ENDODONTIC ROOT CANAL PLUGGER
FDA 510(k) clearance K860569 · decided 1986-03-26
Clearance details
- K-number
- K860569
- Device name
- ENDODONTIC ROOT CANAL PLUGGER
- Applicant
- Dentsply Intl.
- Decision
- Substantially Equivalent
- Date received
- 1986-02-11
- Decision date
- 1986-03-26
- Days to decision
- 43 days
- Clearance type
- Traditional
- Product code
- EKR
- Device class
- 1
- Regulation number
- 872.4565
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- York, PA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| B&L L-BETA, MODEL WL-B1 (K060347) | B&L Biotech Co., Ltd. | 2006-06-05 |
| OBTURA GUTTA PERCHA DELIVERY SYSTEM, MODEL 823-700 (K042828) | Young O/S, LLC | 2004-12-01 |
| ELEMENTS OBTURATION UNIT (K031664) | Sybron Endo/Analytic | 2004-04-28 |
| ENDODONTIC ROOT CANAL PLUGGER FINGER- (K831748) | Union Branch | 1983-07-12 |
| MCSPADDEN CONDENSOR (K791019) | Techdent, Inc. | 1979-08-03 |
Recalls involving this device
No recalls on record reference this clearance.