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

Scaler, Periodontic

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

EMN is the FDA product code for Scaler, Periodontic, a class I device type, regulated under 21 CFR 872.4565. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
EMN
Device name
Scaler, Periodontic
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
5
Ingested recalls
0

Clearances, product code EMN

By decision year
5 clearances under product code EMN with a decision year between 1978 and 2007, 1978 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code EMN by decision year
YearClearances
19781
19821
19851
19941
20071

Applicants with the most clearances

Product code EMN
Applicants holding the most 510(k) clearances under product code EMN
ApplicantClearances
Artiberia1
Kevin Vu, Dds1
Minnesota Prophy Power, Inc.1
Pacific Dental Corp.1
Premier Dental Products Co1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 219 companies shown, in name order