ELZClass I

Crown, Preformed

21 CFR 872.3330 / Dental

ELZ is the FDA product code for Crown, Preformed, a class I device type, regulated under 21 CFR 872.3330. As of 2026-09-10, FDA records hold 9 510(k) clearances under this code, the most recent dated 2009-06-29, and 4 recalls.

Classification record

Product code: ELZ
Device name: Crown, Preformed
Regulation: 21 CFR 872.3330
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: 9
Ingested recalls: 4

Clearances, product code ELZ

By decision year

9 clearances under product code ELZ with a decision year between 1977 and 2009, 1977 the highest year at 2.

Show the numbers

510(k) clearances under FDA product code ELZ by decision year
Year	Clearances
1977	2
1988	1
1989	1
1991	2
1993	1
1994	1
2009	1

Applicants with the most clearances

Product code ELZ

Applicants holding the most 510(k) clearances under product code ELZ
Applicant	Clearances
George M. Wilson, Dds	3
Ez-Pedo, Inc.	1
Parker Laboratories, Inc.	1
South American Dental Exporting Corp.	1
Sterndent Corp.	1
Svenska Dental Instruments AB	1
Whitecap Dental Co.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 127 companies shown, in name order