Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

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

Therapeutic

Yes.
The device is indicated for direct and indirect dental restorations and desensitization of dentin, which are considered therapeutic uses to restore and treat dental conditions.

Diagnostic

No
Explanation: The device description and intended use clearly state that BRUSH&BOND® PLUS is a bonding system used for dental restorations, desensitization, and sealing. It performs a therapeutic/restorative function rather than diagnosing any condition.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "single-bottle, two-component system, comprising: a liquid resin... and an activator brush". This indicates the device is a physical product, 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 direct application within the mouth for dental procedures (restorations, desensitization, sealing). IVDs are used to examine specimens from the body (like blood, urine, tissue) to provide information about a patient's health status.
Device Description: The description details a bonding system applied directly to tooth structures. It does not describe a device used to analyze biological samples.
Anatomical Site: The anatomical sites mentioned are all within the oral cavity (dentin, enamel, cementum, tooth structures, exposed root surfaces), where the device is applied directly.
Performance Studies: The performance studies focus on biocompatibility and bond strength to dental materials, not on the analysis of biological samples for diagnostic purposes.

The device is clearly intended for use in vivo (within the living body) during dental procedures, not for in vitro (outside the living body) diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

BRUSH&BOND® PLUS is indicated for:

Direct Dental Restorations (e.g., resin-modified glass ionomer, resin core build-ups, compomers).
Indirect Dental Restorations (e.g., metal, resin-based composite, dental ceramics (e.g., porcelain, pressed ceramic, lithium disilicate, zirconia).
Desensitization of dentin.
Sealing of dentin, cementum or enamel.

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

KLE

Device Description

BRUSH&BOND® PLUS is a self-etching, self-priming, light-cured bonding system which utilizes proven 4-META 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 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 BRUSH&BOND® PLUS device is essentially a single-bottle, two-component system, comprising: a liquid resin which comprises monomers and 4-META chemistry, and an activator brush which comprises a bonding promoter to ensure complete activation and polymerization when contacted with the liquid resin. After activation, the activated resin can be applied directly onto restorative surfaces (except dental ceramic surfaces) using the activator brush or any appropriate dental instrument. For ceramic surfaces, the surface must first be coated with a ceramic primer (such as EaZy PrimerTM,510K no. 142848) before the activated resin is applied.

BRUSH&BOND® PLUS is packaged as a single 3 mL bottle of liguid resin, an accompanying canister containing 100 activator brushes (either standard size or mini/endo size), and accompanying bottles of Parkell's ceramic rimer Ea PrimerTM 5mL "A" and "B" bottles).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

dentin, cementum or enamel, tooth structures, exposed root surfaces

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Dental Professional

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)

Evaluation of biocompatibility was conducted to determine the safety of BRUSH&BOND® PLUS in accordance with ISO 10993-1: 2009, ISO 10993-5: 2009, ISO 10993-12: 2009, and the guidance document, "Blue Book Memo, G95-1, Use of International Standard IS0-10993, and Biological Evaluation of Medical Devices: Part 1: Evaluation and Testing". The biocompatibility evaluation included cytotoxicity testing in accordance with ISO 10993-5:2009, skin sensitization testing in accordance with ISO 10993-10:2010, and oral mucosa stimulation testing in accordance with ISO 10993-10:2010. The conclusion of the evaluation is that BRUSH&BOND® PLUS can be considered biocompatible.

Information provided in this 510(k) submission demonstrates that BRUSH&BOND® PLUS is substantially equivalent to the Predicate Device, Parkell Inc.'s existing BRUSH&BOND® bonding agent (K020239) in terms of bond strength to dentin and enamel, as well as to the Reference Device (K131734) in terms of bond strength to metals, composite resin, and dental ceramics. The Shear and Tensile Bond Strength tests were performed in accordance with ISO/TS 11405. The shear and tensile strength tests were compared to the Predicates and were determined to be equivalent.

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.

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.

K020239

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.

K131734

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

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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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" 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

September 18, 2015

Parkell, Inc. Mr. David Mott, Esq. VP. Regulatory Affairs 300 Executive Drive Edgewood, New York 11717

Re: 151518

Trade/Device Name: Brush & Bond® Plus Regulation Number: 21 CFR 872.3200 Regulation Name: Resin tooth bonding agent Regulatory Class: II Product Code: KLE Dated: June 19, 2015 Received: June 22, 2015

Dear Mr. 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.

