Predicate Devices

K#110302

Reference Devices

K#130486, K#012436, K#150727

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 product is a dental adhesive used for bonding and repair of dental restorations and prosthetics. It does not provide any therapeutic benefit to the patient beyond enabling the function of these restorative materials.

Diagnostic

No

Explanation: The device is a dental adhesive system used for bonding and repair of dental materials, not for diagnosing diseases or conditions. Its intended uses are restorative and bonding procedures.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "two-component self-cured dental adhesive system" consisting of "Bond A and Bond B are packaged in separate plastic bottles." This describes a physical chemical product, not software.

IVD (In Vitro Diagnostic)

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, tissue) to provide information for diagnosis, monitoring, or screening.
Device Function: The TOKUYAMA UNIVERSAL BOND is a dental adhesive system used for bonding dental materials to tooth structure and other restorative materials. It is applied directly to the patient's teeth or to materials being used in the patient's mouth.
Intended Use: The intended uses listed are all related to dental restoration and repair procedures performed directly on or in the patient's mouth.
Device Description: The description details a chemical bonding process for dental applications, not the analysis of biological specimens.
Performance Studies: The performance studies focus on physical properties like bond strength to various dental materials, not on the analysis of biological samples.

The device is a dental material used in the treatment of patients, not a diagnostic tool that analyzes samples outside the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The TOKUYAMA UNIVERSAL BOND is indicated for:

Direct anterior and posterior restorations with light-curing, and self-curing composite materials
Intraoral repair of composite restorations, porcelain fused to metal, and all-ceramic restorations without an additional primer
Cementation of indirect restorations and veners when combined with light-cure, and self-curing resin cements
Bonding of core build-ups made of core build-up materials
Bonding of denture resin to metal base, clasp or attachment
Repair of denture with metal base, clasp or attachment
Bonding of opaque resin to a metal base in the fabrication of resin-faced crowns

Product codes

KLE

Device Description

The TOKUYAMA UNIVERSAL BOND device is a two-component self-cured dental adhesive system for both direct and indirect restorations that can be used with self-etch, selective-enamel-etch, and total-etch techniques. The TOKUYAMA UNIVERSAL BOND device is fully compatible with light-cured. self-cured, and dual-cured composite materials.

Bond A and Bond B are packaged in separate plastic bottles. A group of polymerization agents is contained in the Bond A and Bond B to avoid reaction during storage, and the polymerization reaction begins upon mixing. When the mixture is applied thinly to adherends and concentrate by air-drying, a cured layer is formed by polymerization of methacrylic monomers. The cured layer functions as an adhesive layer for enhancing adhesiveness of polymerization resin to the adherends.

The device improves the bond strength of polymerizable resin material (adhesive resin cement, acrylic resin, and composite resin) to indirect restorative materials such as glass-ceramics (porcelain), oxide-ceramics (zirconia and alumina), metals (precious and non-precious), and resin materials including inorganic filler.

The TOKUYAMA UNIVERSAL BOND device does not come sterilized and is not intended to be sterilized prior to use.

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

Non-clinical testing of the following physical properties was conducted on the TOKUYAMA UNIVERSAL BOND device.
Tensile bond strength to enamel: Testing was conducted pursuant to Section 5.1 of ISO/TS 11405:2015.
Tensile bond strength to dentin: Testing was conducted pursuant to Section 5.1 of ISO/TS 11405:2015.
Tensile bond strength to metal: Testing was conducted pursuant to Section 5.1 of ISO/TS 11405:2015.
Tensile bond strength to porcelain: Testing was conducted pursuant to Section 5.1 of ISO/TS 11405:2015.
Tensile bond strength to zirconia: Testing was conducted pursuant to Section 5.1 of ISO/TS 11405:2015.
Tensile bond strength to resin material including inorganic filler: Testing was conducted pursuant to Section 5.1 of ISO/TS 11405:2015.
The working time of the device was evaluated by confirming whether the device was cured after 90 seconds. The paintability of the device was evaluated by determining if an even film was formed. The appearance of the device was evaluated via visual inspection.
Substantial biocompatibility testing was conducted in accordance with ISO 10993-1:2009 and ISO 7405:2008.
There were no clinical tests performed for the TOKUYAMA UNIVERSAL BOND device.
Based on the non-clinical testing conducted of the physical properties and the biocompatibility testing of the TOKUYAMA UNIVERSAL BOND device, it is concluded that the TOKUYAMA UNIVERSAL BOND device is substantially equivalent to the primary predicate and reference devices identified above.

Key Metrics

Tensile bond strength to enamel: In-house specification is more than 12 MPa.
Tensile bond strength to dentin: In-house specification is more than 10 MPa.
Tensile bond strength to metal: In-house specification is more than 12 MPa.
Tensile bond strength to porcelain: In-house specification is more than 10 MPa.
Tensile bond strength to zirconia: In-house specification is more than 10 MPa.
Tensile bond strength to resin material including inorganic filler: In-house specification is more than 10 MPa.

