NLC — Bracket, Plastic, Orthodontic, Reprocessed Class II
FDA product code NLC covers "Bracket, Plastic, Orthodontic, Reprocessed", a Class II medical device regulated under 21 CFR 872.5470. Submissions are reviewed by the Dental panel.
Classification Details
- Product Code
- NLC
- Device Class
- Class II
- Regulation Number
- 872.5470
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- No
Definition
same as DYW except it is being reprocessed. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).