This 510(k) summary focuses on the PMN number K992518 which is for a new intended use of an existing device, Prime & Bond® NT™ Dental Adhesive System (predicate K982394). The new intended use is for "pit and fissure sealant".

The acceptance criteria for this new indication appear to be related to achieving comparable adhesive strength to enamel as existing methods when used with pit and fissure sealants.

Here's a breakdown of the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Short-term Adhesion: Adhesive strength to enamel (24h) when used with Dyract® Seal Compomer Pit & Fissure Sealant is comparable to Dyract® Seal with an acid etchant pretreatment.	Immediate Adhesion (24h): - Nupro® Prophylaxis + NRC™ Conditioner + Prime & Bond® NT™ Adhesive + DyractSeal™: $11.09 \pm 2.38$ MPa - Nupro® Prophylaxis + Etchgel Conditioner + Prime & Bond® NT™ Adhesive + DyractSeal™: $13.01 \pm 3.21$ MPa - Nupro® Prophylaxis + Etchgel Conditioner + DyractSeal™: $12.93 \pm 1.41$ MPa - The performance with Prime & Bond® NT™ Adhesive pretreated with NRC™ Conditioner ($11.09 \pm 2.38$ MPa) is numerically lower than the acid etchant alone ($12.93 \pm 1.41$ MPa) at 24 hours, but the inclusion of Prime & Bond® NT™ with acid etchant ($13.01 \pm 3.21$ MPa) shows comparable or slightly better strength than acid etchant alone. The text states "develops an adhesive strength to enamel that is comparable to Dyract® Seal Compomer Pit & Fissure Sealant with an acid etchant pretreatment." which suggests the $11.09 \pm 2.38$ MPa is considered comparable.
Long-term Adhesion: Durable adhesion resulting in long-term protection against microleakage, as demonstrated by adhesion over months. Specifically, adhesion using NRC™ Non-Rinse Conditioner and Prime & Bond® NT™ Dental Adhesive should be comparable to DeTrey® Conditioner 36 (36% phosphoric acid gel).	Long-term Adhesion (up to 12 months): * NRC™ Non-Rinse Conditioner and Prime & Bond® NT™ Dental Adhesive: - 0 months: $12.5 \pm 2.1$ MPa - 2 months: $9.4 \pm 2.0$ MPa - 4 months: $11.7 \pm 0.6$ MPa - 6 months: $11.2 \pm 2.6$ MPa - 8 months: $10.5 \pm 1.7$ MPa - 12 months: $9.4 \pm 2.2$ MPa * DeTrey® Conditioner 36 (36% phosphoric acid gel): - 0 months: $14.1 \pm 1.8$ MPa - 2 months: $12.0 \pm 0.64$ MPa - 4 months: $11.7 \pm 1.0$ MPa - 6 months: $11.1 \pm 1.8$ MPa - 8 months: $12.5 \pm 1.8$ MPa - 12 months: $10.5 \pm 2.2$ MPa The results show similar trends and magnitudes, particularly at later time points (4, 6, 8, 12 months), supporting comparability.
Micromorphology: Good bonding properties observed at a microscopic level.	Micromorphology study: "the results showed good bonding properties." (Details are in Exhibit A, which is not provided).

2. Sample size used for the test set and the data provenance

Sample Size: Not explicitly stated for either the 24-hour or long-term adhesion tests. The adhesion values are presented with standard deviations, implying multiple measurements were taken, but the 'n' value (number of samples/teeth) is missing.
Data Provenance: The document does not specify the country of origin. It is a submission to the FDA, suggesting the studies were conducted by or for DENTSPLY International. The studies appear to be prospective experimental studies (in-vitro adhesion tests) conducted specifically for this submission, although the document does not explicitly state "prospective."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This study involves material science testing (adhesion strength, micromorphology) rather than clinical diagnosis or interpretation by experts. The "ground truth" here is the measured physical properties of the materials.

4. Adjudication method for the test set

Not applicable. This is not a study requiring adjudication of expert opinions or diagnostic findings.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not a study involving human readers or AI.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth relies on physical measurement data (adhesion strength, micromorphological observations) generated from laboratory experiments. In this context, the "ground truth" is the established scientific methods and resulting data for evaluating dental material properties.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This is not a machine learning or AI device that requires a training set.

Summary

{0}------------------------------------------------

510(k) SUMMARY

NAME & ADDRESS:

992518

ENTSPLY International

West College Avenue ). Box 872 k. PA 17405-0872 1 845-7511 542343

P. J. Lehn Telefax (717) 849-4343

CONTACT: P. Jeffery Lehn

DATE PREPARED: "}}}} { } = 1099

TRADE OR PROPRIETARY NAME: PRIME & BOND® NT™ DENTAL ADHESIVE SYSTEM

CLASSIFICATION NAME: Resin tooth bonding agent 872.3200

PREDICATE DEVICE: Prime & Bond® NT™ Universal Dental Adhesive System K982394

DEVICE DESCRIPTION: PRIME & BOND® NT™ DENTAL ADHESIVE SYSTEM is a onecomponent, no-mix visible light-curable dental bonding agent that contains fluoride.

