Plate, Base, Shellac
The Shellac Base Plate is a dental device made from shellac material used as a foundation for fabricating record bases and occlusal rims in the construction of complete or partial dentures, providing a rigid temporary base for recording jaw relationships. 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 EEA and the applicable regulation is 21 CFR 872.6200, under the Dental medical specialty.
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Basic Information
- Product Code
- EEA
- Device Class
- FDA class 1
- Regulation Number
- 872.6200
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 4
Device Characteristics
FEI Numbers
This FDA classification entry is associated with 35 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 35 registration numbers. Click on an entry to view related FDA registrations.