(177 days)
K/DEN number: Not Found
Not Found
No
The description focuses on the chemical composition and physical properties of a dental varnish, with no mention of AI or ML.
No
The device is described as a varnish for sensitive teeth, exposed dentin, and under temporary restoratives, with ingredients like Colophony resin and Sodium Fluoride. Its function is to coat and adhere to tooth structure, providing protection rather than directly treating a disease or health condition as a therapeutic device would. Its intended use is more preventative or palliative.
No.
Explanation: The device is described as a varnish for treating sensitive teeth and exposed dentin, not for identifying or diagnosing a condition. Its function is to provide a protective film and deliver fluoride.
No
The device is a varnish, which is a physical substance applied to teeth, not a software program.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "For use as a varnish on sensitive teeth over exposed dentin and under temporary restoratives and cements." This describes a topical application to the tooth structure for therapeutic purposes (reducing sensitivity).
- Device Description: The description details a varnish applied to the tooth surface, where a solvent evaporates leaving a film. This is a physical application to the body.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the body to provide diagnostic information. This device is applied to the body for a therapeutic effect.
N/A
Intended Use / Indications for Use
For use as a varnish on sensitive teeth over exposed dentin and under temporary restoratives and cements.
Product codes
IBH
Device Description
The varnish has the consistency of a viscous liquid. When applied in a thin layer over tooth dentin, the solvent (ethyl alcohol and water) evaporates within a few minutes, leaving a film of Colophony resin in which Sodium Fluoride is suspended, which adheres well to the tooth structure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth, dentin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
FOR PROFESSIONAL USE ONLY
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Duraphat, Durafluor
Reference Device(s)
Not Found
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 shows a logo with the text "SCI-PHARM" in bold, black letters. To the left of the text is a black silhouette of two beakers. Above the text is a handwritten date, "2/12/99". To the right of the text is a black mortar and pestle.
SCIENTIFIC PHARMACEUTICALS, INC.
3221 Producer Way • Pomona, California USA 91768 PHONE: (909) 595-9922 • Outside California (800) 634-3047 • FAX: (909) 595-0331 E-MAIL: scipharm@msn.com · WEBSITE: http://www.scipharm.com
.chemistry working for medicine and dentistry
Image /page/0/Picture/4 description: The image shows the text "K982915" at the top, followed by the text "510(k) SUMMARY" in bold and underlined. The text appears to be part of a document or form. The text is black and the background is white.
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Dr. Jan A. Orlowski (1) Submitted by: Scientific Pharmaceuticals, Inc. 3221 Producer Way Pomona, California 91768 phone: 909-595-9922
Date Prepared: August 18, 1998 -
(2) Device Trade Name: Sci-Pham DFV Vamish Dental Varnish Device Common Name: Device Classification Name: Cavity Vamish
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Sci-Pharm DFV Vamish is substantially equivalent to Duraphat by Colgate-Palmolive and (3) Durafluor by PharmaScience (as shown in the table in Point 4 below).
(4) Chemical Composition
| Ingredient | Sci-Pharm DFV Varnish | Colgate Duraphat |
|---|---|---|
| Ethyl Alcohol | 71.25% | 75% |
| Colophony | 20% | 20% |
| Sodium Fluoride | 5% | 5% |
| Water | 3.75% |