tenure * 4G is DenMat's next generation of its popular Tenure MPB System with greater bond strength and sensitivity control. It is a 40 generation multi-purpose, self-cure adhesive system for bonding any resin restorative to all intraoral surfaces. They are polymerizable dental monomer resins that are chemically-cured with the reaction initiated when the two parts are mixed together. These polymers form strong leak and stain resistant bonds between the dental surface and restorations placed over them.

AI/ML Overview

This document is a 510(k) premarket notification for the "tenure®4G" resin tooth bonding agent. It evaluates the device's substantial equivalence to predicate devices (ALL-BOND 2 and Tenure MPB) based on intended use, indications for use, chemical components, safety, and technological characteristics.

Here's an analysis of the provided information concerning acceptance criteria, device performance, and the study details:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implicitly tied to demonstrating substantial equivalence to the predicate devices, particularly in terms of shear bond strength. While explicit numerical acceptance criteria (e.g., "must achieve at least X psi") are not stated, the study aims to show that the tenure®4G performs "as good as or even better than the predicate devices."

Material Bonded	Acceptance Criteria (Implicit)	Reported tenure®4G Performance (Mean ± StDev)	ALL-BOND 2 Performance (Mean ± StDev)	Tenure MPB Performance (Mean ± StDev)
Porcelain	Shear bond strength comparable to or better than predicate devices (ALL-BOND 2 and Tenure MPB).	1907.14 ± 294.42 psi (13.149 ± 2.030 MPa)	1627.21 ± 656.00 psi (11.219 ± 4.523 MPa)	2041.29 ± 177.37 psi (14.074 ± 1.223 MPa)
Enamel	Shear bond strength comparable to or better than predicate devices (ALL-BOND 2 and Tenure MPB).	1851.84 ± 512.14 psi (12.768 ± 3.531 MPa)	1147.21 ± 549.74 psi (7.910 ± 3.790 MPa)	1485.50 ± 659.45 psi (10.242 ± 4.547 MPa)
Dentin	Shear bond strength comparable to or better than predicate devices (ALL-BOND 2 and Tenure MPB).	3776.07 ± 478.64 psi (26.035 ± 3.300 MPa)	2830.62 ± 217.68 psi (19.516 ± 1.501 MPa)	3027.60 ± 410.47 psi (20.875 ± 2.830 MPa)

Conclusion from Table: For Porcelain and Enamel, tenure®4G demonstrates higher mean bond strength than ALL-BOND 2, and for Enamel and Dentin, it shows higher mean bond strength than Tenure MPB. For Porcelain, its mean bond strength is slightly lower than Tenure MPB but falls within the standard deviation. Overall, the results support the claim that tenure®4G performs "as good as or even better than" the predicate devices.

2. Sample Size Used for the Test Set and the Data Provenance

The document mentions "Results of shear bond testing indicate that tenure®4G was as effective and performs as good as or even better than the predicate devices." However, it does not explicitly state the sample size used for the shear bond testing. The data provenance is not specified beyond being "tested in the lab using R&D test protocols." It is likely retrospective data collected for this submission. The country of origin of the data is not mentioned but can be inferred to be related to the submitter, DenMat Holdings, LLC, which is based in Lompoc, California, U.S.A.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This type of study (comparative performance of a dental bonding agent) does not involve experts establishing ground truth in the same way clinical diagnostic studies do. The "ground truth" here is the objective measurement of shear bond strength, which is a physical property determined through laboratory testing methods, not expert consensus or interpretation. Therefore, this information is not applicable.

4. Adjudication Method for the Test Set

As the "test set" involves objective laboratory measurements of shear bond strength rather than subjective assessments requiring expert adjudication, this information is not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This document describes the performance of a dental bonding agent, an in-vitro material, not a diagnostic imaging device or an AI application. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This document pertains to a dental bonding agent and not a software algorithm. Therefore, "standalone (algorithm only without human-in-the-loop performance)" is not applicable.

7. The Type of Ground Truth Used

The "ground truth" for this performance study is objective laboratory measurements of shear bond strength. This is determined through physical testing protocols in a lab setting, not through expert consensus, pathology, or outcomes data in a clinical sense.

