRE-IMPRESSION CONDITIONING SOLUTION in legally marketed devices and the data provided, support the safety and effectiveness of PRE-IMPRESSION CONDITIONING SOLUTION for the indicated use."

This suggests that the "data provided" likely refers to prior submissions or existing knowledge about the individual components, rather than a new, dedicated study on the final product with a specific test set. Therefore, information on sample size, country of origin, and retrospective/prospective nature is not available.

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

Given that no specific "test set" for performance evaluation of the final device is described, this information is not applicable/not available from the provided text.

4. Adjudication Method for the Test Set

As no specific "test set" or performance study is described, this information is not applicable/not available from the provided text.

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

The device is a "Pre-Impression Conditioning Solution," a dental material, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving human readers or AI assistance is not applicable to this device.

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

The device is a chemical solution, not an algorithm. Therefore, a standalone algorithm performance study is not applicable to this device.

7. The Type of Ground Truth Used

Based on the submission, the "ground truth" for the device's safety and effectiveness seems to be derived from the known safety and efficacy of its individual components, which have been previously used in legally marketed dental devices. There's no mention of specific pathology, outcomes data, or expert consensus being established for the overall product's performance in a new study.

8. The Sample Size for the Training Set

The document does not describe a "training set" for an algorithm, as this is a chemical solution. If "training set" refers to data supporting the safety of individual components, that information is not provided in terms of sample size for this submission.

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

As this is not an AI algorithm and no specific "training set" is described, this information is not applicable from the provided text. The "ground truth" for component safety would have been established through prior regulatory clearances and extensive historical use in dentistry, but the specifics of how for those individual components are not detailed in this 510(k) summary.

Summary

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K061427

510(k) SUMMARY

JUN 2 6 2006

.NAME & ADDRESS:

్రాలు
మూలాలు

DENTSPLY International World Headquarters Susquehanna Commerce Ctr. 221 West Philadelphia Street York, PA 17405-0872 (717) 845-7511 (voice) (717) 849-4762 (fax) www.dentsply.com

K-3
Helen Lewis

CONTACT:

DATE PREPARED:

May 17, 2006

TRADE OR PROPRIETARY NAME:

PRE-IMPRESSION CONDITIONING SOLUTION

CLASSIFICATION NAME:

Impression material, 872.3660

PREDICATE DEVICES:

Xeno® III Dental Adhesive, K023776 Nupro® Prophylaxis Paste, K983966 Pretreatment Solution, K940685 Aquasil Easy Mix Putty Impression Material. K973781

DEVICE DESCRIPTION:

INTENDED USE:

The PRE-IMPRESSION CONDITIONING SOLUTION is indicated as a preparation conditioning solution for uniform surface wetting prior to elastomeric impression procedures.

TECHNOLOGICAL CHARACTERISTICS:

All of the components found in PRE-IMPRESSION CONDITIONING SOLUTION have been used in legally marketed devices and are safe for dental use. We believe that the prior use of the components of PRE-IMPRESSION CONDITIONING SOLUTION in legally marketed devices and the data provided, support the safety and effectiveness of PRE-IMPRESSION CONDITIONING SOLUTION for the indicated use.

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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 consists of a stylized caduceus, which is a symbol of medicine, with three wavy lines representing the branches of government. The caduceus is surrounded by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" in a circular arrangement. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 6 6 2006

Ms. Helen Lewis Director of Corporate Compliance and Regulatory Affairs DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17405-0872

Re: K061427

Trade/Device Name: Pre-Impression Conditioning Solution Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Codes: ELW and MVL Dated: May 17, 2006 Received: May 23, 2006

Dear Ms. Lewis:

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. Helen Lewis

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 requiremants 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 Paris (201): labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product railition 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 10gal/y 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 (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

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 STATEMENT

(As Required by 21 CFR 807.87(e)

510(K) Number (if known):
K061427

Device Name: PRE-IMPRESSION CONDITIONING SOLUTION

Indications for Use:

Preparation conditioning solution for uniform surface wetting prior to elastomeric impression procedures

Prescription Use X (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)

Sudor Runa

esiology, General Hospital.

K0611727

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).