(172 days)
No
The device description and performance studies focus on the chemical composition and physical properties of the varnish, with no mention of AI or ML algorithms for analysis, diagnosis, or treatment.
Yes
The device is described as a "fluoride-containing resin preparation for the treatment of dentinal hypersensitivity and for the reduction of post-operative sensitivity," which are therapeutic purposes. It directly addresses and treats a medical condition (dentinal hypersensitivity) and aims to reduce a symptom (post-operative sensitivity).
No.
The device is described as a fluoride-containing resin preparation for the treatment of dentinal hypersensitivity and for the reduction of post-operative sensitivity. It is a therapeutic device that coats the tooth to occlude compromised surfaces and dentinal tubules, rather than identifying or analyzing a condition.
No
The device is a physical substance (varnish) applied to teeth, 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 the treatment of dentinal hypersensitivity and reduction of post-operative sensitivity by being applied directly to the tooth. This is a therapeutic and preventative application on the patient's body.
- Device Description: The device is a topical varnish applied to the tooth surface. It works by forming a film and occluding dentinal tubules. This is a physical and chemical interaction with the tooth structure in vivo.
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for diagnostic purposes. This device does not involve the examination of specimens in vitro.
The device is a dental therapeutic/preventative device applied directly to the patient's teeth.
N/A
Intended Use / Indications for Use
SciPharm's DFV Desensitizing Varnish is a fluoride-containing resin preparation for the treatment of dentinal hypersensitivity and for the reduction of post-operative sensitivity.
Product codes (comma separated list FDA assigned to the subject device)
LBH
Device Description
SciPharm's DFV Desensitizing Varnish is a device that consists of a synthetic compound from a natural rosin that is intended to coat a prepared tooth cavity prior to the insertion of a restorative material by forming a film that facilitates occlusion of compromised surfaces, including open dentinal tubules. DFV Desensitizing Varnish and the predicate device consist of a viscous liquid that can be applied to the teeth using a brush or similar applicator. The purpose of the 5% sodium fluoride as the source of fluoride ions for the formation of calcium fluoride, and along with the rosin, occludes the dentin tubules. Both use denatured alcohol (ethanol) as a significant component, providing fluidity for application and to promote quick drying on the tooth surface.
SciPharm's DFV Desensitizing Varnish is a topically applied, flavored (Strawberry, Bubblegum, Spearmint, Chocolate, and Marshmallow) topical varnish containing sodium fluoride on a synthetic rosin based preparation from a natural rosin. Only a professional clinician may apply DFV Desensitizing Varnish. The varnish and applicator are packaged in a thermoformed PET/PVC opaque unit dose tray, and sealed with foil.
The technological difference between DFV Desensitizing Varnish and the other six (6) varnishes that Scientific Pharmaceutical's manufactures is the formulation of components. The components are commonly used in the dental materials industry. The DFV Desensitizing Varnish uses a synthetic resin as the base material instead of the natural rosin used in other formulations. This synthetic rosin is the same used in the predicate device. DFV Desensitizing Varnish also includes additional base material, sweeteners, bitterness blockers, and flavoring agents.
The device is intended to prevent the penetration of restorative materials, such as amalgam, into dental tissue.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tooth/teeth, dentin, gingiva
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional clinician
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:
Cytotoxicity: Followed ISO 10993-5 and ISO 7405. A smear was extracted in Minimal Essential Medium (MEM) with 10% Fetal Bovine Serum for 24 hours at 37°C. L929 cells were exposed to the extracts, and viability was measured by their ability to uptake a vital dye. The viability percentage of cells exposed to extracts from DFV Desensitizing Varnish was 11% (Toxicon Report 17-04113-G1), which is below the 70% threshold. An additional study with an approved dental varnish (predicate product) using the same methodology also showed 11% viability (Toxicon Report 18-00602-G1), indicating no difference despite the low viability due to ethanol, sodium fluoride, and carbamide peroxide.
