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

Cleaner, Denture, Mechanical

21 CFR 872.3530 / Dental
FDA source (opens on fda.gov)

JER is the FDA product code for Cleaner, Denture, Mechanical, a class I device type, regulated under 21 CFR 872.3530. As of , FDA records hold 14 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
JER
Device name
Cleaner, Denture, Mechanical
Regulation
21 CFR 872.3530
Device class
Class I
Review panel
Dental
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
14
Ingested recalls
0

Clearances, product code JER

By decision year
14 clearances under product code JER with a decision year between 1978 and 1988, 1978 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code JER by decision year
YearClearances
19783
19793
19801
19832
19841
19851
19871
19882

Applicants with the most clearances

Product code JER
Applicants holding the most 510(k) clearances under product code JER
ApplicantClearances
Great Lakes Orthodontics, Ltd.2
Astron Dental Corporation1
Connoisseurs Products Corp.1
Den-Mat Corp.1
Dental Research Laboratories1
Dentsply Intl.1
Nexell Corp.1
Norcliff Thayer, Inc.1
Noxell1
Richardson Merrel, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 35 companies shown, in name order