Submission Details
| 510(k) Number | K994357 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 27, 1999 |
| Decision Date | March 14, 2000 |
| Days to Decision | 78 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
Cleared
Traditional
BITEM LOCK, MODELS SW006, SW012
Mar 2000
Decision
78d
Days
Class 1
Risk
About This 510(k) Submission
K994357 is an FDA 510(k) clearance for the BITEM LOCK, MODELS SW006, SW012, a Bracket, Metal, Orthodontic (Class I — General Controls, product code EJF), submitted by Thermoelastic Technologies, Inc. (New Port Riche, US). The FDA issued a Cleared decision on March 14, 2000, 78 days after receiving the submission on December 27, 1999. 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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