Dentin Tubule Occlusion: Human dentin specimens were exposed to Sci-Pharm's DFV Desensitizing Varnish and an equivalent predicate varnish. Surfaces were imaged using reflection optical microscopy (ROM) without dehydration, showing typical granular appearance with dentinal tubule orifices closed by smear plugs. Scanning electron microscope (SEM) examination of the top surface of sectioned specimens showed Sci-Pharm's DFV Desensitizing Varnish remained smooth with minimal surface defects, while the other varnish showed subsurface porosity and heterogeneity. Conclusion: Sci-Pharm's DFV Desensitizing Varnish demonstrated a thick uniform film with fewer defects and protrusions.
Physical Tests:
Contamination: No Foreign Particles
Color: Match Standard
Odor: Match Standard
Viscosity: 4500 – 6500 cps
Non-Pyrolizable %: 7.5% - 8.7%
Fluoride Content: 4.5% - 5.5% NaF (2.0% - 2.5% F)
Shelf Life Study:
Conducted following Sci-Pharm's internal procedure, EX-06. Product analyzed at intervals (Time 0, 6 months, 12 months, 18 months, etc.) up to 4 years for changes in contamination, color, viscosity, fluoride content, non-pyrolizable percentage, and odor. Report 2019-R-012 provides evidence of product stability for at least 24 months.
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 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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 18, 2020
Scientific Pharmaceuticals Thomas Kelly Regulatory Affairs/Quality Assurance Manager 3221 Producer Way Pomona, California 91768
Re: K192381
Trade/Device Name: DFV Desensitizing Varnish-Strawberry Flavor, DFV Desensitizing Varnish-Bubblegum (Tutti-Fruity) Flavor, DFV Desensitizing Varnish-Spearmint Flavor, DFV Desensitizing Varnish-Chocolate Flavor, DFV Desensitizing Varnish-Marshmallow Flavor
Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: Class II Product Code: LBH Dated: November 20, 2019 Received: November 20, 2019
Dear Thomas Kelly:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Srinivas Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K192381
Device Name DFV Desensitizing Varnish
Indications for Use (Describe)
SciPharm's DFV Desensitizing Varnish is a fluoride-containing resin preparation for the treatment of dentinal hypersensitivity and for the reduction of post-operative sensitivity.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary — K192381
| 510(k) Submission: | Traditional |
|---|---|
| Device Type: | Varnish, Cavity |
| Submitter: | Scientific Pharmaceuticals, Inc. |
| 3221 Producer Way | |
| Pomona, CA 91768 | |
| Contact Person: | Thomas Kelly |
| Regulatory Affairs/Quality Assurance Manager | |
| Regulatory@scipharm.com | |
| Telephone: 909-595-9922 ext. 237 | |
| Alternate Contact Person: | David Butler |
| President | |
| Dave@scipharm.com | |
| Telephone: 909-595-9922 ext. 225 | |
| Date: | February 18, 2020 |
| Confidentiality: | According to 21 CFR 807.95 |
| Trade Name: | Sci-Pharm DFV Desensitizing Varnish |
| Common Name: | Cavity Varnish or Topical Varnish |
| Classification Name | |
| and References: | Cavity Varnish |
| 21CFR 872.3260 | |
| Product Code: | LBH |
| Classification Panel: | Dental |
| Classification: | Medical Device, Class II |
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Image /page/4/Picture/1 description: The image shows the logo for SCI-PHARM. The logo is blue and features a graphic of two beakers on the left, the text "SCI-PHARM" in the center, and a mortar and pestle on the right. The logo also includes a registered trademark symbol.
Purpose and Description:
SciPharm's DFV Desensitizing Varnish is a device that consists of a synthetic compound from a natural rosin that is intended to coat a prepared tooth cavity prior to the insertion of a restorative material by forming a film that facilitates occlusion of compromised surfaces, including open dentinal tubules. DFV Desensitizing Varnish and the predicate device consist of a viscous liquid that can be applied to the teeth using a brush or similar applicator. The purpose of the 5% sodium fluoride as the source of fluoride ions for the formation of calcium fluoride, and along with the rosin, occludes the dentin tubules. Both use denatured alcohol (ethanol) as a significant component, providing fluidity for application and to promote quick drying on the tooth surface.
