The following data is part of a premarket notification filed by Tigran Technologies Ab with the FDA for Tigran Peribrush.
| Device ID | K121114 |
| 510k Number | K121114 |
| Device Name: | TIGRAN PERIBRUSH |
| Classification | Scaler, Rotary |
| Applicant | TIGRAN TECHNOLOGIES AB Medeon Science Park Malmo, SE 205 12 |
| Contact | Ulf Lundgren |
| Correspondent | Ulf Lundgren TIGRAN TECHNOLOGIES AB Medeon Science Park Malmo, SE 205 12 |
| Product Code | ELB |
| CFR Regulation Number | 872.4840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-12 |
| Decision Date | 2012-09-17 |
| Summary: | summary |