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EME — Punch, Biopsy, Surgical Class I

FDA Device Classification

FDA product code EME covers "Punch, Biopsy, Surgical", a Class I medical device regulated under 21 CFR 872.4565. Submissions are reviewed by the Dental panel. At least 3 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
EME
Device Class
Class I
Regulation Number
872.4565
Submission Type
Review Panel
DE
Medical Specialty
Dental
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K933670byron medicalBIOPSY PUNCH, SURGICALJanuary 7, 1994
K911285pulpdentPULPDENT POLYAMIDE DENTIN LINEROctober 9, 1991
K884740buckman coEURO-MED LIGHT TOUCH BIOPSY PUNCHMarch 6, 1989

FDA data resources