# K100833: Syle Smartip

- Pathway: 510(k) (Traditional)
- Applicant: Osspray, Ltd.
- Decided: Jun 3, 2010 after 71 days
- Product code: EFB (Handpiece, Air-Powered, Dental)
- Device class: 1
- Regulation: 21 CFR 872.4200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K792561 (1979). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991875: K-L-W Intraoral Distractor, KLS-Martin L.P. (1999) Summary page 1.
- K030292: Groman Prepmaster, Groman, Inc. (2003) Summary page 1.
- K062502: Osspray Cleaning Compound, Ospray, Ltd. (2006) Summary page 1.

## Indications for use
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.

Source page: https://510kreport.com/device/K100833
Methodology: https://510kreport.com/methodology