(15 days)
Not Found
No
The device description and performance studies focus on the chemical and physical properties of the toothpaste and its active ingredient (NovaMin®) for cleaning and desensitizing teeth. There is no mention of AI, ML, image processing, or any data-driven algorithms for diagnosis, treatment planning, or other functions typically associated with AI/ML in medical devices.
Yes
The device is described as providing relief from tooth sensitivity and managing sensitive teeth by physically occluding dentin tubules, which are therapeutic claims.
No
The device is a toothpaste intended for cleaning and relieving tooth sensitivity, not for diagnosing medical conditions.
No
The device description clearly states it is a "toothpaste product" and a "toothpaste device" that incorporates a physical active ingredient (NovaMin®). This indicates a physical product, 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 for cleaning the tooth surface and providing relief from tooth sensitivity by physically occluding dentin tubules. This is a direct therapeutic action on the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The description focuses on the physical and chemical properties of the toothpaste and its mechanism of action in the mouth. It does not describe a device used to analyze biological samples.
- Performance Studies: The performance studies evaluate the clinical efficacy of the toothpaste in reducing tooth sensitivity in patients. This is a clinical trial, not a study validating the performance of a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, saliva, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
Therefore, Oravive™ is a therapeutic device (specifically, a toothpaste for cleaning and managing tooth sensitivity), not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Oravive™ is a fluoride-free toothpaste product intended for cleaning the tooth surface on a daily basis. Clinical studies have shown that Oravive™ also provides relief from tooth sensitivity due to cold, heat, acids, sweets, or contact by the occlusion of dentin tubules.
Product codes (comma separated list FDA assigned to the subject device)
NRE
Device Description
Oravive™ is a daily-use, fluoride-free toothpaste device that incorporates NovaMin® as its active ingredient. The non-aqueous formulation is designed to clean your teeth as well as give your whole mouth a fresh feeling we call REVITALIZING! Oravive™ is also designed to physically occlude dentin tubules for the management of sensitive teeth. NovaMin® (calcium sodium phosphossilicate) is composed of elements that occur naturally in the body (Ca, Na, Si, P, and O). When exposed to an aquoous environment, NovaMin® undergoes a rapid surface reaction, allowing it to physically occlude tubules. Within a short period of time, essentially all of the NovaMin® reacts to form hydroxycarbonate apatite (HCA), which is chemically and structurally similar to natural tooth mineral.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tooth surface, dentin tubules
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)
Biocompatibility Tests: Many different biocompatibility tests have been performed on NovaMin®, the active ingredient in Oravive. The results of these tests indicate that there is no evidence of any hazardous effects to the patient if the product is used as directed.
Tubule Occlusion Efficacy (in vitro): The tubule occlusion efficacy of Oravive™ was evaluated using an in vitro demin block model. The results indicate that Oravive™ occludes a statistically significant number of tubules when compared to controls.
Relative Abrasion Level (in vitro): The relative abrasion level of Oravive™ was evaluated at Indiana University School of Dentistry. The procedure used was the ADA recommended procedure for determination of toothpaste abrasivity. The result was a mean Relative Dentin Abrasivity (RDA) value of 125.55. This RDA value is well under the limit considered safe for daily-use (RDA value
§ 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
MAY 1 0 2004
510(k) Premarket Notification
NovaMin Technology, Inc.
Oravive™ Tooth Revitalizing Paste
the first the state of the states
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1. SUBMITTER INFORMATION:
| Name: | NovaMin Technology, Inc. |
|---|---|
| Address: | 13709 Progress Blvd., #23 |
| Alachua, Florida 32615 USA | |
| Phone: | (386) 418-1551 |
| Facsimile: | (386) 418-1465 |
| Contact: | David C. Greenspan, Ph.D. |
February 23, 2004 Preparation Date:
2. DEVICE NOMENCLATURE:
| Trade Name: | Oravive™ Tooth Revitalizing Paste |
|---|---|
| Common Name: | Dentifrice, Toothpaste |
| Classification Name: | Agent, Polishing, Abrasive, Oral Cavity |
3. LEGALLY MARKETED PREDICATE DEVICE:
| Device Name: | Butler GUM® Prophylaxis Paste with NovaMin® |
|---|---|
| 510(k) Number: | K024343 |
| Applicant: | USBiomaterials Corporation |
4. DEVICE DESCRIPTION:
Oravive™ is a daily-use, fluoride-free toothpaste device that incorporates NovaMin® as its active ingredient. The non-aqueous formulation is designed to clean your teeth as well as give your whole mouth a fresh feeling we call REVITALIZING! Oravive™ is also designed to physically occlude dentin tubules for the management of sensitive teeth. NovaMin® (calcium sodium phosphossilicate) is composed of elements that occur naturally in the body (Ca, Na, Si, P, and O). When exposed to an aquoous environment, NovaMin® undergoes a rapid surface reaction, allowing it to physically occlude tubules. Within a short period of time, essentially all of the NovaMin® reacts to form hydroxycarbonate apatite (HCA), which is chemically and structurally similar to natural tooth mineral.
S. INTENDED USE:
ﺮ
Oravive™ is a fluoride-free toothpaste product intended for cleaning the tooth surface on a daily basis. Clinical studies have shown that Oravive™ also provides relief from tooth sensitivity due to cold, heat, acids, sweets, or contact by the occlusion of dentin tubules.
1
6. TECHNOLOGICAL CHARACTERISTICS:
The technological characteristics of Oravive™ and Butler GUM® Prophylaxis Paste with NovaMine are very similar. Both devices are designed to relieve hypersensitivity associated with exposed dentin by the deposition of a calcium phosphate layer onto the tooth surface. Both devices use NovaMia" to produce a calcium phosphate layer that occludes dentinal tubules and blocks hydrodynamic flow. The primary difference between the two devices is that Oravive™ supplies the calcium and phosphate ions on a daily basis, whereas Butler GUM® Prophylaxis Paste with NovaMin supplies the ions once every professional tooth cleaning. In addition, there are some differences in the proportion of the ingredients in the two products.
7. SAFETY AND PERFORMANCE DATA:
Many different biocompatibility tests have been performed on NovaMin®, the active ingredient in Oravive The results of these tests indicate that there is no evidence of any hazardous effects to the patient if the product is used as directed.
The tubule occlusion efficacy of Oravive™ was evaluated using an in vitro demin block model. The results indicate that Oravive™ occludes a statistically significant number of tubules when compared to controls.
The relative abrasion level of Oravive™ was evaluated at Indiana University School of Dentistry. The procedure used was the ADA recommended procedure for determination of toothpaste abrasivity. The result was a mean Relative Dentin Abrasivity (RDA) value of 125.55, This RDA value is well under the limit considered safe for daily-use (RDA value