Ring, Teething, Non-Fluid Filled
The non-fluid-filled teething ring is a dental device for infants designed to be chewed or gnawed to relieve discomfort and pressure associated with teething, without the risk of fluid leakage associated with gel- or liquid-filled designs. It is classified as FDA Class I under 21 CFR 872.5550 within the Dental specialty, subject only to general controls. The product code is MEF and the device is not GMP-exempt. It is not implanted and does not sustain life.
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Basic Information
- Product Code
- MEF
- Device Class
- FDA class 1
- Regulation Number
- 872.5550
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K034017 | JEJE TEETHER | Oct 18, 2004 | Substantially Equivalent | Vibe 2000 |
FEI Numbers
This FDA classification entry is associated with 85 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 85 registration numbers. Click on an entry to view related FDA registrations.