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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 (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

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Indications for Use

510(k) Number (if known) K151518

Device Name BRUSH&BOND® PLUS

Indications for Use (Describe) BRUSH&BOND® PLUS is indicated for:

Direct Dental Restorations (e.g., resin-modified glass ionomer, resin core build-ups, compomers).
Indirect Dental Restorations (e.g., metal, resin-based composite, dental ceramics (e.g., porcelain, pressed ceramic, lithium disilicate, zirconia).
Desensitization of dentin.
Sealing of dentin, cementum or enamel.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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510(k) Summary

1. Submitter:

Parkell, Inc. 300 Executive Drive Edgewood, NY 11717

2. Contact:

David Mott, Esq. VP, Regulatory Affairs Tel: (631) 249-1134, ext. 145 Fax: (631) 249-1242

3. Submission Date: June 4, 2015

4. Device Identification:

Trade Name:	BRUSH&BOND® PLUS
Common Name:	Dental Bonding Agent
Classification Name:	Resin Tooth Bonding Agent (21CFR Section 872.3200)
Product Code:	KLE
Classification:	Class II

5. Predicate and Reference Devices:

Predicate Device: BRUSH&BOND® (510k no. 020239, filed as Touch&Bond-Pius) Reference Device: All-Bond Universal® (510K no. 131734, filed as All-Bond Universal SC)

Description of Applicant Device: 6.

BRUSH&BOND® PLUS is a self-etching. self-priming. light-cured bonding system which utilizes proven 4-META 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 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 BRUSH&BOND® PLUS device is essentially a single-bottle, two-component system, comprising: a liquid resin which comprises monomers and 4-META chemistry, and an activator brush which comprises a bonding promoter to ensure complete activation and polymerization when contacted with the liquid resin. After activation, the activated resin can be applied directly onto restorative surfaces (except dental ceramic surfaces) using the activator brush or any appropriate dental instrument. For ceramic surfaces, the surface must first be coated with a ceramic primer (such as EaZy Primer'M,510K no. 142848) before the activated resin is applied.

BRUSH&BOND® PLUS is packaged as a single 3 mL bottle of liguid resin, an accompanying canister containing 100 activator brushes (either standard size or mini/endo size), and accompanying bottles of Parkell's ceramic rimer Ea Primer'M

5mL "A" and "B" bottles).

lotewood. New York 11717 USA Edgewood. Ne Toll-Free: 800,243,7446 Phone: 631.249.1134 FAX: 631,249,1242 ww.parkell.com

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7. Intended Uses:

1. Direct dental restorations (e.g., resin-based composite, resin-modified glass ionomer, resin core build-ups, compomers).
1. Indirect dental restorations (e.g., metal, resin-based composite, dental ceramics (e.g., porcelain, pressed ceramic, lithium disilicate, zirconia)).
ന് Desensitization of dentin.
1. Sealing of dentin, cementum or enamel.

8. Technological Characteristics:

BRUSH&BOND® PLUS is a single-bottle, dual-component bonding system, comprising: a liquid resin which comprises monomers and 4-META chemistry; and an activator brush which comprises a bonding promoter to ensure complete activation and polymerization when contact is made with the liquid resin. It is packaged as a single 3 mL bottle of liguid resin, an accompanying canister containing 100 activator brushes (either standard size or mini/endo size), and accompanying bottles of Parkell's ceramic primer, EaZy Primer 1 %, 510K no. 142848 (5-millimeter "A" and "B" bottles).

All components of BRUSH&BOND® PLUS are found in legally marketed predicate devices. The BRUSH&BOND® PLUS is based upon industry standard monomer chemistry and has similar technological characteristics as other legally marketed bonding agents.

9. Biocompatibility:

An evaluation of biocompatibility was conducted to determine the safety of BRUSH&BOND® PLUS in accordance with ISO 10993-1: 2009, ISO 10993-5: 2009, ISO 10993-12: 2009, and the guidance document, "Blue Book Memo, G95-1, Use of International Standard IS0-10993, and Biological Evaluation of Medical Devices: Part 1: Evaluation and Testing". The biocompatibility evaluation included cytotoxicity testing in accordance with ISO 10993-5:2009, skin sensitization testing in accordance with ISO 10993-10:2010, and oral mucosa stimulation testing in accordance with ISO 10993-10:2010. The conclusion of the evaluation is that BRUSH&BOND® PLUS can be considered biocompatible.

