(333 days)
No
The device description and performance studies focus on the chemical composition and physical properties of a dental primer, with no mention of AI or ML algorithms for analysis, decision-making, or image processing.
No.
The device is an aqueous primer designed to prepare a tooth for bonding by optimizing moisture levels and preventing bond degradation, rather than directly treating a disease or condition for therapeutic benefit.
No
Explanation: The device is an aqueous primer for desensitizing, rewetting, and preventing bond degradation in teeth. It does not provide information about a patient's health status or condition.
No
The device description clearly states that RnD TE and RnD SE are "aqueous primer[s]" and are "sold as a kit contain[ing] a 3ml bottle of RnD along with a single cavity well and Mircobrush® applicators." This indicates a physical, chemical substance and associated hardware components, not software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use/Indications for Use: The intended use is for "Desensitizing, Rewetting, Preventing Bond Degradation" of tooth structure. This is a direct treatment applied to the patient's tooth, not a test performed on a sample taken from the body.
- Device Description: The device is described as an "aqueous primer used to rewet and desensitize a tooth prior to bonding." It's applied directly to the tooth.
- Anatomical Site: The anatomical site is "Tooth structure (dentin and enamel)." This is a part of the patient's body.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the body (like blood, urine, tissue, etc.) or providing diagnostic information about a patient's health condition. The device's function is to prepare the tooth surface for a subsequent dental procedure (bonding).
IVDs are devices intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological state, state of health, disease or congenital abnormality. This device does not fit that definition.
N/A
Intended Use / Indications for Use
RnD TE and RnD SE is indicated for
- Desensitizing
- Rewetting
- Preventing Bond Degradation
Product codes (comma separated list FDA assigned to the subject device)
KLE
Device Description
RnD TE and RnD SE is an aqueous primer used to rewet and desensitize a tooth prior to bonding. Bonding to tooth structure presents many challenges including the determination of the proper conditions for starting the bonding protocol. The tooth can be left too wet or too dry which could lead to debonding or post-operative sensitivity. RnD TE and R&D SE have been designed to aid in reaching the appropriate moisture level to provide an initial surface that allows an adhesive to reach its full potential.
The subject device formulations also work to ensure the long term bond integrity by limiting the development of matrix metalloproteinases (MMP's) that have been cited as a contributor to bond degradation over time.
RnD TE and RnD SE will be sold as a kit contain a 3ml bottle of RnD along with a single cavity well and Mircobrush® applicators. RnD has been designed as a single use material and is non-sterile. The material is a single component material that is applied directly to the tooth with no other components added prior to use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tooth, dentin, enamel
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
Non-clinical test data supports the stated equivalence of the subject and predicate devices.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Shear bond testing was completed utilizing the Notched Edge Shear Bond Strength test (*) method. The non-clinical testing of the proposed device included ISO 29022:2013 - Dentistry - notched edge shear bond strength test. The method includes substrate selection, storage and handling of tooth structure, as well as the procedure for testing.
The bond strengths as noted in above table compare the primary predicate device HEMA GLU (K951220) to the subject device. In both enamel and dentin bonding, the results were equivalent.
Bond Strengths to Dentin (*) Mean (sd), [n]:
- RnD TE: 36.2 (5.7) [5]
- RnD SE: 33.4 (4.7) [5]
- HEMA GLU (K951220): 31.7 (2.0) [5]
- Aqua Prep F (K961822): 29.1 (3.1) [5]
- Hemaseal & Cide Desensitizer (K990779): 36.9 (3.1) [5]
Bond Strengths to Enamel (*) Mean (sd), [n]:
- RnD TE: 32.1 (2.9) [5]
- RnD SE: 27.8 (3.9) [5]
- HEMA GLU (K951220): 32.3 (2.8) [5]
- Aqua Prep F (K961822): 27.2 (3.5) [5]
- Hemaseal & Cide Desensitizer (K990779): 37.1 (3.0) [5]
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.
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.
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
§ 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 stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 17, 2017
Apex Dental Materials, Inc. Scott Lamerand Owner 330 Telser Road Lake Zurich, Illinois 60047
Re: K161077
Trade/Device Name: RnD TE and RnD SE Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: Class II Product Code: KLE Dated: February 15, 2017 Received: February 17, 2017
Dear Scott Lamerand:
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
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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/ResourcesforYou/Industry/default.htm. 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.
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.