8. The Sample Size for the Training Set

This submission is for a medical device (dental bonding agent), not a machine learning algorithm. Therefore, there is no concept of a "training set" in this context. The chemical formulation and manufacturing processes are developed through research and development, and the performance is validated through testing, not by training a model on data.

9. How the Ground Truth for the Training Set Was Established

As there is no "training set" for this device, this question is not applicable.

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, with wavy lines representing hair or flowing fabric.

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

August 20, 2014

DenMat Holdings, LLC C/O Ms. Helen Ragus Regulatory Specialist 1017 W. Central Avenue Lompoc, California, 93436

Re: K140537

Trade/Device Name: tenure®4G Regulation Number: 21 CFR 872.3200 Regulation Name: Resin tooth bonding agent Regulatory Class: II Product Code: KLE Dated: May 27, 2014 Received: May 27, 2014

Dear Ms. Ragus:

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

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Page 2 - Ms. Ragus

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 vours.

Mary S. Runner -S

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510{k) Number (if known)

K140537

Device Name tenure@4G

Indications for Use (Describe)

tenure@4G is recommended for the following types of applications:

All routine direct and indirect resin composite bonding
Porcelain, ceramic veneers, amalgams, precious and semi-precious metals bonding
Indirect gold, porcelain and ceramic inlays and onlays bonding
Desensitization of root or dentin prior to impressions or temporaries
Preparation desensitization of crown prior to impressions or temporaries

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement on last page.

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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Image /page/3/Picture/0 description: The image shows a logo for "DenMat". The logo consists of the letters "dm" in a stylized font, with "DenMat" written below the letters. The letters "dm" are connected at the top, and the "d" is slightly smaller than the "m". There is a trademark symbol to the right of the word "DenMat".

1017 West Central Avenue
805-346-3700 www.denmat.com

K140537

V. 510(k) SUMMARY

Submitter:

Owner's Name:	DenMat Holdings, LLC
Address:	1017 W. Central AvenueLompoc, CA 93436U.S.A.
Phone Number:	805 346 3700
Fax Number:	805 347 7940
Contact Person:	Helen RagusRegulatory Specialist805 346 3700, X2932hragus@denmat.com
Date of SummaryPreparation:	February 24, 2014
Device Name:
Trade Name:	tenure* 4G
Common Name:	Bonding Agent
Classification Name:	Agent, Tooth Bonding
Predicate Devices:
ALL-BOND 2 by Bisco	K910860
Tenure MPB(Den-Mat Tenure)	K872510

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Description of the Device

Intended Use of the Device

tenure #G is intended to be used as a resin tooth bonding agent. It is used for composite bonding of porcelain and metals, as well as for desensitizing root, dentin or crown prior to impressions or temporaries.

Indications of Use of the Device

tenure 4G is recommended for the following types of applications:

1. All routine direct and indirect resin composite bonding.
1. Porcelain, ceramic veneers, amalgams, precious and semi-precious metals bonding.
1. Indirect gold, porcelain and ceramic inlays and onlays bonding.
1. Desensitization of root or dentin prior to impressions and temporaries.
1. Preparation desensitization of crown prior to impression or temporaries.

Substantial Equivalence Discussion

1. Intended Uses/Indications for Use
  tenure 4G and the predicate devices are intended to be used as resin tooth bonding agents. They are used for composite bonding of porcelain and metals, as well as for desensitizing root, dentin or crown prior to impressions or temporaries.

tenure 4G and Tenure MPB are recommended for the following types of applications: all routine direct and indirect resin composite bonding; porcelain, ceramic veneers, amalgams, precious and semi-precious metals bonding; indirect gold, porcelain and ceramic inlays and onlays bonding; desensitization of root or dentin prior to impressions and temporaries; and preparation desensitization of crown prior to impression or temporaries.

ALL-BOND 2 applications include bonding to dentin, enamel, new or old composite, precious and non-precious casting alloys, silane treated porcelain, and new or old amalgam; and treatment of tooth sensitivity.

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Scientific literature have been evaluated to determine safety and efficacy of similar products used for the same indications. The intended uses and indications for use of the subject device are substantially equivalent to those of the predicate devices.

