Submission Details
| 510(k) Number | K162543 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 12, 2016 |
| Decision Date | August 28, 2017 |
| Days to Decision | 350 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
Cleared
Traditional
K162543 - Reverse Pull Adjustable Facemask
(FDA 510(k) Clearance)
Aug 2017
Decision
350d
Days
Class 2
Risk
K162543 is an FDA 510(k) clearance for the Reverse Pull Adjustable Facemask. This device is classified as a Headgear, Extraoral, Orthodontic (Class II — Special Controls, product code DZB).
Submitted by Sawbros Industries Pvt., Ltd. (Noida, IN). The FDA issued a Cleared decision on August 28, 2017, 350 days after receiving the submission on September 12, 2016.
This device falls under the Dental FDA 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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