Pulpdent Temporary Crown and Bridge Material is used by the dental professional to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.

Device Description

Pulpdent Temporary Crown and Bridge Material is a dual-cure, glass-filled, resin composite used by the dental professional to make a temporary prosthesis, such as a crown or bridge, to be used until a permanent restoration can be fabricated.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the Pulpdent Temporary Crown and Bridge Material. It does not contain a study with acceptance criteria and device performance metrics in the format requested.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices already on the market, which is a different regulatory pathway than providing specific performance metrics against pre-defined acceptance criteria from a clinical or technical study.

Here's why the requested information cannot be fully extracted from this document:

No specific acceptance criteria: The document doesn't list quantitative or qualitative acceptance criteria that the device had to meet through a dedicated study. Its primary claim is substantial equivalence to existing devices.
No reported device performance data from a specific study: The document states that the device is "substantially equivalent in design, composition, performance, intended use, safety and effectiveness to the predicate products." It also references general usage over 20 years for similar materials. However, it does not present new performance data from a study conducted specifically for the Pulpdent Temporary Crown and Bridge Material against pre-defined criteria.
No information on sample size, ground truth establishment, expert qualifications, or adjudication methods: Since no specific performance study is detailed, these related parameters are not present.
No mention of AI assistance or MRMC studies: The device is a dental material, and the document predates the widespread regulatory consideration of AI in medical devices, so these are not applicable.

Summary of what can be inferred or directly stated from the document regarding "acceptance" for regulatory purposes:

The "acceptance" in this context refers to the FDA's determination of substantial equivalence to legally marketed predicate devices, which allows the device to be marketed.

Acceptance Criteria for Regulatory Approval (Substantial Equivalence):

Acceptance Criteria (Implied for 510(k) Substantial Equivalence)	Reported Device "Performance" (as per document)
Intended Use: Device must have the same intended use as predicate devices.	Met: "Pulpdent Temporary Crown and Bridge Material is a dual-cure, glass-filled, resin composite used by the dental professional to make a temporary prosthesis, such as a crown or bridge, to be used until a permanent restoration can be fabricated." (Matches the general intended use of the listed predicate devices like Luxatemp, Sci-Span, Integrity, and CosmeTemp).
Design/Technology Characteristics: Device must have similar technological characteristics or demonstrate that differences do not raise new questions of safety or effectiveness.	Met: "Pulpdent Temporary Crown and Bridge Material is substantially equivalent in design, composition, performance, intended use, safety and effectiveness to the predicate products listed above." It is "fabricated from materials that have been used in the dental industry for many years."
Safety and Effectiveness: Device must be as safe and effective as predicate devices.	Met: "Pulpdent Temporary Crown and Bridge Material is substantially equivalent in design, composition, performance, intended use, safety and effectiveness to the predicate products listed above that have been on the market and used by dental professionals for more than 15 years with no serious safety or effectiveness problems." The document also cites a "NIN Technology Assessment Conference on Effects and Side-Effects of Dental Restorative Materials" stating, "General usage of these materials over about 20 years indicates a high benefit-to-risk ratio...There is no evidence of short-term or long-term risk...There is no suspicion of any problems after virtually billions of procedures in the United States." This refers to general composite and glass ionomer materials, not specifically the Pulpdent product.

Information Not Found / Not Applicable (based on the provided document):

Sample size used for the test set and the data provenance: Not applicable as a specific performance study with a test set is not detailed. The substantiation relies on equivalence to existing devices and broad general usage data for similar materials.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method for the test set: Not applicable.
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. The device is a dental material, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: For the purposes of substantial equivalence, the "ground truth" is largely assumed by the historical safety and effectiveness of the predicate devices and the general class of materials. No specific new ground truth for this device is established in this document.
The sample size for the training set: Not applicable. The device is a material, not a machine learning algorithm.
How the ground truth for the training set was established: Not applicable.

In conclusion, the document serves as a regulatory submission (510(k)) demonstrating substantial equivalence, not as a detailed technical report of a performance study against specific acceptance criteria.

Summary

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K081810

PULPDENT CORPORATION

SEP 1 7 2008

510 k Premarket Notification Pulpdent Temporary Crown and Bridge Material

EXHIBIT 2

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS DATA

Kenneth J. Berk 80 Oakland Street PO Box 780 Watertown, MA 02472 USA

617-926-6666 Telephone: Fax: 617-926-6262 ken@pulpdent.com

DEVICE: Trade Name: Pulpdent Temporary Crown and Bridge Material Classification Name: Temporary Crown and Bridge Resin Class: Il FDA Product Code: 76 EBG, 21 CFR Part 872.3770

PREDICATE DEVICES:

Luxatemp, DMG Luxatemp Solar, DMG Sci-Span, Scientific Pharmaceuticals Inc. Integrity, Dentsply International CosmeTemp, Cosmedent Inc.

DESCRIPTION AND INTENDED USE:

COMPARISON WITH PREDICATE PRODUCTS:

Pulpdent Temporary Crown and Bridge Material is substantially equivalent in design, composition, performance, intended use, safety and effectiveness to the predicate products listed above. The predicate products have been found substantially equivalent under the 510(k) Premarket Notification process as Class II Dental Devices under CFR 872.3770.

SAFETY AND EFFECTIVENESS:

Pulpdent Temporary Crown and Bridge Material is substantially equivalent in design, composition, performance, intended use, safety and effectiveness to the predicate products listed above that have been on the market and used by dental professionals for more than 15 years with no serious safety or effectiveness problems. Pulpdent Temporary Crown and Bridge Material is fabricated from materials that have been used in the dental industry for many years.

According to the NIN Technology Assessment Conference on Effects and Side-Effects of Dental Restorative Materials: "General usage of these materials over about 20 years indicates a high benefit-torisk ratio...both composites and glass ionomers are relatively trouble-free. There is no evidence of shortterm or long-term risk...There is no suspicion of any problems after virtually billions of procedures in the United States."

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three stripes forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

SEP 1 7 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Kenneth J. Berk Director Pulpdent Corporation 80 Oakland Street P.O. Box 780 Watertown, Massachusetts 02472

Re: K081810

Trade/Device Name: Pulpdent Temporary Crown and Bridge Material Regulation Number: 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: II Product Code: EBG Dated: June 18, 2008 Received: June 26, 2008

Dear Mr. Berk:

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 - Mr. Berk

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complics 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 yours,

Thlmnuels-fleury for 11

Chiu S. Lin. Ph. D Division 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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081810

INDICATIONS FOR USE

510 (k) Number (if known)

Device Name:

PULPDENT TEMPORARY CROWN AND BRIDGE MATERIAL

Indications for Use:

Pulpdent Temporary Crown and Bridge Material is used by the dental professional to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.

Prescription Use X

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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 Dunn

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

510(k) Number:

Regulation Number and Section

§ 872.3770 Temporary crown and bridge resin.

(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.