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

Mouthpiece, Saliva Ejector

21 CFR 872.6640 / Dental
FDA source (opens on fda.gov)

DYN is the FDA product code for Mouthpiece, Saliva Ejector, a class I device type, regulated under 21 CFR 872.6640. As of , FDA records hold 18 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
DYN
Device name
Mouthpiece, Saliva Ejector
Regulation
21 CFR 872.6640
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
18
Ingested recalls
0

Clearances, product code DYN

By decision year
18 clearances under product code DYN with a decision year between 1976 and 1994, 1986 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code DYN by decision year
YearClearances
19762
19781
19802
19864
19872
19901
19922
19931
19943

Applicants with the most clearances

Product code DYN
Applicants holding the most 510(k) clearances under product code DYN
ApplicantClearances
American Instrument Manufacturer'S, Inc.1
Ardent Intl., Inc.1
ASA Instruments S.r.l.1
Carlisle Laboratories, Inc.1
Delsan Dental Systems1
Endovations1
Glenroe Technologies1
Henry Schein, Inc.1
Hygoplastic, Inc.1
J.h.orsing AB1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 149 companies shown, in name order