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

Oral Lubricant

21 CFR 880.6375 / General Hospital
FDA source (opens on fda.gov)

ONK is the FDA product code for Oral Lubricant, a class I device type, regulated under 21 CFR 880.6375. FDA's definition for this code reads: "An oral lubricant to be used adjacent to hard and soft tissue and the lips to prevent adherence of dental cement; Placement of a rubber dam; And to prevent the lips from drying and cracking during dental procedures". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
ONK
Device name
Oral Lubricant
FDA definition
An oral lubricant to be used adjacent to hard and soft tissue and the lips to prevent adherence of dental cement; Placement of a rubber dam; And to prevent the lips from drying and cracking during dental procedures.
Regulation
21 CFR 880.6375
Device class
Class I
Review panel
General Hospital
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
1
Ingested recalls
0

Clearances, product code ONK

By decision year
1 clearance under product code ONK with a decision year between 2009 and 2009, 2009 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code ONK by decision year
YearClearances
20091

Applicants with the most clearances

Product code ONK
Applicants holding the most 510(k) clearances under product code ONK
ApplicantClearances
Pulpdent Corporation1

Companies listing this code with FDA

Companies whose registered establishments list this code