Teeth, Artificial, Posterior With Metal Insert
Posterior Artificial Teeth with Metal Insert are prefabricated denture teeth intended for the posterior occlusal zone, incorporating a metal reinforcement insert to provide increased wear resistance and strength in areas of high occlusal loading within complete or partial dentures. They are classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is ELJ, regulated under 21 CFR 872.3900 in the Dental (DE) specialty.
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Basic Information
- Product Code
- ELJ
- Device Class
- FDA class 1
- Regulation Number
- 872.3900
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 4
Device Characteristics
FEI Numbers
This FDA classification entry is associated with 39 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 39 registration numbers. Click on an entry to view related FDA registrations.