(187 days)
Not Found
No
The device description and performance studies focus on the chemical and physical properties of the gel and its effect on dentinal tubules, with no mention of AI or ML.
Yes
The device is described as an oxalate tooth desensitizing agent intended to relieve dental hypersensitivity and is shown to be effective in reducing sensitivity.
No
Explanation: The device is described as an "oxalate tooth desensitizing agent" intended "To relieve dental hypersensitivity." Its function is to reduce sensitivity, which is a treatment or therapeutic action, not a diagnostic one. While it "reduces dental hypersensitivity to cold, hot and sweets," this is the effect of the treatment, not a diagnostic output.
No
The device description clearly states it is a "one-part, opaque gel," 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 relieve dental hypersensitivity." This is a therapeutic or palliative purpose, not a diagnostic one.
- Device Description: The description details a topical gel that works by occluding dentinal tubules and reducing nerve excitability. This mechanism of action is directly applied to the patient's teeth, not used to test a sample taken from the patient.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (like blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
To relieve dental hypersensitivity.
Product codes (comma separated list FDA assigned to the subject device)
LBH
Device Description
Senzzzzz Away is an oxalate tooth desensitizing agent intended for over-the-counter-use. The combination of tubule occlusion and reduction in nerve excitability shown with oxalate formulations is responsible for the reduction in dentinal hypersensitivity to cold, hot and sweets. Senzzzzz Away is a one-part, opaque gel for single use.
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
Over-The-Counter Use X Prescription Use X
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)
Side-by-side biocompatibility testing was performed on the subject and predicate devices. Scanning electron microscopy images of extracted teeth before and after device application demonstrated that the device seals and occludes dentinal tubules.
A consumer ease-of-use study conducted for Senzzzzz Away to ensure that patient use of the product was appropriate for over-the-counter purchase. A six month effectiveness study was performed to demonstrate the reduction in sensitivity. The combination of these studies shows Senzzzzz Away is safe and effective for over-the-counter use.
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.
K021146, K983477, K120109, K050486, K040858, K082594, K033521, K061438
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
510(k) Summary
Senzzzzzz Away
510(k) Summary
Centrix, Inc.
JUL 2 5 2012
Senzzzzzz Away
July 12, 2012
ADMINISTRATIVE INFORMATION
Manufacturer Name:
Centrix, Inc. 770 River Road Shelton, CT 06484 Telephone: +1 (203) 929-5582 Fax: +1 (203) 929-6804
Official Contact:
Greg Moreau RA/QA Director
Representative/Consultant:
Linda K. Schulz Allison C. Komiyama Floyd G. Larson PaxMed International, LLC l 1234 Ei Camino Real, Suite 200 San Diego, CA 92130 Telephone: +1 (858) 792-1235 Fax: +1 (858) 792-1236 Email: lschulz@paxmed.com akomiyama@paxmed.com flarson@paxmed.com
DEVICE NAME AND CLASSIFICATION
Trade/Proprietary Name: | Senzzzzz Away |
---|---|
Classification Name: | Cavity Varnish |
Classification Regulations: | 21 CFR 872.3260, Class I |
Product Code: | LBH |
Classification Panel: | Dental Products Panel |
Reviewing Branch: | Dental Devices Branch |
1
INTENDED USE
Senzzzzz A way™ is to be used to relieve dental hypersensitivity. or D/Sense® Crystal™ is to be used to relieve dental hypersensitivity.
DEVICE DESCRIPTION
Senzzzzz Away is an oxalate tooth desensitizing agent intended for over-the-counter-use. The combination of tubule occlusion and reduction in nerve excitability shown with oxalate formulations is responsible for the reduction in dentinal hypersensitivity to cold, hot and sweets. Senzzzzz Away is a one-part, opaque gel for single use.
