K Number
K151619
Device Name
Prime&Bond Elect Universal Dental Adhesive
Date Cleared
2015-10-30

(136 days)

Product Code
Regulation Number
872.3200
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
1. Prime&Bond Elect® Universal Dental Adhesive (visible light cured): - 1.1 Direct, light cured composite and compomer restorations - 1.2 Indirect restorations; light cured, resin cemented veneers - 1.3 Indirect restorations; acid-tolerant resin cement (dual cure or self-cure) cemented inlays, onlays, crown and bridge retainers - 1.4 Composite, ceramic and amalgam repairs - 1.5 Cavity varnish for use with fresh amalgam - 2. Prime&Bond Elect® Universal Dental Adhesive mixed with Self-Cure Activator (dual cure or self-cure): - 2.1 Direct, dual cure or self-cure composite restorations and core build-ups - 2.2 Indirect restorations; dual cured and self-cured resin cemented inlays, onlays, crown and bridge retainers - 2.3 Dual cured and self-cured resin cemented endodontic post cementation - 3. Prime&Bond Elect® Universal Dental Adhesive mixed with Self-Cure Activator and Amalgam Bonding Base & Catalyst: - 3.1 Adhesive bonding of direct amalgam restoration - 4. Prime&Bond Elect® Universal Dental Adhesive (without Self-Cure Activator or adhesive curing): - 4.1 Indirect restorations: acid-tolerant resin cement light-cured cementation; light transmissible inlays, onlays, crown and bridge retainers with light curing of cement - 4.2 Indirect restorations; acid-tolerant resin cement dual cure or self-cure cementation; limited light/light opaque inlays, onlays, crown and bridge retainers and endodontic posts with total etch technique
Device Description
Prime&Bond Elect® Universal Dental Adhesive is a universal self-priming dental adhesive system designed to bond resin based materials to enamel and dentin as well as to metals and ceramic. Prime&Bond Elect® Universal Dental Adhesive combines etchant, primer and adhesive in a one-bottle material. This robust formulation allows the operator to utilize selective phosphoric acid etching of enamel, phosphoric acid etching of both enamel and dentin, or no phosphoric acid etching prior to application, ensuring high bond strength and protection against microleakage. When mixed with Self-Cure Activator, Prime&Bond Elect® Universal Dental Adhesive is designed to be used with DENTSPLY manufactured dual cure/self-cure resin cements* to bond all indirect restorations and DENTSPLY manufactured dual cured composite restoratives. When used with the Amalgam Bonding Accessory Kit, available separately, Prime&Bond Elect® Universal Dental Adhesive also adhesively bonds fresh amalgam to enamel and dentin. *Note: Acid-tolerant resin cements may be used following application of Prime&Bond Elect® adhesive without the use of Self-Cure Activator, additionally allowing operator's choice of pre-cementation adhesive curing options (see complete Directions for Use).
More Information

No
The document describes a dental adhesive and its intended uses and physical properties. There is no mention of AI or ML technology in the intended use, device description, or performance studies.

Yes
The device is a dental adhesive system used for bonding various dental materials to enamel and dentin, which is a therapeutic function in the context of dental restorations.

No

This device is a dental adhesive system used for bonding and restoration purposes, not for diagnosing medical conditions. The "Intended Use / Indications for Use" and "Device Description" sections clearly describe its function in various dental procedures.

No

The device description clearly indicates it is a physical dental adhesive system, not software.

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

Here's why:

  • IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
  • Device Description and Intended Use: The description and intended use clearly state that Prime&Bond Elect® Universal Dental Adhesive is a dental adhesive system used to bond materials to enamel and dentin, as well as metals and ceramics, for dental restorations and procedures. It is applied directly to the patient's teeth and surrounding structures.
  • Lack of Specimen Analysis: There is no mention of analyzing any biological specimens taken from the patient. The device's function is to facilitate the physical bonding of dental materials.

Therefore, this device falls under the category of a dental restorative material or adhesive, not an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

    1. Prime&Bond Elect® Universal Dental Adhesive (visible light cured):
    • 1.1 Direct, light cured composite and compomer restorations
    • 1.2 Indirect restorations; light cured, resin cemented veneers

1.3 Indirect restorations; acid-tolerant resin cement (dual cure or self-cure) cemented inlays, onlays, crown and bridge retainers

  • 1.4 Composite, ceramic and amalgam repairs
  • 1.5 Cavity varnish for use with fresh amalgam
    1. Prime&Bond Elect® Universal Dental Adhesive mixed with Self-Cure Activator (dual cure or self-cure):

