(86 days)
Multilink® is a self-curing and self-etching luting composite system for the adhesive whiles is a coll cannons made of metal, metal-ceramic, all-ceramic and composite.
It is Contraindicated if the patient has allergies to any ingredient; and no direct application on pulpa-near dentin or on the open pulp or irritations of the pulp may occur.
Multilink® is a self-curing and self-etching luting composite system
I am sorry, but the provided text from the FDA 510(k) summary for the Multilink device (K032470) does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving device performance.
The document is a clearance letter from the FDA to Ivoclar Vivadent, Inc., confirming that their Multilink dental cement is substantially equivalent to legally marketed predicate devices. It primarily focuses on regulatory approval, classification, and general controls provisions of the Federal Food, Drug, and Cosmetic Act.
The document does not include:
- A table of acceptance criteria and reported device performance.
- Details about a study with sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods.
- Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or standalone algorithm performance.
- Training set sample sizes or how their ground truth was established.
Therefore, I cannot provide the requested information based on the input text.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a bird or eagle with three overlapping profiles, suggesting a sense of community or interconnectedness. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 5 2003
Ivoclar Vivadent, Incorporated Ms. Donna Maria Hartnett Director of Quality Assurance/ Regulatory Affairs and Assistant Corporate Counsel 175 Pineview Drive Amherst, New York 14228
Re: K032470
Trade/Device Name: Multilink Regulation Number: 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: August 6, 2003 Received: August 16, 2003
Dear Ms. Hartnett:
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.
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Page 2 -Ms. Hartnett
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); 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.
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 Office of Compliance at (301) 594-4613. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Patrice Cucentiffoc
Chiu Lin. Ph.D. 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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Page 1 of 1
510(k) Number (if known): Pending
Device Name:
Multilink ____________________________________________________________________________________________________________________________________________________________________
Indications For Use:
Multilink® is a self-curing and self-etching luting composite system for the adhesive whiles is a coll cannons made of metal, metal-ceramic, all-ceramic and composite.
It is Contraindicated if the patient has allergies to any ingredient; and no direct application on pulpa-near dentin or on the open pulp or irritations of the pulp may occur.
Susan Rurrs
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K0032470
( ?LEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDE:D)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_ · Per 21 CFR 801.109)
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ OR
(Optional Format 1-2-96)
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.