Parkell Universal Adhesive

K172176 · Parkell, Inc. · KLE · Nov 21, 2017 · Dental

Device Facts

• Record ID: K172176
• Device Name: Parkell Universal Adhesive
• Applicant: Parkell, Inc.
• Product Code: KLE · Dental
• Decision Date: Nov 21, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2

Intended Use

1. Direct dental restorations (e.g., resin-based composites, resin-modified glass ionomers, resin core build-ups, compomers). 2. Indirect dental restorations (e.g., metal, resin-based composite, dental ceramics such as porcelain, pressed ceramic, lithium disilicate, lithium silicate or zirconia). 3. Desensitization of dentin. 4. Sealing of dentin, cementum or enamel.

Device Story

Parkell Universal Adhesive is a single-component, light-cured dental bonding agent. It utilizes 4-META and 10-MDP chemistry to penetrate prepared enamel and dentin surfaces, establishing bonds to restorative composites, metals, and dental ceramics. Used in dental clinics by dentists; applied via brush to treatment surfaces. Functions as a self-etching, self-priming adhesive compatible with self-, dual-, and light-cure materials. Benefits include simplified application without prior acid-etching of dentin or cutting of enamel, and protection against microleakage. Output is a bonded interface between tooth structure and restorative material.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, specifically shear bond strength testing performed in accordance with ISO standards on various dental substrates (enamel, dentin, metals, ceramics, composites).

Technological Characteristics

Single-component, light-cured, self-etching, self-priming dental adhesive. Contains 4-META and 10-MDP resins. Compatible with self-, dual-, and light-cure materials. Biocompatibility evaluated per ISO 10993-1, -3, -5, -10, -12, and -33.

Indications for Use

Indicated for direct and indirect dental restorations, dentin desensitization, and sealing of dentin, cementum, or enamel in patients requiring dental restorative procedures.

Regulatory Classification

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.

Predicate Devices

• Scotchbond® Universal Adhesive (K110302)

Submission Summary (Full Text)

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November 21, 2017

Parkell. Inc. David Mott VP, Regulatory Affairs; General Counsel 300 Executive Drive Edgewood, New York 11717

Re: K172176

Trade/Device Name: Parkell Universal Adhesive Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: Class II Product Code: KLE Dated: October 23, 2017 Received: October 24, 2017

Dear Mr. David Mott:

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.

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

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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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Mary S. Runner -S

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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# Indications for Use

510(k) Number (if known) K172176

Device Name Parkell® Universal Adhesive

Indications for Use (Describe)

1. Direct dental restorations (e.g., resin-based composites, resin-modified glass ionomers, resin core build-ups, compomers).

- 2. Indirect dental restorations (e.g., metal, resin-based composite, dental ceramics such as porcelain, pressed ceramic, lithium disilicate, lithium silicate or zirconia).
- 3. Desensitization of dentin.
- 4. Sealing of dentin, cementum or enamel.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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# K172176 510(k) Summary

- 1. Submitter:
Parkell, Inc. 300 Executive Drive Edgewood, NY 11717

- 2. Contact:
David Mott, Esq. VP. Requlatory Affairs Tel: [phone] Fax: [phone] [e-mail]

- 3. Submission Date: October 23, 2017
- Device Identification: 4.

| Trade Name: | Parkell® Universal Adhesive |
|----------------------|-----------------------------------------------------|
| Common Name: | Dental Bonding Agent |
| Classification Name: | Resin Tooth Bonding Agent (21 CFR Section 872.3200) |
| Product Code: | KLE |
| Classification: | Class II |

- 5. Predicate Device:
Scotchbond® Universal Adhesive (K110302)/(3M ESPE)

- 6. Description of Proposed Device:
The Parkell® Universal Adhesive is a single-component, one-bottle, light-cured universal bonding agent which utilizes proven 4-META and 10-MDP chemistry to enhance penetration into prepared enamel and dentin surfaces and to establish strong bonds to dental surfaces such as restorative composites, metals, dentin, enamel, cementum, and dental ceramics (e.g., porcelain, lithium disilicate, zirconia, or hybrid ceramics). The Device is useful for all direct and indirect dental restorations, desensitizing teeth, and sealing tooth structures against microleakage. Moreover, the Device can be used without prior acid-etching of dentin or cutting of enamel surfaces.

