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

Chisel, Osteotome, Surgical

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

EMM is the FDA product code for Chisel, Osteotome, Surgical, a class I device type, regulated under 21 CFR 872.4565. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
EMM
Device name
Chisel, Osteotome, Surgical
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
4
Ingested recalls
1

Clearances, product code EMM

By decision year
4 clearances under product code EMM with a decision year between 1976 and 1996, 1976 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code EMM by decision year
YearClearances
19761
19851
19871
19961

Applicants with the most clearances

Product code EMM
Applicants holding the most 510(k) clearances under product code EMM
ApplicantClearances
American Safety Equipment Corp.1
Artiberia1
New England Surgical Instrument Corp.1
Steri-Oss, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 128 companies shown, in name order