EIEClass I

Dam, Rubber

21 CFR 872.6300 / Dental

EIE is the FDA product code for Dam, Rubber, a class I device type, regulated under 21 CFR 872.6300. As of 2026-09-10, FDA records hold 33 510(k) clearances under this code, the most recent dated 2019-05-03, and one recall.

Classification record

Product code: EIE
Device name: Dam, Rubber
Regulation: 21 CFR 872.6300
Device class: Class I
Review panel: Dental
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: Yes
Third party review eligible: No
Ingested clearances: 33
Ingested recalls: 1

Clearances, product code EIE

By decision year

33 clearances under product code EIE with a decision year between 1978 and 2019, 1989 the highest year at 4.

Show the numbers

510(k) clearances under FDA product code EIE by decision year
Year	Clearances
1978	1
1984	2
1985	2
1986	2
1988	1
1989	4
1990	2
1991	1
1992	2
1993	1
1994	1
1995	1
1996	2
1998	2
2001	1
2002	3
2004	1
2005	2
2016	1
2019	1

Applicants with the most clearances

Product code EIE

Applicants holding the most 510(k) clearances under product code EIE
Applicant	Clearances
Aseptico, Inc.	3
Elastomade Accessories Sdn Bhd	3
Britesmile, Inc.	2
Dental Dam, Inc.	2
The Hygenic Company, LLC	2
Bioenvelop Agro, Inc.	1
Center for Marketing Services	1
Columbus Dental Mfg. Co.	1
Cost Rite Health Products, Inc.	1
Delsan Dental Systems	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 110 companies shown, in name order