Submission Details
| 510(k) Number | K052553 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 16, 2005 |
| Decision Date | December 22, 2005 |
| Days to Decision | 97 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
Cleared
Traditional
K052553 - NITOM LOCKING FACEBOW
(FDA 510(k) Clearance)
Dec 2005
Decision
97d
Days
Class 2
Risk
K052553 is an FDA 510(k) clearance for the NITOM LOCKING FACEBOW, a Headgear, Extraoral, Orthodontic (Class II — Special Controls, product code DZB), submitted by Russell Samuels Orthodontic Design (Leicestershire, England, GB). The FDA issued a Cleared decision on December 22, 2005, 97 days after receiving the submission on September 16, 2005. This device falls under the Dental review panel. Regulated under 21 CFR 872.5500.
Device Classification
| Product Code | DZB — Headgear, Extraoral, Orthodontic |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 872.5500 |
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