Submission Details
| 510(k) Number | K091964 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 01, 2009 |
| Decision Date | September 24, 2009 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
Cleared
Traditional
CREST GLIDE CLINICAL GUM PROTECTION DENTAL FLOSS
Sep 2009
Decision
85d
Days
Class 1
Risk
About This 510(k) Submission
K091964 is an FDA 510(k) clearance for the CREST GLIDE CLINICAL GUM PROTECTION DENTAL FLOSS, a Floss, Dental (Class I — General Controls, product code JES), submitted by Procter & Gamble Co. (Mason, US). The FDA issued a Cleared decision on September 24, 2009, 85 days after receiving the submission on July 1, 2009. This device falls under the Dental review panel. Regulated under 21 CFR 872.6390.
Device Classification
| Product Code | JES — Floss, Dental |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 872.6390 |
Manufacturer
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