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

Unit, Syringe, Air And/Or Water

21 CFR 872.4565 / Dental
FDA source (opens on fda.gov)

ECB is the FDA product code for Unit, Syringe, Air And/Or Water, a class I device type, regulated under 21 CFR 872.4565. As of , FDA records hold 12 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
ECB
Device name
Unit, Syringe, Air And/Or Water
Regulation
21 CFR 872.4565
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
12
Ingested recalls
0

Clearances, product code ECB

By decision year
12 clearances under product code ECB with a decision year between 1978 and 1994, 1986 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code ECB by decision year
YearClearances
19781
19801
19862
19891
19911
19922
19932
19942

Applicants with the most clearances

Product code ECB
Applicants holding the most 510(k) clearances under product code ECB
ApplicantClearances
A-dec, Inc.1
Almore Intl., Inc.1
Bull Frog Mfg. Co.1
Dw Industries, Inc.1
Norcliff Thayer, Inc.1
Pacific Dental Corp.1
Rama Corp.1
Richard Wolf Medical Instruments Corp.1
Riskontrol1
Sds Dental, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 136 companies shown, in name order