Correct Plus 1 is a vinyl polysiloxane impression material which is to be used for taking impression of inlays, crowns & bridges, orthodontic appliances, precision attachments and veneers.

Device Description

Correct Plus 1 impression material (Fast Set) are versatile impression materials designed to accommodate impressions of inlays, crowns and bridges, orthodontic appliances, precision attachments and veneers. The hydrophilic nature of these materials provides outstanding detail in the presence of fluids and exceptional tear strength ensures your detailed impression will remain intact upon removal. Correct Plus 1 impression material provides multiple packaging options and various set times to accommodate all of your impression needs. For optimal patient acceptance, Correct Plus 1 impression material is available in unflavored and Berry.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the "Correct Plus 1" device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly list "acceptance criteria" for each performance characteristic with numerical targets. Instead, the study aims to demonstrate substantial equivalence to a predicate device ("Correct Plus" K001218) by comparing performance characteristics. Therefore, the "acceptance criteria" can be inferred as "performance comparable to the predicate device."

Performance Characteristic	Acceptance Criteria (inferred)	Reported Device Performance (Correct Plus 1)	Predicate Device Performance (Correct Plus)
Material Properties
Work Time	Comparable to predicate device	Tested and compared	Baseline for comparison
Oral Set Time	Comparable to predicate device	Tested and compared	Baseline for comparison
Catalyst Viscosity	Comparable to predicate device	Tested and compared	Baseline for comparison
Base Viscosity	Comparable to predicate device	Tested and compared	Baseline for comparison
Out Gassing	Comparable to predicate device	Tested and compared	Baseline for comparison
Hardness	Comparable to predicate device	Tested and compared	Baseline for comparison
Mixed Consistency	Comparable to predicate device	Tested and compared	Baseline for comparison
Dimensional Change	Comparable to predicate device	Tested and compared	Baseline for comparison
Detail Reproduction	Comparable to predicate device	Tested and compared	Baseline for comparison
Compatibility with Gypsum	Comparable to predicate device	Tested and compared	Baseline for comparison
Elastic Recovery	Comparable to predicate device	Tested and compared	Baseline for comparison
Strain in Compression	Comparable to predicate device	Tested and compared	Baseline for comparison
Tensile Strength	Comparable to predicate device	Tested and compared	Baseline for comparison
Tensile Elongation	Comparable to predicate device	Tested and compared	Baseline for comparison
Tear Strength	Comparable to predicate device	Tested and compared	Baseline for comparison
Contact Angle	Comparable to predicate device	Tested and compared	Baseline for comparison
Biocompatibility
Cytotoxicity	Safe for intended use (ISO L929 MEM)	Passed	Implied safe (marketed predicate)
Sensitization	Safe for intended use (ISO Kligman Max)	Passed	Implied safe (marketed predicate)
Irritation	Safe for intended use (ISO Oral Irrit.)	Passed	Implied safe (marketed predicate)

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

The document only states that "bench testing" was conducted to evaluate performance characteristics without specifying the sample size for each test. The data provenance is not explicitly stated as foreign or domestic, but it is retrospective in the sense that the new device's performance is being compared to an already marketed predicate device, and the testing was conducted to support the 510(k) submission.

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

Not applicable. This study focuses on physical and chemical properties of a dental impression material, not diagnostic accuracy or expert interpretation of medical images. The "ground truth" for these tests would be established by validated measurement techniques and adherence to ISO standards, not expert consensus in a clinical context.

4. Adjudication Method for the Test Set

Not applicable. As described above, this study is not evaluating expert-dependent outcomes.

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 device is an impression material, not an AI-powered diagnostic tool. No MRMC studies were conducted.

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

Not applicable. This is not an algorithm or an AI device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for most of the performance characteristics (e.g., Work Time, Hardness, Tear Strength, Dimensional Change, etc.) would be objective measurements obtained through standardized laboratory testing following established protocols (often ISO standards or similar industry-accepted methods). For biocompatibility, the ground truth is established by passing the specified ISO tests (L929 MEM Elution Test, Kligman Maximization Test, Oral Irritation Test), indicating the absence of adverse biological effects according to the test criteria.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set."

