SylcTM SmarTip™ 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 Sylc™ SmarTip™ is effective at occluding exposed dentinal tubules, which has been shown in the literature to be associated with a reduction in hypersensitivity.

Device Description

Sylc™ SmarTip™ is a single-use, disposable hand-held device that utilizes a standard dental hand piece air source, and is designed to project a stream of dry particulate onto a tooth surface to clean tooth surfaces and close exposed dentin tubules. The process of cleaning the tooth surface physically occludes dentin tubules for the management of sensitive teeth. The powder chamber contains OSspray Cleaning Compound (K062502) which is a dry inorganic particulate, (calcium sodium phosphosilicate). When exposed to an aqueous environment, the material undergoes a rapid surface reaction, allowing it to physically adhere to exposed dentin and to physically occlude tubules. Within a short period of time, essentially all of the particles react to form hydroxycarbonate apatite (HCA), which is chemically and structurally similar to natural tooth mineral.

AI/ML Overview

The Sylc™ SmarTip™ device is intended for prophylaxis and polishing of dental enamel surfaces and rapid relief of hypersensitivity associated with exposed tooth dentin. The provided information details in vitro performance and biocompatibility data to demonstrate the safety and efficacy of the device.

Here's an breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Effectiveness of cleaning on extrinsic stains	Sylc™ SmarTip™ is effective at cleaning extrinsic stains on teeth.
Effectiveness of tubule occlusion on dentin slabs	Sylc™ SmarTip™ occludes a statistically significant number of tubules when compared with negative controls. The OSspray Cleaning Compound contained in the device undergoes a rapid surface reaction to physically adhere to exposed dentin and physically occlude tubules. This reaction forms hydroxycarbonate apatite (HCA), similar to natural tooth mineral.
Delivery of appropriate amounts of OSspray Cleaning Compound	Sylc™ SmarTip™ is effective in delivering appropriate amounts of the OSspray Cleaning Compound to the tooth surface.
Connection integrity at 45psi air pressure	Performance testing demonstrated that the connection of the SmarTip to the adapter and air hose remained intact when subjected to air pressure of 45psi.
No leaks at 45psi max pressure	Performance testing demonstrated no leaks in the units at 45psi max pressure.
Proper powder expulsion at 45psi max pressure	Performance testing demonstrated that powder was expelled properly at 45psi max pressure.
Biocompatibility for patient safety	The OSspray Cleaning Compound (K062502) has been evaluated for cytotoxicity (ISO 10993-5), intracutaneous irritation (ISO 10993-10), and sensitization (ISO 10993-10). The results indicated no evidence of hazardous effects to the patient if the product is used as directed. The materials used in the device (medical grade polypropylene and surgical grade 316L stainless steel) are also considered biocompatible components.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: The performance testing for cleaning and tubule occlusion was conducted on a "statistically relevant number of samples." The exact numerical sample size is not specified in the provided document.
Data Provenance: The studies were in-vitro studies conducted on "dentin slabs." The country of origin of the data is not explicitly stated. Based on the submitter's address (United Kingdom), it is reasonable to infer the studies might have been conducted there or by a contracted lab. The studies are by definition prospective as they were specifically designed experiments, although they used in-vitro models rather than human subjects.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not provided in the document, as the studies are described as in-vitro performance tests and not human-read clinical studies requiring expert ground truth establishment for diagnostic accuracy.

4. Adjudication Method for the Test Set:

This information is not applicable as the studies described are in-vitro performance tests and not human-read clinical studies requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. The performance testing described focuses on the device's technical capabilities (cleaning, occlusion, structural integrity) in an in-vitro setting, not on reader performance or improvement with AI assistance. The device itself is not an AI-assisted diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This question is not relevant as the Sylc™ SmarTip™ is a mechanical device for dental prophylaxis and hypersensitivity relief, not an algorithm or AI system. The performance tests described measure the device's intrinsic capabilities.

7. The Type of Ground Truth Used:

For the in-vitro performance studies:

Cleaning Effectiveness: The "ground truth" would likely be established by objective measurements of stain removal (e.g., spectrophotometry or visual scoring against a validated scale by a trained observer), although specific methods are not detailed.
Tubule Occlusion: The "ground truth" was established by comparing the number of occluded tubules in dentin slabs treated with Sylc™ SmarTip™ against negative controls. This would typically involve microscopic examination (e.g., scanning electron microscopy) and quantitative analysis.
Mechanical Integrity (connections, leaks, powder expulsion): The "ground truth" was established by direct physical measurement and observation under specified air pressure (45psi).

8. The Sample Size for the Training Set:

This information is not applicable as the device is not an AI system that requires a training set. The descriptions are of direct performance testing.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable as the device is not an AI system.

Summary

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K100833

SECTION E 510(k) SUMMARY

JUN - 3 2010

1. SUBMITTER INFORMATION:

OSspray Ltd. Name: Address: 37 The Moor Melbourn Royston Herts SG8 6ED United Kingdom

Phone:	+44 (0)207 188 4341
Facsimile:	+44 (0)207 188 4360

Contact: Ian Thompson, Ph.D. Preparation Date: March 2010

2. DEVICE NOMENCLATURE:

Trade Name: Sylc™ SmarTip™ Common Name: n/a Regulation Code: 872.4200 Classification Name: EJR

3. LEGALLY MARKETED PREDICATE DEVICES:

3.1 Physical characteristics and method of application:

Device Name: AirFlow Handy 510(k) Number: K991875 Applicant: EMS, SA.

