The following data is part of a premarket notification filed by D B Orthodontics Ltd with the FDA for Infinitas Mini-implant Model: Db10-0009, Db10-0010,db10-0012,db10-0015,db10-0016.
| Device ID | K100633 |
| 510k Number | K100633 |
| Device Name: | INFINITAS MINI-IMPLANT MODEL: DB10-0009, DB10-0010,DB10-0012,DB10-0015,DB10-0016 |
| Classification | Implant, Endosseous, Orthodontic |
| Applicant | D B ORTHODONTICS LTD RYEFIELD WAY SILSDEN, KEIGHLEY West Yorkshire, GB Bd20 Oef |
| Contact | Anna Dyson |
| Correspondent | Anna Dyson D B ORTHODONTICS LTD RYEFIELD WAY SILSDEN, KEIGHLEY West Yorkshire, GB Bd20 Oef |
| Product Code | OAT |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-05 |
| Decision Date | 2010-04-01 |