# K090457: Oralube

- Pathway: 510(k) (Traditional)
- Applicant: Pulpdent Corporation
- Decided: May 21, 2009 after 87 days
- Product code: ONK (Oral Lubricant)
- Device class: 1
- Regulation: 21 CFR 880.6375
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K896653 (1990). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K896653: Separating Medium (Polyvinyl Alcohol), Pulpdent Corp. (1990) Summary page 1.

## Indications for use
OraLube is a water-soluble, viscous liquid coating intended to be used as an intraoral and perioral release agent for the following clinical situations: Taking an impression, in which OraLube is placed on the gums and inside the lip (areas not critical to the final outcome of the prosthesis) to facilitate the release of impression material and is applied to the lips and the skin around the mouth to prevent adherence of impression material. Using a dental cement, in which OraLube is applied to adjacent hard and soft tissue to prevent adherence of the cement, and to the lips and skin around the mouth. Placement of a rubber dam, in which OraLube is brushed on the tooth to be treated to facilitate slipping the rubber dam over it. Long procedures, in which OraLube can be used to protect the lips from drying out and cracking

Source page: https://510kreport.com/device/K090457
Methodology: https://510kreport.com/methodology