The following data is part of a premarket notification filed by D B Orthodontics Ltd with the FDA for Infinitas Mini-implant System/guidance System.
| Device ID | K072086 |
| 510k Number | K072086 |
| Device Name: | INFINITAS MINI-IMPLANT SYSTEM/GUIDANCE SYSTEM |
| Classification | Implant, Endosseous, Orthodontic |
| Applicant | D B ORTHODONTICS LTD RYEFIELD WAY SILSDEN, KEIGHLEY West Yorkshire, GB Bd20 0ef |
| Contact | Anna M Dyson |
| Correspondent | Anna M Dyson D B ORTHODONTICS LTD RYEFIELD WAY SILSDEN, KEIGHLEY West Yorkshire, GB Bd20 0ef |
| Product Code | OAT |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-30 |
| Decision Date | 2007-10-26 |