10. Substantial Equivalence:

Information provided in this 510(k) submission demonstrates that BRUSH&BOND® PLUS is substantially equivalent to the Predicate Device, Parkell Inc.'s existing BRUSH&BOND® bonding agent (K020239) in terms of bond strength to dentin and enamel, as well as to the Reference Device (K131734) in terms of bond strength to metals, composite resin, and dental ceramics. The Shear and Tensile Bond Strength tests were performed in accordance with ISO/TS 11405. The shear and tensile strength tests were compared to the Predicates and were determined to be equivalent.

Any minor differences between the Device and the Predicate Device do not raise new questions of equivalence.Thus,this submission demonstrates the substantial equivalence of BRUSH&BOND® PLUS. A brief comparison of BRUSH&BOND® PLUS to the Predicate and Reference Devices is provided below:

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Parkell inc.

Table 5-1:
Property
(pass/fail criteria!
if applicable)	BRUSH&BOND®
PLUS
(Parkell, Inc.)	Predicate Device
(Brush&Bond®)
(Parkell, Inc.)	Reference Device
(All-Bond Universal®)
(Bisco, Inc.)
Intended uses	1. Direct Dental
Restorations (e.g.!
resin-based
composite, resin-
modified glass
ionomer, resin core
build-ups,
compomers).

Indirect Dental
Restorations (e.g.,
metal, resin-based
composite, dental
ceramics, e.g.,
porcelain (pressed
ceramic, lithium
disilicate, zirconia).
Desensitization of
dentin.
Sealing of dentin,
cementum or
enamel. | 1. A dentin bonding
agent used with
direct filling
materials
that include but
may not be limited
to, composite resins,
resin modified glass
monomers or
compomers, etc.
A dentin bonding
agent used with
resin cements or
composite luting
agents to retain
indirect tooth-
colored and cast
alloy restorations
that include but
may not be limited
to indirect
composite or
porcelain inlays and
onlays, laminate
veneers, either resin
or porcelain,
porcelain-fused-to-
metal crowns, etc.
Treatment of
hypersensitive areas
o exposed root
surfaces.
A cavity sealant
and desensitizer
applied to exposed
dentin that has
been prepared to
receive a laboratory
fabricated
restoration such as
porcelain-fused-to-
metal crowns, cast
alloy or tooth- colored inlays,
onlays veneers etc. | 1. Direct Restorations
(e.g. resin-based
composite, resin-
modified glass ionomer,
core build-ups)
Indirect Restorations
(e.g. metal, glass,
ceramics,
zirconia/alumina)
Bonding Resin or
Primer for Substrates
Desensitization/Sealing
of Tooth
Intraoral Repair (e.g.
chipped porcelain,
additions to direct
restorations) |
| Classification
Product Code
Self-Etching | KLE | KLE | KLE |
| Self-priming | Yes | Yes | Not available |
| Light-cured | Yes | Yes | Yes |
| | | | |
| Compatible
with self
dual, and
light cured
materials | Yes | Yes | Yes |

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Table 5-1(continued):

| Property | BRUSH&BOND®
PLUS
(Parkell, Inc.) | Predicate Device
(Brush&Bond®)
(Parkell, Inc) | Reference Device
(All-Bond Universal®)
(Sisco, Inc.) |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| {pass/fail criteria,
if applicable} | | | |
| Shelf Life | 3 years | 3 years | 2 years |
| Chemical
components | Bonding agent, comprising a liquid resin which comprises monomers and 4-META chemistry; a ceramic primer; an activator brush comprising a bonding promoter. | Bonding agent, comprising a liquid resin which comprises monomers and 4-META chemistry; and an activator brush comprising a bonding promoter. | Bonding agent, comprising an ethanol/water-based dental adhesive; and a porcelain 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 (BRUSH&BOND® PLUS) has the same or similar intended use, indications, principles of operation, and technological characteristics as the Predicate Device (BRUSH&BOND®). The Device, as designed and manufactured, is determined to be substantially equivalent to the Predicate Device in terms of intended use, design, materials, and function.