JEP — Retainer, Matrix Class I
FDA product code JEP covers "Retainer, Matrix", a Class I medical device regulated under 21 CFR 872.4565. Submissions are reviewed by the Dental panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JEP
- Device Class
- Class I
- Regulation Number
- 872.4565
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K091533 | garrison dental solutions | SLICKS SECTIONAL MATRIX AND MATRIX BANDS, MODELS SM100, SM150, SM175, SM200, SM3 | August 17, 2009 |
| K930151 | innovative technology | OMNI-MATRIX | September 23, 1993 |
| K831136 | almore intl | DOUBLE BOW TOOTH SEPARATOR | June 8, 1983 |