K Number

Device Name

Prime&Bond active Universal Adhesive

Manufacturer

Dentsply Sirona

Date Cleared

2018-09-28

(115 days)

Product Code

KLE

Regulation Number

872.3200

Intended 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.

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K110302

Reference Devices

K040906, K964525

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the chemical and physical properties of a dental adhesive, with no mention of AI or ML.

Therapeutic

No.
The device is a dental adhesive used for restorations and repairs, not for preventing, treating, or diagnosing a disease or condition.

Diagnostic

The device is an adhesive material used in dental restorations and procedures, not a tool or system designed to diagnose medical conditions or diseases. Its purpose is to bond materials, not to provide diagnostic information.

SaMD (Software as a Medical Device)

The device description clearly states it is a "(meth) acrylate-based material" and describes its physical properties and chemical composition, indicating it is a physical substance, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended uses listed are all related to dental procedures performed directly on the patient's teeth (restorations, veneers, repairs, desensitization, cementation). IVDs are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information about a physiological or pathological state.
Device Description: The description details a material applied to the tooth structure (enamel and dentin) to facilitate bonding. This is a direct application to the patient, not a test performed on a sample outside the body.
Performance Studies: The performance studies described are bench tests evaluating physical properties and bond strength on dental materials and tooth structures. These are not studies evaluating the diagnostic accuracy of a test on biological samples.

The device is a dental adhesive used in clinical procedures, not a diagnostic tool that analyzes biological specimens.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

KLE

Device Description

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

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

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)

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.

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

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.

Adhesive EXL 759 K110302

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.

Calibra Ceram K040906, DENTSPLY Self Cure Activator K964525

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

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.

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

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

K181476

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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 Dentsply
International Inc.)
DENTSPLY Self Cure Activator	K964525	Dentsply Sirona
(formerly Dentsply
International Inc.)

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.

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 and
compomer restorations	All classes of fillings (according to Black)
with light-curing composite or compomer
filling materials	No differences – classes of filling according to Black
include direct restorations
Indirect restorations and
endodontic posts cemented with
Calibra Ceram	Cementation of indirect restorations
(inlay, onlay, crowns, bridges, veneers) of
composite, compomer, ceramic, and
metal when combined with Suglue-10
Adhesive Resin Cement, manufactured
by 3M ESPE	No differences- this indication describes the compatibility
of the dental adhesive (proposed and predicate device)
with a specific luting cement used for cementation of
materials within indirect restoration or endodontic
procedures. The adhesive bonds the cement to tooth
substrates, the cement is the luting material for the
indirect/endodontic application (depending on the
indications for the cement).
Calibra Ceram is the assigned (reference) cement for the
proposed device, Suglue-10 Adhesive Resin Cement is the
respective assigned (reference) cement for the predicate
device
Light cured resin cemented
veneers	Cementation of veneers when combined
with RelyX Veneer Cement,
manufactured by 3M ESPE	No differences- RelyX Veneer Cement is a typical resin
based cement
	Bonding of core build-ups made of light-
curing composite or core build-up
materials.	No differences – for the proposed device this indication is
included in "Direct light cured composite and compomer
restorations"
Composite, ceramic and amalgam
repairs	Repair of composite or compomer fillings
Intraoral repair of composite restorations,
porcelain fused to metal, and all-ceramic
restorations without extra primer	No differences- repair of porcelain fused to metal includes
bonding to metal surfaces, which is similar to amalgam
bonding/repair.
Desensitization of exposed dentin	Root surface desensitization	No differences
Cavity varnish for use with fresh
amalgam	Sealing of cavities prior to cementation of
amalgamate restorations	No differences- Sealing of cavities and preparation of tooth
stumps 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 of
tooth stumps prior to temporary
cementation of indirect restorations.	restorations is not a proposed indication for the subject
Prime&Bond active™ Universal Adhesive device.
	Bonding of fissure sealants	Minor indication, it is not a proposed indication for the
subject Prime&Bond active™ Universal Adhesive device.
	Protective varnish for glass ionomer
fillings	Minor indication, it is not a proposed indication for the
subject Prime&Bond active™ Universal Adhesive device.
Surface treatment of zirconia,
metal, and composite	Surface treatment of porcelain, ceramics
(including glass ceramics, zirconia and
alumina), metal and composite.	No differences - treatment of glass ceramics and alumina
is not a proposed indication for the subject Prime&Bond
active™ Universal Adhesive device.
In combination with DENTSPLY
Self-cure Activator :
• Direct dual-cure/ self-cure
composite restorations and core
build-ups	Bonding of dual-cure cements and core
build-up materials and self-cure
composites when combined with Activator
EXL 760	No differences – split into two indications for the proposed
device.
The term "dual-cure” includes "self-cure" mode.
• Cementation of indirect
restorations and endodontic
posts using dual cure/self-cure
resin cements.
Features:	Features:	Differences:
One-component, light-curing
universal dental adhesive	Single-component, light curing adhesive	No differences
Self-etch, selective enamel-etch
mode, or etch-and rinse mode;
light curing of adhesive	Self-etch, selective enamel-etch mode, or
etch-and-rinse mode; light curing of
adhesive	No differences
• Light-curing universal adhesive
used with Self-cure Activator;
traditional resin cement	• Light-curing universal adhesive used
with separate Activator; traditional resin
cement	No differences
• Light-curing universal adhesive
used without Self-cure Activator
for assigned (reference) cement	• Light-curing universal adhesive used
without separate Activator for assigned
(reference) cement

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.

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.