ELB · Class II · 21 CFR 872.4840

FDA Product Code ELB: Scaler, Rotary

Leading manufacturers include Sybron Dental Specialties, Inc., Straumann USA and Tigran Technologies AB.

6
Total
6
Cleared
99d
Avg days
1979
Since

FDA 510(k) Cleared Scaler, Rotary Devices (Product Code ELB)

6 devices
1–6 of 6
Cleared Sep 11, 2017
TN-Brush
K170596
Genoss Co., Ltd.
Dental · 195d
Cleared Sep 17, 2012
TIGRAN PERIBRUSH
K121114
Tigran Technologies AB
Dental · 158d
Cleared Sep 12, 2011
STRAUMANN TIBRUSH
K111724
Straumann USA
Dental · 84d
Cleared Feb 22, 2001
MINIENDO III
K003640
Sybron Dental Specialties, Inc.
Dental · 87d

About Product Code ELB - Regulatory Context