Pulpdent Tuff-Temp 2.0 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.
Dual-cure, glass-filled composite material in two parts. Blended dimethacrylate resins Chemical and Photo-initiators Barium glass and submicron silica fillers.

AI/ML Overview

Below is a summary of the acceptance criteria and the study proving the device meets it, based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Measurement)	Reported Device Performance
Flexural strength	84.0 ± 4.0 MPa
Compressive strength	205.0 ± 18.0 MPa
Deflection at break	2.3 ± 0.3 mm
Heat rise	5.4°C
Initial setting time (Self-cure)	90 seconds
Initial setting time (Light cure)	20 seconds
Final self-cure setting time	5 minutes from beginning of mix

Note: The document does not explicitly state numerical acceptance criteria (e.g., "must be greater than X MPa"). Instead, it presents the reported performance values as evidence that "Tuff-Temp 2.0 performs as intended" and supports substantial equivalence to predicate devices.

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

The provided text does not specify the sample size used for the bench tests (flexural strength, compressive strength, etc.).

For biocompatibility, the text mentions "Pre-production clinical evaluations of Tuff-Temp 2.0 by dentists in the field and by dentist consultants were positive." However, no specific sample size (number of dentists or patients) is given. It also states, "Tuff-Temp 2.0 has been sold in Europe as a CE marked medical device for the past four months," implying real-world usage data.

The data provenance for the bench tests is not explicitly stated (e.g., country of origin), but it is implied to be from internal testing by Pulpdent Corporation. The clinical evaluation data appears to be from Europe (CE marked medical device) and general "field" evaluations. The study appears to be a prospective evaluation for Tuff-Temp 2.0 (pre-production clinical evaluations and 4 months of sales in Europe), while references to the original Tuff-Temp's performance ("ten years of problem-free use" and "two years on the market") are retrospective observations.

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

The text mentions "Pre-production clinical evaluations of Tuff-Temp 2.0 by dentists in the field and by dentist consultants were positive." It does not specify the exact number of dentists or their specific qualifications (e.g., years of experience).

4. Adjudication Method for the Test Set

The document does not describe any formal adjudication method for the clinical evaluations. The statement "Pre-production clinical evaluations... were positive" suggests a general consensus or positive feedback rather than a structured adjudication process.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC study was not conducted. The provided information focuses on bench testing and general clinical feedback, not a comparative effectiveness study involving human readers with and without AI assistance. This device is a material, not an AI or imaging device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This is not applicable as the device is a dental material (temporary crown and bridge resin), not an algorithm or AI system. The performance metrics are physical/material properties.

7. Type of Ground Truth Used

For the bench tests (flexural strength, compressive strength, etc.), the "ground truth" is derived from objective laboratory measurements based on established testing standards (though the specific standards are not cited).

For biocompatibility and clinical performance, the ground truth is based on dentist and patient feedback/observations during pre-production clinical evaluations and post-market use in Europe. It also relies on the "problem-free use" history of similar predicate devices and the original Tuff-Temp.

8. Sample Size for the Training Set

This is not applicable as the device is a material and not an AI or machine learning model that requires a training set.

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

This is not applicable as the device is a material and not an AI or machine learning model.

Summary

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PULPDENT CORPORATION

80 Oakland Street Watertown, MA 02472 USA

Tel: 617 926 6666 Fax: 617 926 6262 Email: Pulpdent@pulpdent.com

510(k) SUMMARY

March 13, 2012

Kenneth J. Berk 80 Oakland Street Watertown, MA 02472 USA Telephone: 617-926-6666 Fax: 617-926-6262 Email: ken@pulpdent.com

DEVICE: Pulpdent Tuff-Temp 2.0 Trade Name: Classification Name: Temporary Crown and Bridge Resin Class: Il FDA Product Code: 76 EBG, 21 CFR Part 872.3770

PREDICATE DEVICES:

Pulpdent Tuff-Temp Luxatemp, DMG

DESCRIPTION AND INTENDED USE:

COMPARISON WITH PREDICATE PRODUCTS:

Pulpdent Tuff-Temp 2.0 is substantially equivalent in design, composition, performance and intended use to the predicate products. The predicate products have been found substantially equivalent under the 510(k) Premarket Notification process as Class II Dental Devices under CFR 872.3770. Tuff-Temp 2.0 is an enhanced version of the original Tuff-Temp with improved esthetics, reduced oxygen inhibited layer and lower heat rise on setting.

