(54 days)
Not Found
No
The device description and performance studies focus on a chemical reaction and physical occlusion mechanism, with no mention of AI/ML algorithms or data processing.
Yes
The device is intended to relieve dentinal sensitivity, which is a therapeutic purpose.
No
The device is intended to provide relief from dentinal sensitivity by blocking fluid flow in the tubules, not to diagnose a condition. Its function is therapeutic rather than diagnostic.
No
The device description clearly states it is a substance applied with an applicator, indicating it is a physical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device description clearly state that Super Seal® Tooth Desensitizer is applied to the tooth by the user to relieve dentinal sensitivity. It interacts with the calcium hydroxyapatite in the dentinal tubules within the tooth.
- The mechanism of action is a physical/chemical reaction within the tooth structure. It forms calcium oxalate crystals to block fluid flow in the tubules. This is a direct interaction with the tooth, not an analysis of a bodily specimen.
- The performance studies are focused on the effect on dentin permeability and tubule occlusion. While some studies are "in-vitro," they are examining the effect on dentin samples, not analyzing bodily fluids or tissues for diagnostic purposes.
Therefore, Super Seal® Tooth Desensitizer is a dental device intended for topical application to the tooth for therapeutic relief of sensitivity, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Intended Use: Single application to aid in the relief from tooth sensitivity.
Indications for Use: To aid in the relief from dentinal sensitivity caused by cold, heat, acids, sweets, or as the result from dental whitening agents.
Indications for Use of Super Seal® Tooth Desensitizer
- To aid in the relief from dentinal sensitivity .
- This could be caused by: ●
- o Cold
- o Heat ·
- o Acids
- Sweets o
- Result from dental whitening agents O
Product codes (comma separated list FDA assigned to the subject device)
LBH
Device Description
Super Seal ® Tooth Desensitizer is applied with an applicator by the user to aid in dentinal sensitivity. It contains an organic salt that reacts with the calcium hydroxyapatite in the dentinal tubules. The formation of these calcium oxalate crystals inhibits and blocks fluid flow in the tubules, thereby relieving dentinal sensitivity.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
The in-vitro Kolker et al. study evaluated the effect on permeability, hydraulic conductance and morphological tubule change. Kolker et al. showed a reduction in dentin permeability and a conical occlusion of the tubules for Super Seal®. A follow up study was performed by Suzaki et al. confirming tubule occlusion. Duran et al. study showed a decrease in permeability by tubule occlusion for HEMA based products.
Suzaki et al., in-vivo portion of their study evaluated 100 cases of human sensitivity and showed Super Seal® was effective to stop patient hypersensitivity. No adverse effects or safety issues pertaining to Super Seal® were found in any of the studies.
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
§ 872.3260 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.
0
KI20109
MAR - 7 2012
510(k) Summary
| Date: | 1/12/12 |
|---|---|
| Submission: | Traditional Premarket Notification 510(k) Submission (21CFR 807.90(e)) for a new OTC medical device. |
| Company: | Phoenix Dental, Inc. |
| Contact: | Jeffrey S. Cox, President/CEO |
| Address: | 3452 West Thompson Rd. |
| City, State, Zip: | Fenton, MI 48430 |
| Phone: | (810)750-2328 |
| Fax: | (810)750-7495 |
| Email: | jeffreycox@phoenixdental.com |
| Trade Name: | Super Seal® Tooth Desensitizer |
| Common Name: | Tooth Desensitizer |
| Panel: | Dental |
| Device Class: | Class II |
| Product Code: | LBH |
| Classification: | Varnish, Cavity |
| Substantially Equivalent: | Protect Tooth Desensitizer |
| LBH, Varnish, Cavity | |
| K050486 | |
| Orajel Advanced Tooth Desensitizer | |
| KLE, Agent, Tooth Bonding, Resin | |
| K041680 | |
| Device Description: | Super Seal ® Tooth Desensitizer is applied with an applicator by the user to aid in |
dentinal sensitivity. It contains an organic salt that reacts with the calcium hydroxyapatite in the dentinal tubules. The formation of these calcium oxalate crystals inhibits and blocks fluid flow in the tubules, thereby relieving dentinal sensitivity.
Intended Use: Single application to aid in the relief from tooth sensitivity.
Indications for Use: To aid in the relief from dentinal sensitivity caused by cold, heat, acids, sweets, or as the result from dental whitening agents.
1
Image /page/1/Picture/0 description: The image shows a handwritten string of characters. The characters appear to be "K120109". The characters are written in black ink on a white background. The handwriting is somewhat messy and the characters are not perfectly formed.
Technological Characteristics: Super Seal® Tooth Desensitizer as well as both predicates occlude the dentinal tubules blocking fluid flow of the dentinal complex. However, Super Seal® Tooth Desensitizer technology differs from the predicates because they place a layer that covers the tooth's surface occluding the tubules; while Super Seal® Tooth Desensitizer reacts with the calcium hydroxyapatite of the surface and peritubular dentin to form calcium oxalate crystals occluding the tubules.
Performance Data: The in-vitro Kolker et al. study evaluated the effect on permeability, hydraulic conductance and morphological tubule change. Kolker et al. showed a reduction in dentin permeability and a conical occlusion of the tubules for Super Seal®. A follow up study was performed by Suzaki et al. confirming tubule occlusion. Duran et al. study showed a decrease in permeability by tubule occlusion for HEMA based products.
Suzaki et al., in-vivo portion of their study evaluated 100 cases of human sensitivity and showed Super Seal® was effective to stop patient hypersensitivity. No adverse effects or safety issues pertaining to Super Seal® were found in any of the studies.
Conclusion:
From the nonclinical and clinical tests that were preformed we conclude that Super Seal® Tooth Desensitizer is substantially equivalent to the predicate devices.
2
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 a stylized symbol that resembles three overlapping human figures or abstract shapes.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Jeffrey S. Cox President / CEO Phoenix Dental, Inc. 3452 West Thompson Road Fenton, Michigan 48430
MAR - 7 2012
Re: K120109
Trade/Device Name: Super Seal® Tooth Desensitizer Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: II Product Code: LBH Dated: February 14, 2012 Received: February 15, 2012
Dear Mr. Cox:
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.
3
Page 2 - Mr. Cox
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to Compriset 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely vours,
h foc
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices. Office of Device Evaluation Center for Devices and Radiological Health
4
Indications for Use
510(k) Number: K120109
Device Name: Super Seal® Tooth Desensitizer
Indications for Use of Super Seal® Tooth Desensitizer
- To aid in the relief from dentinal sensitivity .
- This could be caused by: ●
- o Cold
- o Heat ·
- o Acids
- Sweets o
- Result from dental whitening agents O
Prescription Use __
AND/OR Over-The-Counter Use_
(21 CFR 801 Subpart C)
(Part 21 CFR 801 Subpart D) .
Wagi links
X
(Division Sign-Otf) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K120109
Revision Number: 3 Revision Date: 3/6/12