(54 days)
Kerr Corporation, Nexus Universal Luting Cement
None
No
The summary describes a dental cement and does not mention any AI or ML capabilities.
No
The device is a dental cement used for luting dental restorations, which is not considered a therapeutic function. It is a material used in a restorative procedure.
No
Explanation: The "Intended Use" clearly states that Nexus 2 is a "dental cement designed to be used for luting inlays, crowns, bridges, porcelain veneers and endodontic posts." Luting is a restorative and bonding process, not a diagnostic one.
No
The device is a dental cement, 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 clearly states that Nexus 2 is a dental cement used for luting (bonding) dental restorations (inlays, crowns, bridges, veneers, posts). This is a direct application within the mouth for structural purposes.
- Device Description: The description reinforces its function as a dental cement, a material used for bonding.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze biological samples. This device is used inside the body to bond dental materials.
N/A
Intended Use / Indications for Use
Nexus 2 is a dual cured, resin-based, dental cement designed to be used for luting inlays, crowns, bridges, porcelain veneers and endodontic posts.
Product codes
EMA
Device Description
The device is a dual cured, chemical and light cured, dental cement designed to be used for luting inlays, onlays, crowns, bridges, porcelain veneers and endodontic posts. Nexus 2 is a two-part, base/catalyst - paste/paste, system.
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
Not Found
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)
Kerr Corporation, Nexus Universal Luting Cement
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
1 0 10
Image /page/0/Picture/2 description: The image shows the logo for Sybron Dental Specialties, Inc. The word "SYBRON" is in large, bold, black letters at the top of the image. Below that, in smaller, bold, black letters, are the words "DENTAL SPECIALTIES, INC."
Section III - 510(k) Summary of Safety and Effectiveness
Submitter:
Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 (714) 516-7484 - Phone (714) 516-7488 - Facsimile Colleen Boswell - Contact Person
Date Summary Prepared: June 1999
Device Name:
- . Trade Name - Nexus 2
- Common Name - Luting Cement
- Classification Name -- Dental Cement, per 21 CFR § 872.3275 .
Devices for Which Substantial Equivalence is Claimed:
- Kerr Corporation, Nexus Universal Luting Cement .
Device Description:
The device is a dual cured, chemical and light cured, dental cement designed to be used for luting inlays, onlays, crowns, bridges, porcelain veneers and endodontic posts. Nexus 2 is a two-part, base/catalyst - paste/paste, system.
Intended Use of the Device:
The intended use of Nexus 2 is for luting inlays, crowns, bridges, porcelain veneers and endodontic posts.
Substantial Equivalence:
Nexus 2 is substantially equivalent to other legally marketed devices in the United States. The modified formulation of Nexus functions in a manner similar to and is intended for the same use as the original Nexus formula currently manufactured by Kerr Dental Materials Center.
1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Image /page/1/Picture/3 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus-like symbol with three wavy lines, representing health and well-being. Encircling the symbol are the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
AUG 1 8 1999
AUG 1 8 1999
Ms. Colleen Boswell Manager, Requlatory Affairs Sybron Dental Specialties Incorporated 1717 West Collins Avenue Orange, California 92867
K992160 Re : Trade Name: Nexus 2 Requlatory Class: II Product Code: EMA Dated: June 24, 1999 Received: June 24, 1999
Dear Ms. Boswell:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obliqation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
2
Page 2 - Ms. Boswell
This letter will allow you to begin marketing your device as Inis lected will arow you on begdescribed in your siews, e of your device to a legally marketed or subscantial equiration a classification for your device and predicate acrisour device to proceed to the market. ends, bermine for your device for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in xİtro regulation (ar crx rais ase contact the Office of Compliance at Additionally, for questions on the promotion and (301) 594-4692. advertising of your device, please contact the Office of Also, please note the regulation Compliance at (301) 594-4639. entitled, "Misbranding by reference to premarket notification" (21 Other general information on your responsibilities CFR 807.97). under the Act may be obtained from the Division of Small anael one not may at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Latino Cucariffox
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
K 4 4