Protector, Silicate
The Silicate Protector is a dental material or device applied to tooth surfaces or restorations as a protective coating or sealant to reduce the solubility and surface degradation of silicate cement restorations, prolonging their clinical longevity. It is classified as FDA Class 1, the lowest risk category, and is GMP exempt, meaning it is also exempt from most good manufacturing practice requirements. The product code is EFX and the applicable regulation is 21 CFR 872.6670, under the Dental medical specialty.
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Basic Information
- Product Code
- EFX
- Device Class
- FDA class 1
- Regulation Number
- 872.6670
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 4
Device Characteristics
FEI Numbers
This FDA classification entry is associated with 13 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 13 registration numbers. Click on an entry to view related FDA registrations.