Susan Runco, DDS, MA
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) K161077
Device Name
RnD TE and RnD SE
Indications for Use (Describe)
RnD TE and RnD SE is indicated for
- · Desensitizing
- · Rewetting
- · Preventing Bond Degradation
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
K161077 510(k) Summary
Submitter Information: 1)
Apex Dental Materials, Inc 330 Telser Road Lake Zurich, IL 60047 Registration Number: 3004402215
2) Contact Information:
| Scott Lamerand | Owner |
|---|---|
| Telephone (Office): | 847-719-1133 |
| Telephone (Mobile): | 847-975-0425 |
| Fax: | 847-719-1122 |
| Email: | Scott.Lamerand@apexdentalmaterials.com |
3) Date Submitted: March 17, 2017
Device Name: 4)
Trade Name: Common Name: RnD TE and RnD SE Tooth Conditioner
Classification Name: Regulation: Device Class: Product Code:
Resin Tooth Bonding Agent 872.3200 Class II KLE
ട്) Predicate Devices:
| Predicate
Device | 510K Number | Company Name | Commercial
Name |
|---------------------|-------------|------------------------------|-------------------------------------------|
| HEMA-GLU | K951220 | Health-Dent'l, LLC | HEMA-GLU |
| Wet Prep | K961822 | Bisco, Inc | Aqua Prep F
Rewetting and Desensitizer |
| Hemaseal & Cide | K990779 | Advantage Dental
Products | Hemaseal &Cide
Desensitizer |
510K Submission for RnD K161077 Apex Dental Materials, 330 Telser Road Lake Zurich, IL 60047
CONFIDENTIAL
4
6) Description of Subiect Device:
RnD TE and RnD SE is an aqueous primer used to rewet and desensitize a tooth prior to bonding. Bonding to tooth structure presents many challenges including the determination of the proper conditions for starting the bonding protocol. The tooth can be left too wet or too dry which could lead to debonding or post-operative sensitivity. RnD TE and R&D SE have been designed to aid in reaching the appropriate moisture level to provide an initial surface that allows an adhesive to reach its full potential.
The subject device formulations also work to ensure the long term bond integrity by limiting the development of matrix metalloproteinases (MMP's) that have been cited as a contributor to bond degradation over time.
RnD TE and RnD SE will be sold as a kit contain a 3ml bottle of RnD along with a single cavity well and Mircobrush® applicators. RnD has been designed as a single use material and is non-sterile. The material is a single component material that is applied directly to the tooth with no other components added prior to use.
7) Indications for Use:
-
- Rewetting tooth surface prior to bonding
-
- Desensitizing
-
- Preventing bond degradation
The indications for use for the proposed device are smiliar to the indications for use for the predicate devices: HEMA-GLU (K951220) and Hemaseal & Cide (K990779). Aqua Prep F (K961822) does not specifically address any impacts on bond degradation but is consistent in stressing rewetting and desensitizing. The indications for use are similar for two of the three predicate devices, and thus the
materials are substantially equivalent in terms of intended use.
A comparison table of the indications for use is shown below:
| Device | Subject Device
K161077
RnD TE and RnD SE | Primary Predicate
K951220
HEMA GLU | Reference
K961822
Aqua Prep | Reference
K990779
Hemaseal & Cide
Desenstizer |
|-------------------------------------|------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use
Statement | 1) Rewetting tooth
surface prior to
bonding
2) Desensitizing
3) Preventing bond
degradation | 1) superior desensitizing
agent, to be placed
under dental cements or
other restorative
materials - temporary,
provisional or final.
2) can be used for
desensitization of
amalgam restorations,
either conventional or
bonded.
3) helps kill bacteria,
4) alter nerve
responses
5) aids bonding
primers in penetrating
etched dentin. | 1) Rewetting dentin
and enamel following
etching and drying of
the dental cavity
preparation
2) Rewetting dried
hydrophilic dental
tissues following
dental procedures
3) Rewetting etched
and dried enamel prior
to Pit & Fissure
Sealant treatment
4) Desensitizing | 1) Elimination of post-
op sensitivity -
precluding the need to
do remakes
2) Superior
disinfection of
preparations
3) Enhancement and
prolongation of bond
strength
4) Reduction of
microleakage |
510K Submission for RnD K161077 Apex Dental Materials, 330 Telser Road Lake Zurich, IL 60047
CONFIDENTIAL
5
Technological Characteristics: 8)
All components of RnD formulations are found in legally marketed predicate devices and are industry standard materials used in rewetting and desensitizing materials for more than 20 years. The final characteristics and indications for use are similar to other legally marketed devices with similar indications for use. The proposed device utilizes a solvent coupled with glutaraldehyde, methacrylate monomer and sodium fluoride to provide the stated benefits.
