(86 days)
Caulk® Tooth Conditioner Liquid Pre-1976 Device
Not Found
No
The device description and performance studies focus on the chemical properties and safety of a dental conditioning solution, with no mention of AI or ML.
No
The device is described as a "no-rinse etching/ conditioning solution" used to clean and prepare enamel for dental restorations by creating micro-porosities for better adhesion. Its function is to modify the tooth surface for bonding, not to treat a disease or condition. It is a preparatory agent, not a therapeutic agent.
No
The device is described as an etching/conditioning solution used to prepare tooth enamel for dental restorations, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a "no-rinse etching/ conditioning solution," which is a chemical substance, 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 to "clean instrumented enamel prior to restoration of tooth structure with selected dental adhesive and preventive dental materials." This describes a procedure performed directly on the patient's tooth (in vivo) to prepare it for a dental restoration.
- Device Description: The description explains how the solution works by partially dissolving enamel minerals to improve adhesion of dental materials. This is a physical/chemical action on the tooth structure, not a test performed on a sample taken from the body.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a disease, condition, or state of health. It is purely a preparatory step for a dental procedure.
- No mention of testing biological samples: IVDs are used to test samples taken from the human body (like blood, urine, tissue). This device is applied directly to the tooth.
Therefore, this device falls under the category of a dental device used for preparing tooth structure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Used to clean instrumented enamel prior to the application of selected dental adhesive and preventive dental materials.
Used to clean instrumented enamel prior to restoration of tooth structure with selected dental adhesive and preventive dental materials.
Product codes
EBC
Device Description
NRC™ NON-RINSE CONDITIONER is a no-rinse etching/ conditioning solution for use on enamel with selected adhesive and preventive dental materials.
NRC ™ NON-RINSE CONDITIONER partially dissolves the minerals within the enamel. This partial dissolution results in increased surface area due to micro-porosities created in the affected substrates. This allows for more intimate contact and penetration of the sealant material with the tooth, increasing the potential for adhesion of the sealant. To aid in the adhesive bonding agent is applied to the acid treated surfaces.
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
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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)
NRC™ NON-RINSE CONDITIONER was evaluated by the Ames Mutagenicity Test and found to be non-mutagenic.
We believe that the prior use of the components of NRC™ NON-RINSE CONDITIONER in legally marketed devices, the biocompatibility testing, and the performance data provided support the safety and effectiveness of NRC™ NON-RINSE CONDITIONER for the indicated uses.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Caulk® Tooth Conditioner Liquid Pre-1976 Device
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3765 Pit and fissure sealant and conditioner.
(a)
Identification. A pit and fissure sealant and conditioner is a device composed of resin, such as polymethylmethacrylate, intended for use primarily in young children to seal pit and fissure depressions (faults in the enamel) in the biting surfaces of teeth to prevent cavities.(b)
Classification. Class II.
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510(k) SUMMARY
DENTSPLY
NAME & ADDRESS:
DENTSPLY International
992510
OCT 2 2 1999
570 West College Avenue P.O. Box 872 York, PA 17405-0872 (717) 845-7511 ax 777 854-2343 P. J. Lehn Telefax (717) 849-4343
CONTACT: P. Jeffery Lehn
DATE PREPARED:
| TRADE OR PROPRIETARY NAME: | NRC TM NON-RINSE CONDITIONER | |
|---|---|---|
| COMMON OR USUAL NAME: | Tooth conditioner | |
| CLASSIFICATION NAME: | Conditioner, pit and fissure sealant and | 872.3765 |
| PREDICATE DEVICE: | Caulk® Tooth Conditioner Liquid | Pre-1976 Device |
DEVICE DESCRIPTION: NRC™ NON-RINSE CONDITIONER is a no-rinse etching/ conditioning solution for use on enamel with selected adhesive and preventive dental materials.
NRC ™ NON-RINSE CONDITIONER partially dissolves the minerals within the enamel. This partial dissolution results in increased surface area due to micro-porosities created in the affected substrates. This allows for more intimate contact and penetration of the sealant material with the tooth, increasing the potential for adhesion of the sealant. To aid in the adhesive bonding agent is applied to the acid treated surfaces.
INTENDED USE: Used to clean instrumented enamel prior to the application of selected dental adhesive and preventive dental materials.
TECHNOLOGICAL CHARACTERISTICS: All of the components found in NRC™ NON-RINSE CONDITIONER have been used in legally marketed devices.
NRC™ NON-RINSE CONDITIONER was evaluated by the Ames Mutagenicity Test and found to be non-mutagenic.
We believe that the prior use of the components of NRC™ NON-RINSE CONDITIONER in legally marketed devices, the biocompatibility testing, and the performance data provided support the safety and effectiveness of NRC™ NON-RINSE CONDITIONER for the indicated uses.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three curved shapes resembling a bird or abstract human form.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 22 1999
Mr. P. Jeffery Lehn Director, Corporate Compliance and Requlatory Affairs Dentsply International 570 West College Avenue P.O. Box 872 York, PA 17405-0872
K992519 Re : NRC™ Non-Rinse Conditioner Trade Name: Requlatory Class: II Product Code: EBC Dated: July 27 1999
Received: July 28, 1999
Dear Mr. Lehn:
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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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. ਸੇ 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 requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in
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Page 2 - Mr. Lehn
the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation 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 regulations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4692. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance 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,
Susan Runnes
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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PREMARKET NOTIFICATION
INDICATIONS FOR USE STATEMENT
(As Required by 21 CFR 801.109)
510(K) Number:
8992519
Device Name:
NRC™ NON-RINSE CONDITIONER
Used to clean instrumented enamel prior to restoration of tooth structure with selected dental adhesive and preventive dental materials.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use _
Susan Russo
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital 510(k) Number
000007