Direct, light cured composite and compomer restorations.
Light cured resin cemented veneers.
Composite, ceramic and amalgam repairs.
Cavity varnish for use with fresh amalgam.
Indirect restorations and endodontic posts cemented with Calibra® Ceram.
Desensitization of exposed dentin.
Surface treatment of zirconia, metal, and composite.
In combination with DENTSPLY Self Cure Activator:
Direct dual cure / self-cure composite restorations and core build-ups.
Cementation of indirect restorations and endodontic posts using dual cure / self-cure resin cements.

Device Description

Prime&Bond active™ Universal Adhesive is a (meth) acrylate-based material which functions as a combined etch-and-rinse (Total-Etch), selfetch and selective-etch dental adhesive. It offers a simple adhesive application technique for both direct and indirect indications and bonds to enamel, dentin, composites, zirconia, and metals. When used with DENTSPLY Self Cure Activator, Prime&Bond active™ Universal Adhesive is compatible with dual cure / self-cure resin cements, composites and core build-ups materials. Prime&Bond active™ universal adhesive offers operators the choice of enamel and dentin pre-treatment: Self-etch mode: no phosphoric acid etching prior to application; Selective enamel-etch mode: selective phosphoric acid etching of enamel; Etch-and-rinse mode: phosphoric acid etching of both enamel and dentin.

AI/ML Overview

The provided text describes the regulatory clearance for the "Prime&Bond active™ Universal Adhesive" and focuses on demonstrating substantial equivalence to a predicate device. This document does NOT contain information about a study proving the device meets specific acceptance criteria in the context of AI/ML device performance (e.g., accuracy, sensitivity, specificity, or human-in-the-loop improvement).

The document is a 510(k) summary for a dental adhesive, which is a physical material, not an AI/ML software device. Therefore, the questions related to AI/ML device performance metrics, sample sizes for test/training sets, ground truth establishment, expert adjudication, and MRMC studies are not applicable to the content provided.

However, I can extract information regarding the non-clinical performance data that was submitted to demonstrate substantial equivalence, which serves as the "study that proves the device meets the acceptance criteria" in this context.

Here's a breakdown based on the information provided, reinterpreting "acceptance criteria" and "study" to fit the type of device and submission:

1. Table of Acceptance Criteria and Reported Device Performance:

The document generally states that the device "satisfactorily met the requirements" of the non-clinical bench testing. Specific acceptance criteria are not numerically detailed in the given text; they are referenced as "requirements" of internal methods or ISO standards. However, the types of tests performed indicate the areas where performance was evaluated.

Acceptance Criteria Category (Measured Property)	Reported Device Performance (General)
Physical Properties
pH measurement	Satisfactorily met requirements (according to internal method).
Density measurement	Satisfactorily met requirements (according to internal method).
Film thickness measurement	Satisfactorily met requirements (according to internal method).
Shear Bond Strength (enamel & dentin - direct)	Satisfactorily met requirements (according to ISO 29022 "Dentistry – Adhesion – Notched edge shear bond strength test"). The document implies the results were comparable to the predicate device to establish substantial equivalence, though specific numerical results are not provided in this summary.
Shear Bond Strength (enamel & dentin - indirect)	Satisfactorily met requirements (according to internal test method).
Shear Bond Strength (Zirconia, Base Metal, Noble Metal, Composite - indirect)	Satisfactorily met requirements (according to internal test method).
Biocompatibility
Cytotoxicity	Results supported substantial equivalence (in compliance with EN ISO 10993-1).
Chemical Analysis (leachable compounds)	Results supported substantial equivalence (in compliance with EN ISO 10993-1).

2. Sample size(s) used for the test set and the data provenance:

Sample Size: Not specified in the provided text for any of the bench tests.
Data Provenance: The tests are described as "in vitro bench tests" and "non-clinical bench testing." The location and retrospective/prospective nature are not stated, but "in vitro" implies laboratory-based testing.

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

Not applicable. This is a material-based device, not an AI/ML diagnostic tool requiring expert ground truth for imaging or similar data. The "ground truth" for these tests would be the measured physical and chemical properties themselves, verified by standard laboratory procedures.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable, as this is not an AI/ML diagnostic device requiring adjudication of expert interpretations.

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:

No. This is not an AI/ML device.

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

No. This is not an AI/ML device.

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

For the physical properties tests: The "ground truth" is established by the methods themselves (e.g., pH meter readings, density measurements, force gauges for shear bond strength) against pre-defined internal or ISO standard specifications.
For biocompatibility: Ground truth is established by the results of standardized biological assays (e.g., cell viability in cytotoxicity tests, chemical identification and quantification in leachable studies) against allowable limits set by standards like EN ISO 10993-1.

8. The sample size for the training set:

Not applicable. This device does not involve a "training set" in the context of AI/ML.

