(72 days)
Desensitizing agent for dentin surfaces by occluding dentin tubules to help prevent microleakage. Use under direct or indirect restorations following dentin etch and province dentin adhesive application. Desensitizing agent for use in treatment of cervical erosion in Class V restorations.
AdPharma™ Occlude® Dentin Tubule Agents are for use in one of a number of steps normally involved in the restoration of teeth. This device comes into use following the dentin-etching step and prior to the application of a dentin adhesive or adhesive/primer. The Occlude® is applied to the exposed dentin and the solvent evaporated off, leaving the active glass. It is also anticipated to market Occlude® Dentin Tubule Agents combined with a commercially available, non-aqueous dentin adhesive to condense these two application steps into one step. In vitro testing indicated this combination version is still efficacious. The Occlude® is manufactured in such a way that it is intended to enter the exposed dentin tubules and penetrate to a greater depth than the adhesive itself or adhesive/primer itself.
The provided text describes a 510(k) summary for the AdPharma™ Occlude® Dentin Tubule Agent. This is a dental device, and the evaluation for such devices typically involves bench testing for physical properties rather than clinical studies with human participants assessing diagnostic accuracy or comparative effectiveness with AI. Therefore, many of the requested points related to AI, human readers, and ground truth established by experts are not applicable here.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Micro-leakage reduction | Should reduce micro-leakage | "demonstrates Occlude® Dentin Tubule Agents work for their intended use of reducing micro-leakage" |
| Bond strength | Should not adversely affect bond strength | "demonstrate that Occlude® Dentin Tubule Agents do not exhibit adverse affects on bond strengths" |
| Biocompatibility | Safe for use in body | "biocompatibility assessment was completed for the Occlude® Dentin Tubule Agents indicating them to be safe for use in body" |
Note: The document does not provide specific quantitative acceptance criteria or numerical results for these performance metrics. The descriptions are qualitative confirmations of meeting the intended function.
2. Sample size used for the test set and the data provenance
The document mentions "Bench testing" which typically involves laboratory-based experiments on materials or simulated conditions. It does not specify the sample size for these tests. The data provenance is "in vitro testing" performed for the purpose of this 510(k) submission. No country of origin for the data is mentioned beyond AdPharma being a USA corporate office. These tests would be retrospective in the sense that they were completed before the filing, but prospective in terms of being designed for the submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The "ground truth" for this type of device is established through an objective measurement of physical properties (e.g., micro-leakage, bond strength) rather than expert interpretation of images or clinical outcomes.
4. Adjudication method for the test set
Not applicable, as the evaluation is based on objective bench testing, not expert adjudication of subjective assessments.
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-powered diagnostic device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used
The ground truth was based on objective measurements from bench testing for properties like micro-leakage and bond strength, and a biocompatibility assessment.
8. The sample size for the training set
Not applicable. This is not an AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
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K08207)
Image /page/0/Picture/1 description: The image shows the logo for AdPharma. The logo consists of a globe being held by two hands, with the text "AdPharma" to the right of the globe. Below the globe and text is the phrase "Advanced Solutions to Pharma Safety & Success".
OCT 02 2008
USA CORPORATE OFFICE
415 West Golf Road # 57 Arlington Heights, IL 60005, USA Telephone : 847 806 6789 Fax : 847 806 6791 E.mail : info@ad-pharma.com Web site : www.ad-pharma.com
5. 510(k) Summary
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
| 510(k) Submitter | AdPharma, Inc.415 West Golf Road #57Arlington Heights, IL 60005 |
|---|---|
| Contact Person | Dr. Vivek Ramana, MDExecutive Vice-President of Clinical Affairsand Chief Operating OfficerPhone: (847) 806-6789Cell phone: (203) 314-1417Fax: (847) 806-6791email: vramana@ad-pharma.com |
| Date Summary was Prepared | 6/16/08 |
| Trade Name: | AdPharma™ Occlude® Dentin Tubule AgentAdPharma™ Occlude® F Dentin Tubule Agent |
| Common Name(s): | Dentin Desensitizer; Dentin Sealer;Cavity Varnish; Dentin Tubule Protection |
| Recommended Classification: | Cavity Varnish (21CFR 872.3260, ProductCode LBH, Class II Dental Device) |
| Predicate Device: | Centrix D/SENSE II Dentin Desensitizer510(k) # K992629 |
Description of the Device:
AdPharma™ Occlude® Dentin Tubule Agents are for use in one of a number of steps normally involved in the restoration of teeth. This device comes into use following the dentin-etching step and prior to the application of a dentin adhesive or adhesive/primer. The Occlude® is applied to the exposed dentin and the solvent evaporated off, leaving the active glass. It is also
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anticipated to market Occlude® Dentin Tubule Agents combined with a commercially available, non-aqueous dentin adhesive to condense these two application steps into one step. In vitro testing indicated this combination version is still efficacious. The Occlude® is manufactured in such a way that it is intended to enter the exposed dentin tubules and penetrate to a greater depth than the adhesive itself or adhesive/primer itself.
Indications for use:
Desensitizing agents for dentin surfaces by occluding dentin tubules to help prevent microleakage. Use Occlude® under direct or indirect restorations following dentin etch and prior to dentin adhesive application. Use Occlude® as a desensitizing agent for use in treatment of cervical erosion in Class V restorations.
Substantial Equivalence:
The information included in this 510(k) Pre-market Notification shows that the AdPharma™ Occlude® Dentin Tubule Agents are substantially equivalent to the predicate device in terms of indications for use and safety characteristics. A biocompatibility assessment was completed for the Occlude® Dentin Tubule Agents indicating them to be safe for use in body.
Bench testing includes micro-leakage and bond strength determinations. This micro-leakage testing demonstrates Occlude® Dentin Tubule Agents work for their intended use of reducing micro-leakage, thus reducing sensitivity. The bond strength determinations demonstrate that Occlude® Dentin Tubule Agents do not exhibit adverse affects on bond strengths.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 02 2008
Dr. Vivek Ramana Executive Vice-President of Clinical Affairs AdPharma, Incorporated 415 West Golf Road #57 Arlington Heights, Illinois 60005
Re: K082071
Trade/Device Name: AdPharma™ Occlude® Dentin Tubule Agent AdPharma™ Occlude®F Dentin Tubule Agent Regulation Number: 21 CFR 872.3260
Regulation Name: Cavity Varnish Regulatory Class: II Product Code: LBH Dated: July 11, 2008 Received: July 22, 2008
Dear Dr. Ramana:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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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Page 2 - Dr. Ramana
Please be advised that FDA's issuance of a substantial equivalence determination does not mcan 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); good manufacturing practice requirements as sct 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Vikramule pendus for
Chiu S. Lin. Ph. D Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4. Indications for Use Statement
Indications for Use 510(k) Number (if known):
Device Name: AdPharma™ Occlude® Dentin Tubule Agent /
AdPharma™ Occlude® F Dentin Tubule Agent
Indications for Use:
Desensitizing agent for dentin surfaces by occluding dentin tubules to help prevent microleakage. Use under direct or indirect restorations following dentin etch and province dentin adhesive application. Desensitizing agent for use in treatment of cervical erosion in Class V restorations.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-the-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Turner
(Division Sign-off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K052071
§ 872.3260 Cavity varnish.
(a)
Identification. Cavity varnish is a device that consists of a compound intended to coat a prepared cavity of a tooth before insertion of restorative materials. The device is intended to prevent penetration of restorative materials, such as amalgam, into the dentinal tissue.(b)
Classification. Class II (special controls). The device, when it is an external cleaning solution, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.