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

Not applicable. There is no training set for this type of device.

Summary of the Study Proving Device Meets Acceptance Criteria:

The study proving the device meets acceptance criteria is a non-clinical performance study focusing on physical, chemical, and biological properties.

Study Type: Bench testing and biocompatibility testing.
Objective: To demonstrate substantial equivalence of Correct Plus 1 to the predicate device, Correct Plus (K001218).
Methods:
- Biocompatibility: Correct Plus 1 was subjected to ISO L929 MEM Elution Test (cytotoxicity), ISO Kligman Maximization Test (sensitization), and ISO Oral Irritation Test. The device "passed" these tests, demonstrating it is safe for its intended use.
- Bench Testing (Physical/Chemical Properties): Correct Plus 1 was tested for various performance characteristics including Work Time, Oral Set Time, Catalyst Viscosity, Base Viscosity, Out Gassing, Hardness, Mixed Consistency, Dimensional Change, Detail Reproduction, Compatibility with Gypsum, Elastic Recovery, Strain in Compression, Tensile Strength, Tensile Elongation, Tear Strength, and Contact Angle. The results of these tests were compared "as compare to the predicate device, Correct Plus."
Results & Conclusion: Based on the successful biocompatibility tests and the comparison of bench testing data showing similar performance characteristics to the predicate device, the manufacturer concluded that the "clinical performance of Correct Plus 1 is substantially equivalent to the predicate device."
Clinical Testing: No clinical testing was conducted on this product.

Summary

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K130920

Image /page/0/Picture/1 description: The image shows a logo for Sybron Dental Specialties. The logo features the letters 'sds' in a stylized font, with a swoosh above the letters. Below the letters, the words 'SYBRON DENTAL SPECIALTIES' are printed in a smaller, sans-serif font. The logo appears to be black and white.

JUL 0 2 2013

510(k) Summary

Submitter:

Sybron Dental Specialties, Inc. 1717 West Collins Avenue Orange, California 92867 (714) 516-7602 - Phone (714) 516-7488 - Facsimile Wendy Garman - Contact Person

Date Summary Prepared: June 2013

Trade name Correct Plus 1 이
Common name Impression Material 0
Classification name Material, Impression (21 CFR 872.3660, Product Code ELW) o

Devices for Which Substantial Eguivalence is Claimed:

Correct Plus, Class II, K001218, Product Code ELW, Pentron Clinical 0

Summary

Device Description

Indications of Use

Correct Plus 1 is a vinyl polysiloxane impression material which is to be used for taking impression of inlays, crowns & bridges, orthodontic appliances, precision attachments and veneers.

