Product code EME— Dental

BIOPSY PUNCH, SURGICAL

Classification name: Punch, Biopsy, Surgical
Device class: Class 1
Regulation: 21 CFR 872.4565
Advisory panel: Dental
Total cleared: 3
First cleared: 1989-03-06
Most recent: 1994-01-07

Market context for product code EME

FDA has cleared 3 devices under product code EME between 1989 and 1994, filed by 3 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

19941 clearance
19911 clearance
19891 clearance

Top applicants under product code EME

Pulpdent Corp.1 clearance
Byron Medical1 clearance
Buckman Co., Inc.1 clearance

Recent clearances under product code EME

K933670 — BIOPSY PUNCH, SURGICALByron Medical·1994-01-07
K911285 — PULPDENT POLYAMIDE DENTIN LINERPulpdent Corp.·1991-10-09
K884740 — EURO-MED LIGHT TOUCH BIOPSY PUNCHBuckman Co., Inc.·1989-03-06

Data sourced from openFDA. This site is unofficial and independent of the FDA.