(83 days)
Pulpdent Micro-Hybrid Composite is a radiopaque, light-cured, fine-particle hybrid dental composite used for esthetic, direct resin restorations including all cavity classifications (1-V),) anterior and posterior restorations, Class V restorations and direct veneering.
Pulpdent Micro-Hybrid Composite is a radiopaque, light-cured, fine-particle hybrid dental composite for esthetic, direct resin restorations.
The provided document is a 510(k) premarket notification for a dental composite material, not an AI/ML medical device. Therefore, it does not contain the information requested about acceptance criteria, study details for AI performance, sample sizes for test/training sets, expert adjudication, or MRMC studies.
The document focuses on demonstrating substantial equivalence of the Pulpdent Micro-Hybrid Composite to existing predicate devices based on design, composition, performance, intended use, safety, and effectiveness, as per 21 CFR Part 872.3690. The safety and effectiveness are supported by general usage over 20 years for similar materials.
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MAY 1 1 2009
EXHIBIT 2
SUMMARY OF SAFETY AND 🇪두ΕΣΤΙVENESS DATA
Kenneth J. Berk 80 Oakland Street PO Box 780 Watertown, MA 02472 USA
Telephone: 617-926-6666 Fax: 617-926-6262 ken@pulpdent.com
DEVICE:
Trade Name: PULPDENT MICRO-HYBRID COMPC¡SITE Classification Name: Tooth shade resin material FDA Product Code: 76 EBF, 21 CFR Part 872.3690
PREDICATE DEVICES:
Ivoclar Vivadent 4 Seasoris Dentsply/Caulk Esthet*X GC Gradia Direct
DESCRIPTION AND INTENDED USE:
Pulpdent Micro-Hybrid Composite is a radiopaque, light-cured, fine-particle hybrid dental composite for esthetic, direct resin restorations.
Pulpdent Micro-Hybrid Composite is used by the dental professional for the restoration of all cavity classifications (I-VI) in anterior and posterior teeth, Class V restorations, and for direct veneering,
COMPARISON WITH PREDICATE PRODUCTS:
Pulpdent Micro-Hybrid Composite is substantially equivalent in design, composition, performance, intended use, safety and effectiveness to the predicate products listed above.
SAFETY AND EFFECTIVENESS:
Pulpdent Micro-Hybrid Composite is substantially equivalent in design, composition, performance, intended use, safety and effectiveness to the predically products listed above. The products have been found substantially equivalent under the 510(k) Premarket Notification process as Class II Dental Devices under CFR 872.3690.
According to the NH Technology Assessment Conlerence on Effects and Side-Effects of Dental Restorative Materials: "General usage of these materials over about 20 years indicates a high benefit to-risk ration..both composites and glass ionomers are relatively trouble-free. There is no evidence of short-term of long-term risk...There is no suspicion of any problems after virtually billions of procedures in the United States."
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three overlapping wings, symbolizing health, services, and humanism. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle emblem.
Public Health Service
MAY 1 1 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Kenneth J. Berk Director Pulpdent Corporation 80 Oakland Street Watertown, Massachusetts 02472
Re: K090391
Trade/Device Name: Pulpdent Micro-Hybrid Composite Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: February 12, 2009 Received: February 18, 2009
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 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 l'ederal 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 Parl 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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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,
Susan Lumoe
Susan Runner, D.D.S., MA Acting 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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Indications for Use
Ko90391 510(k) Number (if known):
Device Name: Pulpdent Micro-Hybrid Composite
Indications For Use:
Pulpdent Micro-Hybrid Composite is a radiopaque, light-cured, fine-particle hybrid dental composite used for esthetic, direct resin restorations including all cavity classifications (1-V),) anterior and posterior restorations, Class V restorations and direct veneering.
Prescription Use (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)
K-Mulu for WSR
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page 1 of 1
510(k) Number: K090821
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.