2.1 Direct, dual cure or self-cure composite restorations and core build-ups

2.2 Indirect restorations; dual cured and self-cured resin cemented inlays, onlays, crown and bridge retainers

  • 2.3 Dual cured and self-cured resin cemented endodontic post cementation
    1. Prime&Bond Elect® Universal Dental Adhesive mixed with Self-Cure Activator and Amalgam Bonding Base & Catalyst:

3.1 Adhesive bonding of direct amalgam restoration

    1. Prime&Bond Elect® Universal Dental Adhesive (without Self-Cure Activator or adhesive curing):
      4.1 Indirect restorations: acid-tolerant resin cement light-cured cementation; light transmissible inlays, onlays, crown and bridge retainers with light curing of cement

4.2 Indirect restorations; acid-tolerant resin cement dual cure or self-cure cementation; limited light/light opaque inlays, onlays, crown and bridge retainers and endodontic posts with total etch technique

Product codes

KLE

Device Description

Prime&Bond Elect® Universal Dental Adhesive is a universal self-priming dental adhesive system designed to bond resin based materials to enamel and dentin as well as to metals and ceramic. Prime&Bond Elect® Universal Dental Adhesive combines etchant, primer and adhesive in a one-bottle material. This robust formulation allows the operator to utilize selective phosphoric acid etching of enamel, phosphoric acid etching of both enamel and dentin, or no phosphoric acid etching prior to application, ensuring high bond strength and protection against microleakage.

When mixed with Self-Cure Activator, Prime&Bond Elect® Universal Dental Adhesive is designed to be used with DENTSPLY manufactured dual cure/self-cure resin cements* to bond all indirect restorations and DENTSPLY manufactured dual cured composite restoratives. When used with the Amalgam Bonding Accessory Kit, available separately, Prime&Bond Elect® Universal Dental Adhesive also adhesively bonds fresh amalgam to enamel and dentin.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

enamel and dentin

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)

Non-Clinical Performance Data:

Biocompatibility Testing

The biocompatibility requirements for the proposed device, Prime&Bond Elect® Universal Dental Adhesive have not changed from the predicate device XENO® Adhesive with Activator (K051463). Therefore, no additional biocompatibility tests were performed as the proposed device is identical in design and formulation to the predicate device XENO® Adhesive with Activator (K051463).

Physical Properties

There are no changes affecting the fundamental technology and chemical composition of Prime&Bond Elect® Universal Dental Adhesive. The physical characteristics and mechanical properties of the material are not affected. Table 5.2 shows the testing performed on the proposed device and all of the test results have met the specifications:
Physical Property: Film Thickness, Results: Meets specification
Physical Property: Dentin Shear Bond Strength, Indirect, Results: Meets specification
Physical Property: Enamel Shear Bond Strength, Indirect, Results: Meets specification
Physical Property: Dentin Shear Bond Strength, Direct, Results: Meets specification
Physical Property: Enamel Shear Bond Strength, Direct, Results: Meets specification
Physical Property: Composite Bond Strength, Indirect, Results: Meets specification
Physical Property: Base Metal Shear Bond Strength, Indirect, Results: Meets specification
Physical Property: Noble Metal Shear Bond Strength, Indirect, Results: Meets specification
Physical Property: Zirconia Ceramics Bond Strength, Indirect, Results: Meets specification
Physical Property: Glass Ceramic Shear Bond Strength, Indirect, Results: Meets specification
Physical Property: Shelf Life, Results: 2 Years

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K051463

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.

0

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are simple and abstract, with only the outlines of the faces visible.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 30, 2015

DENTSPLY International Inc. Ms. Helen Lewis Director Corporate Regulatory Affairs 221 West Philadelphia Street, Suite 60 York, PA 17401

Re: K151619

Trade/Device Name: Prime&Bond Elect® Universal Dental Adhesive Regulation Number: 21 CFR 872.3200 Regulation Name: Resin tooth bonding agent Regulatory Class: II Product Code: KLE Dated: August 03, 2015 Received: August 04, 2015

Dear Ms. Lewis:

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. 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.

