Tip, Rubber, Oral Hygiene
A Rubber Oral Hygiene Tip is a soft dental accessory attached to a handle or toothbrush and used to massage gingival tissue, stimulate circulation in the gums, and clean interproximal areas. It is classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is JEW, regulated under 21 CFR 872.6650, within the Dental medical specialty. This device is exempt from Good Manufacturing Practice (GMP) regulations.
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Basic Information
- Product Code
- JEW
- Device Class
- FDA class 1
- Regulation Number
- 872.6650
- 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 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K862635 | RABINOWITZ GUM MASSAGER | Sep 25, 1986 | Substantially Equivalent | Arnell, Inc. |
| K843406 | CHEW-DENT | Dec 11, 1984 | Substantially Equivalent | Senair-Mot |
| K790588 | ASSAY REAGENTS, LSA 290 | May 15, 1979 | Substantially Equivalent | Kallestad Laboratories, Inc. |
FEI Numbers
This FDA classification entry is associated with 47 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 48 registration numbers. Click on an entry to view related FDA registrations.