ELA · Class I · 21 CFR 872.4565

FDA Product Code ELA: Instrument, Hand, Calculus Removal

Leading manufacturers include Analytic Technology, Miltex, Inc. and Travenol Laboratories, S.A..

4
Total
4
Cleared
89d
Avg days
1980
Since

FDA 510(k) Cleared Instrument, Hand, Calculus Removal Devices (Product Code ELA)

4 devices
1–4 of 4
Cleared Aug 15, 1995
OPUS PACEMAKERS (MODELS 4021, 4033, AND 4034)
K952363
Ela Medical, Inc.
Dental · 106d
Cleared Mar 13, 1986
TRAVENOL DISPOSABLE DENTAL SCALERS/CURETTES
K854168
Travenol Laboratories, S.A.
Dental · 149d
Cleared Nov 24, 1982
DENTAL INSTRUMENTS - CUTTING INSTRUMENT
K823326
Miltex, Inc.
Dental · 16d
Cleared Nov 12, 1980
ANALYTIC TECH. METAL POINT HEATER #3001
K801974
Analytic Technology
Dental · 85d

About Product Code ELA - Regulatory Context