(80 days)
Kerr Corporation, XR Primer
Not Found
No
The 510(k) summary describes a chemical primer for dental use and contains no mention of AI, ML, image processing, or performance studies typically associated with AI/ML devices.
No
A therapeutic device is one that treats or prevents a disease or condition. This device is a primer used to improve the retention of dental restorations, which is a supportive rather than therapeutic function.
No
Explanation: The device is a primer used to prepare a tooth for a restoration, which is a treatment-related function rather than a diagnostic one. It does not identify or detect a disease or condition.
No
The device description clearly states it is a "light-cured cavity primer," which is a physical substance applied to a tooth, not a software program.
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 XR Primer 2 is used to "wet the interior of a prepared cavity of a tooth prior to application of an adhesive to improve retention of a restoration." This describes a direct application to a tooth for a restorative dental procedure.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections.
- No Mention of Samples or Testing: The description of XR Primer 2 does not involve any collection of samples from the body or any form of testing or analysis of those samples.
Therefore, XR Primer 2 is a dental material used in a clinical procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
XR Primer 2 is a light-cured cavity primer used to wet the interior of a prepared cavity of a tooth prior to application of an adhesive to improve retention of a restoration.
Product codes
KLE
Device Description
XR Primer 2 is a light-cured cavity primer used to wet the interior of a prepared cavity of a tooth prior to application of an adhesive to improve retention of a restoration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tooth
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, XR Primer
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.
0
R 1 9 2002 SYBRON DENTAL SPECIALTIES
11 020303
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
January 2002 Date Summary Prepared:
Device Name:
- Trade Name XR Primer 2 .
- Common Name Light-Cured Cavity Primer .
- Classification Name -- Resin Tooth Bonding Agent, per 21 CFR § 872.3200 .
Devices for Which Substantial Equivalence is Claimed:
- Kerr Corporation, XR Primer .
Device Description:
XR Primer 2 is a light-cured cavity primer used to wet the interior of a prepared cavity of a tooth prior to application of an adhesive to improve retention of a restoration.
Intended Use of the Device:
The intended use of XR Primer 2 is to wet the interior of a prepared cavity of a tooth to prior to application of an adhesive to improve retention of a restoration.
Substantial Equivalence:
XR Primer 2 is substantially equivalent to other legally marketed devices in the United States. XR Primer 2 functions in a manner similar to and is intended for the same use as the original XR Primer formulation that is currently manufactured by Kerr Corporation.
1
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 curved lines representing its body and wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle. The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 9 2002
Kerr Dental Materials Center C/O Ms. Colleen Boswell Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867
Re: K020303
Trade/Device Name: XP Primer 2 Regulation Number: 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: January 25, 2002 Received: January 29, 2002
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 r od intiles compry was a807); labeling (21 CFR Part 801); good manufacturing practice and ilsung (21 CF Part 827), and in 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 11ms letter will and w your it ought finding of substantial equivalence of your device to 910(x) premium in a classification for your 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
Timothy 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 Material Center
510(k) Number (if known):
Device Name: XR Primer 2
Indications For Use:
XR Primer 2 is a light-cured cavity primer used to wet the interior of a prepared cavity of a tooth
prior to application of an adhesive to improve retention of a restoration.
Susan Runne
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K000309
(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)