Product Code: EMD
FDA class 1
21 CFR 872.4565
Hemostat, Surgical
Dental
The Surgical Hemostat is a dental hand instrument with locking, ratcheted handles and serrated beaks used to clamp blood vessels, grasp tissue, and apply hemostatic pressure to control bleeding during oral surgical procedures. It is classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is EMD, regulated under 21 CFR 872.4565 in the Dental (DE) specialty.
510(k)s
2
FEI Numbers
122
Registration Numbers
122
Unique Applicants
2
Years Active
15
Basic Information
- Product Code
- EMD
- Device Class
- FDA class 1
- Regulation Number
- 872.4565
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 4
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 122 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 122 registration numbers. Click on an entry to view related FDA registrations.