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

Clasp, Preformed

21 CFR 872.3285 / Dental
FDA source (opens on fda.gov)

EHP is the FDA product code for Clasp, Preformed, a class I device type, regulated under 21 CFR 872.3285. As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
EHP
Device name
Clasp, Preformed
Regulation
21 CFR 872.3285
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
8
Ingested recalls
0

Clearances, product code EHP

By decision year
8 clearances under product code EHP with a decision year between 1980 and 2002, 1980 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code EHP by decision year
YearClearances
19802
19861
19952
19981
19991
20021

Applicants with the most clearances

Product code EHP
Applicants holding the most 510(k) clearances under product code EHP
ApplicantClearances
Vacudent Sales Corp.2
B & H Technical Services, Ltd.1
C&C Systems, Inc.1
Dentamax, Inc.1
Inovativ, LLC1
Micro Dental Laboratories1
Pressing di Monticelli Rag. Stefano1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 24 companies shown, in name order