IONOSIT SEAL

K954867 · Foremost Dental Mfg., Inc. · EBC · Mar 8, 1996 · Dental

Device Facts

• Record ID: K954867
• Device Name: IONOSIT SEAL
• Applicant: Foremost Dental Mfg., Inc.
• Product Code: EBC · Dental
• Decision Date: Mar 8, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3765
• Device Class: Class 2
• 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.

Indications for Use

Indicated for sealing pits and fissures of occlusal non-carious posterior teeth in patients requiring dental caries prevention.

Regulatory Classification

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)

Submission Summary (Full Text)

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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
[phone]

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

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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