Submission Details
| 510(k) Number | K103114 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 21, 2010 |
| Decision Date | March 14, 2011 |
| Days to Decision | 144 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
Cleared
Traditional
OSSPRAY SYLC CR
Mar 2011
Decision
144d
Days
Class 1
Risk
About This 510(k) Submission
K103114 is an FDA 510(k) clearance for the OSSPRAY SYLC CR, a Agent, Polishing, Abrasive, Oral Cavity (Class I — General Controls, product code EJR), submitted by Osspray, Ltd. (London, GB). The FDA issued a Cleared decision on March 14, 2011, 144 days after receiving the submission on October 21, 2010. This device falls under the Dental review panel. Regulated under 21 CFR 872.6030.
Device Classification
| Product Code | EJR — Agent, Polishing, Abrasive, Oral Cavity |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 872.6030 |
Manufacturer
Similar Devices — EJR Agent, Polishing, Abrasive, Oral Cavity
All 76
K171189 · E.M.S Electro Medical Systems S.A
· Sep 2017
K131760 · Whip-Mix Corp.
· Mar 2014
K121698 · Dentsply International, Inc.
· Aug 2012
K102053 · Sunstar Americas, Inc.
· Feb 2011
K101104 · Voco GmbH
· Oct 2010
K100539 · Preventive Technologies, Inc.
· Jun 2010