(77 days)
Kerr Corporation, Nexus 2 Modified
Not Found
No
The 510(k) 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 a structural material rather than a device designed to treat or prevent a disease or condition.
No
The device is described as a dental cement used for luting, which implies a therapeutic or restorative function, not a diagnostic one.
No
The device description clearly states it is a "dual cured, resin-based, 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 is for "luting inlays, onlays, crowns, bridges, porcelain veneers and endodontic posts." This describes a dental procedure performed directly on a patient's teeth, not a test performed on a sample taken from the body.
- Device Description: The description details a "dental cement" used for bonding dental restorations. This is a material used in a clinical setting, not a diagnostic tool.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health status
- Using reagents or assays
Therefore, Nexus 2 Clear is a dental material used for restorative procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of Nexus 2 Clear is for luting inlays, crowns, bridges, porcelain veneers and endodontic posts. Nexus 2 Clear is a dual cured, resin-based, dental cement designed to be used for luting inlays, onlays, crowns, bridges, porcelain veneers and endodontic posts.
Product codes
EMA
Device Description
Nexus 2 Clear 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 Clear 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Kerr Corporation, Nexus 2 Modified
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
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 written in a smaller, sans-serif font. The logo is black and white.
JAN 1 6 2002
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: October 2001
Device Name:
-
Trade Name Nexus 2 Clear .
KO13609 -
Common Name Luting Cement .
-
Classification Name Dental Cement, per 21 CFR & 872.3275 .
Devices for Which Substantial Equivalence is Claimed:
- Kerr Corporation, Nexus 2 Modified .
Device Description:
Nexus 2 Clear 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 Clear is a two-part, base/catalyst - paste/paste, system.
Intended Use of the Device:
The intended use of Nexus 2 Clear is for luting inlays, crowns, bridges, porcelain veneers and endodontic posts.
Substantial Equivalence:
Nexus 2 Clear is substantially equivalent to other legally marketed devices in the United States. Nexus 2 Clear functions in a manner similar to and is intended for the same use as the original Nexus 2 Modified formulation that is currently manufactured by Kerr Corporation.
1
Image /page/1/Picture/12 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 6 2002
Ms. Colleen Boswell Director, Corporation Compliance Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867
Re: K013609
Trade/Device Name: Nexus 2 Clear Regulation Number: 872.3275 Regulation Name: Luting Cement Regulatory Class: II Product Code: EMA Dated: October 29, 2001 Received: October 31, 2001
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 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.
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.
2
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Timothee Al Ustaoglu
Timot Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Section I
Indications for Use Statement
| Ver/ 3-4/24/96 | |
|---|---|
| Applicant: | Kerr Dental Materials Center |
| 510(k) Number (if known): | K013609 |
| Device Name: | Nexus 2 Clear |
| Indications For Use: |
Nexus 2 Clear is a dual cured, resin-based, dental cement designed to be used for luting inlays, onlays, crowns, bridges, porcelain veneers and endodontic posts.
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices
| 510(k) Number | K013609 |
|---|---|
| --------------- | --------- |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Per 21 CFR 801.109)
(Optional Format 1-2-96)