FDA Product Code
FDA Product Code EKR — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.4565
510(k) Clearances — 6 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K060347 | B&L L-BETA, MODEL WL-B1 | B&L Biotech Co., Ltd. | 2006-06-05 | Traditional | PDF ↗ |
| K042828 | OBTURA GUTTA PERCHA DELIVERY SYSTEM, MODEL 823-700 | Young O/S, LLC | 2004-12-01 | Abbreviated | PDF ↗ |
| K031664 | ELEMENTS OBTURATION UNIT | Sybron Endo/Analytic | 2004-04-28 | Traditional | PDF ↗ |
| K860569 | ENDODONTIC ROOT CANAL PLUGGER | Dentsply Intl. | 1986-03-26 | Traditional | PDF ↗ |
| K831748 | ENDODONTIC ROOT CANAL PLUGGER FINGER- | Union Branch | 1983-07-12 | Traditional | PDF ↗ |
| K791019 | MCSPADDEN CONDENSOR | Techdent, Inc. | 1979-08-03 | Traditional | PDF ↗ |
Product code EKR · Class I · Dental. Data: openFDA.