EQUIVALENCE TO MARKETED DEVICE
Centrix, Inc., D/Sense® 1-Step cleared under K021146,
Phoenix Dental, Inc., Super Seal® Tooth Desensitizer cleared under K983477 and K 120109
Sunstar Butler, Protect™ Tooth Desensitizer cleared under K050486
NovaMin Technology, Inc., Oralief™ Therapy for Sensitive Teeth cleared under K040858
Remedent NV, Remesense cleared under K082594
Bisco, Inc., BisBlock cleared under K033521
Ultradent Products, Inc., UltraEZ Desensitizing Gel cleared under K061438
Device Name | Classification Name | Mode of Action | Application | Material |
---|---|---|---|---|
Senzzzzz Away | ||||
(or D/Sense Crystal) | ||||
D/Sense® 1-Step | Cavity varnish, Calcium | |||
hydroxide cavity liner | Tubule | |||
Occlusion | Paint-on gel | Oxalate | ||
Super Seal® Tooth | ||||
Desensitizer | Cavity varnish | Tubule | ||
Occlusion | Applicator | Oxalate | ||
Protect™ Tooth | ||||
Desensitizer | Cavity varnish | Tubule | ||
Occlusion | Paint on liquid | Oxalate | ||
Oralief™ Therapy | ||||
for Sensitive Teeth | Cavity varnish | Tubule | ||
Occlusion | Brush on paste | Calcium sodium | ||
phosphosilicate | ||||
Remesense | Cavity varnish | Tubule | ||
Occlusion | Tray and | |||
foam strips | Oxalate | |||
BisBlock | Calcium | |||
hydroxide cavity liner | Tubule | |||
Occlusion | Etch+apply | |||
liquid+seal | Oxalate | |||
UltraEZ | ||||
Desensitizing Gel | Cavity varnish | Tubule | ||
Occlusion | Tray and gel | Potassium nitrate | ||
Fluoride ion gel |
Comparison of Technological Characteristics
Senzzzzz Away tooth desensitizer is the over-the-counter version of D/Sense® Crystal™ (previously D/Sense 1-Step). Senzzzzz Away is packaged in a single use tray with applicator for consumer use. All of the predicates use tubule occlusion as a mechanism for controlling dental hypersensitivity. Oxalate formulations also have an effect on nerve excitability to reduce pain sensitivity.
2
510(k) Summary
Side-by-side biocompatibility testing was performed on the subject and predicate devices. Scanning electron microscopy images of extracted teeth before and after device application demonstrated that the device seals and occludes dentinal tubules.
A consumer ease-of-use study conducted for Senzzzzz Away to ensure that patient use of the product was appropriate for over-the-counter purchase. A six month effectiveness study was performed to demonstrate the reduction in sensitivity. The combination of these studies shows Senzzzzz Away is safe and effective for over-the-counter use.
Overall, Senzzzzz Away has the following similarities to the predicate devices:
- . has the same intended use,
- . uses a similar operating principle,
- . incorporates the same basic design, .
- incorporates the same or similar materials, and ●
- . has similar packaging.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle in flight, rendered in blue. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The logo is simple and recognizable, representing the department's role in protecting the health of all Americans.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
AUG -3 2012
Centrix. Incorporated C/O Ms. Linda K. Schulz PaxMed International. LLC 11234 Camino Real, Suite 200 San Diego, California 92130
Re: K120176
Trade/Device Name: Senzzzzz Away™ (OTC), D/Sense® Crystal™ (Rx) Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: II Product Code: LBH Dated: June 29, 2012 Received: July 2, 2012
Dear Ms. Schulz:
This letter corrects our substantially equivalent letter of July 25, 2012.
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 (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 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.
4
Page 2- Ms. Schulz
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 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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
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
Enclosure
5
Indications for Use
K120176 510(k) Number:
Senzzzzz Away™ (OTC), D/Sense® Crystal™ (Rx) Device Name:
Indications for Use:
To relieve dental hypersensitivity.
Over-The-Counter Use X Prescription Use X AND/OR (Part 21 CFR 801 Subpart D) (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)
Page 1 of 1
Suna Runa
(Division Sign-Off) wision of Anesthesiology, General Hospital nfection Control, Dental Devices
510(k) Number: K120176