Submission Details
| 510(k) Number | K923372 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 09, 1992 |
| Decision Date | April 22, 1994 |
| Days to Decision | 652 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
Cleared
Traditional
MEMORY WIRE
Apr 1994
Decision
652d
Days
Class 1
Risk
About This 510(k) Submission
K923372 is an FDA 510(k) clearance for the MEMORY WIRE, a Bracket, Metal, Orthodontic (Class I — General Controls, product code EJF), submitted by Althan, Inc. (Cincinnati, US). The FDA issued a Cleared decision on April 22, 1994, 652 days after receiving the submission on July 9, 1992. This device falls under the Dental review panel. Regulated under 21 CFR 872.5410.
Device Classification
| Product Code | EJF — Bracket, Metal, Orthodontic |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 872.5410 |
Manufacturer
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