The Parkell® Universal Adhesive will be provided in a single bottle, with standard applicator brushes for applying the adhesive to treatment surfaces.

- 7. Intended Use:
- Direct dental restorations (e.g., resin-based composites, resin-modified glass ionomers, ﮯ resin core build-ups, compomers).
- ನ Indirect dental restorations (e.g., metal, resin-based composite, dental ceramics such as porcelain, pressed ceramic, lithium disilicate, lithium silicate or zirconia).
- ನ Desensitization of dentin.
- Sealing of dentin, cementum or enamel. ব

As so described and as demonstrated in Table 5-A, the Device has the same intended uses as the Predicate Device (Scotchbond™ Universal Adhesive, 510K no. 110302, which has been marketed since about 2011), in that both devices are useful for direct and indirect dental restorations (e.g., inlays, onlays, crowns, bridges, varnishes and veneers), desensitizing

Image /page/3/Picture/21 description: The image shows the logo for DirectaDentalGroup. The logo is white text on a black background. Underneath the main logo are the logos for DIRECTA, topdental, ORSING, and parkell.

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teeth and root surfaces, and sealing tooth structures and cavities. Any differences in the descriptions of intended uses of the Device and Predicate Device, to the extent that they exist, are minor, not critical to the intended therapeutic uses of the Device, and do not affect the safety and/or effectiveness of the Device when used as labeled.

#### 8. Technological Characteristics:

The proposed device, Parkell® Universal Adhesive, has the same intended use and contains similar chemical components to that of the predicate device (Scotchbond™ Universal Adhesive, K110302). The proposed device and its predicate both contain several of the same chemical components as well as identical functional categories of components, with the exception of a "filler" which is included only in the Predicate Device. The differences in chemical composition across the Device and Predicate Device are believed to have insubstantial effects on the intended use of the Device. This is evidenced by substantially similar performance by the proposed device and predicate devices in performance tests on a variety of dental substrates, as described in the device comparison table below.

Most importantly, all chemical components found in the proposed Device, but not within the Predicate Device, are commonly-used chemicals that are present in many FDA-cleared dental products which have long histories of safe use.

#### 9. Biocompatibility:

An evaluation of biocompatibility was conducted to determine the safety of Parkell® Universal Adhesive in accordance with ISO 10993-1:2009, ISO 10993-3:2014, ISO 10993-5: 2009, ISO 10993-10:2010, ISO 10993-12: 2012, ISO 10993-33:2015, and the Final FDA Guidance, "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (June 16, 2016). The conclusion of the evaluation is that Parkell® Universal Adhesive can be considered biocompatible.

## 10. Substantial Equivalence2:

Information provided in this 510(k) submission demonstrates that Parkell® Universal Adhesive is substantially equivalent to the Predicate Device, 3M ESPE's Scotchbond® Universal Adhesive (K110302) in terms of bond strength to dentin, enamel,metals, composite resins, and dental ceramics. The shear bond strength tests were performed in accordance with ISO standards. The bond strengths achieved by the Device were compared to that of the Predicate Device and were determined to be equivalent.

Any differences between the Device and the Predicate Device, for purposes of this 510(k) submission, do not raise new questions of safety or effectiveness. Thus, this submission demonstrates the safety and effectiveness of Parkell® Universal Adhesive. A brief comparison of Parkell® Universal Adhesive to the Predicate Device is provided below:

All statements contained herein are made solely for the purpose of demonstrating substantial equivalence as that term is defined in the context of SIO(k) submissions; the statements cannot be applied reliably or accurately in the context of U.S. patent or other intellectual property laws which involve vastly different legal standards and definitions (such as, e.g., within the context of 35 U.S.C. §§ 102, 103, 112, 271).

