LIQCRYLIC PRO DENTAL RESIN by DENTSPLY INTL.

LIQCRYLIC™ PRO DENTAL RESIN is a pourable, cold-curing powder and liquid polymethyl methacrylate denture base material. It is color stable due to the fact that it utilizes a barbituric acid based catalyst system in lieu of the conventional benzoyl peroxide/amine catalyst system. It will be marketed in the popular Lucitone® 199 denture base shades. LIQCRYLIC™ PRO DENTAL RESIN mixes more quickly, has a shorter cure cycle and can be finished easier than the conventional pour resins currently available in the U.S. market.

AI/ML Overview

Here's an analysis of the provided 510(k) summary, specifically addressing your points about acceptance criteria and supporting studies.

Important Note: The provided document is a 510(k) summary for a dental resin (LIQCRYLIC™ PRO DENTAL RESIN), which is a material used for dentures. This type of device typically undergoes testing for material properties (e.g., strength, color stability, biocompatibility) rather than diagnostic accuracy or performance against a "ground truth" as you might find with an AI-powered medical imaging device. Therefore, many of your specific questions related to AI device performance metrics (MRMC studies, standalone performance, expert consensus on images, training sets) are not applicable in this context.

Based on the provided document, here's the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal acceptance criteria in a quantitative table format that lists specific thresholds for performance metrics. Instead, it relies on substantial equivalence to a predicate device and a history of safe use.

Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility: Safe for use in contact with human tissue (implied by predicate device and long clinical history).	"We believe that biocompatibility studies are not necessary to prove the safety and efficacy of this formulation" due to over 30 years of market history of the technology and the predicate device.
Material Properties: Equivalent performance in terms of setting time, strength, color stability, ease of finishing to the predicate device.	"LIQCRYLIC™ PRO DENTAL RESIN mixes more quickly, has a shorter cure cycle and can be finished easier than the conventional pour resins currently available in the U.S. market." (Suggests improvement, not just equivalence). "It is color stable due to the fact that it utilizes a barbituric acid based catalyst system in lieu of the conventional benzoyl peroxide/amine catalyst system." (Specific property improvement mentioned).
Intended Use: Suitable for fabrication, repair, or rebasing of complete or partial removable dentures and other removable dental appliances.	The device is intended and asserted to be suitable for these uses, based on substantial equivalence and performance data.
Substantial Equivalence: To predicate device Palapress Vario (K902115).	"LIQCRYLIC™ PRO DENTAL RESIN is substantially equivalent to Palapress Vario (K902115) by Kulzer."

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

Sample Size: Not specified in terms of a formal test "set" for human or AI performance. The equivalence is based on the long history of the material.
Data Provenance: The "data" primarily stems from the long-term clinical use and market history of the predicate device (Palapress Vario) and similar formulations marketed by DENTSPLY in Europe and South America for over 25 years (technology is over 30 years old). This would be considered retrospective observational data (clinical history). The countries of origin mentioned are the U.S. (for predicate), Europe, and South America (for similar devices).

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

This is not applicable. The device is a material, not a diagnostic tool requiring expert interpretation of images or clinical data for ground truth establishment. Equivalence is primarily based on material properties and clinical history.

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

Not applicable for this type of device and submission.

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 a material, not an AI-assisted diagnostic device.

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

Not applicable.

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

The "ground truth" here is primarily established through:
- Clinical Outcomes Data (Historical): The long clinical history of the predicate and similar devices demonstrating safe and effective use in patients.
- Material Science Testing: Implied mechanical and physical property testing to ensure the new resin performs comparably or better than the predicate, though specific results are not detailed in this summary.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device.

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

Not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria (as described in the 510(k) summary):

The submission for LIQCRYLIC™ PRO DENTAL RESIN relies on demonstrating substantial equivalence to an already legally marketed predicate device, Palapress Vario (K902115), and leveraging the long clinical history of this technology.

Basis of Proof:
- Substantial Equivalence: The manufacturer asserts that LIQCRYLIC™ PRO DENTAL RESIN is "substantially equivalent" to Palapress Vario in its technological characteristics. This implies that the new device has similar fundamental scientific technology, design, and performance characteristics compared to the predicate.
- Long Clinical History: DENTSPLY highlights that the predicate device has been marketed in the U.S. since 1992, and DENTSPLY itself has marketed similar devices (Selecta-plus® Material and Trevapress® Material) in Europe and South America for over 25 years. The underlying technology is stated to be "over 30 years old." This extensive market history serves as the primary evidence for safety and effectiveness, obviating the need for de novo biocompatibility studies.
- Performance Data: While not detailed, the summary states that "the performance data support the safety and effectiveness." This would typically involve laboratory testing of material properties (e.g., strength, working time, cure time, color stability) to ensure it meets appropriate standards and is comparable or superior to the predicate. The summary specifically calls out that it "mixes more quickly, has a shorter cure cycle and can be finished easier," and is "color stable due to the fact that it utilizes a barbituric acid based catalyst system."