SciPharm's DFV Desensitizing Varnish is a topically applied, flavored (Strawberry, Bubblegum, Spearmint, Chocolate, and Marshmallow) topical varnish containing sodium fluoride on a synthetic rosin based preparation from a natural rosin. Only a professional clinician may apply DFV Desensitizing Varnish. The varnish and applicator are packaged in a thermoformed PET/PVC opaque unit dose tray, and sealed with foil.
The technological difference between DFV Desensitizing Varnish and the other six (6) varnishes that Scientific Pharmaceutical's manufactures is the formulation of components. The components are commonly used in the dental materials industry. The DFV Desensitizing Varnish uses a synthetic resin as the base material instead of the natural rosin used in other formulations. This synthetic rosin is the same used in the predicate device. DFV Desensitizing Varnish also includes additional base material, sweeteners, bitterness blockers, and flavoring agents.
The device is intended to prevent the penetration of restorative materials, such as amalgam, into dental tissue.
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Image /page/5/Picture/0 description: The image shows the logo for SCI-PHARM. The logo consists of a blue Erlenmeyer flask on the left, followed by the text "SCI-PHARM" in blue. On the right, there is a blue mortar and pestle with a registered trademark symbol above it. The logo is simple and professional, and it conveys the company's focus on science and pharmaceuticals.
Chemical Composition:
| | Raw Material
(Ingredient) | Purpose of Ingredient | Concentration of
Ingredient |
|-----|----------------------------------------------------------------------------------------|-----------------------------------------|--------------------------------|
| 1. | Purified Rosin | Film Former | 45.0% - 75.0% |
| 2. | Polyamide | Film Former | 10.0% - 25.0% |
| 3. | Ethanol,
200 Proof | Solvent,
Surface Wettability | 10.0% - 25.0% |
| 4. | Sodium Fluoride | Reduce Tooth Decay | 4.50% - 5.50% |
| 5. | Carbamide
Peroxide | Whitening Agent for
color stability | 0.25% - 5.0% |
| 6. | Xylitol | Sweetener and
stimulates saliva flow | 0.5% - 4.0% |
| 7. | Sucralose | Sweetener | 0.25% - 5.0% |
| 8. | Bitter Blocker | Flavoring Agent | 0.10% - 3.00 % |
| 9. | Silica Filler | Thickener | 1.0% - 5.0% |
| 10. | Flavorants
(Strawberry,
Bubblegum,
Spearmint,
Chocolate, &
Marshmallow) | Flavoring Agent | 0.25% - 10.0% |
Contraindications: Patients allergic, or hypersensitive, to natural resin or colophony (kolophonium or resembling agents) should avoid the use of this product. In case of an adverse reaction, the varnish may be removed by brushing with a soft toothbrush and flossing, followed by rinsing with warm water. Direct ingestion should be avoided. Dyspnea, (difficult or labored breathing) associated with asthmatic children, has been reported in rare cases. Patients with sensitive digestive systems may experience nausea, usually after a prolonged treatment. Patients with stomatitis or ulcerative gingivitis should avoid this product. Primary Predicate Device: Young Dental Manufacturing: Oral-B 5% Sodium Fluoride Varnish (K153334). Reference Device: 3M: Vanish 5% Sodium Fluoride White Varnish (K090519) Unit dose container, Nylon Brushes for application, mixing Accessories(s):
well.
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Image /page/6/Picture/0 description: The image shows the logo for SCI-PHARM. The logo consists of two blue Erlenmeyer flasks, the text "SCI-PHARM" in blue, and a blue mortar and pestle. The registered trademark symbol is located to the right of the text.
