A thixotropic 37% phosphoric acid dental etchant gel for etching enamel, dentin, and glass ionomer cements to produce the necessary micro-retentive surface for successful bonding of restorations.

Device Description

Thixotropic dental etchant gel with 37% phosphoric acid

AI/ML Overview

The provided text is a 510(k) summary for a dental etchant gel, not a study involving AI or complex medical device performance metrics like sensitivity, specificity, or reader studies. Therefore, many of the requested categories related to AI systems, clinical trials, and expert adjudication are not applicable.

However, I can extract the relevant information regarding the acceptance criteria (comparative performance to a predicate device) and the study that "proves" the device meets these criteria, based on the provided text.

Device Name: Jade 37% Phosphoric Acid Etchant Gel

1. A table of acceptance criteria and the reported device performance

The acceptance criteria for the Jade 37% Phosphoric Acid Etchant Gel are based on demonstrating substantial equivalence to its predicate device, Seity 37% Phosphoric Acid Etchant Gel (K112597). This equivalence is primarily established through comparisons of technological characteristics and bench testing results.

Acceptance Criteria (Comparison to Predicate Device)	Predicate Device Performance (Seity 37% Phosphoric Acid Etchant Gel)	Reported Device Performance (Jade 37% Phosphoric Acid Etchant Gel)	Outcome
Phosphoric Acid Concentration	37%	37%	Equivalent
Consistency	Thick gel	Thick gel	Equivalent
Color	Blue or Green	Blue or Green	Equivalent
Odor	No characteristic	No characteristic	Equivalent
Viscosity (cps)	40,000 cps	60,000 cps	Comparable*
pH	1.20	1.52	Comparable*
Shelf-Life	Appears to be 2-years (based on label example in MISC files)	Proposed 2-years (based on existing shelf-life studies)	Comparable
Intended Use	A thixotropic 37% phosphoric acid dental etchant gel for etching enamel, dentin, and glass ionomer cements to produce the necessary micro-retentive surface for successful bonding of restorations.	A thixotropic 37% phosphoric acid dental etchant gel for etching enamel, dentin, and glass ionomer cements to produce the necessary micro-retentive surface for successful bonding of restorations.	Equivalent
Technological Characteristics	Thixotropic gel with 37% phosphoric acid, thickeners, and emulsifiers.	Thixotropic gel with 37% phosphoric acid, thickeners, and emulsifiers. Coloring agents are also similar.	Substantially Equivalent

Note: While viscosity and pH values are not identical, the submission asserts that bench testing demonstrates the equivalence of Jade to the predicate device, implying these differences are not clinically significant for the intended use and do not raise new issues of safety or efficacy. The conclusion specifically states that "Even though the chemical compositions are not identical, bench testing has demonstrated that Jade has comparable material properties and performance."

2. Sample size used for the test set and the data provenance

The document describes "bench testing" without specifying a particular sample size for each characteristic tested. The data provenance is derived from these bench tests, which are laboratory-based and not tied to patient data or specific countries of origin in this context. It's prospective in the sense that Dharma Research likely conducted these tests specifically for this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is not a study involving expert consensus for ground truth but rather laboratory measurements comparing physical and chemical properties.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There was no expert adjudication in the context of clinical outcomes or imaging reviews.

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

Not applicable. This is not an AI-assisted device or a diagnostic imaging device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" here is the established properties and performance of the legally marketed predicate device (Seity 37% Phosphoric Acid Etchant Gel, K112597) and the measured chemical/physical properties of both the predicate and the new device through laboratory bench testing.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/machine learning device.

Summary

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

June 23, 2015

Dharma Research Inc. Mr. Ricardo Carles President 5220 NW 72nd Avenue #15 Miami, FL 33166

Re: K150696

Trade/Device Name: Jade 37% Phosphoric Acid Etchant Gel Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: February 3, 2015 Received: March 25, 2015

Dear Mr. Carles:

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.

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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 (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.

Tina
Kiang -S

for 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

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Image /page/2/Picture/0 description: The image shows the logo for Dharma Research. The logo consists of a circular graphic on the left and the text "DHARMA RESEARCH" on the right. The circular graphic is made up of three overlapping shapes in shades of orange. The text "DHARMA" is in a large, sans-serif font, and the text "RESEARCH" is in a smaller font below the word "DHARMA".

Section 5 – Form FDA-3881 Indications for Use

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration	Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement below.
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Indications for Use

510(k) Number (if known)	K150696
Device Name	Jade 37% Phosphoric Acid Etchant Gel
Indications for Use (Describe)	A thixotropic 37% phosphoric acid dental etchant gel for etching enamel, dentin, and glass ionomer cements to produce the necessary micro-retentive surface for successful bonding of restorations.
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)

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FORM FDA 3881 (8/14)

Page 1 of 1

PSC Publishing Services (301) 443-6740 EF

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Image /page/3/Picture/0 description: The image shows the logo for Dharma Research. The logo consists of an orange circular icon on the left and the words "DHARMA RESEARCH" on the right. The word "DHARMA" is in a larger, bolder font than the word "RESEARCH", which is located underneath the word "DHARMA".

