Carver, Dental Amalgam, Operative
The Dental Amalgam Carver is a hand instrument with a sharp-edged working tip used to carve and contour freshly placed dental amalgam into proper anatomical form, reproducing the natural tooth morphology before the material fully sets. It is classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is EKH, regulated under 21 CFR 872.4565 in the Dental (DE) specialty.
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Basic Information
- Product Code
- EKH
- 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 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K823321 | DENTAL INSTRUMENTS - CARVER | Nov 24, 1982 | Substantially Equivalent | Miltex, Inc. |
| K821785 | BEACH AMALGAM CARVER | Jul 06, 1982 | Substantially Equivalent | Pacific Dental Corp. |
| K780528 | PREMIER CARVERS, STYLE #21C & 21D | Apr 19, 1978 | Substantially Equivalent | Premier Dental Products Co. |
FEI Numbers
This FDA classification entry is associated with 91 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 91 registration numbers. Click on an entry to view related FDA registrations.