(83 days)
Not Found
Not Found
No
The 510(k) summary describes a dental material, not a software or imaging device, and explicitly states "Not Found" for mentions of AI, DNN, or ML.
No.
The device is a material used for temporary prostheses, which are restorative rather than therapeutic. Its function is to fill a deficit until a permanent solution can be made, not to treat a disease or condition.
No
Explanation: The device is a material used to create temporary prostheses, not to diagnose medical conditions.
No
The device description clearly states it is a "dual-cure, glass-filled, resin composite," which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to create a temporary dental prosthesis (crown or bridge) for use in the mouth until a permanent restoration is made. This is a direct application within the patient's body, not a test performed on a sample outside the body.
- Device Description: The description confirms it's a material used to make a temporary prosthesis, not a diagnostic test or reagent.
- Lack of IVD Characteristics: The information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
Therefore, the Pulpdent Temporary Crown and Bridge Material is a dental restorative material, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
76 EBG
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.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Luxatemp, DMG Luxatemp Solar, DMG Sci-Span, Scientific Pharmaceuticals Inc. Integrity, Dentsply International CosmeTemp, Cosmedent Inc.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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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:
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.
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.
2
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
3
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
or
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:
1