Submission Details
| 510(k) Number | K182017 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 27, 2018 |
| Decision Date | April 29, 2019 |
| Days to Decision | 276 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
Cleared
Traditional
K182017 - Compex HD
(FDA 510(k) Clearance)
Apr 2019
Decision
276d
Days
Class 1
Risk
K182017 is an FDA 510(k) clearance for the Compex HD, a Composite Resin Warmer (Class I — General Controls, product code QGO), submitted by Addent, Inc. (Danbury, US). The FDA issued a Cleared decision on April 29, 2019, 276 days after receiving the submission on July 27, 2018. This device falls under the Dental review panel. Regulated under 21 CFR 872.6100.
Device Classification
| Product Code | QGO — Composite Resin Warmer |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 872.6100 |
| Definition | Intended To Warm Composite Materials Prior To Use |