The following data is part of a premarket notification filed by Russell Samuels Orthodontic Design with the FDA for Nitom Locking Facebow.
| Device ID | K052553 |
| 510k Number | K052553 |
| Device Name: | NITOM LOCKING FACEBOW |
| Classification | Headgear, Extraoral, Orthodontic |
| Applicant | RUSSELL SAMUELS ORTHODONTIC DESIGN 7 CRICKET LANE LOUGHBOROUGH, Leicestershire, England, GB Le11 3pd |
| Contact | Russell Henry Ashleigh Samuels |
| Correspondent | Russell Henry Ashleigh Samuels RUSSELL SAMUELS ORTHODONTIC DESIGN 7 CRICKET LANE LOUGHBOROUGH, Leicestershire, England, GB Le11 3pd |
| Product Code | DZB |
| CFR Regulation Number | 872.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-16 |
| Decision Date | 2005-12-22 |
| Summary: | summary |