Predicate Device(s)

K#110302

Reference Device(s)

K#130486, K#012436, K#150727

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

0

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.

November 28, 2017

Tokuyama Dental Corporation % Keith Barritt Attorney Fish & Richardson 901 15th Street, N.W., Suite 700 Washington, District of Columbia 20005

Re: K171226

Trade/Device Name: TOKUYAMA UNIVERSAL BOND 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 Keith Barritt:

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 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 (QS) regulation (21 CFR Part 820);

1

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

2

Indications for Use

510(k) Number (if known) K171226

Device Name TOKUYAMA UNIVERSAL BOND

Indications for Use (Describe) The TOKUYAMA UNIVERSAL BOND is indicated for:

Direct anterior and posterior restorations with light-curing, and self-curing composite materials
Intraoral repair of composite restorations, porcelain fused to metal, and all-ceramic restorations without an additional primer
Cementation of indirect restorations and veners when combined with light-cure, and self-curing resin cements
Bonding of core build-ups made of core build-up materials
Bonding of denture resin to metal base, clasp or attachment
Repair of denture with metal base, clasp or attachment
Bonding of opaque resin to a metal base in the fabrication of resin-faced crowns

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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3

510(k) SUMMARY Tokuyama Dental Corporation TOKUYAMA UNIVERSAL BOND

Submitter's Name and Address

(i) 510(k) Submitter

Tokuyama Dental Corporation 38-9 Taitou 1-chome, Taitou-ku Tokyo 110-0016 Japan Phone: 011-81-3-3835-2261

(ii) 510(k) Submitter Contact

Keith A. Barritt Fish & Richardson P.C. 901 15th Street, N.W., Suite 700 Washington, DC 20005 Phone: (202) 783-5070 Facsimile: (202) 783-2331 barritt@fr.com Email:

(iii) Preparation Date

November 24, 2017

Name of Device

Trade or Proprietary Name:	TOKUYAMA UNIVERSAL BOND
Common Name:	self-cured dental adhesive
Classification Name:	agent, tooth bonding, resin
Product Code:	KLE
Regulation:	21 CFR 872.3200

4

Predicate Devices

Primary Predicate: ADHESIVE EXL-759 (K#110302) Reference Predicates: FUTURABOND UNIVERSAL (K#130486), ALLOY PRIMER (K#012436), and ESTECEM (K#150727).

Device Description

The TOKUYAMA UNIVERSAL BOND device is a two-component self-cured dental adhesive system for both direct and indirect restorations that can be used with self-etch, selective-enamel-etch, and total-etch techniques. The TOKUYAMA UNIVERSAL BOND device is fully compatible with light-cured. self-cured, and dual-cured composite materials.

Bond A and Bond B are packaged in separate plastic bottles. A group of polymerization agents is contained in the Bond A and Bond B to avoid reaction during storage, and the polymerization reaction begins upon mixing. When the mixture is applied thinly to adherends and concentrate by air-drying, a cured layer is formed by polymerization of methacrylic monomers. The cured layer functions as an adhesive layer for enhancing adhesiveness of polymerization resin to the adherends.

The device improves the bond strength of polymerizable resin material (adhesive resin cement, acrylic resin, and composite resin) to indirect restorative materials such as glass-ceramics (porcelain), oxide-ceramics (zirconia and alumina), metals (precious and non-precious), and resin materials including inorganic filler.

The device is depicted below:

5

K#171226

Image /page/5/Picture/1 description: The image shows a dental adhesive kit with several components. The kit includes an outer box, two bottles labeled "Bond A" and "Bond B", a mixing well, and a disposable mixing well. Additionally, there is a disposable applicator included in the kit. The adhesive kit appears to be a comprehensive set for dental bonding procedures.

The TOKUYAMA UNIVERSAL BOND device does not come sterilized and is not intended to be sterilized prior to use.

Intended Use/Indications for Use

The TOKUYAMA UNIVERSAL BOND is indicated for:

Direct anterior and posterior restorations with light-curing, dual-curing, and self-curing composite materials
Intraoral repair of composite restorations, porcelain fused to metal, metal, and all-ceramic restorations without an additional primer
Cementation of indirect restorations and veneers when combined with light-cure, dual-cure, and self-curing resin cements
Bonding of core build-ups made of core build-up materials
Bonding of denture resin to metal base, clasp or attachment
Repair of denture with metal base, clasp or attachment
Bonding of opaque resin to a metal base in the fabrication of resin-faced crowns

6

Technological Characteristics

The TOKUYAMA UNIVERSAL BOND device has the same basic technological characteristics in terms of design, material, and chemical composition as the devices identified above. The TOKUYAMA UNIVERSAL BOND device does not have an energy source. Although the chemical compositions are not identical, the material properties, principles of operation, and performance characteristics of the TOKUYAMA UNIVERSAL BOND device are comparable to the previously authorized devices identified above, as demonstrated in part by the non-clinical performance bench testing described below.

