Punch, Biopsy, Surgical
The Surgical Biopsy Punch is a circular, sharp-edged cutting instrument used to remove a small, cylindrical tissue specimen from the oral mucosa or gingiva for histopathological examination, aiding in the diagnosis of oral lesions and pathology. It is classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is EME, regulated under 21 CFR 872.4565 in the Dental (DE) specialty.
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Basic Information
- Product Code
- EME
- 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 |
|---|---|---|---|---|
| K933670 | BIOPSY PUNCH, SURGICAL | Jan 07, 1994 | Substantially Equivalent | Byron Medical |
| K911285 | PULPDENT POLYAMIDE DENTIN LINER | Oct 09, 1991 | Substantially Equivalent | Pulpdent Corp. |
| K884740 | EURO-MED LIGHT TOUCH BIOPSY PUNCH | Mar 06, 1989 | Substantially Equivalent | Buckman Co., Inc. |
FEI Numbers
This FDA classification entry is associated with 85 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 85 registration numbers. Click on an entry to view related FDA registrations.