TUFF-TEMP 2.0

K120784 · Pulpdent Corporation · EBG · Jun 8, 2012 · Dental

Device Facts

• Record ID: K120784
• Device Name: TUFF-TEMP 2.0
• Applicant: Pulpdent Corporation
• Product Code: EBG · Dental
• Decision Date: Jun 8, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3770
• Device Class: Class 2

Intended Use

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.

Device Story

Pulpdent Tuff-Temp 2.0 is a dual-cure, glass-filled resin composite material used by dental professionals in clinical settings to fabricate temporary dental prostheses (crowns/bridges). The material is supplied in two parts; it utilizes both chemical and photo-initiators to achieve polymerization. The device is applied by the clinician to create a temporary restoration that remains in the patient's mouth until a permanent restoration is fabricated. The material features improved esthetics, reduced oxygen-inhibited layer, and lower heat rise during setting compared to its predecessor. It provides a temporary functional and esthetic solution for patients during the interim period of restorative dental treatment.

Clinical Evidence

No clinical trials were conducted. Evidence consists of bench testing (flexural strength 84.0 MPa, compressive strength 205.0 MPa, heat rise 5.4°C) and pre-production clinical evaluations by dental consultants. The device has been marketed in Europe as a CE-marked device with no reported adverse events. Biocompatibility is supported by the established safety profile of the original Tuff-Temp formulation.

Technological Characteristics

Dual-cure, glass-filled resin composite. Composition: blended dimethacrylate resins, chemical and photo-initiators, barium glass, and submicron silica fillers. Form factor: two-part system. Setting mechanism: dual-cure (light-cure and self-cure).

Indications for Use

Indicated for use by dental professionals to fabricate temporary prostheses, including crowns and bridges, for patients requiring interim restorations until a permanent restoration is completed.

Regulatory Classification

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.

Predicate Devices

• Pulpdent Tuff-Temp (K081810)
• DMG Luxatemp Solar (K013674)

Submission Summary (Full Text)

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# PULPDENT CORPORATION

80 Oakland Street Watertown, MA 02472 USA

Tel: [phone] Fax: [phone] Email: [e-mail]

# 510(k) SUMMARY

March 13, 2012

Kenneth J. Berk 80 Oakland Street Watertown, MA 02472 USA Telephone: [phone] Fax: [phone] Email: [e-mail]

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:

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.

## 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-filled<br>composite material in<br>two parts | To make a temporary<br>prosthesis, such as a crown<br>or bridge, for use until a<br>permanent restoration can<br>be fabricated. | Blended dimethacrylate resins<br>Chemical and Photo-initiators<br>Barium glass and submicron silica fillers |
| Pulpdent Tuff-Temp<br>K081810 | Dual-cure, glass-filled<br>composite material in<br>two parts | To make a temporary<br>prosthesis, such as a crown<br>or bridge, for use until a<br>permanent restoration can<br>be fabricated. | Blended dimethacrylate resins<br>Chemical and Photo-initiators<br>Barium glass and submicron silica fillers |
| DMG Luxatemp Solar<br>K013674 | Dual cure, bis-acryl<br>composite material in<br>two parts | To make a temporary<br>prosthesis, such as a crown<br>or bridge, for use until a<br>permanent restoration can<br>be fabricated. | Bis-acryl resins (Urethane dimethacrylate, aromatic<br>dimethacyrlate, glycol methacrylate)<br>Chemical and Photo-initiators<br>Barium 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 | |
| | <b>Self-cure</b> | <b>Light cure</b> |
| 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 [phone] or [phone] 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:

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.

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: