510(k) · Cleared
ClearedSyle Smartip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osspray, Ltd. · EFB Handpiece, Air-Powered, Dental
Cleared on Jun 3, 2010 as substantially equivalent to K991875 (KLS-Martin L.P., 1999) and 2 other predicates after a 71-day review. Its family tree reaches back 4 generations to 1979.
- Decided
- Jun 3, 2010
- Review
- 71 days
- Class
- Class I
- Product code
- EFB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K792561 (1979). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK792561 Mini-H-FixationGeny Medical, Inc. · 1979
- 3 generations backK962272 Synthes Mandible DistractorSynthes (Usa) · 1996
- 2 generations backK973275 KLS-Martin Intraoral DistractorKLS-Martin L.P. · 1997
- 1 generation backK991875 K-L-W Intraoral DistractorKLS-Martin L.P. · 1999
- This deviceK100833 Syle SmartipOsspray, Ltd. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K792561 | Mini-H-Fixation | Geny Medical, Inc. | 1979 | — |
| −3 | K962272 | Synthes Mandible Distractor | Synthes (Usa) | 1996 | — |
| −2 | K973275 | KLS-Martin Intraoral Distractor | KLS-Martin L.P. | 1997 | — |
| −1 | K991875 | K-L-W Intraoral Distractor | KLS-Martin L.P. | 1999 | — |
| 0 (this device) | K100833 | Syle Smartip | Osspray, Ltd. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 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 EFB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new EFB device
- #1 K262144 DIAMED Handpiece;DIAMED Airmotor;DIAMED…score 13.3 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K991875 | K-L-W Intraoral DistractorSummary page 1…4200 Classification Name: FIR 3. LEGALLY MARKETED PREDICATE DEVICES: 3.1 Physical characteristics and method of application: Device Name: AirFlow Handy 5 10(k) Number: K99 1875 Applicant: EMS, SA. 3.2 Physical Characteristics, Method of manufacture and method of application: Device Name: Groman PrepMast… | 1999 |
| * | K030292 | Groman PrepmasterSummary page 1…0(k) Number: K99 1875 Applicant: EMS, SA. 3.2 Physical Characteristics, Method of manufacture and method of application: Device Name: Groman PrepMaster 5 10(k) Number: K030292 Applicant: Groman Dental. 3.3 Physical and Chemical Characteristics and Mode of Action; Device Name: OSspray Cleaning Compound,… | 2003 |
| * | K062502 | Osspray Cleaning CompoundSummary page 1…licant: Groman Dental. 3.3 Physical and Chemical Characteristics and Mode of Action; Device Name: OSspray Cleaning Compound, also Trade named - Sylc'rh 5 10(k) Number: K062502 Applicant: OSspray LTD. 4. DEVICE DESCRIPTION: Syl~c'8SmarTipTm is a single-use, disposable hand-held device that utilizes a sta… | 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 31 years and passes through 4 companies; a new generation was cleared every 10.8 years on median.
- None of the 9 ancestors has a recall.
- 1 other device also cites its predicate K991875.
How does its category compare?
All EFB devicesEFB Handpiece, Air-Powered, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · EFB
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EFB
209in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EFB
No recall names EFB since 2007.
Adverse event reports per year · EFB
83in 2025
MAUDE reports naming product code EFB, 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 | 12 | 61 | 0 | 13 |
| 2008 | 7 | 97 | 0 | 19 |
| 2009 | 11 | 120 | 0 | 40 |
| 2010 | 8 | 116 | 0 | 78 |
| 2011 | 4 | 168 | 0 | 96 |
| 2012 | 8 | 130 | 0 | 97 |
| 2013 | 3 | 207 | 0 | 61 |
| 2014 | 7 | 200 | 0 | 73 |
| 2015 | 7 | 296 | 0 | 87 |
| 2016 | 3 | 205 | 0 | 122 |
| 2017 | 7 | 246 | 0 | 153 |
| 2018 | 3 | 210 | 0 | 81 |
| 2019 | 3 | 348 | 0 | 117 |
| 2020 | 5 | 259 | 0 | 94 |
| 2021 | 2 | — | 0 | 123 |
| 2022 | 5 | 430 | 0 | 157 |
| 2023 | 4 | 158 | 0 | 116 |
| 2024 | 5 | 209 | 0 | 104 |
| 2025 | 1 | — | 0 | 83 |
| 2026 | 4 | 252 | 0 | — |
What is it indicated for?
SylcTM SmarTipTrm is a disposable, single-use device containing OSspray Cleaning Compound powder, intended for prophylaxis and polishing of dental enamel surfaces and rapid relief of hypersensitivity associated with exposed tooth dentin. Studies have shown that SylcTm SmarTip'm is effective at occluding exposed dentinal tubules, which has been shown in the literature to be associated with a reduction in hypersensitivity.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100833 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100833: Syle Smartip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100833
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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