(136 days)
Not Found
No
The device description and performance studies focus on the material properties and clinical equivalence to a predicate device, with no mention of AI or ML.
No
The device is a sealant for teeth, preventing future issues rather than treating an existing condition.
No
The device, Ionosit Seal, is a sealant used to seal pits and fissures in teeth. Its intended use is a treatment (sealing), and its performance studies relate to adhesion and leakage of the sealant, not to detecting or diagnosing a condition.
No
The device description clearly states it is a "one-component light cured liquid resin," which is a physical material, 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 to "seal the pits and fissures of occlusual non-carious posterior teeth." This is a direct treatment or preventative measure applied to the patient's teeth.
- Device Description: The device is a "one-component light cured liquid resin." This is a material applied to the teeth.
- Lack of In Vitro Testing: While there are "in-vitro tests" mentioned in the performance studies, these are standard material property tests for dental sealants (adhesion, leakage) and not tests performed on biological samples outside the body to diagnose or monitor a condition.
- Anatomical Site: The anatomical site is "occlusual non-carious posterior teeth," which are part of the patient's body.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device is applied directly to the patient's teeth for a preventative/restorative purpose.
N/A
Intended Use / Indications for 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.
Product codes
Not Found
Device Description
A one-component light cured liquid resin. Lightly filled with a fluoride containing glass powder.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Pits and fissures of occlusual non-carious posterior teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
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Summary of Performance Studies
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.
Key Metrics
P. 2 of 3
| 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 After 24 hours After 7 days | - 0.22% - 0.21% + 0.12% | - 0.22% - 0.21% - 0.07% |
| Water uptake (ISO 4049) Water solubility (ISO 4049) | 50mg/mm³ 0mg/mm³ | 30mg/mm³ 0mg/mm³ |
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3765 Pit and fissure sealant and conditioner.
(a)
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.(b)
Classification. Class II.
0
ATTACHMENT "C"
Date: February 7, 1996
M4 - 8 - -
SUMMARY STATEMENT OF SAFETY AND EFFECTIVENESS For 510(k) SUBMISSION OF IONOSIT SEAL PIT & FISSURE SEALANT
Dental Material Gesellschaft (DMG) Produced by: Elbgaustr. 248 22547 Hamburq 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.
- Ionosit Seal is a dental pit and fissure sealant Intended Use: 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 | ||
| After 24 hours | ||
| After 7 days | - 0.22% |
- 0.21%
- 0.12% | - 0.22%
- 0.21%
- 0.07% |
| Water uptake (ISO 4049)
Water solubility (ISO 4049) | 50mg/mm³
0mg/mm³ | 30mg/mm³
0mg/mm³ |
P. 2 of 3
2
| Accepted Typical Formula
Pit and Fissure Sealant
| Component | % by Weight |
|---|---|
| Bis-GMA | 35% |
| Urethane-dimethacrylate | 28% |
| Hexane-dioldimethacrylate | 27% |
| SiO₂ | 9% |
| Amine-camphor-quinane | |
| (as catalyst) | 1% |
Comparison of chemical composition:
:
| Formula
Ionosit Seal
| Component | % by Weight |
|---|---|
| Bis-GMA | 30% |
| Glass Powder | 28% |
| TEDMA | 25% |
| Aerosil (fumed silica) | 7% |
| PolyMethacrylated | 4% |
| Oligomaleic acid | 2% |
| Polyacrylic | >1% |
| Camperquinone/amine | |
| (catalyst) | >1% |
| 2,6. Di-tetributyl-hydroxytoluene | |
| (stabilizer) | >1% |
| TiO₂ | >1% |
DTW:ht file:fda.96