(144 days)
No
The device description and performance studies focus on the physical and chemical properties of the ceramic powder and its mechanical action, with no mention of AI or ML.
Yes
The device is intended for the removal of decayed enamel and provides relief of hypersensitivity, addressing a health condition in the oral cavity.
No
The device is described as a product for removing weakened or decayed enamel, cleaning surfaces, and providing relief for hypersensitivity, making it a treatment device rather than a diagnostic one.
No
The device description clearly states it is a "single-phase calcium phosphosilicate ceramic product" and a "dry inorganic particulate," indicating it is a physical substance, not software. It is applied via an air polishing or air abrasion delivery system, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a product for the removal of weakened enamel, cleaning tooth surfaces, and providing relief of hypersensitivity. These are all direct treatments or procedures performed on the patient's body (in vivo).
- Device Description: The device is a powder applied via an air polishing or air abrasion system to abrade tissue and occlude tubules. This is a physical interaction with the patient's tissues.
- Lack of In Vitro Testing: While there are performance studies mentioned, they focus on biocompatibility and tubule occlusion efficacy using an in vitro dentin block model. This is a test of the device's performance, not a diagnostic test performed on a patient sample to provide diagnostic information.
- No Mention of Patient Samples: IVDs typically involve testing patient samples (blood, urine, tissue, etc.) to diagnose, monitor, or screen for conditions. This device does not involve the analysis of any patient samples.
In summary, the device is a therapeutic or procedural device used directly on the patient's teeth, not a diagnostic device used to analyze patient samples in vitro.
N/A
Intended Use / Indications for Use
OSspray Sylc CR compound is a single-phase calcium phosphosilicate ceramic product intended for the removal of weakened or decayed small enamel lesions, in addition to the cleaning of enamel surfaces and providing relief of hypersensitivity associated with exposed dentin and open dentinal tubules.
Product codes
EJR
Device Description
OSspray Sylc CR is a biologically-compatible device designed to selectively remove weakened or decayed carious enamel without damaging underlying healthy enamel in addition to cleaning tooth surfaces and closing exposed dentine tubules.
The device when applied as a dry powder via an air polishing or air abrasion delivery system to a decayed enamel surface will abrade away the decayed tissue.
The process of cleaning the tooth surface physically occludes exposed dentin tubules for the management of sensitive teeth.
OSspray cares removal powder is a dry inorganic particulate, (calcium phosphosilicate), composed of elements that occur naturally in the body's hard tissues (Ca, Na, Si, P, and O). To aid powder flow less than 2% by weight of silicon dioxide (Aerosil R972 Pharma) is added to the calcium phosphosilicate.
Bench testing has shown that Sylc CR is a more accurate method for selectively removing decayed dental tissue than traditional dental burs and aluminum oxide air abrasion
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
enamel surfaces, dentin tubules, tooth surface
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The biocompatibility of OSspray Sylc CR, with 2% by weight silicon dioxide flow aid (Aerosil R972 Pharma) was evaluated for cytotoxicity (L-929), intracutaneous irritation sensitization sensitization. The results of these tests indicate that there is no evidence of any hazardous effects to the patient if the product is used as directed.
The tubule occlusion efficacy of OSspray Svlc CR was evaluated using an in vitro dentin block model. The results indicate that OSspray Sylc CR compound occludes a statistically equivalent number of tubules when compared with OSspray Cleaning Compound.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.6030 Oral cavity abrasive polishing agent.
(a)
Identification. An oral cavity abrasive polishing agent is a device in paste or powder form that contains an abrasive material, such as silica pumice, intended to remove debris from the teeth. The abrasive polish is applied to the teeth by a handpiece attachment (prophylaxis cup).(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
0
510(k) Premarket Notification
CONFIDENTIAL
OSSpray Ltd
OSSpray Sylc-CR
SECTION E 510(k) SUMMARY
103114 MAR 1 4 2011
1. SUBMITTER INFORMATION:
Name: Address: OSspray Ltd. Hodgkin Building King's College London Guys Hospital Campus London SEI IUL
Phone: +44 (0)207 188 4341 Facsimile: +44 (0)207 188 4360
Contact: Ian Thompson, Ph.D.
Preparation Date: September 2010
2. DEVICE NOMENCLATURE:
Trade Name: OSspray Sylc CR Common Name: Calcium Phosphosilicate Classification Name: (EJR) Agent, Polishing, Abrasive, Oral Cavity
3. LEGALLY MARKETED PREDICATE DEVICE:
Device Name: OSspray Cleaning Compound 510(k) Number: K062502 Applicant: OSspray Ltd, Hodgkin Building, King's College London, Guys Hospital Campus, London, SE1 1UL
4. DEVICE DESCRIPTION:
OSspray Sylc CR is a biologically-compatible device designed to selectively remove weakened or decayed carious enamel without damaging underlying healthy enamel in addition to cleaning tooth surfaces and closing exposed dentine tubules.
