(279 days)
No
The device description and performance studies focus on the chemical and physical properties of the liquid/gel components and their application, with no mention of AI or ML.
Yes
The device is intended for the "Treatment of dentinal hypersensitivity" and operates by "reducing tooth sensitivity by physically occluding the open dentinal tubules," which are direct therapeutic actions to alleviate a medical condition.
No
The device is described as a treatment for dentinal hypersensitivity by physically occluding open dentinal tubules, not for diagnosing conditions.
No
The device description clearly states it is a two-component liquid device applied to teeth, which are physical substances, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Treatment of dentinal hypersensitivity." This is a therapeutic treatment applied directly to the patient's teeth to alleviate a symptom.
- Device Description: The device is a liquid/gel applied to the teeth to physically occlude dentinal tubules. This is a direct treatment mechanism.
- IVD Definition: An In Vitro Diagnostic device is used to examine specimens derived from the human body (like blood, urine, tissue) outside the body to provide information for diagnosis, monitoring, or screening.
This device is applied in vivo (within the living body) and its purpose is to treat a condition, not to analyze a sample for diagnostic purposes.
N/A
Intended Use / Indications for Use
Treatment of dentinal hypersensitivity. For use in adults over the age of 21.
Product codes
PHR
Device Description
Riva Star is a two-component device made up of Riva Star Step 1, containing silver diamine fluoride liquid, and Riva Star Step 2, containing aqueous potassium iodide liquid. Riva Star Step 1 silver diamine fluoride solution is applied to the tooth, immediately followed by Riva Star Step 2 aqueous potassium iodide, which forms an immediate reaction precipitate of silver iodide, thereby reducing tooth sensitivity by physically occluding the open dentinal tubules.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tooth / dentine
Indicated Patient Age Range
adults over the age of 21
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)
Non-clinical performance testing:
A Hydraulic Conductance study of Riva Star and Super Seal tooth desensitisers was conducted. The data demonstrated that Riva Star is an effective agent to reduce fluid flow through dentine, and is substantially equivalent to Super Seal in treating dentinal hypersensitivity. Scanning electron microscope (SEM) images showed both Riva Star and Super Seal formed a precipitate to occlude the open dentinal tubules.
A comparative 7-day in vitro fluoride and silver ion release study was conducted on Riva Star and the primary predicate device Advantage Arrest. The data showed that Riva Star released less fluoride and silver ions compared to Advantage Arrest, demonstrating that Riva Star is as safe as Advantage Arrest.
Biocompatibility testing was conducted according to ISO 10993-1:2009 - Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process, ISO 7405:2008 – Dentistry – Evaluation of biocompatibility of medical devices used in dentistry, and FDA General Guidance on the Use of International Standard ISO 10993-1 (2016).
The tests carried out for Riva Star and standards applied for each test are as follows:
- Cytotoxicity (ISO Agarose, ISO Direct contact) - ISO 10993-5; ISO 7405
- Sensitisation (ISO Guinea Pig Maximization Sensitization) - ISO 10993-10
- Oral Mucosal Irritation (Hamsters, collar method, 7 day) - ISO 10993-10
- Oral Acute Toxicity (Mice - 7 day) - ISO 10993-11.
Riva Star and predicate device Advantage Arrest cytotoxicity testing produced equivalent results. Riva Star testing for irritation, sensitisation and acute oral toxicity provides evidence of biocompatibility.
Stability testing of Riva Star was conducted by evaluating the physical properties of the device to confirm a shelf life of 25 months when stored between 2ºC (35ºF) to 8ºC (45ºF).
Clinical performance testing:
A double blind randomised clinical trial on patients with recognisable tooth sensitivity on both sides of their upper arch was performed, with Riva Star applied to the sensitive tooth on one arch, and predicate device Super Seal applied to the sensitive tooth on the other arch, and patients responses were recorded initially and following 1 week, on a visual analogue scale (VAS). The study showed that Riva Star was more effective than Super Seal in reducing dentine hypersensitivity after 7 days.
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.
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
SDI Limited Rav Cahill Chief Quality and Compliance Officer 3-13 Brunsdon Street Bayswater, Victoria 3153, Australia
Re: K172047
Trade/Device Name: Riva Star Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: Class II Product Code: PHR Dated: March 2, 2018 Received: March 7, 2018
Dear Ray Cahill:
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.
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 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);
April 11, 2018
1
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mary-S. Runner -S
forTina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K172047
Device Name Riva Star
Indications for Use (Describe) Treatment of dentinal hypersensitivity. For use in adults over the age of 21.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary K172047
This 510(k) summary is submitted in accordance with the requirements of 21 CFR 807.92.
