Submission Details
| 510(k) Number | K952091 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 03, 1995 |
| Decision Date | June 28, 1995 |
| Days to Decision | 56 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
Cleared
Traditional
K952091 - VUTLER G.U.M. WITH FLUORIDE
(FDA 510(k) Clearance)
Jun 1995
Decision
56d
Days
Class 1
Risk
K952091 is an FDA 510(k) clearance for the VUTLER G.U.M. WITH FLUORIDE, a Floss, Dental (Class I — General Controls, product code JES), submitted by John O. Butler Co. (Chicago, US). The FDA issued a Cleared decision on June 28, 1995, 56 days after receiving the submission on May 3, 1995. 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 |
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