3.2 Physical Characteristics, Method of manufacture and method of application:

Device Name: Groman PrepMaster 510(k) Number: K030292 Applicant: Groman Dental.

3.3 Physical and Chemical Characteristics and Mode of Action:

Device Name: OSspray Cleaning Compound, also Trade named - Sylc™ 510(k) Number: K062502 Applicant: OSspray LTD.

4. DEVICE DESCRIPTION:

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The powder chamber contains OSspray Cleaning Compound (K062502) which is a dry inorganic particulate, (calcium sodium phosphosilicate). When exposed to an aqueous environment, the material undergoes a rapid surface reaction, allowing it to physically adhere to exposed dentin and to physically occlude tubules. Within a short period of time, essentially all of the particles react to form hydroxycarbonate apatite (HCA), which is chemically and structurally similar to natural tooth mineral.

5. INTENDED USE:

Sylc™ SmarTip™ is a disposable, single-use product intended for the prophylaxis and polishing of enamel surfaces and to provide rapid relief of hypersensitivity associated with exposed tooth dentin. Studies have shown that OSspray Cleaning Compound contained in the device is effective at occluding exposed dentinal tubules, which has been shown in the literature to be associated with a reduction in hypersensitivity.

6. TECHNOLOGICAL CHARACTERISTICS:

The technological characteristics of Sylc™ SmarTip™ and AirFlow Handy are similar, but not identical. Both devices function by mixing the polishing powder with compressed air, accelerating the particles through a tube to impact against the target tooth surface. Both devices use standard compressed air available at the dental operatory chair.

The primary difference between the two devices is that Sylc™ SmarTip™ is a single use, disposable device that comes with a reusable adapter that delivers OSspray Cleaning Compound (K062502). The SmartTip is discarded after each use whereas the AirFlow Handy is a reusable device that must be disassembled and sterilized after every use. AirFlow Handy has a built in powder chamber which can be filled with any number of dry powders for the intended application.

Sylc™ SmarTip™ and Groman PrepMaster are both disposable single use devices that comes pre filled with a dry powder. Sylc™ SmarTip™ and Groman PrepMaster are manufactured using the same materials and operate using the same principles. Both devices use standard compressed air at the operatory. Both use standard adapters to connect to the operatory air supply to mix the dry powder with air in the chamber and expel it onto the tooth surface. Sylc™ SmarTip™ differs from PrepMaster in that Sylc™ SmarTip™ is filled with OSspray Cleaning Compound identical to that cleared in 510(k) K062502, and is used in a standard prophylaxis and polishing procedures whereas the PrepMaster utilizes other dry powder compounds.

7. SAFETY AND PERFORMANCE DATA:

The Performance Testing was conducted with Sylc™ SmarTip™ on a statistically relevant number of samples to demonstrate the effectiveness of cleaning and of tubule occlusion on dentin slabs in-vitro. The results indicate that Sylc™ SmarTip™ is effective delivering appropriate amounts of OSspray Cleaning Compound to the tooth surface and that it is effective at cleaning extrinsic stains on teeth and that it occludes a statistically significant number of tubules when compared with negative controls.

Performance testing was also conducted to insure that the connection of the SmarTip to the adapter and air hose remained intact when subjected to air pressure of 45psi. In addition, this testing demonstrated that at 45psi max pressure there were no leaks in the units and that powder was expelled properly.

The biocompatibility of the OSspray Cleaning Compound contained within the device has previously been evaluated for cytotoxicity (1-929), intracutaneous irritation sensitization. The results of these tests indicate that there is no evidence of any hazardous effects to the patient if the product is

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used as directed. (See 510(k) K062502). The materials used in the manufacture of the Sylc™ SmarTip™ device are medical grade polypropylene and surgical grade 316L stainless steel.

8. CONCLUSIONS:

Sylc™ SmarTip™ is considered to be substantially equivalent to the legally marketed predicate device, AirFlow Handy (K99187) and Groman PrepMaster (K030292). Furthermore, the material delivered to the patient is the OSspray Cleaning Compound (K062502). The provided in vitro performance and biocompatibility data demonstrate the safety and efficacy of Sylc™ SmarTip™ for the intended uses.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and tail feathers. The eagle is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

OSspray, Limited C/O Mr. David C. Greenspan President Spinode Consulting 3116 N.W. 62nd Terrace Gainesville, Florida 32606

JUN - 3 2010

Re: K100833

Trade/Device Name: Sylc™ SmarTip" Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Codes: EFB and EJR Dated: March 17, 2010 Received: March 24, 2010

Dear Mr. Greenspan:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.\

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

h for

Anthony D. Watson, B.S., M.S., M.B.A.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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SECTION D STATEMENT OF INDICATIONS FOR USE

100833 510(k) Number (if known):

Device Name: SylcTM SmarTipTM

INDICATIONS FOR USE:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X

OR (Per 21 CFR 801.109) Over-The-Counter Use ----

RSBetz DDS for K.L. Mulvey

(Division Sign-Off) Division of Anesthesiology. General Hosp Infection Control, Dental Devices

510(k) Number: K100833

Regulation Number and Section

§ 872.4200 Dental handpiece and accessories.

(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.