NRC NON-RINSE CONDITIONER by DENTSPLY INTL.

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.

AI/ML Overview

Acceptance Criteria and Reported Device Performance:

NRC™ NON-RINSE CONDITIONER is a dental device intended for use as a no-rinse etching/conditioning solution on enamel. The provided summary does not explicitly state quantitative acceptance criteria or results from a performance study in the format of a table with specific metrics. Instead, the justification for safety and effectiveness is based on:

Acceptance Criterion (Implicit)	Reported Device Performance
Biocompatibility/Safety: Non-mutagenic.	Evaluated by the Ames Mutagenicity Test and found to be non-mutagenic.
Functional Equivalence: Ability to partially dissolve enamel minerals, increase surface area, and allow intimate contact/penetration of sealant material for increased adhesion potential, similar to legally marketed predicate devices.	"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."
Material Safety/Prior Use: Components have a history of safe use in legally marketed devices.	"All of the components found in NRC™ NON-RINSE CONDITIONER have been used in legally marketed devices."

Sample Size for Test Set and Data Provenance:
- The provided 510(k) summary does not specify a distinct "test set" or its sample size for evaluating the NRC™ NON-RINSE CONDITIONER's performance with respect to its functional claims (e.g., enamel etching effectiveness, bond strength). The Ames Mutagenicity Test would have a specific sample size for its evaluation, but this is not detailed.
- Data provenance (e.g., country of origin, retrospective/prospective) is not mentioned for any studies.
Number of Experts and Qualifications for Ground Truth:
- No information is provided regarding the number or qualifications of experts used to establish any ground truth for performance studies related to the device's functional claims on enamel. The Ames test is a standard biological assay, and while it requires trained personnel, they are typically toxicology experts rather than clinical experts.
Adjudication Method for Test Set:
- Not applicable, as no clinical or interpretative test set requiring expert adjudication is described.
Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
- No MRMC study was done or reported in the provided summary. The device is a dental material, not an imaging or diagnostic AI tool that would typically involve human readers.
Standalone (Algorithm Only) Performance:
- Not applicable. This device is a chemical dental conditioner, not an algorithm or software. Its performance is assessed through material properties and biological safety.
Type of Ground Truth Used:
- Biocompatibility: The ground truth for biocompatibility (specifically mutagenicity) was established through the results of the Ames Mutagenicity Test, a well-established in vitro assay.
- Functional Claims: For the functional claims related to enamel etching and increased surface area, the summary describes the mechanism of action rather than providing specific ground truth data from defined studies. It implies an understanding of dental material science. The basis for these claims relies on the chemical properties of the conditioner and analogies to predicate devices. There's no mention of pathology, clinical outcomes data, or expert consensus specific to this device's performance.
Sample Size for Training Set:
- Not applicable. The NRC™ NON-RINSE CONDITIONER is a physical/chemical dental product, not an AI algorithm requiring a training set.
How Ground Truth for Training Set Was Established:
- Not applicable, as there is no training set for this type of device.

Summary

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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.

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

Over-The-Counter Use _

Susan Russo

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital 510(k) Number

000007

Regulation Number and Section

§ 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.