(169 days)
No
The device description and performance studies focus on the chemical and mechanical properties of a dental adhesive system, with no mention of AI or ML technologies.
No
The device is a dental adhesive used for bonding restorations and desensitizing teeth, not for treating diseases or conditions.
No
This device is a dental adhesive used for bonding restorations to intraoral surfaces and for desensitization, not for diagnosing medical conditions.
No
The device description clearly states it is a "multi-purpose, self-cure adhesive system" composed of "polymerizable dental monomer resins" that are "chemically-cured." This describes a physical material, not software.
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 bonding dental materials to intraoral surfaces for restorative and desensitization purposes. These are procedures performed directly on the patient's body, not on samples taken from the body for diagnostic purposes.
- Device Description: The device is described as a self-cure adhesive system for bonding dental materials. This aligns with a dental restorative or bonding agent, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health condition.
- Performance Metrics: The key metrics are related to physical/mechanical properties like shear bond strength, which are relevant to the performance of a dental adhesive, not a diagnostic test.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is entirely focused on facilitating dental restorations and desensitization within the mouth.
N/A
Intended Use / Indications for Use
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
Product codes
KLE
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intraoral surfaces, root, dentin, crown
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
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.
Key Metrics
| 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 |
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510{k) Number (if known)
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)
B
3
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
V. 510(k) SUMMARY
Submitter:
| Owner's Name: | DenMat Holdings, LLC |
|---|---|
| Address: | 1017 W. Central Avenue |
| Lompoc, CA 93436 | |
| U.S.A. | |
| Phone Number: | 805 346 3700 |
| Fax Number: | 805 347 7940 |
| Contact Person: | Helen Ragus |
| Regulatory Specialist | |
| 805 346 3700, X2932 | |
| hragus@denmat.com | |
| Date of Summary | |
| Preparation: | 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 |
:
4
Description of the Device
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.
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:
-
- 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.
-
- Preparation desensitization of crown prior to impression or temporaries.
Substantial Equivalence Discussion
-
- 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.
- Intended Uses/Indications for Use
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.
5
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.
-
- 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.
- Chemical Components/Safety
-
- 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.
- Technological Characteristics/Effectiveness and Performance
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
6
| 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 | Chemical
Compositon | Technique
Application |
|----------------|---------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|--------------------------|
| tenure®4G | | - 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 - Preparation desensitization of
crown prior to impression or
temporaries | - Self-cure - Methacrylate
resin based - Contains
acetone solvent - Contains
ethanol solvent | Total-Etch |
| ALL-
BOND 2 | K910860 | - All dental surfaces including
precious and non precious
casting alloys, and amalgam
bonding - Root sensitivity treatment | - Self-Cure
- Methacrylate
resin based - Contains
acetone solvent - Contains
ethanol solvent | Total-Etch |
7
| Tenure
Multi-
purpose
Bonding | K872510 | - 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 - Preparation desensitization of
crown prior to impression or
temporaries | - Self-Cure - Methacrylate
resin based - Contains
acetone 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.
8
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.
-
- 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.
-
- I. 510(k) Cover Letter (page 2)
1017 W. Central Avenue, Lompoc, CA 93436 denmat.com
- I. 510(k) Cover Letter (page 2)
P: 805-346-3700 F: 805-347-7933
9
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.
-
- V. 510(k) Summary (Summary of Features and Characteristics of the Device Compared to the Predicate Device) (page 16)
-
- X. Executive Summary (Features and Characteristics of the Device Compared to the Predicate Device) (page 23)
-
- 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
10
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
II
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