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

Sleep Appliances With Patient Monitoring

21 CFR 872.5570 / Dental
FDA source (opens on fda.gov)

PLC is the FDA product code for Sleep Appliances With Patient Monitoring, a class II device type, regulated under 21 CFR 872.5570. FDA's definition for this code reads: "For the treatment of night time snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older while also measuring patient compliance to oral appliance therapy". As of , FDA records hold 10 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PLC
Device name
Sleep Appliances With Patient Monitoring
FDA definition
For the treatment of night time snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older while also measuring patient compliance to oral appliance therapy.
Regulation
21 CFR 872.5570
Device class
Class II
Review panel
Dental
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
10
Ingested recalls
0

Clearances, product code PLC

By decision year
10 clearances under product code PLC with a decision year between 2015 and 2026, 2016 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code PLC by decision year
YearClearances
20151
20162
20172
20191
20201
20241
20262

Applicants with the most clearances

Product code PLC
Applicants holding the most 510(k) clearances under product code PLC
ApplicantClearances
Somnomed Inc.2
Achaemenid, LLC1
Airway Management Inc.1
Gergens Orthodontic Lab1
Mark Abramson, D.D.S., Inc.1
Microdental, Inc.1
Prosomnous Sleep Technologies1
Prosomnus Sleep Technologies1
Residential Home Sleep Services1

Companies listing this code with FDA

Companies whose registered establishments list this code