Plugger, Root Canal, Endodontic
The Endodontic Root Canal Plugger is a blunt-ended instrument used to compact and vertically condense gutta-percha or other filling materials within the root canal space during obturation, ensuring a dense apical fill. It is classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is EKR, regulated under 21 CFR 872.4565 in the Dental (DE) specialty.
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Basic Information
- Product Code
- EKR
- Device Class
- FDA class 1
- Regulation Number
- 872.4565
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K060347 | B&L L-BETA, MODEL WL-B1 | Jun 05, 2006 | Substantially Equivalent | B&L Biotech Co., Ltd. |
| K042828 | OBTURA GUTTA PERCHA DELIVERY SYSTEM, MODEL 823-700 | Dec 01, 2004 | Substantially Equivalent | Young O/S, LLC |
| K031664 | ELEMENTS OBTURATION UNIT | Apr 28, 2004 | Substantially Equivalent | Sybron Endo/Analytic |
| K860569 | ENDODONTIC ROOT CANAL PLUGGER | Mar 26, 1986 | Substantially Equivalent | Dentsply Intl. |
| K831748 | ENDODONTIC ROOT CANAL PLUGGER FINGER- | Jul 12, 1983 | Substantially Equivalent | Union Branch |
| K791019 | MCSPADDEN CONDENSOR | Aug 03, 1979 | Substantially Equivalent | Techdent, Inc. |
FEI Numbers
This FDA classification entry is associated with 136 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 136 registration numbers. Click on an entry to view related FDA registrations.