9) Predicate Device Comparison
All of the components utilized within the RnD formulations are industry standard materials used in similar materials which have the same indications for use. The following table further substantiates this claim:
| Property | Subject Device
K161077 | Primary
Predicate
K951220 | Reference
K961822 | Reference
K990779 | |
|---------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Device 510K
Name | RnD TE | RnD SE | HEMA GLU | Aqua Prep F | Hemaseal &
Cide
Desenstizer |
| Commercial
Name | RnD TE | RnD SE | HEMA GLU | Aqua Prep F | Hemaseal &
Cide
Desenstizer |
| 510K
Number | K161077 | K161077 | K951220 | K961822 | K990779 |
| Manufacturer | Apex Dental
Materials, Inc. | Apex Dental
Materials, Inc. | Health-Dent'l
LLC | Bisco, Inc | Advantage
Dental
Products |
| Classification | KLE | KLE | KLE | KLE | LBH |
| Indications
for Use:
Desensitizing | Yes | Yes | Yes | Yes | Yes |
| Indications
for Use:
Rewetting | Yes | Yes | Yes | Yes | Yes |
| Indications
for Use:
Improve
Bond
Strength | Yes | Yes | Yes | Yes | Yes |
| Bond
Strengths to
Dentin ()
Mean (sd),
[n] | 36.2 (5.7) [5] | 33.4 (4.7) [5] | 31.7 (2.0) [5] | 29.1 (3.1)
[5] | 36.9 (3.1) [5] |
| Bond
Strengths to
Enamel ()
Mean (sd),
[n] | 32.1 (2.9) [5] | 27.8 (3.9) [5] | 32.3 (2.8) [5] | 27.2 (3.5)
[5] | 37.1 (3.0) [5] |
| Film
Thickness | 4 microns | 4 microns | 5 microns | 4 microns | 5 microns |
| pH | Neutral | Neutral | Neutral | Neutral | Neutral |
| Components | Aqueous
primer containing
desensitizing
components,
specifically
Glutaraldehyde,
NaF and
HEMA | Aqueous
primer containing
desensitizing
components,
specifically
Glutaraldehyde,
NaF and
HEMA | Aqueous primer
containing
desensitizing
components,
specifically
Glutaraldehyde,
NaF and
HEMA | Aqueous
primer
containing
desensitizing
components,
specifically
HEMA and
NaF | Aqueous
primer
containing
desensitizing
components,
specifically
HEMA and
Chlorhexidine
Gluconate |
| Application:
Surface to be
applied to | Dentin | Dentin | Dentin | Dentin | Dentin |
| Application:
of coats
(Amount) | 1 coat | 1 coat | 1 coat | 1 coat | 1 coat |
| Application:
Dwell Time on
Tooth Surface | 5 seconds | 5 seconds | 15 – 30 seconds | 20 seconds | 10 – 15 seconds |
| Application:
Dried or Left
Moist | Left moist | Left moist | Left moist | Left moist | Left moist |
510K Submission for RnD K161077 Apex Dental Materials, 330 Telser Road Lake Zurich, IL 60047
CONFIDENTIAL
6
7
Shear bond testing was completed utilizing the Notched Edge Shear Bond Strength test (*) method.
10) Discussion of Substantial Equivalence:
The subject device has the same intended use and technical characteristics as the named predicate devices. The indications for use for the proposed device are similar to the indications for use for the predicate devices: HEMA-GLU (K951220) and Hemaseal & Cide (K990779). Aqua Prep F (K961822) does not specifically mention any impacts on bond degradation in its indications for use, but is consistent with the subject device in including rewetting and desensitizing. The final predicate device which does not contemplate bond degradation is still used in a consistent manner with similar uses. All of the components utilized within the RnD formulations are industry standard materials used in similar materials which have the same indications for use.
Differences are also noted between the subject and predicate devices. The subject device demonstrates higher bond strength to dentin than its primary predicate, and a slightly decreased film thickness. While the material composition of the subject device features all components observed in the primary predicate, the subject device also featured NaF as part of its formulation, unlike the primary predicate. Reference devices are included to address these differences noted between the subject and primary predicate devices.
The specifications that are important to determine substantial equivalency of a dental adhesive system are bond strengths associated to enamel and dentin (tooth structure). The bond strengths as noted in above table compare the primary predicate device HEMA GLU (K951220) to the subject device. In both enamel and dentin bonding, the results were equivalent.
11) Clinical and Non-clinical Performance Data:
No clinical testing was required to support the applicant device as the indications for use and components are equivalent to the predicate devices along with other legally marketed products.
8
These types of products have been utilized within the Dental Industry for more than 20 years with no reported adverse effects. The non-clinical testing of the proposed device included ISO 29022:2013 - Dentistry - notched edge shear bond strength test. The method includes substrate selection, storage and handling of tooth structure, as well as the procedure for testing. Nonclinical test data supports the stated equivalence of the subject and predicate devices.
12) Conclusion:
The subject device has the same intended use and technical characteristics as the named predicate devices. Device comparisons presented above illustrates this with a direct comparison of the devices in terms of intended use, components, and function. As such, the subject device may be considered substantially equivalent to the predicate devices.