Comparison to Predicate Device
| | DFV Desensitizing
Varnish | Primary Predicate
Device
Oral-B 5% Sodium
Fluoride Varnish | Reference Device
Vanish Varnish |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use
(abbreviated) | Treatment of dental
hypersensitivity and
reduction of post-
operative sensitivity | K153334
Treatment of dental
hypersensitivity and
reduction of post-
operative sensitivity | K090519
Treatment of dental
hypersensitivity and
reduction of post-
operative sensitivity |
| Contraindications | Hypersensitivity to
colophony should avoid
this product, as well as
patients with ulcerative
gingivitis and stomatitis | Ulcerative gingivitis and
stomatitis | Hypersensitivity to
colophony should avoid
this product, as well as
patients with ulcerative
gingivitis and stomatitis |
| Mode of Action | Dentin Tubule Occlusion | Dentin Tubule Occlusion | Dentin Tubule Occlusion |
| Method of
Application | Application of a thin coat
of varnish of varnish on
tooth surfaces only by a
professional. Not for
home use. | Application of a thin coat
of varnish of varnish on
tooth surfaces. | Application of a thin coat
of varnish of varnish on
tooth surfaces only by a
professional. Not for
home use. |
| Percentage of
Sodium Fluoride | 5% | 5% | 5% |
| Packaging | Varnish and applicator
brush placed in a
thermoformed PET/PVC
opaque unit dose tray
and closed with a
peelable foil seal. | Varnish and applicator
brush placed in a molded
opaque acclar tray and
closed with a foil seal. | Varnish and applicator
brush placed in a molded
opaque tray and closed
with a foil seal. |
| Unit Package | 0.4 mL | 0.4 mL | 0.5 mL |
| Basic Composition | Synthetic Rosin | Synthetic Rosin | Synthetic Rosin |
Technological Characteristics:
The basic composition, fundamental technology, and intended use of DFV Desensitizing Varnish is substantially equivalent to the predicate device and comparable to devices that have been on the market for many decades. These products use components used in the dental industry such as resins, rosins, modified rosins hydroxypropyl cellulose, polyurethane, methacrylates, polyethylene glycol, amides, dimethacrylates, and other film forming ingredients to cover dentinal tubules, which provide relief from dentinal
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Image /page/7/Picture/0 description: The image shows the logo for SCI-PHARM. The logo consists of a blue graphic of two Erlenmeyer flasks on the left, the text "SCI-PHARM" in blue in the center, and a blue mortar and pestle on the right. There is a registered trademark symbol next to the mortar and pestle.
hypersensitivity. DFV Desensitizing Varnish is a varnish that contains sodium fluoride, like all of the others, and contains rosin that provides immediate and sustained relief of dental pain or sensitivity. The immediate relief of hypersensitivity is achieved by the hardened resin films that forms immediately after application and occludes the dentin tubules.
Biocompatibility Tests: The chemical components in Sci-Pharm's DFV Desensitizing Varnish have been used in a variety of predicate devices. Rosin and other rosin derivatives are used as adhesive agents in approved dental varnishes.
Biocompatibility testing is an essential element of developing a medical device. Each medical device used in dentistry shall be subjected to a structured biological evaluation program within a risk management process. In order to comply with the requirements, DFV Desensitizing Varnish was tested for cytotoxicity and to provide evidence that the formula blocks dentinal tubules.