The device when applied as a dry powder via an air polishing or air abrasion delivery system to a decayed enamel surface will abrade away the decayed tissue.
The process of cleaning the tooth surface physically occludes exposed dentin tubules for the management of sensitive teeth.
OSspray cares removal powder is a dry inorganic particulate, (calcium phosphosilicate), composed of elements that occur naturally in the body's hard tissues (Ca, Na, Si, P, and O). To aid powder flow less than 2% by weight of silicon dioxide (Aerosil R972 Pharma) is added to the calcium phosphosilicate.
Bench testing has shown that Sylc CR is a more accurate method for selectively removing decayed dental tissue than traditional dental burs and aluminum oxide air abrasion
Confidential
3/10/2011
1
5. INTENDED USE:
OSspray Sylc CR compound is a single-phase calcium phosphosilicate ceramic product intended for the removal of weakened or decaved small enamel lesions, in addition to the cleaning of enamel surfaces and providing relief of hypersensitivity associated with exposed dentin and open dentinal tubules.
6. Technological Characteristics:
The technological characteristics of OSspray Sylc CR and FDA cleared OSspray Cleaning Compound (K062502) are identical, except for particle size and the addition of up to 2 wt% silicon dioxide flow aid (Aerosil R972 Pharma). Both devices clean tooth enamel, desensitize and are a single-phase dry powder.
The primary difference between the two devices is that OSspray Sylc CR has a smaller particle size distribution of 5-50 microns. Sylc CR is designed to selectively remove weakened enamel or caries decay. This process requires the particle flow, delivered via an air polishing or abrasion unit, to be focused onto the weakened enamel site for a short period of time. The kinetic energy of the particles is such that it is able to selectively remove any weakened or infected enamel and leave healthy or affected enamel intact. The OSspray Cleaning Compound has a mean particle size distribution of 55-75 microns and is designed to remove heavy stain and plaque.
Neither OSspray Cleaning Compound nor Sylc CR is suitable for the removal of bulk healthy enamel.
The OSspray Sylc CR is a bioactive glass intended to remove decayed enamel by abrasion of weakened enamel when the powder is directed at the tooth surface in a compressed air stream.
7. SAFETY AND PERFORMANCE DATA:
The biocompatibility of OSspray Sylc CR, with 2% by weight silicon dioxide flow aid (Aerosil R972 Pharma) was evaluated for cytotoxicity (L-929), intracutaneous irritation sensitization sensitization. The results of these tests indicate that there is no evidence of any hazardous effects to the patient if the product is used as directed.
The tubule occlusion efficacy of OSspray Svlc CR was evaluated using an in vitro dentin block model. The results indicate that OSspray Sylc CR compound occludes a statistically equivalent number of tubules when compared with OSspray Cleaning Compound.
8. CONCLUSIONS:
OSspray Sylc CR compound is considered to be equivalent in cleaning and desensitization properties to that of OSspray Cleaning Compound. The provided in vitro performance and biocompatibility data demonstrate the substantial equivalence of OSspray Sylc CR compound for the intended uses.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring a symbol that resembles an abstract bird or a series of interconnected human figures.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Dr. Ian Thompson Technical Director OSspray, Limited Hodgkin Building, Kings College London London, United Kingdom SE1 1UL
MAR 1 4 201
Re: K103114 Trade/Device Name: OSspray Sylc CR Regulation Number: 21 CFR 872.6030 Regulation Name: Oral Cavity Abrasive Polishing Agent Regulatory Class: I Product Code: EJR Dated: December 12, 2010 Received: February 2, 2011
Dear Dr. Thompson:
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.
3
Page 2- Dr. Thompson
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 (QS) 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Anthony D. Martson
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
4
SECTION D STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known): 上 () 3/14
Device Name: OSspray Sylc CR
INDICATIONS FOR USE:
OSspray Sylc CR compound is a single-phase calcium phosphosilicate ceramic product intended for the removal of weakened or decayed small enamel lesions, in addition to the cleaning of enamel surfaces and providing relief of hypersensitivity associated with exposed dentin and open dentinal tubules.
(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 _________________________________________________________________________________________________________________________________________________________
Susan Bunner
(Division Sign-Off) Division of Anesthestology, General Hospital Infection Control, Dental Devices
510(k) Number: