Prime&Bond active Universal Adhesive

{0}------------------------------------------------ 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. {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 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 {2}------------------------------------------------ #### 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) | <span style="font-size: 10pt;"> <input checked="true" type="checkbox"/> Registration in a State (i.e. NYS, NJ, California, etc.) </span> | |-----------------------------------------------------------------------------------------------------------------------------------------------| | <span style="font-size: 10pt;"> <input type="checkbox"/> Registration in a State with EPA-delegated Authority </span> | > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 {3}------------------------------------------------ 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 - 2. 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<br>(formerly Dentsply<br>International Inc.) | | DENTSPLY Self Cure Activator | K964525 | Dentsply Sirona<br>(formerly Dentsply<br>International Inc.) | {4}------------------------------------------------ ## 4. Description of Device: 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-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 - 5. 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. {5}------------------------------------------------ # 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<br>compomer restorations | All classes of fillings (according to Black)<br>with light-curing composite or compomer<br>filling materials | No differences – classes of filling according to Black<br>include direct restorations | | Indirect restorations and<br>endodontic posts cemented with<br>Calibra Ceram | Cementation of indirect restorations<br>(inlay, onlay, crowns, bridges, veneers) of<br>composite, compomer, ceramic, and<br>metal when combined with Suglue-10<br>Adhesive Resin Cement, manufactured<br>by 3M ESPE | No differences- this indication describes the compatibility<br>of the dental adhesive (proposed and predicate device)<br>with a specific luting cement used for cementation of<br>materials within indirect restoration or endodontic<br>procedures. The adhesive bonds the cement to tooth<br>substrates, the cement is the luting material for the<br>indirect/endodontic application (depending on the<br>indications for the cement).<br>Calibra Ceram is the assigned (reference) cement for the<br>proposed device, Suglue-10 Adhesive Resin Cement is the<br>respective assigned (reference) cement for the predicate<br>device | | Light cured resin cemented<br>veneers | Cementation of veneers when combined<br>with RelyX Veneer Cement,<br>manufactured by 3M ESPE | No differences- RelyX Veneer Cement is a typical resin<br>based cement | | | Bonding of core build-ups made of light-<br>curing composite or core build-up<br>materials. | No differences – for the proposed device this indication is<br>included in "Direct light cured composite and compomer<br>restorations" | | Composite, ceramic and amalgam<br>repairs | Repair of composite or compomer fillings<br>Intraoral repair of composite restorations,<br>porcelain fused to metal, and all-ceramic<br>restorations without extra primer | No differences- repair of porcelain fused to metal includes<br>bonding to metal surfaces, which is similar to amalgam<br>bonding/repair. | | Desensitization of exposed dentin | Root surface desensitization | No differences | | Cavity varnish for use with fresh<br>amalgam | Sealing of cavities prior to cementation of<br>amalgamate restorations | No differences- Sealing of cavities and preparation of tooth<br>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<br>tooth stumps prior to temporary<br>cementation of indirect restorations. | restorations is not a proposed indication for the subject<br>Prime&Bond active™ Universal Adhesive device. | | | Bonding of fissure sealants | Minor indication, it is not a proposed indication for the<br>subject Prime&Bond active™ Universal Adhesive device. | | | Protective varnish for glass ionomer<br>fillings | Minor indication, it is not a proposed indication for the<br>subject Prime&Bond active™ Universal Adhesive device. | | Surface treatment of zirconia,<br>metal, and composite | Surface treatment of porcelain, ceramics<br>(including glass ceramics, zirconia and<br>alumina), metal and composite. | No differences - treatment of glass ceramics and alumina<br>is not a proposed indication for the subject Prime&Bond<br>active™ Universal Adhesive device. | | In combination with DENTSPLY<br>Self-cure Activator :<br>• Direct dual-cure/ self-cure<br>composite restorations and core<br>build-ups | Bonding of dual-cure cements and core<br>build-up materials and self-cure<br>composites when combined with Activator<br>EXL 760 | No differences – split into two indications for the proposed<br>device.<br>The term "dual-cure” includes "self-cure" mode. | | • Cementation of indirect<br>restorations and endodontic<br>posts using dual cure/self-cure<br>resin cements. | | | | Features: | Features: | Differences: | | One-component, light-curing<br>universal dental adhesive | Single-component, light curing adhesive | No differences | | Self-etch, selective enamel-etch<br>mode, or etch-and rinse mode;<br>light curing of adhesive | Self-etch, selective enamel-etch mode, or<br>etch-and-rinse mode; light curing of<br>adhesive | No differences | | • Light-curing universal adhesive<br>used with Self-cure Activator;<br>traditional resin cement | • Light-curing universal adhesive used<br>with separate Activator; traditional resin<br>cement | No differences | | • Light-curing universal adhesive<br>used without Self-cure Activator<br>for assigned (reference) cement | • Light-curing universal adhesive used<br>without separate Activator for assigned<br>(reference) cement | | {6}------------------------------------------------ {7}------------------------------------------------ ### 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. - 9. 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.