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.

AI/ML Overview

This document describes a 510(k) submission for new dental materials, RnD TE and RnD SE, which are resin tooth bonding agents. The submission aims to demonstrate substantial equivalence to previously marketed predicate devices.

Although the document is a 510(k) summary and not a detailed study report, we can extract information regarding acceptance criteria and performance data for these dental materials.

Here's an attempt to answer your questions based on the provided text, recognizing that this is a summary and likely doesn't contain all the granular detail of a full study report:

Table of acceptance criteria and the reported device performance

The document does not explicitly state pre-defined "acceptance criteria" as pass/fail thresholds for specific performance metrics. Instead, it compares the performance of the subject devices (RnD TE and RnD SE) against predicate devices to demonstrate "substantial equivalence." The implication is that if the subject devices perform comparably to or better than the predicate devices, they meet the criteria for substantial equivalence.

Acceptance Criteria (Implied: Comparable to Predicate)	Reported Device Performance (Mean (sd) [n])	Predicate Device Performance (Mean (sd) [n])
Indications for Use:
Desensitizing	Yes	Yes
Rewetting	Yes	Yes
Preventing/Improve Bond Degradation/Strength	Yes	Yes (Aqua Prep F does not explicitly mention bond degradation)
Bond Strengths to Dentin (MPa)	RnD TE: 36.2 (5.7) [5]	HEMA GLU: 31.7 (2.0) [5]
	RnD SE: 33.4 (4.7) [5]	Aqua Prep F: 29.1 (3.1) [5]
		Hemaseal & Cide: 36.9 (3.1) [5]
Bond Strengths to Enamel (MPa)	RnD TE: 32.1 (2.9) [5]	HEMA GLU: 32.3 (2.8) [5]
	RnD SE: 27.8 (3.9) [5]	Aqua Prep F: 27.2 (3.5) [5]
		Hemaseal & Cide: 37.1 (3.0) [5]
Film Thickness (microns)	4	HEMA GLU: 5
		Aqua Prep F: 4
		Hemaseal & Cide: 5
pH	Neutral	Neutral
Components	Aqueous primer with Glutaraldehyde, NaF, HEMA	Various combinations of these components and Chlorhexidine Gluconate

Sample size used for the test set and the data provenance
- Sample Size (Test Set): For bond strength tests to dentin and enamel, the sample size was n=5 for each subject device (RnD TE and RnD SE) and each predicate device.
- Data Provenance: The document does not explicitly state the country of origin or whether the study was retrospective or prospective. It is a non-clinical in vitro test, so "retrospective" or "prospective" as typically applied to human studies is not directly applicable.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This non-clinical study involves material property testing (bond strength, film thickness, pH). Ground truth is established by the measurement methodology (ISO 29022:2013 - Dentistry - notched edge shear bond strength test), not by expert consensus on interpretations of images or clinical outcomes. Therefore, the concept of "experts establishing ground truth" in the way it's used for AI or diagnostic studies does not apply here. The measurements are objective physical properties.
Adjudication method (e.g. 2+1, 3+1, none) for the test set

There was no adjudication method as this was a non-clinical, in vitro measurement of physical properties.
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

No MRMC study was performed. This is a non-clinical laboratory test of dental materials, not a diagnostic device involving human readers or AI.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a material science study, not an AI or algorithm-based device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth for the performance metrics (bond strength, film thickness, pH) was established through standardized, objective in vitro laboratory measurements based on the ISO 29022:2013 standard.
The sample size for the training set

Not applicable. There is no machine learning or AI component to this device or its evaluation that would require a "training set."
How the ground truth for the training set was established

Not applicable, as there is no training set.

Summary

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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

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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

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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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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:

PredicateDevice	510K Number	Company Name	CommercialName
HEMA-GLU	K951220	Health-Dent'l, LLC	HEMA-GLU
Wet Prep	K961822	Bisco, Inc	Aqua Prep FRewetting and Desensitizer
Hemaseal & Cide	K990779	Advantage DentalProducts	Hemaseal &CideDesensitizer

510K Submission for RnD K161077 Apex Dental Materials, 330 Telser Road Lake Zurich, IL 60047

CONFIDENTIAL

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6) Description of Subiect Device:

7) Indications for Use:

1. Rewetting tooth surface prior to bonding
1. Desensitizing
1. 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 DeviceK161077RnD TE and RnD SE	Primary PredicateK951220HEMA GLU	ReferenceK961822Aqua Prep	ReferenceK990779Hemaseal & CideDesenstizer
Indications forUseStatement	1) Rewetting toothsurface prior tobonding2) Desensitizing3) Preventing bonddegradation	1) superior desensitizingagent, to be placedunder dental cements orother restorativematerials - temporary,provisional or final.2) can be used fordesensitization ofamalgam restorations,either conventional orbonded.3) helps kill bacteria,4) alter nerveresponses5) aids bondingprimers in penetratingetched dentin.	1) Rewetting dentinand enamel followingetching and drying ofthe dental cavitypreparation2) Rewetting driedhydrophilic dentaltissues followingdental procedures3) Rewetting etchedand dried enamel priorto Pit & FissureSealant treatment4) Desensitizing	1) Elimination of post-op sensitivity -precluding the need todo remakes2) Superiordisinfection ofpreparations3) Enhancement andprolongation of bondstrength4) Reduction ofmicroleakage

510K Submission for RnD K161077 Apex Dental Materials, 330 Telser Road Lake Zurich, IL 60047

CONFIDENTIAL

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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 DeviceK161077	PrimaryPredicateK951220	ReferenceK961822	ReferenceK990779
Device 510KName	RnD TE	RnD SE	HEMA GLU	Aqua Prep F	Hemaseal &CideDesenstizer
CommercialName	RnD TE	RnD SE	HEMA GLU	Aqua Prep F	Hemaseal &CideDesenstizer
510KNumber	K161077	K161077	K951220	K961822	K990779
Manufacturer	Apex DentalMaterials, Inc.	Apex DentalMaterials, Inc.	Health-Dent'lLLC	Bisco, Inc	AdvantageDentalProducts
Classification	KLE	KLE	KLE	KLE	LBH
Indicationsfor Use:Desensitizing	Yes	Yes	Yes	Yes	Yes
Indicationsfor Use:Rewetting	Yes	Yes	Yes	Yes	Yes
Indicationsfor Use:ImproveBondStrength	Yes	Yes	Yes	Yes	Yes
BondStrengths toDentin (*)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]
BondStrengths toEnamel (*)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]
FilmThickness	4 microns	4 microns	5 microns	4 microns	5 microns
pH	Neutral	Neutral	Neutral	Neutral	Neutral
Components	Aqueousprimer containingdesensitizingcomponents,specificallyGlutaraldehyde,NaF andHEMA	Aqueousprimer containingdesensitizingcomponents,specificallyGlutaraldehyde,NaF andHEMA	Aqueous primercontainingdesensitizingcomponents,specificallyGlutaraldehyde,NaF andHEMA	Aqueousprimercontainingdesensitizingcomponents,specificallyHEMA andNaF	Aqueousprimercontainingdesensitizingcomponents,specificallyHEMA andChlorhexidineGluconate
Application:Surface to beapplied to	Dentin	Dentin	Dentin	Dentin	Dentin
Application:# of coats(Amount)	1 coat	1 coat	1 coat	1 coat	1 coat
Application:Dwell Time onTooth Surface	5 seconds	5 seconds	15 – 30 seconds	20 seconds	10 – 15 seconds
Application:Dried or LeftMoist	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

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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.

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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.

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.