Product	Description	Intended Use	Composition
Pulpdent Tuff-Temp 2.0	Dual-cure, glass-filledcomposite material intwo parts	To make a temporaryprosthesis, such as a crownor bridge, for use until apermanent restoration canbe fabricated.	Blended dimethacrylate resinsChemical and Photo-initiatorsBarium glass and submicron silica fillers
Pulpdent Tuff-TempK081810	Dual-cure, glass-filledcomposite material intwo parts	To make a temporaryprosthesis, such as a crownor bridge, for use until apermanent restoration canbe fabricated.	Blended dimethacrylate resinsChemical and Photo-initiatorsBarium glass and submicron silica fillers
DMG Luxatemp SolarK013674	Dual cure, bis-acrylcomposite material intwo parts	To make a temporaryprosthesis, such as a crownor bridge, for use until apermanent restoration canbe fabricated.	Bis-acryl resins (Urethane dimethacrylate, aromaticdimethacyrlate, glycol methacrylate)Chemical and Photo-initiatorsBarium glass and submicron silica fillers

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PULPDENT CORPORATION

80 Oakland Street Watertown, MA 02472 USA

SUMMARY OF PERFORMANCE TESTING - BENCH:

The following test results demonstrate that Tuff-Temp 2.0 performs as intended:

Flexural strength	$84.0 \pm 4.0$ MPa
Compressive strength	$205.0 \pm 18.0$ MPa
Deflection at break	$2.3 \pm 0.3$ mm
Heat rise	5.4°C
	Self-cure	Light cure
Initial setting time	90 seconds	20 seconds
Final self-cure setting time	5 minutes from beginning of mix	Not applicable

B10COMPATIBILITY:

Pre-production clinical evaluations of Tuff-Temp 2.0 by dentists in the field and by dentist consultants were positive. Tuff-Temp 2.0 has been sold in Europe as a CE marked medical device for the past four months. Its use in clinical practice has met both user and patient needs and there have been no reports of adverse events.

The original Tuff-Temp has been on the market for two years. Field Reports from sales people, dentists. and other customers have praised Tuff-Temp for its qualities. During that time there have been no reports of adverse events, i.e., allergic reactions, soft tissue irritation, etc. There is sufficient similarity between Tuff-Temp and Tuff-Temp 2.0 to expect that it will have equivalent biocompatibility.

CONCLUSION:

From the above comparisons, the bench testing and more than ten years of problem-free use of similar temporary crown and bridge resins in the dental profession, it can be concluded that Pulpdent Tuff-Temp 2.0 is substantially equivalent in design, composition, performance and intended use to the predicate products listed above.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol on the right. To the left of the symbol is a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged around the perimeter of the circle.

Public Health Service

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

JUN - 8 2012

Mr. Kenneth J. Berk Director Pulpdent Corporation 80 Oakland Street Watertown, Massachusetts 02472

Re: K120784

Trade/Device Name: Pulpdent Tuff-Temp 2.0 Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: II Product Code: EBG Dated: March 13, 2012 Received: March 15, 2012

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. 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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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 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 device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,

Nh foc

Anthony D. Watson, B.S., M.S., M.B.A. 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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6120784 Indications for Use

510(k) Number: 《 |Q()7&l)

Device Name: Pulpdent Tuff-Temp 2.0

Indications For Use:

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)

Susan Runse

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

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K1267 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.