. HAP West Collins Avenue, Orange, CA 92867 800-537-7824 714-516-7400 15 of 17

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DescriptionInformation	Correct Plus 1	Correct PlusK001218
Company Name	Pentron Clinical	Pentron Clinical
Intended Use	Correct Plus 1 is a vinyl polysiloxaneimpression material which is to beused for taking impression of inlays,crowns & bridges, orthodonticappliances, precision attachmentsand veneers.	Correct Plus is a vinyl polysiloxaneimpression material which is to beused for taking impression ofinlays, crowns & bridges,orthodontic appliances, precisionattachments and veneers.
Description ofMaterial	Vinly Polysiloxane	Vinyl Polysiloxane
Mode of Use	Thick n' Thin fast set:A thixotropic light viscosity washimpression material that is used intwo-step heavy-wash or putty-washprocedures to capture accuratesubgingival details.	Hydrophilic Light Body:A thixotropic light viscosity washimpression material that is used intwo-step heavy-wash or putty-wash procedures to captureaccurate subgingival details.
	Universal fast set:A medium viscosity material thatproduces a highly detailed,extremely accurate monophaseimpression. It can also be used as analginate substitute impressionmaterial.	Hydrophilic Universal:A medium viscosity material thatproduces a highly detailed,extremely accurate monophaseimpression. It can also be used asan alginate substitute impressionmaterial.
	Auto-mix Putty fast set:A heavy viscosity material thatprovides the hydraulic drive of ahand-mix putty in a convenient auto-mix cartridge. It can be used in allapplications putties are used.	Putty:'A heavy viscosity material thatprovides the hydraulic drive of ahand-mix putty in a convenientauto-mix cartridge. It can be usedin all applications putties are used.
	Principles ofOperation	Correct Plus 1 is a dental impressionthat takes imprints of hard (teeth)and/or soft tissues. Correct Plus 1captures a part or all of a person'sdentition and surrounding structuresof oral cavity. The dental impression	Correct Plus is a dental impressionthat takes imprints of hard (teeth)and/or soft tissues. Correct Pluscaptures a part or all of a person'sdentition and surroundingstructures of oral cavity. The
		DescriptionInformation	Correct Plus 1
		forms an imprint (i.e. a 'negative'mold) of teeth and soft tissues,which can then be used to make acast of the dentition. An impressionis made by placing a viscous,thixotropic Impression material intothe mouth via a dental Impressiontray. The material, then sets tobecome an elastic solid, and, whenremoved from the mouth, provides adetailed and stable negative ofteeth.	dental impression forms an imprint(i.e. a 'negative' mold) of teeth andsoft tissues, which can then beused to make a cast of thedentition. An impression is madeby placing a viscous, thixotropicimpression material into themouth via a dental impressiontray. The material, then sets tobecome an elastic solid, and, whenremoved from the mouth, providesa detailed and stable negative ofteeth.
Shelf- Life	3 Years	3 Years

Summary of Technological Characteristics Compared to Predicate

K130920, Correct Plus 1

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Non-Clinical Performance Data

Biocompatibility study was completed, which demonstrates that the material is safe for its intended use. Correct Plus 1 was tested through the following tests: ISO L929 MEM Elution Test, ISO Kligman Maximization Test and ISO Oral Irritation Test.

The 510(k) submission also includes data from bench testing used to evaluate performance characteristics of Correct Plus 1 as compare to the predicate device, Correct Plus currently marketed by Pentron Clinical. The characteristics evaluated include Work Time, Oral Set Time, Catalyst Viscosity, Base Viscosity, Out Gassing, Hardness, Mixed Consistency, Dimensional Change, Detail Reproduction, Compatibility with Gypsum, Elastic Recovery, Strain in Compression, Tensile Strength, Tensile Elongation, Tear Strength and Contact Angle.

Clinical Testing

Clinical testing has not been conducted on this product.

Conclusion

Based upon the biocompatibility tests and bench testing, the clinical performance of Correct Plus 1 is substantially equivalent to the predicate device.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 2, 2013

Sybron Dental Specialties, Incorporated C/O Ms. Wendy Garman 1717 West Collins Avenue ORANGE CA 92867

Re: K130920

Trade/Device Name: Correct Plus 1 Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: April 1, 2013 Received: April 3, 2013

Dear Ms. Garman:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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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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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Kwame O. Ulmer -S

Kwame Ulmer, M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, 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):

K130920

Device Name: Correct Plus 1

Indications For Use: Correct Plus 1 is a vinyl polysiloxane impression material which is to be used for taking impression of inlays, crowns & bridges, orthodontic appliances, precision attachments and veneers.

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) Sheena A. Green -S 2013.06.28 16:56:48 -04'00' for M. Susan Runner, DDS, MA (Division Sign-Off) (Division Sign-on)
Division of Anesthesiology, General Hospital Division of Antalia.org/w/index. Pentron Clinical - Correct Plus 1 - 510(k) Submis Seguion 004 - Page 2 of 2

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).