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

Not applicable.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 28, 2018

Dentsply Sirona Karl Nittinger Director, Corporate Regulatory Affairs 221 West Philadelphia Street, Suite 60W York. Pennsylvania 17401

Re: K181476

Trade/Device Name: Prime&Bond active Universal Adhesive Regulation Number: 21 CFR 872.3200 Regulation Name: Resin tooth bonding agent Regulatory Class: Class II Product Code: KLE Dated: June 29, 2018 Received: July 2, 2018

Dear Karl Nittinger:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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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. 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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Mary S. Runner -S3

For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K181476

Device Name

Prime&Bond active™ Universal Adhesive

Indications for Use (Describe)

· Direct, light cured composite and compomer restorations.
· Light cured resin cemented veneers.
· Composite, ceramic and amalgam repairs.
· Cavity varnish for use with fresh amalgam.
· Indirect restorations and endodontic posts cemented with Calibra® Ceram.
· Desensitization of exposed dentin.
· Surface treatment of zirconia, metal, and composite.

In combination with DENTSPLY Self Cure Activator:

· Direct dual cure / self-cure composite restorations and core build-ups.
· Cementation of indirect restorations and endodontic posts using dual cure / self-cure resin cements.

Type of Use (Select one or both, as applicable)

Registration in a State (i.e. NYS, NJ, California, etc.)
Registration in a State with EPA-delegated Authority

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2020

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Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401

K181476

Image /page/3/Picture/2 description: The image shows the logo for Dentsply Sirona. The logo consists of a stylized leaf-like shape on the left, with the words "Dentsply" above "Sirona" on the right. The text is in a simple, sans-serif font and is a light gray color. The leaf-like shape is a darker gray with a white stripe running through it.

SECTION 5. 510(k) SUMMARY

for

Prime&Bond active™ Universal Adhesive

1. Submitter Information:
  Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401

Contact Person:	Karl Nittinger
Telephone Number:	717-849-4424
Fax Number:	717-849-4343

Date Prepared: 04 June 2018

1. Device Name:
- Prime&Bond active™ Universal Adhesive Proprietary Name: ●

872.3200

Classification Name: Resin Tooth Bonding Agent .
CFR Number: .
Device Class: ll .
Product Code: KLE .

3. Predicate Device:

Company Name Predicate Device Name 510(k) Adhesive EXL 759 K110302 3M Espe AG (Currently marketed as Scotchbond™ Universal)

Reference Device:

Reference Device Name	510(k)	Company Name
Calibra Ceram	K040906	Dentsply Sirona(formerly DentsplyInternational Inc.)
DENTSPLY Self Cure Activator	K964525	Dentsply Sirona(formerly DentsplyInternational Inc.)

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4. Description of Device:

When used with DENTSPLY Self Cure Activator, Prime&Bond active™ Universal Adhesive is compatible with dual cure / self-cure resin cements, composites and core build-up materials.

Prime&Bond active™ universal adhesive offers operators the choice of enamel and dentin pre-treatment:

. Self-etch mode: no phosphoric acid etching prior to application
. Selective enamel-etch mode: selective phosphoric acid etching of enamel
Etch-and-rinse mode: phosphoric acid etching of both enamel and dentin
1. Indications for Use:
- . Direct, light cured composite and compomer restorations.
- . Light cured resin cemented veneers.
- . Composite, ceramic and amalgam repairs.
- . Cavity varnish for use with fresh amalgam.
- . Indirect restorations and endodontic posts cemented with Calibra® Ceram.
- . Desensitization of exposed dentin.
- . Surface treatment of zirconia, metal, and composite.

In combination with DENTSPLY Self Cure Activator:

. Direct dual cure / self-cure composite restorations and core build-ups.
. Cementation of indirect restorations and endodontic posts using dual cure / self-cure resin cements.

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6. Substantial Equivalence:

Technological Characteristics:

