510(k) · Cleared
ClearedOralube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pulpdent Corporation · ONK Oral Lubricant
Cleared on May 21, 2009 as substantially equivalent to K896653 (Pulpdent Corp., 1990) after an 87-day review. Its family tree reaches back 1 generation to 1990.
- Decided
- May 21, 2009
- Review
- 87 days
- Class
- Class I
- Product code
- ONK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K896653 (1990). No later device cites it as a predicate yet.
- Root · 1 generation backK896653 Separating Medium (Polyvinyl Alcohol)Pulpdent Corp. · 1990
- This deviceK090457 OralubePulpdent Corporation · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K896653 | Separating Medium (Polyvinyl Alcohol) | Pulpdent Corp. | 1990 | — |
| 0 (this device) | K090457 | Oralube | Pulpdent Corporation | 2009 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in ONK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K896653 | Separating Medium (Polyvinyl Alcohol)Summary page 1…lpdent.com Watertown, MA 02472 USA DEVICE: Trade Name: Pulpdent Oratube Classification Name: Class: FDA Product Code: PREDICATE DEVICE: Pu/pdent Separating Medium K 896653 DESCRIPTION AND INTENDED USE: Pulpdent OraLube is a water-soluble, viscous liquid coating intended to be used as an intraoral an… | 1990 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All ONK devicesONK Oral Lubricant: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · ONK
1in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · ONK
Too few ONK 510(k)s in any year since 2007 to give a median.
Recalls per year · ONK
No recall names ONK since 2007.
Adverse event reports per year · ONK
No MAUDE report names ONK since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (144 words)
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090457 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090457: Oralube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090457
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026