510(k) Summary

Date Prepared: 03 February 2015

K 150696

Device Common Name	Agent, tooth bonding, resin	Product Name	Jade 37% Phosphoric Acid Etchant Gel	Seity 37% Phosphoric Acid Etching Gel
Trade Name	Jade 37% Phosphoric Acid Etchant Gel	Sponsor	Dharma Research, Inc.	Mycone Dental
Classification Name	Tgukp tooth bonding agent	510(k)	K150696	K112597
510(k) Submitter	Dharma Research, Inc.5220 NW 72nd Avenue, Unit 15Miami, Florida 33166	Indication for Use	A thixotropic 37% phosphoric acid dental etchant gel for etching enamel, dentin, and glass ionomer cements to produce the necessary micro-retentive surface for successful bonding of restorations.	A thixotropic 37% phosphoric acid dental etchant gel for etching enamel, dentin, and glass ionomer cements to produce the necessary micro-retentive surface for successful bonding of restorations.
Contact	Ricardo Carles, PresidentTelephone (305) 482-9669Facsimile (305) 482-9670E-mail: rcarles@dharmaresearch.com	Phosphoric Acid	37%	37%
Classification Regulation	21 CFR §872.3200	Consistency	Thick gel	Thick gel
Device Class	II	Color	Blue or Green	Blue or Green
Classification Panel	Dental	Odor	No characteristic	No characteristic
Product Code	KLE	Viscosity	60,000 cps	40,000 cps
Predicate Device	K112597, Seity 37% Phosphoric Acid Etchant Gel	pH	1.52	1.20
Device Description	Thixotropic dental etchant gel with 37% phosphoric acid	Shelf-Life	Proposed 2-years, based on existing shelf-life studies (refer to Section 15)	Appears to be 2-years based on expiry date printed on label example in MISC files.
Indications for Use	A thixotropic 37% phosphoric acid dental etchant gel for etchingenamel, dentin, and glass ionomer cements to produce the necessarymicro-retentive surface for successful bonding of restorations.	How Supplied	Pre-filled syringes with applicators, 1.2 ml, 12 g (10 ml), and 50 ml	Pre-filled syringe, 12 g
Technological characteristics	Thixotropic gel with 37% phosphoric acid, whichis the same as the predicate device.	Applicator	Standard 23 ga bentOptional 25 ga bent	Not available
Bench testing	Both Jade 37% Phosphoric Acid Etchant Gel andthe predicate device were tested for the followingcharacteristics:Percent phosphoric acid pH Viscosity Consistency, Color and Odor Each test demonstrates the equivalence of Jade tothe predicate device.

The information in this submission demonstrates that Jade 37% Phosphoric Acid Etchant Gel device is as safe, as effective, and performs as well the predicate device.

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Image /page/4/Picture/0 description: The image contains the logo for Dharma Research. The logo consists of a circular graphic on the left and the text "DHARMA RESEARCH" on the right. The circular graphic is a gradient of orange and red, with three curved shapes that appear to be overlapping. The text "DHARMA" is in a larger, bolder font than the text "RESEARCH", which is located below it.

Substantial Equivalence

510(k) "Substantial Equivalence" Decision Making Process

Dec. No.	Question	Answer	Comment
1.	Is the predicate device legally marketed?	Yes	K112597
2.	Do the devices have the same intended use?	Yes	A thixotropic 37% phosphoric aciddental etchant gel for etching enamel,dentin, and glass ionomer cements toproduce the necessary micro-retentivesurface for successful bonding ofrestorations.
3.	Do the devices have the same technologicalcharacteristics?	Yes	The formula for Jade and the predicateare substantially equivalent, usingthickeners and emulsifiers to provide athick gel vehicle through which todeliver the phosphoric acid. Thecoloring agents are also substantiallyequivalent.

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Image /page/5/Picture/0 description: The image shows the logo for Dharma Research. The logo consists of an orange circular icon on the left and the text "DHARMA RESEARCH" on the right. The word "DHARMA" is in a larger, bolder font than the word "RESEARCH", which is positioned below it.

Conclusion

These key similarities and the results of the bench testing comparison demonstrate that Jade is substantially equivalent to the predicate product and raises no new issues of safety or efficacy. The formula for Jade and the predicate are very similar. Dharma Research was the contract manufacturer of the predicate product at the time that K 1 12597 was cleared and for many years thereafter. Even though the chemical compositions are not identical, bench testing has demonstrated that Jade has comparable material properties and performance.

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.