Technological Characteristics:
Proposed Device	Predicate Device	Differences
Prime&Bond active™	Adhesive EXL 759
Universal Adhesive	K110302
Indications for Use:	Indications for Use:
Direct light cured composite andcompomer restorations	All classes of fillings (according to Black)with light-curing composite or compomerfilling materials	No differences – classes of filling according to Blackinclude direct restorations
Indirect restorations andendodontic posts cemented withCalibra Ceram	Cementation of indirect restorations(inlay, onlay, crowns, bridges, veneers) ofcomposite, compomer, ceramic, andmetal when combined with Suglue-10Adhesive Resin Cement, manufacturedby 3M ESPE	No differences- this indication describes the compatibilityof the dental adhesive (proposed and predicate device)with a specific luting cement used for cementation ofmaterials within indirect restoration or endodonticprocedures. The adhesive bonds the cement to toothsubstrates, the cement is the luting material for theindirect/endodontic application (depending on theindications for the cement).Calibra Ceram is the assigned (reference) cement for theproposed device, Suglue-10 Adhesive Resin Cement is therespective assigned (reference) cement for the predicatedevice
Light cured resin cementedveneers	Cementation of veneers when combinedwith RelyX Veneer Cement,manufactured by 3M ESPE	No differences- RelyX Veneer Cement is a typical resinbased cement
	Bonding of core build-ups made of light-curing composite or core build-upmaterials.	No differences – for the proposed device this indication isincluded in "Direct light cured composite and compomerrestorations"
Composite, ceramic and amalgamrepairs	Repair of composite or compomer fillingsIntraoral repair of composite restorations,porcelain fused to metal, and all-ceramicrestorations without extra primer	No differences- repair of porcelain fused to metal includesbonding to metal surfaces, which is similar to amalgambonding/repair.
Desensitization of exposed dentin	Root surface desensitization	No differences
Cavity varnish for use with freshamalgam	Sealing of cavities prior to cementation ofamalgamate restorations	No differences- Sealing of cavities and preparation of toothstumps prior to temporary cementation of indirect
Proposed Device	Predicate Device	Differences
Prime&Bond active™	Adhesive EXL 759
Universal Adhesive	K110302
	Sealing of cavities and preparation oftooth stumps prior to temporarycementation of indirect restorations.	restorations is not a proposed indication for the subjectPrime&Bond active™ Universal Adhesive device.
	Bonding of fissure sealants	Minor indication, it is not a proposed indication for thesubject Prime&Bond active™ Universal Adhesive device.
	Protective varnish for glass ionomerfillings	Minor indication, it is not a proposed indication for thesubject Prime&Bond active™ Universal Adhesive device.
Surface treatment of zirconia,metal, and composite	Surface treatment of porcelain, ceramics(including glass ceramics, zirconia andalumina), metal and composite.	No differences - treatment of glass ceramics and aluminais not a proposed indication for the subject Prime&Bondactive™ Universal Adhesive device.
In combination with DENTSPLYSelf-cure Activator :• Direct dual-cure/ self-curecomposite restorations and corebuild-ups	Bonding of dual-cure cements and corebuild-up materials and self-curecomposites when combined with ActivatorEXL 760	No differences – split into two indications for the proposeddevice.The term "dual-cure” includes "self-cure" mode.
• Cementation of indirectrestorations and endodonticposts using dual cure/self-cureresin cements.
Features:	Features:	Differences:
One-component, light-curinguniversal dental adhesive	Single-component, light curing adhesive	No differences
Self-etch, selective enamel-etchmode, or etch-and rinse mode;light curing of adhesive	Self-etch, selective enamel-etch mode, oretch-and-rinse mode; light curing ofadhesive	No differences
• Light-curing universal adhesiveused with Self-cure Activator;traditional resin cement	• Light-curing universal adhesive usedwith separate Activator; traditional resincement	No differences
• Light-curing universal adhesiveused without Self-cure Activatorfor assigned (reference) cement	• Light-curing universal adhesive usedwithout separate Activator for assigned(reference) cement

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7. Non-Clinical Performance Data:

The following in vitro bench tests were performed on the Prime&Bond active™ Universal Adhesive to verify physical properties and performance in support of substantial equivalence:

. pH measurement according to internal method.
. Density measurement according to internal method.
Film thickness measurement according to internal method. .
Shear Bond Strength on enamel and dentin according to ISO 29022 . "Dentistry – Adhesion – Notched edge shear bond strength test" (direct restorations).
Shear Bond Strength on enamel and dentin (indirect restorations) . according to internal test method.
Shear Bond Strength on Zirconia Ceramic, Base Metal, Noble Metal, ● and Composite (indirect restorations) according to internal test method.

The performance of the Prime&Bond active™ Universal Adhesive satisfactorily met the requirements of the non-clinical bench testing conducted to support substantial equivalence.

A cytotoxicity test was performed for the Prime&Bond active™ Universal Adhesive as well as chemical analysis of leachable organic and inorganic compounds in compliance with the standard EN ISO 10993-1. The results of the biocompatibility testing and chemical analysis conducted relating to the subject Prime&Bond active™ Universal Adhesive support its substantial equivalence.

8. Clinical Performance Data.

No data from human clinical studies has been included to support the substantial equivalence of the Prime&Bond active™ Universal Adhesive.

1. Conclusion Regarding Substantial Equivalence
  The Prime&Bond active™ Universal Adhesive is a dental adhesive which is intended to bond resin-based materials to enamel and dentin as well as to metal and ceramic. The Prime&Bond active™ Universal Adhesive has the same intended use, incorporates the same fundamental technology, and has similar indications for use as the predicate Adhesive EXL 759 cleared under premarket notification K110302. Test data to verify physical properties and the performance of the Prime&Bond active™ Universal Adhesive has been provided including: appearance, pH, density, film thickness, Shear Bond Strength on various substrates. The results of this testing, combined with the design and intended use comparison with the predicate device Adhesive EXL 759 (K110302), support substantial equivalence.

Regulation Number and Section

§ 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.