1. Submitters information:
SDI Limited
3-13 Brunsdon Street, Bayswater, Victoria 3153, Australia
2. Contact information:
Rav Cahill Chief Quality and Compliance Officer Phone: +61 3 8727 7111 Fax: +61 3 8727 7222 Email:ray.cahill@sdi.com.au
3. Device Information:
| Proprietary Name: | Riva Star |
|---|---|
| Common name: | Tooth desensitiser |
| Classification Name: | Cavity varnish |
| Regulation Number: | 21 CFR 872.3260 |
| Product Code: | PHR |
| Classification: | Medical device, Class II |
4. Date summary prepared: 2 March 2018
5. Primary Predicate device:
Riva Star is substantially equivalent to predicate device Advantage Arrest (K102973) by Elevate Oral Care, product code PHR.
6. Reference predicate devices:
Super Seal (K120109), D/Sense (K120176), Remesense (K082594), with Product Code LBH.
7. Indications for Use:
Treatment of dentinal hypersensitivity. For use in adults over the age of 21.
8. Purpose and description Device Description and technological characteristics:
Riva Star is a two-component device made up of Riva Star Step 1, containing silver diamine fluoride liquid, and Riva Star Step 2, containing aqueous potassium iodide liquid.
Riva Star Step 1 silver diamine fluoride solution is applied to the tooth, immediately followed by Riva Star Step 2 aqueous potassium iodide, which forms an immediate reaction precipitate of silver iodide, thereby reducing tooth sensitivity by physically occluding the open dentinal tubules.
4
Riva Star as well as predicates are liquids or gels that are applied to the teeth using an applicator brush or similar application. With D/Sense, however, the product is in contact with the teeth by foam strips impregnated with the solution.
9. Comparison of technological characteristics:
The fundamental principle and mode of action of Riva Star and the predicate devices in reducing dentinal hypersensitivity is the occlusion of open dentin tubules by the formation of a precipitate.
Both Riva Star and primary predicate Advantage Arrest employ silver diamine fluoride as the main chemical to form the precipitate to occlude the open dentinal tubules. Riva Star, however, also uses a second component, potassium iodide solution, which allows for an immediate reaction precipitate of silver iodide to be formed to occlude the open dentinal tubules. Advantage Arrest, a one component device containing silver diamine fluoride, reacts with the hydroxyapatite of the tooth component. Upon reaction with the silver diamine fluoride, the calcium and phosphate of the hydroxyapatite are converted into calcium fluoride and silver phosphate, respectively to occlude the open dentinal tubules.
With the reference predicate devices Super Seal, D/Sense and Remesense, the oxalate reacts with the dentin calcium to form a deposit of calcium oxalate crystals to occlude the open dentinal tubules and thus reduce tooth sensitivity.
10. Comparison of Indications for Use:
This device is indicated for the treatment of dentinal hypersensitivity, for use in adults over the age of 21.
Its Indications for Use are identical to predicate device Advantage Arrest.
Although Riva Star's indications for use are not identical to the reference predicate devices. the differences in phrasing does not change the overall intended purpose as a tooth desensitiser.
11. Comparison to the Predicate Devices:
A comparison of Riva Star with the predicate devices is as follows:
| | Subject device | Primary
predicate device | Reference
predicate device | Reference
predicate
device
D/Sense | Reference
predicate
device
Remesense |
|--------------------------------|-----------------------|--------------------------------------------------------------------------------|-------------------------------|---------------------------------------------|-----------------------------------------------|
| | RIVA STAR | ADVANTAGE
ARREST | Super Seal | | |
| 510(k) number | K172047 | K102973 | K120109 | K120176 | K082594 |
| Company | SDI Limited | Elevate Oral Care
(named as ADP
Silver Dental
Arrest, LLC in
510k) | Phoenix Dental,
Inc | Centrix, Inc. | Remedent |
| Classification
name | Cavity varnish | Cavity varnish | Cavity varnish | Cavity varnish | Cavity varnish |
| Common name | Tooth
desensitiser | Tooth
desensitiser | Tooth
desensitiser | Tooth
desensitiser | Tooth
desensitiser |
| Regulation
number | 872.3260 | 872.3260 | 872.3260 | 872.3260 | 872.3260 |
| Classification
Product Code | PHR | PHR | LBH | LBH | LBH |
| Indications for | Treatment of | Treatment of | Assists in the | Dual-action | Relief of tooth |
5
| Use | dentinal
hypersensitivity.
For use in adults
over the age of
21 | dentinal
hypersensitivity.
