510(k) · Cleared
ClearedButler Calci-Flor Prophylaxis Paste
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sunstar Americas, Inc. · EJR Agent, Polishing, Abrasive, Oral Cavity
Cleared on Feb 3, 2011 as substantially equivalent to K952091 (John O. Butler Co., 1995) and 2 other predicates after a 196-day review. Its family tree reaches back 3 generations to 1993.
- Decided
- Feb 3, 2011
- Review
- 196 days
- Class
- Class I
- Product code
- EJR
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K925409 (1993). 6 ancestors in all, the oldest K912945 (1991). No later device cites it as a predicate yet.
- Root · 3 generations backK925409 Oral-B Dental Floss with FluorideOral-B Laboratories · 1993
- 2 generations backK935440 Johnson & Johnson Fluoride Dental Floss, Mint WaxedJohnson & Johnson Consumer Products, Inc. · 1994
- 1 generation backK952091 Vutler G.U.M. with FluorideJohn O. Butler Co. · 1995
- This deviceK102053 Butler Calci-Flor Prophylaxis PasteSunstar Americas, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K925409 | Oral-B Dental Floss with Fluoride | Oral-B Laboratories | 1993 | — |
| −2 | K935440 | Johnson & Johnson Fluoride Dental Floss, Mint Waxed | Johnson & Johnson Consumer Products, Inc. | 1994 | — |
| −1 | K952091 | Vutler G.U.M. with Fluoride | John O. Butler Co. | 1995 | — |
| 0 (this device) | K102053 | Butler Calci-Flor Prophylaxis Paste | Sunstar Americas, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 2006 | 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 |
|---|---|---|---|
| * | K952091 | Vutler G.U.M. with FluorideSummary page 1…Device Class: I Legally Marketed BUTLER G.U.M. WITH FLUORIDE Predicate Devices JOHN 0. BUTLER CO. K95209 1 ProCode: JES SATIN PROPHYLAXIS PASTE… | 1995 |
| * | K912945 | Satin Prophylaxis PasteSummary page 1…ProCode: JES SATIN PROPHYLAXIS PASTE DENTSPLY INTL. K912945 ProCode: EJR ENAMEL PRO PR… | 1991 |
| * | K062166 | Enamel ProSummary page 1…ProCode: EJR ENAMEL PRO PREMIER DENTAL PRODUCTS CO. K062 166 ProCode: EJR Device Description Butler®8 Calci-Flor Prophylaxis Paste is an oral… | 2006 |
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?
- The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- None of the 6 ancestors has a recall.
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. 2011, 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?
Butler® Calci-Flor Prophylaxis Paste is intended for cleaning and polishing procedures as part of a professionally administered dental prophylaxis treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102053 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102053: Butler Calci-Flor Prophylaxis Paste.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102053
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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