EHYClass I

Tray, Impression, Preformed

21 CFR 872.6880 / Dental

EHY is the FDA product code for Tray, Impression, Preformed, a class I device type, regulated under 21 CFR 872.6880. As of 2026-09-10, FDA records hold 16 510(k) clearances under this code, the most recent dated 1994-07-22, and 3 recalls.

Classification record

Product code: EHY
Device name: Tray, Impression, Preformed
Regulation: 21 CFR 872.6880
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: 16
Ingested recalls: 3

Clearances, product code EHY

By decision year

16 clearances under product code EHY with a decision year between 1978 and 1994, 1984 the highest year at 4.

Show the numbers

510(k) clearances under FDA product code EHY by decision year
Year	Clearances
1978	2
1980	2
1981	2
1983	1
1984	4
1985	1
1986	1
1988	1
1990	1
1994	1

Applicants with the most clearances

Product code EHY

Applicants holding the most 510(k) clearances under product code EHY
Applicant	Clearances
Buffalo Dental Mfg Co Inc	2
Di-Equi Dental Products	2
J. Aderer, Inc.	2
Advantage Dental Co.	1
Dentauraum, Inc.	1
Dentsply Intl.	1
Ivoclar North America, Inc.	1
Kerr Corporation (Danbury)	1
L.A.K. Ent., Inc.	1
Market Masters, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 314 companies shown, in name order