1

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina
Kiang -S

for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

2

SECTION 4. INDICATIONS FOR USE STATEMENT

K151619 510(k) Number (if known):

Device Name: Prime&Bond Elect® Universal Dental Adhesive

Indications for Use:

    1. Prime&Bond Elect® Universal Dental Adhesive (visible light cured):
    • 1.1 Direct, light cured composite and compomer restorations
    • 1.2 Indirect restorations; light cured, resin cemented veneers

1.3 Indirect restorations; acid-tolerant resin cement (dual cure or self-cure) cemented inlays, onlays, crown and bridge retainers

  • 1.4 Composite, ceramic and amalgam repairs
  • 1.5 Cavity varnish for use with fresh amalgam
    1. Prime&Bond Elect® Universal Dental Adhesive mixed with Self-Cure Activator (dual cure or self-cure):

2.1 Direct, dual cure or self-cure composite restorations and core build-ups

2.2 Indirect restorations; dual cured and self-cured resin cemented inlays, onlays, crown and bridge retainers

  • 2.3 Dual cured and self-cured resin cemented endodontic post cementation
    1. Prime&Bond Elect® Universal Dental Adhesive mixed with Self-Cure Activator and Amalgam Bonding Base & Catalyst:

3.1 Adhesive bonding of direct amalgam restoration

    1. Prime&Bond Elect® Universal Dental Adhesive (without Self-Cure Activator or adhesive curing):
      4.1 Indirect restorations: acid-tolerant resin cement light-cured cementation; light transmissible inlays, onlays, crown and bridge retainers with light curing of cement

4.2 Indirect restorations; acid-tolerant resin cement dual cure or self-cure cementation; limited light/light opaque inlays, onlays, crown and bridge retainers and endodontic posts with total etch technique

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

3

SECTION 5. 510(k) SUMMARY

Image /page/3/Picture/23 description: The image shows the word "DENTSPLY" in a bold, sans-serif font. The letters are all capitalized and black. The letter "T" is slightly angled to the right, and the letter "S" is slightly smaller than the other letters. The word is centered and takes up most of the image.

for Prime&Bond Elect® Universal Dental Adhesive

    1. Submitter Information: DENTSPLY International Susquehanna Commerce Center 221 West Philadelphia Street York, PA 17401
      Contact Person: Helen Lewis Telephone Number: 717-487-1332 Fax Number: 717-849-4343

Date Prepared: 12 June 2015

2. Device Name:

  • Proprietary Name: .
  • . Classification Name:
  • CFR Number: 9

Prime&Bond Elect® Universal Dental Adhesive Resin tooth bonding agent 872.3200

  • Device Class:
  • Product Code: .

Class II

  • KLE

3. Predicate Device:

.

Predicate Device Name510(k)Company Name
XENO® Adhesive with ActivatorK051463DENTSPLY International Inc.

4. Description of Device:

Prime&Bond Elect® Universal Dental Adhesive is a universal self-priming dental adhesive system designed to bond resin based materials to enamel and dentin as well as to metals and ceramic. Prime&Bond Elect® Universal Dental Adhesive combines etchant, primer and adhesive in a one-bottle material. This robust formulation allows the operator to utilize selective phosphoric acid etching of enamel, phosphoric acid etching of both enamel and dentin, or no phosphoric acid etching prior to application, ensuring high bond strength and protection against microleakage.

When mixed with Self-Cure Activator, Prime&Bond Elect® Universal Dental Adhesive is designed to be used with DENTSPLY manufactured dual cure/self-cure resin cements* to bond all indirect restorations and DENTSPLY manufactured dual cured composite restoratives. When used with the Amalgam Bonding Accessory Kit, available separately, Prime&Bond Elect® Universal Dental Adhesive also adhesively bonds fresh amalgam to enamel and dentin.

*Note: Acid-tolerant resin cements may be used following application of Prime&Bond Elect® adhesive without the use of Self-Cure Activator, additionally allowing operator's choice of pre-cementation adhesive curing options (see complete Directions for Use).

DENTSPLY International

World Headquarters Susquehanna Commerce Center 221 West Philadelphia Street Suite 60W York, PA 17401 (800) 877-0020 Fax (717) 849-4343 www.dentsply.com

4

1. Indications for Use:

    1. Prime&Bond Elect® Universal Dental Adhesive (visible light cured):
    • 1.1 Direct, light cured composite and compomer restorations
    • 1.2 Indirect restorations: light cured. resin cemented veneers
    • 1.3 Indirect restorations; acid-tolerant resin cement (dual cure or self-cure) cemented inlays, onlays, crown and bridge retainers
    • 1.4 Composite, ceramic and amalgam repairs
    • 1.5 Cavity varnish for use with fresh amalgam
    1. Prime&Bond Elect® Universal Dental Adhesive mixed with Self-Cure Activator (dual cure or self-cure):
    • 2.1 Direct, dual cure or self-cure composite restorations and core build-ups
    • 2.2 Indirect restorations; dual cured and self-cured resin cemented inlays, onlays, crown and bridge retainers
    • 2.3 Dual cured and self-cured resin cemented endodontic post cementation
    1. Prime&Bond Elect® Universal Dental Adhesive mixed with Self-Cure Activator and Amalgam Bonding Base & Catalyst:
    • 1.1 Adhesive bonding of direct amalgam restoration
    1. Prime&Bond Elect® Universal Dental Adhesive (without Self-Cure Activator or adhesive curing):
    • 4.1 Indirect restorations; acid-tolerant resin cement light-cured cementation; light transmissible inlays, onlays, crown and bridge retainers with light curing of cement
    • 4.2 Indirect restorations; acid-tolerant resin cement dual cure or self-cure cementation; limited light/light opaque inlays, onlays, crown and bridge retainers and endodontic posts with total etch technique