Cytotoxicity followed the procedure outlined in ISO 10993-5 and ISO 7405, where a smear was extracted in Minimal Essential Medium (MEM) with 10% Fetal Bovine Serum for 24 hours at 37°C. Then L929 cells were exposed to the extracts and the viability of the cells were measured by their ability to uptake a vital dye. The viability percentage of the cells exposed to the extracts from DFV Desensitizing Varnish was 11%, which is below the 70% (Toxicon Report 17-04113-G1). This value is expected as it contains significant ethanol, so an additional study was conducted using an approved dental varnish that is similar, and currently being used on the market. The predicate product is another dental varnish already on the market and compared with the same methodology to determine cytotoxicity from DFV Desensitizing varnish. The viability percentage of the cells exposed to the extracts from an equivalent device was also 11%, which is also below the 70% (Toxicon Report 18-00602-G1). The cytotoxicity for both varnishes are the same, indicating that there is no difference. Based on the chemical content, the residual ethanol will disrupt cellular integrity, the sodium fluoride is a bacterial growth inhibitor, which can also affect the viability of the cells, as can the carbamide peroxide. All of these chemicals had an effect that contributed towards the low cellular viability result, but since these are the very same chemicals used for all approved dental varnishes
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Image /page/8/Picture/0 description: The image shows the logo for SCI-PHARM. The logo is blue and features a beaker on the left, the text "SCI-PHARM" in the middle, and a mortar and pestle on the right. The logo is simple and professional.
currently on the market, then they are found acceptable. Additional testing can be requested, but the results will be the same due to the ethanol, not the flavor.
The second test is where dentin is exposed to the varnish and viewed under SEM to verify that the varnish blocks dentinal tubulae. There were two varnishes evaluated, Sci-Pharm's DFV Desensitizing Varnish and an equivalent predicate varnish. Disk-shaped human dentine specimens had the varnishes applied separately using a plastic brush and a single stroke. The surfaces were imaged using reflection optical microscopy (ROM), allowing the identification morphology of the specimen surfaces without the dehydration effects. Then the top surface of the sectioned specimens were examined using a scanning electron microscope (SEM). The ROM images demonstrated a typical granular appearance with dentinal tubule orifices closed by smear plugs. Both varnishes tested showed highly smooth material layer covering all of the dentine and when evaluated by SEM, Sci-Pharm's DFV Desensitizing Varnish remained smooth with minimal surface defects while the other varnish showed subsurface porosity and heterogeneity. The conclusion was that Sci-Pharm's DFV Desensitizing Varnish demonstrated a thick uniform film with fewer defects and protrusions than the competitors varnish. Additional testing is not necessary as the benefits are from sodium fluoride and the rosin mixture, not the flavors.
| | Proposed DFV
Desensitizing
Varnish | Equivalent Varnish |
|-----------------------|------------------------------------------|------------------------------------|
| Test | | |
| Contamination | No Foreign
Particles | No Foreign
Particles |
| Color | Match Standard | Match Standard |
| Odor | Match Standard | Match Standard |
| Viscosity | 4500 – 6500 cps | 7000 – 8500 cps |
| Non-
Pyrolizable % | 7.5% - 8.7% | 8.4% - 9.5% |
| Fluoride
Content | 4.5% - 5.5% NaF
(2.0% - 2.5% F) | 4.5% - 5.5% NaF
(2.0% - 2.5% F) |
Physical Tests:
Shelf Life
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Image /page/9/Picture/0 description: The image shows the logo for SCI-PHARM. The logo consists of a blue graphic of two Erlenmeyer flasks on the left, followed by the text "SCI-PHARM" in blue. To the right of the text is a blue mortar and pestle with a registered trademark symbol.
Shelf Life was established following Sci-Pharm's internal procedure, EX-06, where the product being tested is analyzed during intervals within the shelf life, such as Time 0, Time 6 months, Time 12 months, Time 18 months, etc., and continued for up to 4 years. The product is evaluated for any changes that may occur over time. Testing is performed on contamination, color, viscosity, fluoride content, nonpyrolizable percentage, and odor. Color changes may occur over time, but since a small thin layer that is washed off within hours, the color change in the product is not substantial. Report 2019-R-012 provides evidence that the product is stable for at least 24 months.
Substantial Equivalence: In summary, this submission demonstrates that Sci-Pharm's DFV Desensitizing Varnish is substantially equivalent in safety and effectiveness, and performs equivalently or better than the identified primary predicate device and the reference device varnishes for their intended use. Device is biocompatible when used as directed by dental professionals per ISO 10993-1. DFV Desensitizing Varnish does not introduce any new indications for use or potential hazards.