Kit, Earmold, Impression
An earmold impression kit is a materials set used in audiology and hearing aid fitting to take anatomical impressions of the ear canal and concha, which are used to fabricate custom-fitted earmolds or hearing aid shells. It is classified as FDA Class 1, the lowest risk tier, subject only to general controls with no premarket notification required. The product code is LDG, regulated under 21 CFR 874.3300, in the Ear, Nose, Throat specialty. No special risk flags apply.
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Basic Information
- Product Code
- LDG
- Device Class
- FDA class 1
- Regulation Number
- 874.3300
- Medical Specialty
- Ear, Nose, Throat
- Review Panel
- EN
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.