Product Code: ELJ FDA class 1 21 CFR 872.3900

Teeth, Artificial, Posterior With Metal Insert

Dental

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.

510(k)s
0
FEI Numbers
39
Registration Numbers
39
Unique Applicants
0
Years Active

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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

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

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.