In essence, the "study" for this device is not a single, formalized clinical trial as one might see for a drug or an interventional device, nor is it a performance study for an AI algorithm. Instead, it's a compilation of evidence derived from:

Comparison of technological characteristics to a legally marketed predicate.
The established safety and efficacy profile of the predicate and similar long-marketed devices based on their historical clinical use.
Internal performance testing to support claims of equivalence and, in some cases, improvement.

Summary

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510(k) SUMMARY

Image /page/0/Picture/21 description: The image shows the word "DENTSPLY" in a bold, sans-serif font. The letters are all capitalized and are closely spaced together. The word appears to be a logo or brand name. The font is a solid black color, and the background is white.

NAME & ADDRESS:

DENTSPLY International

570 West College Avenue P.O. Box 872 York, PA 17405-0872 (717) 845-7511

SEP 1 6 1997

K972573

P. J. Lehn Telefax (717) 849-4343

CONTACT: P. Jeffery Lehn

DATE PREPARED: July 9, 1997

TRADE OR PROPRIETARY NAME: LIQCRYLIC™ PRO DENTAL RESIN

Denture relining, repairing or rebasing resin 872.3760 CLASSIFICATION NAME:

K902115 PREDICATE DEVICE: Palapress Vario Resin

DEVICE DESCRIPTION: LIQCRYLIC™ PRO DENTAL RESIN is a pourable, cold-curing powder and liquid polymethyl methacrylate denture base material. It is color stable due to the fact that it utilizes a barbituric acid based catalyst system in lieu of the conventional benzoyl peroxide/amine catalyst system. It will be marketed in the popular Lucitone® 199 denture base shades. LIQCRYLIC™ PRO DENTAL RESIN mixes more quickly, has a shorter cure cycle and can be finished easier than the conventional pour resins currently available in the U.S. market.

INTENDED USE: LIQCRYLIC™ PRO DENTAL RESIN is used in the fabrication, repair or rebasing of complete or partial removable dentures and other removal dental appliances.

TECHNOLOGICAL CHARACTERISTICS: LIQCRYLIC™ PRO DENTAL RESIN is substantially equivalent to Palapress Vario (K902115) by Kulzer.

Kulzer has marketed the predicate device, Palapress Vario, in the United States since 1992 (K902115), and DENTSPLY has marketed this device (as Selecta-plus® Material and Trevapress® Material) in Europe and South America for over 25 years. The technology is over 30 years old and has a long clinical history. Therefore, we believe that biocompatibility studies are not necessary to prove the safety and efficacy of this formulation.

We believe that the substantial equivalence of LIQCRYLIC™ PRO DENTAL RESIN to the predicate device (K902115) marketed in the U.S., the long market history of the device of the U.S., and the performance data support the safety and effectiveness of LIQCRYLIC™ PRO DENTAL RESIN for the intended use.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized depiction of a bird-like figure composed of three human profiles facing right, symbolizing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 6 1907

Mr. P. Jeffrey Lehn Director, Corporate Compliance and Regulatory Affairs DENTSPLY International 570 West College Avenue York, Pennsylvania 17405

Re: K972573 Trade Name: Liqcrylic™ Pro Dental Resin Requlatory Class: II Product Code: EBI Dated: July 9, 1997 Received: July 10, 1997

Dear Mr. Lehn:

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 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਬ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does

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Page 2 - Mr. Lehn

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 requlations.

Please also be advised that FDA is examining whether the Modified Human Draize Test, as it is currently conducted on medical gloves, is a valid means of predicting the sensitization potential of latex or synthetic materials. I E FDA finds that the test is not a scientifically sound means to predict latex or synthetic materials hypersensitivity reactions in users, then hypoallergenic claims included in labeling for medical gloves may be considered misleading, and we will move to have the claim removed from labeling for all medical gloves.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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 gener 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,

Patrici Cucureatz /for

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

Enclosure

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PREMARKET NOTIFICATION

INDICATIONS FOR USE STATEMENT

(As Required by 21 CFR 801.109)

510(K) Number:

1972573

Device Name:

LIQCRYLIC™ PRO DENTAL RESIN

Indications for Use:

Used in the fabrication, repair or rebasing of complete or partial

removable dentures and other removable dental appliances.

Susan Rump

rence of CDRH, Office of Device Evaluation (ODE) Divisio and Gene 510(k) Numb Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ OR Prescription

000007

Regulation Number and Section

§ 872.3760 Denture relining, repairing, or rebasing resin.

(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.