(85 days)
Not Found
No
The device description and performance studies focus on the material properties and clinical performance of a dental resin composite, with no mention of AI or ML technologies.
No.
The device is a temporary dental material, not a therapeutic device. It is used to create a temporary prosthesis until a permanent restoration can be fabricated, indicating a restorative or prosthetic function rather than a therapeutic one (i.e., treating or curing a disease or condition).
No
The device is a resin composite for making temporary prostheses, not for diagnosing conditions. Its listed functions involve fabrication and material properties (e.g., strength, setting time), not diagnostic analysis.
No
The device description clearly states it is a "dual-cure, glass-filled, resin composite" and lists material components, indicating it is a physical material, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that Pulpdent Tuff-Temp 2.0 is used to make a temporary prosthesis (crown or bridge) for use in the mouth of a patient.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a material used for fabrication, not for analyzing biological samples.
This device is a dental material intended for direct application and use within the patient's oral cavity, making it a medical device, but not an IVD.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
EBG
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental professional
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following test results demonstrate that Tuff-Temp 2.0 performs as intended:
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, Light cure 20 seconds
Final self-cure setting time: 5 minutes from beginning of mix
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Pulpdent Tuff-Temp K081810, DMG Luxatemp Solar K013674
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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:
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 | ||
| composite material in | |||
| two parts | To make a temporary | ||
| prosthesis, such as a crown | |||
| or bridge, for use until a | |||
| permanent restoration can | |||
| be fabricated. | Blended dimethacrylate resins | ||
| Chemical and Photo-initiators | |||
| Barium glass and submicron silica fillers | |||
| Pulpdent Tuff-Temp | |||
| K081810 | Dual-cure, glass-filled | ||
| composite material in | |||
| two parts | To make a temporary | ||
| prosthesis, such as a crown | |||
| or bridge, for use until a | |||
| permanent restoration can | |||
| be fabricated. | Blended dimethacrylate resins | ||
| Chemical and Photo-initiators | |||
| Barium glass and submicron silica fillers | |||
| DMG Luxatemp Solar | |||
| K013674 | Dual cure, bis-acryl | ||
| composite material in | |||
| two parts | To make a temporary | ||
| prosthesis, such as a crown | |||
| or bridge, for use until a | |||
| permanent restoration can | |||
| be fabricated. | Bis-acryl resins (Urethane dimethacrylate, aromatic | ||
| dimethacyrlate, glycol methacrylate) | |||
| Chemical and Photo-initiators | |||
| Barium glass and submicron silica fillers |
1
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.
2
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.
3
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
4
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
Page 1 of 1
K1267 510(k) Number: