Elevator, Surgical, Dental
The dental surgical elevator is an instrument used to loosen teeth from the surrounding periodontal ligament and bone prior to extraction. It is classified as FDA Class 1, representing the lowest regulatory risk, and is subject only to general controls without a premarket submission requirement. The product code is EMJ, regulated under 21 CFR 872.4565 in the Dental specialty. No special regulatory flags apply to this device.
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Basic Information
- Product Code
- EMJ
- 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 |
|---|---|---|---|---|
| K870589 | ELEVATOR, ROOT, SINGLE-ENDED | Apr 03, 1987 | Substantially Equivalent | Military Engineering, Inc. |
| K851717 | 880/1 TO 890/4 VARIOUS TYPES OF PERIOTEAL ELEVATOR | Jun 14, 1985 | Substantially Equivalent | Artiberia |
| K851713 | 680/1 TO 785/2 VARIOUS TYPES & SIZES OF ROOT ELEVA | Jun 11, 1985 | Substantially Equivalent | Artiberia |
| K850906 | TACTILE PLUS DENTAL ELEVATORS | Apr 12, 1985 | Substantially Equivalent | Ipco Corp. |
| K821788 | BEACH DERIOSTEAL ELEVATOR, #2 STRAIGHT | Jul 06, 1982 | Substantially Equivalent | Pacific Dental Corp. |
| K771747 | PERIOSTEAL ELEVATOR | Sep 28, 1977 | Substantially Equivalent | Depuy, Inc. |
FEI Numbers
This FDA classification entry is associated with 226 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 226 registration numbers. Click on an entry to view related FDA registrations.