(57 days)
Not Found
No
The summary describes a toothpaste that uses a chemical reaction to occlude dentin tubules for sensitivity relief. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is marketed for "rapid and continual relief from tooth sensitivity" by "occlusion of dentin tubules," which is a therapeutic action. Additionally, its predicate device is named "Oralief™ Therapy for Sensitive Teeth," further indicating a therapeutic purpose.
No
The device is a toothpaste intended for cleaning teeth and reducing tooth sensitivity by physically occluding dentin tubules, not for diagnosing a condition. Its function is therapeutic/palliative, not diagnostic.
No
The device description clearly identifies the device as a toothpaste, which is a physical substance and 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 provide relief from tooth sensitivity by physically occluding dentin tubules. This is a therapeutic action performed directly on the patient's teeth, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description details the mechanism of action (occlusion of dentin tubules) and the active ingredient (NovaMin®), which are related to the therapeutic effect, not a diagnostic process.
- Lack of Diagnostic Elements: There is no mention of analyzing a sample (blood, urine, tissue, etc.) or providing information for the diagnosis of a disease or condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This toothpaste does not fit that description.
N/A
Intended Use / Indications for Use
Oralief™ OTC Toothpaste for Sensitive Teeth is a fluoride-free daily use cleaning toothpaste that provides rapid and continual relief from tooth sensitivity due to cold, heat, acids, sweets or contact, through its action of the occlusion of dentin tubules.
Product codes (comma separated list FDA assigned to the subject device)
LBH
Device Description
Oralief™ OTC Toothpaste for Sensitive Teeth is a daily-use, fluoride-free toothpaste device that incorporates NovaMin® (calcium sodium phosphosilicate) as its active ingredient. The non-aqueous formulation is designed to clean teeth as well as to physically occlude dentin tubules for the reduction of tooth sensitivity. When exposed to an aqueous 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
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)
Many different biocompatibility tests have been performed on NovaMin. 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 Oralief™ OTC Toothpaste for Sensitive Teeth was evaluated using an in vitro dentin block model. The results indicate that Oralief™ OTC Toothpaste for Sensitive Teeth occludes a statistically significant number of tubules when compared to controls.
The relative abrasion level of Oralief™ OTC Toothpaste for Sensitive Teeth 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 Radioactive Dentin Abrasion (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
1. SUBMITTER INFORMATION:
MAR 2 7 2008
| Name: | NovaMin Technology, Inc. |
|---|---|
| Address: | 13859 Progress Blvd., #600 |
| Alachua, Florida 32615 USA | |
| Phone: | (386) 418-1551 |
| Facsimile: | (386) 418-1465 |
| Contact: | Robert G. Rothfritz |
Preparation Date: January 9, 2008
2. DEVICE NOMENCLATURE:
| Trade Name: | Oralief™ OTC Toothpaste for Sensitive Teeth |
|---|---|
| Common Name: | Dentifrice, Toothpaste |
| Classification Name: | Cavity Varnish (21 CFR 872.3260 Product Code LBH) |
3. LEGALLY MARKETED PREDICATE DEVICE:
| Device Name: | Oralief™ Therapy for Sensitive Teeth |
|---|---|
| 510(k) Number: | K040858 |
| Applicant: | NovaMin Technology, Inc. |
4. DEVICE DESCRIPTION:
Oralief™ OTC Toothpaste for Sensitive Teeth is a daily-use, fluoride-free toothpaste device that incorporates NovaMin® (calcium sodium phosphosilicate) as its active ingredient. The non-aqueous formulation is designed to clean teeth as well as to physically occlude dentin tubules for the reduction of tooth sensitivity. When exposed to an aqueous 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.
5. INTENDED USE:
Oralief™ OTC Toothpaste for Sensitive Teeth is a fluoride-free daily use cleaning toothpaste that also provides rapid and continual relief from tooth sensitivity due to cold, heat, acids, sweets or contact, through its action of the occlusion of dentin tubules.
6. TECHNOLOGICAL CHARACTERISTICS:
1
The technological characteristics of Oralief™ OTC Toothpaste for Sensitive Teeth are identical to the predicate device Oralief™ Therapy for Sensitive Teeth. Oralief™ OTC Toothpaste for Sensitive Teeth is designed to relieve hypersensitivity associated with exposed dentin by the deposition of a calcium phosphate layer onto the tooth surface that occludes dentinal tubules and blocks hydrodynamic flow.
7. SAFETY AND PERFORMANCE DATA:
Many different biocompatibility tests have been performed on NovaMin. 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 Oralief™ OTC Toothpaste for Sensitive Teeth was evaluated using an in vitro dentin block model. The results indicate that Oralief™ OTC Toothpaste for Sensitive Teeth occludes a statistically significant number of tubules when compared to controls.
The relative abrasion level of Oralief™ OTC Toothpaste for Sensitive Teeth 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 Radioactive Dentin Abrasion (RDA) value of 125.55. This RDA value is well under the limit considered safe for daily-use (RDA value