(97 days)
Not Found
No
The device is a chemical etchant gel and the description and performance studies focus on its chemical and physical properties, with no mention of AI/ML.
No
The device is described as a dental etchant gel used to prepare surfaces for bonding restorations, which is a preparatory step in a dental procedure, not a therapeutic treatment itself.
No
The device is described as an etchant gel used to prepare surfaces for bonding restorations, not to diagnose a condition or disease.
No
The device description clearly states it is a "Thixotropic dental etchant gel with 37% phosphoric acid," indicating it is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to etch enamel, dentin, and glass ionomer cements in the mouth to prepare the surface for bonding dental restorations. This is a procedure performed directly on the patient's tissues.
- Device Description: The device is a gel applied directly to the anatomical site.
- Lack of In Vitro Testing: While there is bench testing mentioned, it focuses on the physical and chemical properties of the gel itself (percent phosphoric acid, pH, viscosity, etc.) and its equivalence to a predicate device. There is no indication that this device is used to test samples outside of the body to diagnose a condition or provide information about a patient's health state.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications 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.
Product codes (comma separated list FDA assigned to the subject device)
KLE
Device Description
Thixotropic dental etchant gel with 37% phosphoric acid
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
enamel, dentin, and glass ionomer cements
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing: Both Jade 37% Phosphoric Acid Etchant Gel and the predicate device were tested for the following characteristics: Percent phosphoric acid pH Viscosity Consistency, Color and Odor Each test demonstrates the equivalence of Jade to the predicate device.
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.
Not Found
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 circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are black against a white background.
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.
1
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
2
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 SERVICES
Food and Drug Administration | Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below. |
| ------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------- |
|---|
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect
collection of informa estimate or any other લપુર્વો ાસ of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/14)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
3
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 15 | ||||
| Miami, 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, President | |||
| Telephone (305) 482-9669 | ||||
| Facsimile (305) 482-9670 | ||||
| E-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 etching | |||
| enamel, dentin, and glass ionomer cements to produce the necessary | ||||
| micro-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, which | |||
| is the same as the predicate device. | Applicator | Standard 23 ga bent | ||
| Optional 25 ga bent | Not available | |||
| Bench testing | Both Jade 37% Phosphoric Acid Etchant Gel and | |||
| the predicate device were tested for the following | ||||
| characteristics: | ||||
| Percent phosphoric acid pH Viscosity Consistency, Color and Odor Each test demonstrates the equivalence of Jade to | ||||
| the 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.
4
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 acid |
| dental etchant gel for etching enamel, | |||
| dentin, and glass ionomer cements to | |||
| produce the necessary micro-retentive | |||
| surface for successful bonding of | |||
| restorations. | |||
| 3. | Do the devices have the same technological | ||
| characteristics? | Yes | The formula for Jade and the predicate | |
| are substantially equivalent, using | |||
| thickeners and emulsifiers to provide a | |||
| thick gel vehicle through which to | |||
| deliver the phosphoric acid. The | |||
| coloring agents are also substantially | |||
| equivalent. |
5
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.