510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K090457Substantially Equivalent

Oralube

Pulpdent Corporation, Watertown MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K090457 is the FDA 510(k) clearance record for ORALUBE, a class I device, cleared for Pulpdent Corporation on under FDA product code ONK (Oral Lubricant). FDA's definition for product code ONK 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". FDA records list 110 510(k) clearances for Pulpdent Corporation, from to . As of , FDA records show no recalls naming K090457.

Clearance record

Decision date
Received
(87 days to decision)
Product code
ONK Oral Lubricant
Regulation
21 CFR 880.6375
Device class
Class I
Review panel
General Hospital
Applicant
Pulpdent Corporation 80 Oakland St., Watertown MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ONK

Trailing 12 months

FDA records hold no clearances under product code ONK in the trailing twelve months.

FDA records show no clearances under product code ONK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ONK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260