A comprehensive chart comparing the devices appears below.

7

226
I
L
I
K#

| Device name | Manufacturer
510(k) No.
Classification
name | Subject device
TOKUYAMA UNIVERSAL
BOND
Tokuyama Dental Corporation
K171226
Agent, Tooth Bonding, Resin | Primary predicate
Adhesive EXL 759
3M ESPE AG
K110302
Agent, Tooth Bonding, Resin | Reference
Futurabond Universal
VOCO GmbH
K130486
Agent, Tooth Bonding, Resin | Reference
Alloy Primer
Kuraray Noritake Dental Inc.
K012436
Agent, Tooth Bonding, Resin | Reference
Estecem
Tokuyama Dental Corporation
K150727
Cement, Dental | Difference |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|------------|
| Indications for Use | The TOKUYAMA UNIVERSAL
BOND is indicated for:

Direct anterior and posterior
restorations with light-curing,
dual-curing, and self-curing
composite materials
Intraoral repair of composite
restorations, porcelain fused to
metal, metal, and all-ceramic
restorations without an
additional primer
Cementation of indirect
restorations and veneers when
combined with light-cure, dual-
cure, and self-curing resin
cements
Bonding of core build-ups made
of core build-up materials
Bonding of denture resin to
metal base, clasp or attachment
Repair of denture with metal
base, clasp or attachment
Bonding of opaque resin to a
metal base in the fabrication of
resin-faced crowns | All classes of fillings (according
to Black) with light-curing
composite or compomer filling
materials
Cementation of indirect
restorations (inlays, onlays,
crowns, bridges, veneers) of
composite, compomer, cramic,
and metal when combined with
Suglue-10 Adhesive Resin
Cement, manufactured by 3M
ESPE
Cementation of veneers when
combined with RelyX Veneer
Cement, manufactured by 3M
ESPE
Bonding of core build-ups made
of light-curing composite or core
build-up materials
Bonding of dual-cure cements
and core build-up materials and
self-cure composites when
combined with Activator EXL
760
Repair of composite or
compomer fillings
Intraoral repair of composite
restorations, porcelain fused to
metal, and all-ceramic
restorations without extra
primer
Root surface desensitization | Futurabond Universal is
intended for use as:

Adhesive for direct restorations
of all classes of cavities using
light-curing composite/
compomer/Ormocer materials
with a methacrylate base
Adhesive for core build-ups
made of light-curing composite
materials
Adhesive for indirect
restorations with light-curing
luting composites
Intraoral repair of composite,
compomer or Ormocer
rstorations, ceramic veneers
and all ceramic restorations
without an additional primer
Treatment of hypersensitive
tooth necks
Protective varnish for glass
ionomer cement restorations
Sealing of cavities prior to
amalgam restorations
Sealing of cavities and core
preparations prior to the
temporary luting of indirect
restorations
Adhesive for direct self-curing
or dual-curing composite
restorations of all classes of | ALLOY PRIMER is indicated
for the following applications:

Adhesion of metal posts,
metal inlays, onlays, crown
and bridges
Repair of fractures resin-
based facing crowns and
porcelain-fused metal
crowns
Fabrication of removable
dentures with metal base,
clasp or attachment. Repair
of dentures | The ESTECEM device is an
adhesive resin cement for the
cementation of crowns, bridges,
inlays, and onlays made of
glass/oxide ceramics (porcelain,
zirconia and alumina),
metals/alloys (precious and
non-precious) and resin
materials including inorganic
filler (composite materials).
The ESTECEM device is
indicated for:

Repair of fractured porcelain
fused to metal crowns and all
ceramic restorations
Cementation of veneers
Cementation of adhesion
bridges
Cementation of metal or resin
cores, metal or glass-fiber posts | The Indications
for Use of the
subject device is
within that of the
predicate and the
reference devices. | |

Comparison of TOKUYAMA UNIVERSAL BOND device with the primary predicate and the reference devices