1. Chemical Components/Safety
  Chemical components in tenure 4G have been used in the predicate devices. Scientific literature have been evaluated to determine safety and efficacy of similar products used for the same indications. The predicate devices have not been a focus of any advisory notice or recalls according to the post-market adverse event reporting requirements in the United States. The conclusion can be made that the safety of the subject device is substantially cquivalent to those of the predicate devices.
1. Technological Characteristics/Effectiveness and Performance
  There are no international standards concerning performance for these types of devices. Scientific literature have been evaluated to determine safety and efficacy of similar products used for the same indications. The physical/mechanical properties of tenure 4G were tested in the lab using R&D test protocols. Results of shear bond testing indicate that tenure 4G was as effective and performs as good as or even better than the predicate devices. The conclusion can be made that the effectiveness and performance of the subject device is substantially equivalent to those of the predicate devices.

Biocompatibility

The subject device is categorized as an external communicating device with contact to tissue/bone/dentin and is a permanent contact device. tenure "4G's chemical ingredients are equivalent to those of the predicate devices. All devices are made of materials with a long history of safe use. The predicate devices have not been a focus of any advisory notice or recalls according to the post-market adverse event reporting requirements in the United States. Accordingly. conclusion can be made that the subject device is substantially equivalent in safety to the predicate devices.

tenure* 4G
	Porcelain		Enamel		Dentin
	psi	MPa	psi	MPa	psi	MPa
Mean	1907.14	13.149	1851.84	12.768	3776.07	26.035
Stdev	294.42	2.030	512.14	3.531	478.64	3.300

Comparative Performance Data

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	Porcelain			Enamel			Dentin
	psi	MPa		psi	MPa		psi	MPa
Mean	1627.21	11.219	Mean	1147.21	7.910	Mean	2830.62	19.516
Stdev	656.00	4.523	Stdev	549.74	3.790	Stdev	217.68	1.501

ALL-BOND 2

Tenure MPB
Porcelain		Enamel		Dentin
	psi	MPa	psi	MPa	Psi	MPa
Mean	2041.29	14.074	Mean 1485.50	10.242	Mean 3027.60	20.875
Stdev	177.37	1.223	Stdev 659.45	4.547	Stdev 410.47	2.830

Summary of Features and Characteristics of the Device Compared to the Predicate Device:

Product	510(k)	Applications	ChemicalCompositon	TechniqueApplication
tenure®4G		- All routine direct and indirectresin composite bonding- Porcelain, ceramic veneers,amalgams, precious and semi-precious metals bonding- Indirect gold, porcelain andceramic inlays and onlaysbonding- Desensitization of root ordentin prior to impressions andtemporaries- Preparation desensitization ofcrown prior to impression ortemporaries	- Self-cure- Methacrylateresin based- Containsacetone solvent- Containsethanol solvent	Total-Etch
ALL-BOND 2	K910860	- All dental surfaces includingprecious and non preciouscasting alloys, and amalgambonding- Root sensitivity treatment	- Self-Cure- Methacrylateresin based- Containsacetone solvent- Containsethanol solvent	Total-Etch

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TenureMulti-purposeBonding	K872510	- All routine direct and indirectresin composite bonding- Porcelain, ceramic veneers,amalgams, precious and semi-precious metals bonding- Indirect gold, porcelain andceramic inlays and onlaysbonding- Desensitization of root ordentin prior to impressions andtemporaries- Preparation desensitization ofcrown prior to impression ortemporaries	- Self-Cure- Methacrylateresin based- Containsacetone solvent	Total -Etch
----------------------------------------	---------	---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	-------------------------------------------------------------------------------	-------------

Conclusion

The information provided in this 510(k) submission demonstrates that tenure *40 is substantially equivalent to the predicate devices All-Bond 2 and Tenure MPB in terms of intended use, indications for use, chemical composition and physical properties.

It is concluded that the information supplied in this submission has proven the safety and efficacy of this product.

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Image /page/8/Picture/0 description: The image shows a logo for "DenMat". The logo consists of the letters "dm" in a stylized font, with "DenMat" written below in a smaller font. The letters "dm" are connected, with the "d" on the left and the "m" on the right. The logo is in black and white.

