Smile Flow re-engineers two of dentistry's most established topical actives — 38% silver diamine fluoride and 5% sodium fluoride varnish — into a sterile, single-use, single-tooth transfer pipette. A pre-metered dose. A counted unit in, a treated tooth out.
Caries is a dynamic, bacterially-driven loss of tooth mineral. It does not begin as a hole; it begins as a chemical imbalance at the tooth surface. Catch it early and it remineralizes. Catch it late and, increasingly, it can be arrested rather than excavated. Smile Flow places the right agent at the right point on that curve — per tooth.
Healthy, fully mineralized surface in equilibrium with saliva. The goal is to keep it here.
Smile Flow Varnish · preventionSubsurface demineralization — the first visible sign. Still reversible: fluoride drives remineralization toward acid-resistant fluorapatite.
Smile Flow Varnish · remineralizeThe surface has broken down into the dentin. Conventional answer is restoration — but where that isn't feasible, the lesion can be chemically arrested.
Smile Flow SDF · non-surgical arrestDecay approaching the pulp. Beyond the scope of topical therapy — requires definitive restorative or endodontic care.
Refer for definitive careSDF and fluoride varnish are not interchangeable — they are complementary. A program that carries both, in one consistent single-tooth format, can manage the full caries continuum with one workflow, one dose-accountability system and one supplier relationship.
| Active substance | Silver diamine fluoride (CAS 34445-07-3) |
| Concentration | 38% w/v ammoniacal silver fluoride |
| Fluoride content | ~44,800 ppm F⁻ (44.8 mg F⁻/mL) |
| Silver content | ~250,000 ppm Ag (~25% w/v) |
| Physical form | Alkaline aqueous solution, pH ~10 |
| Primary indication* | Arrest of active carious lesions; dentin hypersensitivity |
| Application cadence | Per-tooth; biannual reapplication for sustained arrest |
| Disclosed limitation | Permanent black staining of treated carious tissue |
| Active substance | Sodium fluoride (NaF) |
| Concentration | 5% w/v NaF in resin/solvent varnish |
| Fluoride content | 22,600 ppm F⁻ (2.26% fluoride ion) |
| Silver content | None |
| Physical form | Viscous resin varnish, ethanol-based |
| Primary indication* | Caries prevention / remineralization; sensitivity |
| Application cadence | Per-tooth or quadrant; every 3–6 months by risk |
| Disclosed limitation | Solvent loss & film-quality drift on storage |
Why two products, one platform. Clinical guidance prioritizes 38% SDF for arresting cavitated lesions, while fluoride varnish remains the workhorse for prevention and early, non-cavitated lesions. Together they cover prevention through non-restorative arrest — the right agent on the right tooth, without shared reservoirs or cross-product contamination. *On-label claim set is confirmed per jurisdiction (see Regulatory).
Conventional SDF is dripped from a multi-use bottle into a shared dappen dish; varnish is dispensed from a tube or peel-open well. Both share the same weaknesses — operator-dependent dosing, an open reservoir exposed to the oral environment, and a unit of dispensing that doesn't match the unit of care. Smile Flow re-engineers the primary presentation to solve all three.
One pre-metered dose intended for a single tooth or lesion. No shared reservoir, no carry-over between teeth or patients.
Volume is fixed by pipette geometry and fill control, giving a defined maximum available fluoride (and, for SDF, silver) per application — the foundation of the dose-safety story.
The transfer pipette is supplied sterile and single-use. The fill is, at minimum, a validated low-bioburden product; an aseptically-filled upgrade leverages Eknox sterile-manufacturing capability.
Each unit carries lot and, where regulated as a device, a UDI. Per-tooth use maps directly to per-tooth clinical coding and dose accountability.
Single-use disposal after one tooth removes reservoir cross-contamination — decisive in mobile, school and low-resource settings.
The probably-toxic dose of fluoride is on the order of 5 mg per kg of body weight. Because every Smile Flow unit is pre-metered and sealed, the maximum available fluoride per application is fixed — and it stays well under the threshold even for a small child. Explore the headroom below.
Probably-toxic dose modelled at 5 mg F⁻/kg. Figures are design targets for illustration; final fills are confirmed by fill-mass validation. Smile Flow is for professional use under clinical governance.
Both products are designed for local action with minimal systemic exposure. SDF works through complementary silver and fluoride chemistry; varnish behaves as a localized fluoride reservoir. Neither relies on systemic distribution.
Black discoloration of arrested decay is a silver-phosphate precipitate that forms where silver reacts with demineralized carious tissue. Crucially, SDF does not stain sound enamel or sound dentin — so prevention and sensitivity uses on healthy surfaces are far less likely to discolor. Black staining of treated decay is permanent and must be disclosed in informed consent. A potassium-iodide co-treatment can shift the discoloration toward a less conspicuous yellow-brown (planned line extension).
Both actives are long-established and guideline-supported. The numbers below position Smile Flow clinically and underpin the registration narrative. Each market may require its own evidence package; on-label claims are set per jurisdiction.
The same SDF solution may be a Class II device for sensitivity and a medicinal product for caries arrest. The dossier is structured to the ICH Common Technical Document so it can be lifted into jurisdiction-specific submissions. Select a market for the planning frame — this is not legal advice; every entry is confirmed with the authority and counsel.
Build the dossier once, in CTD structure, and adapt locally. Lock a conservative, defensible on-label claim set per market, and carry the full evidence base as clinical-positioning support where an indication is not yet on-label. Treat the sterile single-tooth pipette as a device / container-closure feature that is consistent across all markets — even where the medicament classification differs.
One master quality file is designed to support either a device path (ISO 13485 / US QMSR) or a medicinal-product path (pharmaceutical GMP, ICH Q7–Q10), with a quality agreement allocating release, complaint-handling and vigilance duties.
Silver & fluoride assay, pH, appearance/clarity, fill volume/mass, container-closure integrity and microbiological quality — with performance endpoints (release, tubule occlusion).
ICH Q8 · Q9 · Q10The sterile transfer pipette is a primary product feature: validated polymer compatibility, fixed-volume metering, validated sterilization with documented sterility assurance, light/solvent barrier, tamper-evidence.
CCI · E&L · SALFor SDF the watched failure is silver reduction (darkening); for varnish it is solvent loss and film drift. ICH Q1A/Q1B conditions, thermal cycling, transport and performance endpoints at initial and terminal time points.
ICH Q1A · Q1BDesign controls, supplier qualification and incoming control, process & cleaning validation (silver / fluoride / resin residues), deviation/CAPA and QA disposition.
ISO 13485 / QMSR · ICH Q7Good distribution practice with temperature/light protection through the lane; serialization / track-and-trace per market (DSCSA-style where applicable); lot & UDI on every single-use unit.
GDP · DSCSA · UDIVigilance/PV per market with a named responsible person, complaint intake, lot-level traceability, signal focus on SDF staining/consent and varnish allergy, and periodic benefit–risk review.
Device vigilance · PVLow-volume, no-tray, rapid placement suits pre-cooperative children, persons with disabilities and frail elders — exactly the populations for whom SDF and varnish are most valuable.
For ministries of health, public dental programmes, hospitals, clinics, distributors and procurement bodies. Tell us your setting and indicative volumes; the Eknox Pharma SmileFlow team will follow up with the technical dossier, classification pathway for your jurisdiction, and a supply discussion.
Thank you. The Eknox Pharma SmileFlow team will be in touch with the technical dossier and a jurisdiction-specific pathway for your market.