Disk, Abrasive
The Abrasive Disk is a dental instrument consisting of a circular abrasive-coated disc used to contour, finish, and polish restorations, remove tooth structure, or smooth surfaces on prosthetic materials during operative and laboratory procedures. It is classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is EHJ, regulated under 21 CFR 872.6010 in the Dental (DE) specialty. This device is exempt from GMP requirements.
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Basic Information
- Product Code
- EHJ
- Device Class
- FDA class 1
- Regulation Number
- 872.6010
- 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 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K911111 | MICROMILLS, PATRIOTS, ALPHA GOLD DIAMONDS | Nov 19, 1991 | Substantially Equivalent | Vermont Diamond Instruments |
| K873002 | MIN-IDENTOFLEX | Aug 17, 1987 | Substantially Equivalent | Centrix, Inc. |
| K790640 | HOWMEDICA BRASS CENTER DISC | May 01, 1979 | Substantially Equivalent | E.C. Moore Co. |
| K771658 | IDENTOFLEX | Sep 12, 1977 | Substantially Equivalent | Cavitron Corp. |
FEI Numbers
This FDA classification entry is associated with 90 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 90 registration numbers. Click on an entry to view related FDA registrations.