Carver, Wax, Dental
The Dental Wax Carver is a hand instrument with a shaped blade or tip used by dental technicians and clinicians to carve, contour, and shape dental wax patterns during the fabrication of indirect restorations such as inlays, onlays, and crowns. It is classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is EIK, regulated under 21 CFR 872.4565 in the Dental (DE) specialty.
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Basic Information
- Product Code
- EIK
- 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 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K013993 | NEOCALEX | Feb 22, 2002 | Substantially Equivalent | Stephen M Koral, Dmd |
| K972642 | PERIO CONTROL II | Jan 26, 1998 | Substantially Equivalent | Estrad B.V. |
| K902653 | PDS-2000 | Sep 13, 1990 | Substantially Equivalent | Intl. Equipment and Supply Corp. |
| K860817 | ROOT CANAL ORGANIZER | Mar 17, 1986 | Substantially Equivalent | Pacific Union Dental, Inc. |
| K851727 | 2020-1/2 TO 2220 VARIOUS DENTAL WAX & MODELLING CA | Jul 02, 1985 | Substantially Equivalent | Artiberia |
FEI Numbers
This FDA classification entry is associated with 98 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 98 registration numbers. Click on an entry to view related FDA registrations.