510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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ELBClass II

Scaler, Rotary

21 CFR 872.4840 / Dental
FDA source (opens on fda.gov)

ELB is the FDA product code for Scaler, Rotary, a class II device type, regulated under 21 CFR 872.4840. As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
ELB
Device name
Scaler, Rotary
Regulation
21 CFR 872.4840
Device class
Class II
Review panel
Dental
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
6
Ingested recalls
0

Clearances, product code ELB

By decision year
6 clearances under product code ELB with a decision year between 1979 and 2017, 1979 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code ELB by decision year
YearClearances
19791
19831
20011
20111
20121
20171

Applicants with the most clearances

Product code ELB
Applicants holding the most 510(k) clearances under product code ELB
ApplicantClearances
GENOSS Co., Ltd.1
Star Dental Mfg. Co.1
Straumann USA, LLC1
Sybron Dental Specialties, Inc.1
Taco Dental, Inc.1
Tigran Technologies AB1

Companies listing this code with FDA

Companies whose registered establishments list this code