6. Substantial Equivalence:

All of the components found in proposed Prime&Bond Elect® Universal Dental Adhesive have been used in legally marketed devices.

The proposed device, Prime&Bond Elect® Universal Dental Adhesive, includes light curing Prime&Bond Elect® Universal Dental Adhesive and separate Self-Cure Activator (SCA). The predicate device. XENO® Adhesive with Activator (K051463), includes light curing Xeno® Adhesive and separate Self-Cure Activator (SCA). The light curing adhesive formulation of Prime&Bond Elect® Universal Dental Adhesive is identical to light curing portion of the predicate XENO® Adhesive with Activator (K051463). When used for direct applications, Prime&Bond Elect® Universal Dental Adhesive in self-etch mode is exactly the same as light curing portion of the predicate XENO® Adhesive with Activator (K051463).

Prime&Bond Elect® Universal Dental Adhesive allows the operator to utilize selective phosphoric acid etching of enamel, phosphoric acid etching of both enamel and dentin, or no phosphoric acid etching prior to application. XENO® Adhesive with Activator (K051463) has been marketed as a self-etch adhesive only, without the option of phosphoric acid conditioning.

5

This technique modification allowing utilization of phosphoric acid conditioning prior to adhesive application is new in comparison to the predicate device, XENO® Adhesive with Activator (K051463).

When used for indirect applications in combination with traditional resin cements. which are not compatible with most one-bottle light curing adhesives, Prime&Bond Elect Universal Dental Adhesive should be coupled with the same Self-Cure Activator, in exactly the same way as XENO® Adhesive with Activator (K051463).

When Prime&Bond Elect® Universal Dental Adhesive is used with an acid tolerant resin cement, no separate Self-Cure Activator is needed if:

  • The adhesive is applied in self-etch, selective enamel etch, or total (enamel and . dentin) etch technique and light cured prior to application of acid tolerant resin cement, all types of indirect restorations
  • The adhesive is applied in self-etch, selective enamel etch, or total (enamel and dentin) etch technique without light curing: light curing of acid tolerant resin cement through light transmissible indirect restorations
  • The adhesive is applied in total (enamel and dentin) etch technique without light curing; self-curing of acid tolerant resin cement through light opaque indirect restorations

The design and formulation is identical to the predicate device, XENO® Adhesive with Activator (K051463), and therefore the biocompatibility data and the performance data of the legally marketed of XENO® Adhesive with Activator (K051463) provided in premarket notification K051463 support the proposed device, Prime&Bond Elect® Universal Dental Adhesive, for the indicated uses.

Table 5.1 shows the similarities and differences of the indications for use for: XENO® Adhesive with Activator (K051463) as the predicate device, and proposed changes for Prime&Bond Elect® Universal Dental Adhesive.

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ElementPredicate deviceProposed device
Product NameXENO® Adhesive with
Activator (K051463)Prime&Bond Elect® Universal
Dental Adhesive
FeaturesLight, Dual, Self-cured
Dental AdhesiveUniversal Dental Adhesive
Identical Adhesive and
Self-Cure Activator to
K051463
Adds Optional Self-Cure
Activator for additional
Dual Cure/Self-cure
Compatibility IndicationsAdds technique
modification; selective etch
capability
Adds Indications for
Adhesive use alone when
used with acid tolerant
cement; No Light Cure, No
Self-Cure Activator
Indications for use1. Prime&Bond Elect®
Universal Dental Adhesive
(visible light cured)
Direct, light-cured
composite and compomer
restorations1.1 Direct, light-cured
composite and
compomer restorations
Indirect restorations;
Light-cured resin
cemented veneers1.2 Indirect restorations;
Light-cured resin
cemented veneers
1.3 Indirect restorations;
acid tolerant resin
cement (dual or self-
cure) cemented inlays,
onlays, crown and bridge
retainers
Composite, ceramic and
amalgam repairs1.4 Composite, ceramic and
amalgam repairs
Cavity Varnish for use
with fresh amalgam1.5 Cavity Varnish for use
with fresh amalgam
2. Prime&Bond Elect®
Universal Dental
Adhesive mixed with Self-
Cure Activator (Dual Cure
or Self-cure)
Direct, dual-cure or self-
cure composite
restorations and core
build-ups2.1 Direct, dual-cure or self-
cure composite
restorations and core
build-ups