For use in adults
over the age of 21 | removal of the
smear layer, seals
the tubules,
desensitizes and
functions as a re-
wetting agent. | dentin
desensitizer
and cavity
liner. | sensitivity |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technical
method /
characteristics: | Silver diamine
fluoride and
potassium
iodide form a
precipitate of
silver iodide to
block open
dentinal tubules. | Silver diamine
fluoride forms
precipitates with
calcium or
phosphate in the
dentinal tubules to
block open
dentinal tubules | Demineralises the
organic and
mineral debris of
the smear layer
and the outer
most ring of
peritubular dentin
(the very hard
mineralized dentin
of each tubule
complex) and
restructures the
demineralized
material as a
calcium oxalate
precipitate. It
creates an acid
resistant layer
bound both to the
surface as well as
into the dentinal
tubules. | Reacts with
the smear later
to precipitate
micro crystals
of calcium
oxalate and
potassium
nitrate. These
crystals
penetrate
deeply into the
tubules, and
seal the entire
dentinal
surface with a
continuous,
acid-resistant
complex. | Potassium
oxalate breaks
down into
potassium and
oxalic acid. The
oxalic acid
reacts with the
calcium ions to
form calcium-
oxalate crystals.
These crystals
block the dentin
tubules, thereby
alleviating
dental
sensitivity. |
| Mode of action | Tubule
occlusion | Tubule occlusion | Tubule occlusion | Tubule
occlusion | Tubule
occlusion |
| Material
composition: | Silver
diamine
fluoride,
Aqueous
Potassium
lodide | Silver
diamine
fluoride | Oxalic
acid,
potassium salt | Potassium
binoxalate,
nitric
acid,
water. | Water, Glycerin,
Dipotassium
Oxalate, Aroma,
EDTA, BHT,
Sodium
Hydroxide |
| Application: | liquid | liquid | gel | liquid | Tray/kit/gel |
| Rx / OTC | Rx | Rx | Rx | Rx | Rx |
12. Non-clinical performance testing:
A Hydraulic Conductance study of Riva Star and Super Seal tooth desensitisers was conducted. The data demonstrated that Riva Star is an effective agent to reduce fluid flow through dentine, and is substantially equivalent to Super Seal in treating dentinal hypersensitivity. Scanning electron microscope (SEM) images showed both Riva Star and Super Seal formed a precipitate to occlude the open dentinal tubules.
A comparative 7-day in vitro fluoride and silver ion release study was conducted on Riva Star and the primary predicate device Advantage Arrest. The data showed that Riva Star released less fluoride and silver ions compared to Advantage Arrest, demonstrating that Riva Star is as safe as Advantage Arrest.
Biocompatibility testing was conducted according to ISO 10993-1:2009 - Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process, ISO 7405:2008 – Dentistry – Evaluation of biocompatibility of medical devices used in dentistry, and FDA General Guidance on the Use of International Standard ISO 10993-1 (2016).
The tests carried out for Riva Star and standards applied for each test are as follows: - Cytotoxicity (ISO Agarose, ISO Direct contact) - ISO 10993-5; ISO 7405
6
-
Sensitisation (ISO Guinea Pig Maximization Sensitization) - ISO 10993-10
-
Oral Mucosal Irritation (Hamsters, collar method, 7 day) - ISO 10993-10
-
Oral Acute Toxicity (Mice - 7 day) - ISO 10993-11.
Riva Star has limited contact with dentine, being an externally communicating device.
The test carried out for predicate device Advantage Arrest and standards applied is as follows: - Cytotoxicity (ISO Direct contact) - ISO 10993-5; ISO 7405
Riva Star and predicate device Advantage Arrest cytotoxicity testing produced equivalent results. Riva Star testing for irritation, sensitisation and acute oral toxicity provides evidence of biocompatibility.
Stability testing of Riva Star was conducted by evaluating the physical properties of the device to confirm a shelf life of 25 months when stored between 2ºC (35ºF) to 8ºC (45ºF).
13. Clinical performance testing:
A double blind randomised clinical trial on patients with recognisable tooth sensitivity on both sides of their upper arch was performed, with Riva Star applied to the sensitive tooth on one arch, and predicate device Super Seal applied to the sensitive tooth on the other arch, and patients responses were recorded initially and following 1 week, on a visual analogue scale (VAS). The study showed that Riva Star was more effective than Super Seal in reducing dentine hypersensitivity after 7 days.
14. Conclusion:
The information presented in this submission, including compositions for use, mode of action and technological characteristics, biocompatibility, non-clinical and clinical performance testing, establishes that Riva Star is substantially equivalent to the predicate devices.