(52 days)
Nexus 3 is a resin cement for the cementation of ceramic, resin, and metal-based veneers, inlays, onlays, crowns, bridges and posts, bonding of amalgam restorations, and as core-buildup material.
Nexus 3 is a resin cement system comprising of a single-syringe light-cure veneer cement and a dual-syringe dual-cure all-purpose resin cement.
The provided document is a 510(k) premarket notification for a dental cement product called "Nexus 3". It describes the device, its intended use, and claims substantial equivalence to a predicate device ("Nexus 2").
However, the document does not contain any information regarding acceptance criteria, performance studies, sample sizes, expert qualifications, ground truth establishment, or any of the other specific details requested in your prompt regarding artificial intelligence (AI) device performance evaluation.
The document states: "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..." This indicates that the approval was based on substantial equivalence to an existing device, not on a new performance study that would typically involve acceptance criteria and detailed study results as described in your prompt.
Therefore, I cannot provide the requested information from this document. The information you are asking for is typically found in performance study reports for AI/ML-enabled devices, which this document is not.
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Image /page/0/Picture/0 description: The image shows a logo for Sybron Dental Specialties. The logo features the letters 'sds' in a stylized font, with a curved line above the letters. Below the letters, the words 'SYBRON DENTAL SPECIALTIES' are printed in a simple, sans-serif font. The logo is black and white.
Image /page/0/Picture/1 description: The image shows the text "K062519" on the first line and "p. 1 of 1" on the second line. The text is written in a handwritten style. The numbers and letters are clearly visible and legible.
Section III - 510(k) Summary of Safety and Effectiveness
Submitter:
OCT 1 9 2006
Sybron Dental Specialties, Inc. 100 Bayview Circle, Suite 6000 Newport Beach, California 92660 (949) 255-8766 - Phone (949) 255-8763 - Facsimile Colleen Boswell - Contact Person
Date Summary Prepared: August 2006
Device Name:
- . Trade Name - Nexus 3
- Common Name -- Dental Cement ●
- Classification Name Dental Cement, per 21 CFR § 872.3275 .
Devices for Which Substantial Equivalence is Claimed:
- . Sybron Dental Specialties, Inc., Nexus 2
Device Description:
Nexus 3 is a resin cement system comprising of a single-syringe light-cure veneer cement and a dual-syringe dual-cure all-purpose resin cement.
Intended Use of the Device:
The intended use of Nexus 3 is as a resin cement for the cementation of ceramic, resin, and metal-based veneers, inlays, onlays, crowns, bridges and posts, bonding of conding of amalgam restorations, and as core-buildup material.
Substantial Equivalence:
Nexus 3 is substantially equivalent to other legally marketed devices in the United States. Nexus 3 functions in a manner similar to and is intended for the same use as the product Nexus 2 cleared for marketing for Sybron Dental Specialties, Inc.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its wings. The eagle is positioned to the right of a circular inscription that reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 9 2006
Ms. Colleen Boswell Director, Corporate Compliance Sybron Dental Specialties, Incorporated 100 Bayview Circle, Suite 6000 Newport Beach, California 92660
Re: K062519
Trade/Device Name: Nexus 3 Regulation Number: 21 CFR 872.3275(b) Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: August 25, 2006 Received: August 29, 2006
Dear Ms. Boswell:
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 commence 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 coan. therefore, market the device, subject to the general controls provisions of the Act. To ameral controls provisions of the Act include requirements for annual registration, listing of levines, 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 an be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA nav publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Colleen Boswell
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 (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/industry/support/index.html.
Sincerely vours.
Chiu S. Lin, PhD
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 K062519
510(k) Number (if known):
Device Name: Nexus 3
Indications For Use:
Nexus 3 is a resin cement for the cementation of ceramic, resin, and metal-based veneers, inlays, onlays, crowns, bridges and posts, bonding of amalgam restorations, and as corebuildup material.
× Prescription Use (Part 21 CFR 801 Subpart D)
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AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
[Signature]
| Division of Anesthesiology, General Hospital | |
|---|---|
| Infection Control, Dental Devices | |
| K062519 |
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§ 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.