Table 5.1 Similarities and Differences between the proposed and the predicate devices

7

ElementPredicate deviceProposed device
Resin cemented inlays, onlays, crown and bridge retainers
and endodontic post cementation;2.2 Indirect restorations; dual cured and self-cured resin cemented inlays, onlays, crown and bridge retainers
2.3 Dual Cured and Self-cured resin cemented endodontic post cementation
Adhesive bonding of direct amalgam restorations3. Prime&Bond Elect® Universal Dental Adhesive mixed with Self-Cure Activator and Amalgam Bonding Base & Catalyst)
3.1 Adhesive bonding of direct amalgam restorations
  1. Prime&Bond Elect® Universal Dental Adhesive (Self-cure without Self-Cure Activator or adhesive curing) |
    | | | 4.1 Indirect restorations; acid-tolerant resin cement light-cured cementation; light transmissible inlays, onlays, crown and bridge retainers with light curing of cement
    4.2 Indirect restorations; acid-tolerant resin cement dual cure or self-cure cementation; limited light/light opaque inlays, onlays, crown and bridge retainers and endodontic posts with total etch technique |
    | Component for direct | One-bottle light curing adhesive | One-bottle light curing adhesive |
    | Technique for direct | Self-etch only; light curing of adhesive | Self-etch, selective enamel etch or total etch; light curing of adhesive |

8

ElementPredicate deviceProposed device
Component for
indirectLight curing adhesive used
with Self-Cure Activator;
traditional resin cementLight curing adhesive
used with Self-Cure
Activator; traditional
resin cement One-bottle light curing
adhesive without Self-
Cure Activator; acid-
tolerant resin cement
Technique for
IndirectSelf-etch only. Light curing
adhesive mixed with Self-
Cure Activator (1:1)Self-etch, selective enamel
etch or total etch:
Light curing adhesive
mixed with Self-Cure
Activator (1:1) One-bottle light curing
adhesive; with acid-
tolerant cement One-bottle adhesive, no
light curing; light cured
acid tolerant cement,
light transmissible
restoration Total etch: One-bottle adhesive, no
light curing; self-cured
acid tolerant cement,
light opaque restoration

7. Non-Clinical Performance Data.

Biocompatibility Testing

The biocompatibility requirements for the proposed device, Prime&Bond Elect® Universal Dental Adhesive have not changed from the predicate device XENO® Adhesive with Activator (K051463). Therefore, no additional biocompatibility tests were performed as the proposed device is identical in design and formulation to the predicate device XENO® Adhesive with Activator (K051463).

Physical Properties

There are no changes affecting the fundamental technology and chemical composition of Prime&Bond Elect® Universal Dental Adhesive. The physical characteristics and mechanical properties of the material are not affected. Table 5.2 shows the testing performed on the proposed device and all of the test results have met the specifications.

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Table 5.2- Physical Properties Tested
Physical PropertyResults
Film ThicknessMeets specification
Dentin Shear Bond Strength, IndirectMeets specification
Enamel Shear Bond Strength, IndirectMeets specification
Dentin Shear Bond Strength, DirectMeets specification
Enamel Shear Bond Strength, DirectMeets specification
Composite Bond Strength, IndirectMeets specification
Base Metal Shear Bond Strength, IndirectMeets specification
Noble Metal Shear Bond Strength, IndirectMeets specification
Zirconia Ceramics Bond Strength, IndirectMeets specification
Glass Ceramic Shear Bond Strength, IndirectMeets specification
Shelf Life2 Years
    1. Clinical Performance Data. Clinical performance is not required for this 510(k) submission for there are no changes affecting the proposed device, Prime&Bond Elect® Universal Dental Adhesive.

9. Conclusion Regarding Substantial Equivalence

The Prime&Bond Elect® Universal Dental Adhesive is a self-priming dental adhesive which is intended to bond resin based materials to enamel and dentin as well as to metals and ceramic. The Prime&Bond Elect® Universal Dental Adhesive has the same intended use, incorporates the same fundamental technology, and has similar indications for use as the predicate XENO® Adhesive with Activator cleared under premarket notification K051463. Test data such as appearance, pH, Specific Gravity and Film Thickness to verify the performance of the Prime&Bond Elect® Universal Dental Adhesive have been provided. The results of this testing, combined with the design and intended use comparison with the predicate device, XENO® Adhesive with Activator (K051463), support substantial equivalence.