INTENDED USE: The new Indication for Use for PRIME & BOND® NT™ DENTAL ADHESIVE SYSTEM is for use in conjunction with pit and fissure sealant.

TECHNOLOGICAL CHARACTERISTICS: PRIME & BOND® NT™ Dental Adhesive System is unchanged from the initial submission, K982394. This premarket submission is for a new intended use only.

We believe the fact that the device is unchanged from the predicate device (K982394) and that the performance data provided,support the safety and effectiveness of PRIME & BOND® NT™ DENTAL ADHESIVE SYSTEM for the new indication for use.

000012

{1}------------------------------------------------

Substantial Equivalence Comparison:

Prime & Bond® NT™ Dental Adhesive System is unchanged from the initial submission, K982394. This premarket submission is for a new intended use only.

Performance Data:

Dyract® Seal Compomer Pit & Fissure Sealant with NRC™ Non-Rinse Conditioner pretreatment, combined with PRIME & BOND® NT™ DENTAL ADHESIVE, develops an adhesive strength to enamel that is comparable to Dyract® Seal Compomer Pit & Fissure Sealant with an acid etchant pretreatment.

PRETREATMENT USED	ADHESION(24h) MPa
Nupro® Prophylaxis Paste, Medium Grit; rinse; dry; NRCTM Conditioner;20"; dry; DyractSealTM Pit and Fissure Sealant	$8.79 \pm 1.56$
Nupro® Prophylaxis Paste, Medium Grit; rinse; dry; Etchgel Conditioner;20"; rinse; dry; DyractSealTM Pit and Fissure Sealant	$12.93 \pm 1.41$
Nupro® Prophylaxis Paste, Medium Grit; rinse; dry; NRCTM Conditioner;20"; dry; Prime & Bond® NTTM Adhesive; 20"; DyractSealTM Pit andFissure Sealant	$11.09 \pm 2.38$
Nupro® Prophylaxis Paste, Medium Grit; rinse; dry; Etchgel Conditioner;20"; rinse; dry; Prime & Bond® NTTM Adhesive; 20"; DyractSealTM Pitand Fissure Sealant	$13.01 \pm 3.21$

It is essential for the clinical success of a pit and fissure sealant, that the sealant develops a durable adhesion resulting in long-term protection , e.g., against microleakage. Therefore the long-term adhesion of DyractSeal was tested under various pretreatments.

Time(months)	Adhesion (MPa) of Dyract® Seal Pit & Fissure Sealant to enamel using:
	DeTrey® Conditioner 36*	NRC™ Non-Rinse Conditioner andPrime & Bond® NT™ Dental Adhesive
0	14.1 ± 1.8	12.5 ± 2.1
2	12.0 ± 0.64	9.4 ± 2.0
4	11.7 ± 1.0	11.7 ± 0.6
6	11.1 ± 1.8	11.2 ± 2.6
8	12.5 ± 1.8	10.5 ± 1.7
12	10.5 ± 2.2	9.4 ± 2.2

*36% phosphoric acid gel

In addition to the above data, a micromorphology study was also conducted; the results showed good bonding properties. The study report can be found in Exhibit A.

{2}------------------------------------------------

Safety Data:

Prime & Bond® NT™ Dental Adhesive System is unchanged from the initial submission, K982394. This premarket submission is for a new intended use only.

The safety of the device has not been affected.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract design that resembles a bird or a stylized human profile.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 2 1999

Mr. P. Jeffery Lehn Director, Corporate Compliance and Regulatory Affairs Dentsply International 570 West College Avenue P.O. Box 872 York, Pennsylvania 17405-0872

K992518 Re :

Prime & Bond® NT™ Universal Dental Adhesive Trade Name: System Regulatory 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, Drug, 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 regulation may result in regulatory 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

{4}------------------------------------------------

Page 2 - Mr. Lehn

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 diagnostic devices), please contact the Office of Compliance at (301) 594-4690. 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,

Patricia Cuardeflor

Timothy A. Ulatowski Director Division of Dental, Infection Cor and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the text "ENCLOSURE A K972518 Revised 9/14/99". The text is in black and is bolded. The text is centered in the image. The text is likely a document number or a reference number.

510(k) NUMBER (IF KNOWN): K992518

DEVICE NAME: PRIME & BOND® NT™ DENTAL ADHESIVE SYSTEM

INDICATIONS FOR USE:

Addition of New Indication: To be used in conjunction with pit and fissure sealant

Current Indications, K982394:

Direct composite and compomer restorations .
Composite, ceramic and amalgam repairs .
Cavity varnish for use with fresh amalgam .
Indirect restorations: Dual Cure, inlays, onlays, veneers, crowns and bridges
. Endodontic post cementation
Adhesive bonding of direct amalgam restorations .

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use (Optional Format 1-2-96)

000007

Susan Ruan

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

escription Use
(Per 21 CFR 801.109)

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.