8

9

Device name	Subject device	Primary predicate	Futurabond Universal	Reference	Estecem	Difference
TOKUYAMA UNIVERSAL BOND	Tokuyama Dental Corporation	Adhesive EXL 759	VOCO GmbH	Alloy Primer
				Kuraray Noritake Dental Inc.
	K171226	3M ESPE AG	K130486	K012436	Tokuyama Dental Corporation
Manufacturer
10(k) No.
Material	Phosphate monomer
Bis-GMA
TEGDMA
HEMA
Thiouracil monomer
(functioning as adhesion to metal)
Silane coupling agent
Peroxide
Borate catalyst (initiator)
Acetone
Isopropanol
Water	Phosphate monomer
Methacrylate-modified
polyalkenoic acid copolymer
Dimethacrylate resins
HEMA
Silane
Initiators
Ethanol
Water	Acidic monomers
Methacrylates
Catalysts
Initiators
Ethanol
Water	Phosphate monomer
VBATDT (functioning as adhesion to metal)
Acetone	(Adhesive components such as Estelink and Tokuyama Universal Primer:)
K150727
Phosphate monomer
Carboxylic acid monomer
Bis-GMA
TEGDMA
HEMA
UDMA
Thiouracil monomer
(functioning as adhesion to metal)
Silane coupling agent
Peroxide
Borate catalyst (initiator)
Acetone
Isopropanol
Ethanol
Water	The subject device contains a phosphate monomer,
methacrylic monomer, adhesive compound to prosthetic materials, initiator and solvent as with the predicate and the reference devices. The biocompatibility of the device has been thoroughly evaluated and performance tested.
Sterilization	Non-sterile	Non-sterile	Non-sterile	Non-sterile	Non-sterile	Non-sterile

K#171226

Physical Property Testing

(1) Tensile bond strength to tooth structure

	Tifferen.
	Estecem ***	1
I	-
I
Leference	uturabond Universa	L LI
I	1
I
Primary predicat
0	759
Adhesive EXL	ڪ ا
I	1
I
Subject device	TOKUYAMA UNIVERSA
BOND	> 12	L V

10 | |
| | Evaluation item | 'ensile bond strength to enamel * [MPa] | 'ensile bond strength to dentin ** [MPa] | |

In-house specification is more than 12 MP *

10

K#171226

**

in-house specification is more than 10 MPa.
The component tested was "Estelink" which was a component in the device for adhesion to tooth struct

Tensile bond strength to meta (ढ

Evaluation item	Subject device	Primary predicate	Reference	Difference
Tensile bond strength to metal * [MPa]
In-house specification is more than 12 MPa	TOKUYAMA UNIVERSAL BOND	Adhesive EXL 759	Alloy Primer	Estecem **
> 12	> 12	> 12	> 12	> 12

**

ouse specification is more than 12 ML a.
component tested was "Tokuyama Universal Primer" which was a component in the device for adhesion mater

(3) Tensile bond strength to ceramics and resin material including inorganic f

Evaluation item	Subject device	Primary predicate	Reference	Difference
Tensile bond strength to porcelain * [MPa]	TOKUYAMA UNIVERSAL BOND	Adhesive EXL 759	Estecem **	≥ 10
Tensile bond strength to zirconia * [MPa]	TOKUYAMA UNIVERSAL BOND	Adhesive EXL 759	Estecem **	≥ 10
Tensile bond strength to resin material including inorganic filler * [MPa]	TOKUYAMA UNIVERSAL BOND	Adhesive EXL 759	Estecem **	≥ 10

**

In house specification is more than 10 MPa.
The component tested was "Tokuyama Universal Primer" which was a component in the device for adhesion to prosthetic materia

11

Non-clinical Testing

Non-clinical testing of the following physical properties was conducted on the TOKUYAMA UNIVERSAL BOND device.

Tensile bond strength to enamel: Testing was conducted pursuant to Section 5.1 of ISO/TS 11405:2015.

Tensile bond strength to dentin: Testing was conducted pursuant to Section 5.1 of ISO/TS 11405:2015.

Tensile bond strength to metal: Testing was conducted pursuant to Section 5.1 of ISO/TS 11405:2015.

Tensile bond strength to porcelain: Testing was conducted pursuant to Section 5.1 of ISO/TS 11405:2015.

Tensile bond strength to zirconia: Testing was conducted pursuant to Section 5.1 of ISO/TS 11405:2015.

Tensile bond strength to resin material including inorganic filler: Testing was conducted pursuant to Section 5.1 of ISO/TS 11405:2015.

The working time of the device was evaluated by confirming whether the device was cured after 90 seconds. The paintability of the device was evaluated by determining if an even film was formed. The appearance of the device was evaluated via visual inspection.

The precise formulation of the device is confidential. Substantial biocompatibility testing was conducted in accordance with ISO 10993-1:2009 and ISO 7405:2008.

Clinical Testing

There were no clinical tests performed for the TOKUYAMA UNIVERSAL BOND device.

Conclusions from Testing

Based on the non-clinical testing conducted of the physical properties and the biocompatibility testing of the TOKUYAMA UNIVERSAL BOND device, it is concluded that the TOKUYAMA UNIVERSAL BOND device is substantially equivalent to the primary predicate and reference devices identified above.