K891775 is an FDA 510(k) clearance for the MANDIBULAR LIP BUMPER AND LIP BUMPER TUBES. This device is classified as a Bracket, Metal, Orthodontic (Class I - General Controls, product code EJF).
Submitted by American Orthodontics (Sheboygan, US). The FDA issued a Cleared decision on May 11, 1989, 48 days after receiving the submission on March 24, 1989.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5410.
| 510(k) Number | K891775 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 24, 1989 |
| Decision Date | May 11, 1989 |
| Days to Decision | 48 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | EJF — Bracket, Metal, Orthodontic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.5410 |