Cleared Traditional

ORALUBE

K090457 · Pulpdent Corporation · Dental

May 2009

Decision

87d

Days

Class 1

Risk

About This 510(k) Submission

K090457 is an FDA 510(k) clearance for the ORALUBE, a Oral Lubricant (Class I — General Controls, product code ONK), submitted by Pulpdent Corporation (Watertown, US). The FDA issued a Cleared decision on May 21, 2009, 87 days after receiving the submission on February 23, 2009. This device falls under the Dental review panel. Regulated under 21 CFR 880.6375.

Submission Details

510(k) Number	K090457 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 23, 2009
Decision Date	May 21, 2009
Days to Decision	87 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF

Device Classification

Product Code	ONK — Oral Lubricant
Device Class	Class I — General Controls
CFR Regulation	21 CFR 880.6375
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.