← Product Code [EBC](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBC) · K954867 # IONOSIT SEAL (K954867) _Foremost Dental Mfg., Inc. · EBC · Mar 8, 1996 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBC/K954867 ## Device Facts - **Applicant:** Foremost Dental Mfg., Inc. - **Product Code:** [EBC](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBC.md) - **Decision Date:** Mar 8, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.3765 - **Device Class:** Class 2 - **Review Panel:** Dental - **Attributes:** Therapeutic ## Intended Use Ionosit Seal is a dental pit and fissure sealant intended to be used to seal the pits and fissures of occlusual non-carious posterior teeth. ## Device Story Ionosit Seal is a one-component, light-cured liquid resin dental sealant. It is applied by a dental professional to the pits and fissures of non-carious posterior teeth to prevent caries. The material contains fluoride-releasing glass powder. It is cured via light activation using a catalyst system (camphorquinone/amine). The sealant acts as a physical barrier to protect tooth surfaces. Clinical benefit is the prevention of dental decay in susceptible occlusal areas. ## Clinical Evidence Bench testing only. In-vitro study comparing physical properties (compressive strength, tensile strength, modulus, shear bond strength) and chemical stability (volume change, water uptake, water solubility) against the predicate device. ## Technological Characteristics One-component light-cured liquid resin. Composition includes Bis-GMA, glass powder, TEDMA, fumed silica (Aerosil), polymethacrylated oligomaleic acid, polyacrylic acid, camphorquinone/amine catalyst, stabilizer, and TiO2. Water uptake and solubility tested per ISO 4049. ## Regulatory Identification A pit and fissure sealant and conditioner is a device composed of resin, such as polymethylmethacrylate, intended for use primarily in young children to seal pit and fissure depressions (faults in the enamel) in the biting surfaces of teeth to prevent cavities. ## Predicate Devices - Fluoro-Shield ([K862284](/device/K862284.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} ATTACHMENT "C" K954867 MAR 8 Date: February 7, 1996 SUMMARY STATEMENT OF SAFETY AND EFFECTIVENESS For 510(k) SUBMISSION OF IONOSIT SEAL PIT & FISSURE SEALANT Produced by: Dental Material Gesellschaft (DMG) Elbgaustr. 248 22547 Hamburg Germany Marketed in United States by: Foremost Dental Mfg. Co., Inc. 242 South Dean Street Englewood, NJ 07631 Contact Person: D. T. Wolf 242 South Dean Street Englewood, NJ 07631 (201) 894-5500 Predicate Product: Fluoro-Shield By: Dentsply 510(k) #K862284 Product Description: A one-component light cured liquid resin. Lightly filled with a fluoride containing glass powder. Intended Use: Ionosit Seal is a dental pit and fissure sealant intended to be used to seal the pits and fissures of occlusual non-carious posterior teeth. BASIS OF SUBSTANTIAL EQUIVALENCE: When tested in standard in-vitro tests for pit and fissure sealants, Ionosit seal material demonstrated that in the critical areas of adhesion and leakage, it was equivalent to Fluoro-Shield. Attached is this reprint from: Daniel Chan, DMD, MS, DDS, The University of Texas Health Science Center at San Antonio Dental School 7703 Floyd Curl Drive San Antonio, Texas 78284-7890 P. 1 of 3 {1} Comparison of physical properties: | | | Ionosit Seal | Fluoro-Shield | | --- | --- | --- | --- | | Compressure | | | | | Strength | mpa | 230 | 270 | | Tensile | | | | | Strength | mpa | 107 | 109 | | Tensile | | | | | Modulus | mpa | 3,000 | 3.200 | | Shear Bond Strength mpa | | | | | on Etched Enamel, 60 sec. etch | | 25 | 22 | | Change in Volume: | | | | | Immediately | | - 0.22% | - 0.22% | | After 24 hours | | - 0.21% | - 0.21% | | After 7 days | | + 0.12% | - 0.07% | | Water uptake | (ISO 4049 | 50mg/mm³ | 30mg/mm³ | | Water solubility | (ISO 4049) | 0mg/mm³ | 0mg/mm³ | {2} Comparison of chemical composition: | Accepted Typical Formula | % by Weight | | --- | --- | | Pit and Fissure Sealant | | | Component | | | Bis-GMA | 35% | | Urethane-dimethacrylate | 28% | | Hexane-dioldimethacrylate | 27% | | SiO₂ | 9% | | Amine-camphor-quinane (as catalyst) | 1% | | Formula | % by Weight | | --- | --- | | Ionosit Seal | | | Component | | | Bis-GMA | 30% | | Glass Powder | 28% | | TEDMA | 25% | | Aerosil (fumed silica) | 7% | | PolyMethacrylated | | | Oligomaleic acid | 4% | | Polyacrylic | 2% | | Camperquinone/amine (catalyst) | >1% | | 2,6. Di-tetributyl-hydroxytoluene (stabilizer) | >1% | | TiO₂ | >1% | DTW:ht file:fda.96 --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBC/K954867](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBC/K954867) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com