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# Table 5-A:

| | Parkell® Universal Adhesive<br>(Parkell, Inc.) | Predicate Device<br>(Scotchbond® Universal Adhesive)<br>(3M) | Shear Bond Strength, Initial (MPa)<br>Pass/fail criteria: at least about 6MPa<br>("<::6MPa") | Parkell® Universal<br>Adhesive<br>(Parkell, Inc.)<br>K172176 | Predicate Device<br>(Scotchbond® Universal Adhesive)<br>(3M)<br>K110302 |
|------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|--------------------------------------------------------------|-------------------------------------------------------------------------|
| | K172176 | K110302 | Enamel | <::6MPa | <::6MPa |
| Intended use | 1. Direct dental restorations<br>(e.g., resin-based composites,<br>resin-modified glass ionomers,<br>resin core build-ups,<br>compomers).<br><br>2. Indirect dental restorations<br>(e.g., metal, resin-based<br>composite, dental ceramics such<br>as porcelain, pressed ceramic,<br>lithium disilicate, lithium silicate<br>or zirconia).<br><br>3. Desensitization of dentin.<br><br>4. Sealing of dentin, cementum<br>or enamel. | 1. All classes of fillings (according to<br>Black) with composite or compomer.<br><br>2. Cementation of indirect<br>restorations (crowns, inlays) of<br>composite or compomer, ceramic and<br>metal; Bonding of dual cure and<br>chemical cure cements, core build-up<br>materials and composites (with<br>activator); Cementation of veneers;<br>Intraoral repair of existing composite,<br>porcelain fused to metal, and all<br>ceramic restorations w/o extra<br>primer; Bonding of core build-ups<br>made of composite or core build-up<br>materials; Repair of composite or<br>compomer fillings<br><br>3. Root surface desensitization<br><br>4. Sealing of cavities prior to<br>cementation of amalgam<br>restorations; Sealing of cavities and<br>preparations of tooth stumps prior to<br>temporary cementation of indirect<br>restorations<br><br>5. Protective varnish for glass<br>ionomer fillings;<br><br>6. Bonding of pit and fissure sealants | Dentin | <::6MPa | <::6MPa |
| Classification Product<br>Code | KLE | KLE | Silver alloy | <::6MPa | <::6MPa |
| Regulation Number | 872.300 | 872.300 | Cobalt-chrome alloy | <::6MPa | <::6MPa |
| Self-Etching | Yes | Yes | Porcelain, following acid etching | <::6MPa | <::6MPa |
| Self-Priming | Yes | Yes | Porcelain, following sandblasting | <::6MPa | <::6MPa |
| Light-Cured | Yes | Yes | Lithium disilicate, following<br>sandblasting | <::6MPa | <::6MPa |
| Single bottle svstem | Yes | Yes | Lithium d1s111cate, followmg HF acid<br>etching | <::6MPa | <::6MPa |
| Compatible with Self-,<br>Dual-, & Light-Cure<br>Materials | Yes | Yes | Zirconia, following sandblasting | <::6MPa | <::61vwa |
| Chemical components | Comprises several resins<br>including 10 MDB | Comprises several resins<br>including 10 MDB | Composite<br>Resin | selt-cure<br><::6MPa | <::bMPa |
| 11gnt-cure<br><::bMPa | <::6MPa | | | | |

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### Table 5-B:

* - pretreated with silane/ceramic primer.

#### 11. Clinical Performance Data

There was no clinical testing required to support the Device as the indications for use are equivalent to the Predicate Device. These types of devices, including the Predicate Device, have been on the market for many years with no reported adverse events. The non-clinical testing detailed in this submission supports the substantial equivalence of the Device.

### 12. Statement of Substantial Equivalence:

By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device.

The Device (Parkell® Universal Adhesive) has the same or similar intended use, indications, principles of operation, and technological characteristics as the Predicate Device (Scotchbond® Universal Adhesive). The Device, as designed and manufactured, is determined to be substantially equivalent to the Predicate Device in terms of intended use, design, and function.