510(k) · Cleared
ClearedWhip Mix Preppies Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Whip-Mix Corp. · EJR Agent, Polishing, Abrasive, Oral Cavity
Cleared on Mar 26, 2014 as substantially equivalent to K915668 (Bisco, Inc., 1992) and 1 other predicate after a 282-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- Mar 26, 2014
- Review
- 282 days
- Class
- Class I
- Product code
- EJR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K915668 (1992). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK915668 Bisco Cavity CleanserBisco, Inc. · 1992
- This deviceK131760 Whip Mix Preppies PlusWhip-Mix Corp. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K915668 | Bisco Cavity Cleanser | Bisco, Inc. | 1992 | — |
| 0 (this device) | K131760 | Whip Mix Preppies Plus | Whip-Mix Corp. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
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 EJR? 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? (3)
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 |
|---|---|---|---|
| * | K915668 | Bisco Cavity CleanserSummary page 2…R Classification: Class I S. PREDICATE DEVICE INFORMATION Preppies flour of pumice (Whip Mix product 510(k) exempt) Bisco Cavity Cleanser (K915668) Ultradent Consepsis Scrub (K(925375) DEVICE DESCRIPTION Whip Mix Preppies Plus is an innovative blend of polishing and cleaning… | 1992 |
| * | K925375 | Consepsis ScrubSummary page 2…PREDICATE DEVICE INFORMATION Preppies flour of pumice (Whip Mix product 510(k) exempt) Bisco Cavity Cleanser (K915668) Ultradent Consepsis Scrub (K(925375) DEVICE DESCRIPTION Whip Mix Preppies Plus is an innovative blend of polishing and cleaning agents including 2% Chlorhexidline G… | 1993 |
| * | — | Preppies flour of pumice Named without a submission number |
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?
- None of the 2 ancestors has a recall.
- 3 other devices also cite its predicate K915668.
How does its category compare?
All EJR devicesEJR Agent, Polishing, Abrasive, Oral Cavity: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · EJR
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · EJR
Too few EJR 510(k)s in any year since 2007 to give a median.
Recalls per year · EJR
No recall names EJR since 2007.
Adverse event reports per year · EJR
4in 2025
MAUDE reports naming product code EJR, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 6 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 2 | — | 0 | 3 |
| 2011 | 2 | — | 0 | 1 |
| 2012 | 1 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 9 |
| 2014 | 1 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 10 |
| 2016 | 0 | — | 0 | 9 |
| 2017 | 1 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 8 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 6 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 4 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Whip Mix Preppies Plus is a device used as part of a professionally administered prophylaxis treatment. It is used on the tooth surface prior to;
* Restoration cementation.
* Acid etching procedures:
o Sealants
o Orthodontic brackets
o Composite restorations
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131760 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131760: Whip Mix Preppies Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131760
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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