Product code EKR
- Device name
- Plugger, Root Canal, Endodontic
- Medical specialty
- Dental
- Device class
- 1
- Regulation number
- 872.4565
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K060347 | B&L L-BETA, MODEL WL-B1 | B&L Biotech Co., Ltd. | 2006-06-05 |
| K042828 | OBTURA GUTTA PERCHA DELIVERY SYSTEM, MODEL 823-700 | Young O/S, LLC | 2004-12-01 |
| K031664 | ELEMENTS OBTURATION UNIT | Sybron Endo/Analytic | 2004-04-28 |
| K860569 | ENDODONTIC ROOT CANAL PLUGGER | Dentsply Intl. | 1986-03-26 |
| K831748 | ENDODONTIC ROOT CANAL PLUGGER FINGER- | Union Branch | 1983-07-12 |
| K791019 | MCSPADDEN CONDENSOR | Techdent, Inc. | 1979-08-03 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07899798204546 | Schobell | Schobell Industrial Ltda | 2022-12-08 |
| 07899798204539 | Schobell | Schobell Industrial Ltda | 2022-12-08 |
| 10381780386742 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-19 |
| 10381780386735 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-19 |
| 10381780386728 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-19 |
| 10381780386711 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-19 |
| 10381780385530 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-19 |
| 10381780385523 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-19 |
| 10381780385387 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-19 |
| 10381780385257 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-19 |
| 10381780385240 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-19 |
| 10381780385233 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-19 |
| 10381780385226 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-19 |
| 10381780384823 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-19 |
| 10381780203285 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-18 |
| 10381780203292 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-18 |
| 10381780203308 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-18 |
| 10381780203315 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-18 |
| 10381780203278 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-18 |
| 10381780203261 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-18 |
| 10381780203254 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-18 |
| 10381780203247 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-18 |
| 10381780203230 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-18 |
| 10381780203223 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-18 |
| 10381780203216 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-18 |
| 10381780203209 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-18 |
| 10381780203193 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-18 |
| 10381780203162 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-18 |
| 10381780203155 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-18 |
| 10381780203148 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-18 |