(295 days)
No
The summary describes a dental sealant material and its physical properties, with no mention of AI or ML.
No
The device is used to prevent cavities and repair composite restorations, which are considered prophylactic and restorative functions, not therapeutic.
No
The device, Prevent Seal, is used to fill and seal teeth, cover composite restorations, and repair them. These are treatment procedures aimed at preventing cavities or restoring teeth, not diagnosing conditions.
No
The device description clearly states that Prevent Seal is a physical material (a fluoride releasing, white, light-cured acrylate resin) used for dental procedures, not a software program.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Prevent Seal's Intended Use: Prevent Seal is used by dental professionals to fill and seal pits and fissures on teeth, cover composite restorations, and repair composite restorations. This is a direct application to the tooth structure within the mouth.
- Device Description: The description of Prevent Seal as a fluoride releasing, white, light-cured acrylate resin further supports its use as a dental material applied directly to the tooth.
- Anatomical Site: The anatomical site is listed as "Teeth," which are part of the body but the application is external to the internal biological processes that IVDs analyze.
Therefore, Prevent Seal is a dental material used for restorative and preventative purposes on teeth, not a diagnostic test performed on samples taken from the body.
N/A
Intended Use / Indications for Use
Prevent Seal is used by dental professionals primarily in young children:
- to fill and seal pit and fissure depressions (faults in the enamel) of teeth to prevent . cavities:
- . covering layer or "initial layer" in the fabrication of esthetically demanding composite restorations; and
- . for repairs of composite restorations (in particular filling of voids, leveling out of porosities and minor chips).
Product codes
EBC
Device Description
Prevent Seal is a fluoride releasing, white, light-cured acrylate resin. Not manufactured with Bisphenol A.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth
Indicated Patient Age Range
young children
Intended User / Care Setting
dental professionals
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)
The following laboratory results demonstrate that Prevent Seal performs as intended:
| Flexural Strength (MPa) | 250 |
|---|---|
| Compressive Strength (MPa) | 160 |
| Shear Bond Strength to Etched Enamel (MPa) | 35 |
| Light Curing Time @ 23°C (sec) | 20 |
| Sensitivity to Ambient Light @ 22°C (sec) | 75 |
| Film Thickness (μm) | 10 |
| Radiopacity | Yes |
| Wavelength (nm) | 465 |
| Intensity of the light source (mW/sqcm) | 600 |
| Shade | White |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Flexural Strength: 250 MPa
- Compressive Strength: 160 MPa
- Shear Bond Strength to Etched Enamel: 35 MPa
- Light Curing Time @ 23°C: 20 sec
- Sensitivity to Ambient Light @ 22°C: 75 sec
- Film Thickness: 10 μm
- Wavelength: 465 nm
- Intensity of the light source: 600 mW/sqcm
Predicate Device(s)
HelioSeal F K932078, IPS Empress Direct Flow K103528
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
510(k) Summary
K122521
- Name/Address of Submitter: Itena Clinical JUN 1 1 2013 83 avenue Foch 75116 Paris FRANCE 2.
Contact Person: Louis-Paul Marin Co-President, BCF Certification inc. Phone: (514) 397-5546 (514) 397-8515 Fax: Email: Ipmarin@bcf.ca
- Date Summary Prepared: July 30th, 2012
-
- Devices Names: Prevent Seal
. 5. Device Classification: II
- Devices Names: Prevent Seal
-
- Common name: Pit and Fissure Sealant
-
Classification Product Code: EBC; 21 CFR 872.3765 7.
8. Predicate Devices:
HelioSeal F K932078 IPS Empress Direct Flow K103528
9. Device Description:
Prevent Seal is a fluoride releasing, white, light-cured acrylate resin. Not manufactured with Bisphenol A.
10. Indication for Use:
Prevent Seal is used by dental professionals primarily in young children:
- to fill and seal pit and fissure depressions (faults in the enamel) of teeth to prevent . cavities:
- . covering layer or "initial layer" in the fabrication of esthetically demanding composite restorations; and
- . for repairs of composite restorations (in particular filling of voids, leveling out of porosities and minor chips).
1
11. Comparison with Predicate Products:
Prevent Seal is substantially equivalent in design, composition, intended use and performance to the predicate products listed above, notably as regards the following:
| Technological
Characteristics | Subject Device | HelioSeal F
K932078 | IPS Empress Direct Flow
K103528 |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Type | light-cured acrylate
resin | light-cured
acrylate
resin | light-cured acrylate resin |
| Intended Use | • to fill and seal
pit and fissure
depressions
(faults in the
enamel) of teeth
to prevent
cavities;
• covering layer or
"initial layer" in
the fabrication of
esthetically
demanding
composite
restorations;
• for repairs of
composite
restorations (in
particular filling
of voids,
leveling out of
porosities and
minor chips). | To fill and
seal the pits
and fissures
of teeth. | • As an intermediate or covering layer
in the fabrication of esthetically
demanding composite restorations
• Repair of composite restorations (in
particular filling of voids, levelling
out of porosities and minor chips)
• As a thin (