K140537/52

FDA CDRH DMC MAY 2 7 2014 Received

1-15

510(k) COVER LETTER

U.S. Food and Drug Administration Center for Devices and Radiological Heath Document Control Center - WO66-G609 10903 New Hampshire Avenue Silver Spring, MD 20993-0002

Reference: K140537/S001

Type of Submission:	Traditional
Trade Name:	tenure® 4G
Common Name:	Dental Bonding Agent
Classification Regulation:	872.3200
Device Class:	II
Panel:	Dental
Product Code:	KLE
510(k) Submitter:	DenMat Holdings, LLC
Establishment Registration #:	2018957
Contact Person:	Helen Ragus

Phone Number:

Dear Sir or Madam,

In Reference to 510(k) number K140537/S001, please find the attached response addressing the elements identified as missing or inconsistent in the provided checklist attached to Acceptance Review Notification - Refuse To Accept (RTA) dated May 21, 2014.

Regulatory Specialist

805 346-3700, X2932

In addition, 2 pages from the response to the FDA Acceptance Review Notification - Refuse to Accept dated March 18, 2014 and received by the FDA on 5/8/14 (eCopy 5/13/14) are also provided with corrected information.

1. In Response to Section C. Substantial Equivalence Discussion, the 510(k) predicate device number for Tenure MPB (K801216) was listed in error instead of the correct 510(k) K872510.
1. In Response to Section G. Biocompatibility, water was listed with the incorrect chemical name. The corrected information simply listed it as water.

Corrections were also made to the initial submission received by the FDA on 3/4/14 where the incorrect predicate device for Tenure MPB (K801216) was listed instead of the correct 510(k) K872510.

1. I. 510(k) Cover Letter (page 2)
  1017 W. Central Avenue, Lompoc, CA 93436 denmat.com

P: 805-346-3700 F: 805-347-7933

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Image /page/9/Picture/0 description: The image shows a logo for "DenMat". The logo consists of the letters "d" and "m" in a stylized font, with the "d" slightly overlapping the "m". Below the letters "dm" is the word "DenMat" in a smaller, sans-serif font. The logo is black and white.

1. V. 510(k) Summary (Summary of Features and Characteristics of the Device Compared to the Predicate Device) (page 16)
1. X. Executive Summary (Features and Characteristics of the Device Compared to the Predicate Device) (page 23)
1. XII. Substantial Equivalence Discussion (Comparison of Features and Characteristics) (page 30)

In accordance to Section 745A (b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), added by section 1136 of the Food and Drug Administration Safety and Innovation Act (FDASIA) (Pub. L. 112-144), an eCopy in the form of a CD is submitted with the paper copy,

If you have any questions and/or concerns, please call or e-mail me using the information below.

Sincerely,

Helen Ragn

Helen Ragus Regulatory Specialist (805) 346-3700, X2932 hragus@denmat.com

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Image /page/10/Picture/0 description: The image shows a logo for DenMat. The logo consists of the letters 'dm' in a stylized font, with the 'd' being smaller and to the left of the 'm'. Below the letters 'dm' is the word 'DenMat' in a smaller, sans-serif font. The logo is black and white.

K140537/5001

510(k) COVER LETTER

ಲ್ಲಿ

U.S. Food and Drug Administration Center for Devices and Radiological Heath Document Control Center - WO66-G609 10903 New Hampshire Avenue Silver Spring, MD 20993-0002

I·DA CDRH DMC MAY 1 3 2014 Received

Reference: K140537/S001

Type of Submission: Trade Name: Common Name: Classification Regulation: Device Class: Panel: Product Code:

510(k) Submitter: Establishment Registration #: Contact Person:

Phone Number:

DenMat Holdings, LLC 2018957 Helen Ragus Regulatory Specialist 805 346-3700, X2932

Dental Bonding Agent

Dear Sir or Madam,

In Reference to 510(k) number K140537/S001, please find the revised eCopy with the corrected PDF naming convention.

The eCopy is an exact duplicate of the paper copy except for the revised cover letter.

of the states and the became comments of any the section of the count

Traditional

tenure@4G .

872.3200

Dental KLE

If you have any questions and/or concerns, please call or e-mail me using the information below.

Sincerely,

Helen Rogers

Helen Ragus Regulatory Specialist (805) 346-3700, X2932 hragus@denmat.com

1017 W. Central Avenue, Lompoc, CA 93436 denmat.com

P: 805-346-3700 F: 805-347-7933

and and and and the States of Cameral

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.