(97 days)
Not Found
No
The summary describes a composite resin material for dental restorations and provides performance data from bench testing, with no mention of AI or ML technology.
No
The device is a restorative material for dental use, not a therapeutic device designed to treat a disease or condition.
No
The device is described as a restorative material (light-cured composite resin) used for direct restorations and other dental procedures, not for diagnosing conditions.
No
The device description clearly states it is a "light cured restorative micro hybrid composite resin," which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for direct anterior and posterior restorations, core build-ups, and splinting. These are all procedures performed directly on the patient's tooth structure.
- Device Description: The description confirms it's a light-cured restorative composite resin used for restorations.
- Anatomical Site: The anatomical site is the tooth structure.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health condition. IVDs are used in vitro (outside the body) to examine specimens.
This device is a dental restorative material, which is a type of medical device, but not an IVD.
N/A
Intended Use / Indications for Use
ProFil: Direct anterior & posterior restorations, Core Build ups, Splinting
ProFil Flow: Class III, V & smaller Class IV restorations, Base/liner in Class I & Class II restorations, Repair resin, porcelain & acrylic temporary materials, Pit & fissure sealant, Undercut blockout, Restoration of minimally invasive cavity preparations
Product codes (comma separated list FDA assigned to the subject device)
EBF
Device Description
The ProFil Composites are light cured restorative micro hybrid composite resins for use in both posterior and anterior restorations. The restoratives are available in a variety of tooth colored shades and are packaged in syringes and capsules.
ProFil Composites are a heterogeneous blend of organic filler. The proportion of these two components determines the physical properties of the restoration.
The resin matrix contains bisphenol A glycidyl dimethacrylate( Bis-GMA) and triethylene glycol dimethacrylate (TEDGMA) is added to decrease the viscosity.
The filler particles are silane-coated (for adhesion and coupling) barium silicate glass combined with 5 to 15 percent weight of very small-sized (0.04 micrometer) particles of colloidal silica. These Ight-cured composites include a photo-polymerizable synthetic organic resin matrix. A radiopaque oxide is added to make the composite fillings visible on radiographs.
Resin Matrix: BISGMA (bisphenol A-glycidyl methacrylate) and TEGDMA (Triethyleneglycol dimethacrylate)
Filler particles: Silica filler, Barium silicate glass combined with 5-15% weight of very small-sized (0.04 um) particles of colloidal silica.
Filler type: Micro hybrid
The polymer materials are blended together with the finely divided inorganic material such as a barium aluminosilicate glass with a trace of radiopaque oxide that renders the resultant glass radiopaque to x-rays.
Activation system: Light cured composites, photochemical initiation causes polymerization. The composites cure under halogen or LED lights (blue light).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tooth
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)
This 510(k) submission includes data from bench testing to evaluate the performance of the ProFil Composites compared to predicate devices GrandiO, Unifil Flow and Filtek Supreme Ultra Flowable. Properties evaluated include: Compressive Strength Flexural Strength Surface Hardness Water sorption Polymerization shrinkage Diametral Tensile Strength Flexural Modulus Radiopacity Water solubility
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the word "SILMET" in bold, black letters. To the right of the word, there are three small, square images with a grainy texture. The first square is mostly white with some black speckles, the second is a mix of black and white, and the third is mostly black with some white speckles. The word "SILMET" is the most prominent feature of the image.
5. 510(k) Summary
This summary of 510(k) safety and effectiveness is being submitted in accordance with requirements of 21 C.F.R. part 872.3690
Date prepared: January 24, 2011
Company
| Name | Silmet Ltd |
|---|---|
| Address | 12 Hassadna St., Industrial Park |
| Or Yehuda 60200. Israel | |
| Telephone | 972 3 5331474 |
| Fax | 972 3 5331581 |
| Contact | Moshe Zalsman |
| moshe@silmet.co.il |
FEB - 2 2011
FLA CDRIALAC
Repaired -
JAN 3 1 2011
Devices
| Trade Name: | ProFil Composites (ProFil, ProFil Flow) |
|---|---|
| Classification Name: | Tooth shade resin, material (21 CFR 872.3690) |
| Common Name: | Dental Composites and Filling Materials |
| Regulatory class: | Class II |
Predicate Devices
| GrandiO | (K051867, VOCO America) |
|---|---|
| Unifil Flow | (K020342, GC America) |
| Filtek Supreme Ultra Flowable | (K100235, 3M ESPE Dental Products) |
Description
FENS, KIT - Pollusion (1981-149
SPORTED PORT PORTERS STORE STORE SERVER ASSEMBLE OF SEPT 1.
The ProFil Composites are light cured restorative micro hybrid composite resins for use in both posterior and anterior restorations. The restoratives are available in a variety of tooth colored shades and are packaged in syringes and capsules.
Device function, scientific concept, physical and performance characteristics
ProFil Composites are a heterogeneous blend of organic filler. The proportion of these two components determines the physical properties of the restoration.
The resin matrix contains bisphenol A glycidyl dimethacrylate( Bis-GMA) and triethylene glycol dimethacrylate (TEDGMA) is added to decrease the viscosity.
The filler particles are silane-coated (for adhesion and coupling) barium silicate glass combined with 5 to 15 percent weight of very small-sized (0.04 micrometer) particles of colloidal silica. These Ight-cured composites include a photo-polymerizable synthetic organic resin matrix. A radiopaque oxide is added to make the composite fillings visible on radiographs.
11
1
Image /page/1/Picture/0 description: The image contains the word "SILMET" in bold, black letters. To the right of the word are three squares with different textures. The first square has a light, speckled texture, the second square has a darker, more dense speckled texture, and the third square is almost completely black.
Device components
Resin Matrix: BISGMA (bisphenol A-glycidyl methacrylate) and TEGDMA (Triethyleneglycol dimethacrylate)
Filler particles: Silica filler
Barium silicate glass combined with 5-15% weight of very small-sized (0.04 um) particles of colloidal silica.
Filler type: Micro hybrid
- the fillers are a mixture of different particle sizes all less than one micron (very fine colloidal silica particles, approx 0.04 microns). The extremely small filler particles lend superior polishability and allow for finer color characterization, while the composite, as a whole, remains about 70% -80% filled.
The polymer materials are blended together with the finely divided inorganic material such as a barium aluminosilicate glass with a trace of radiopaque oxide that renders the resultant glass radiopaque to x-rays.
Activation system: Light cured composites, photochemical initiation causes polymerization. The composites cure under halogen or LED lights (blue light)'
Indication for use
| Products | Indications for Use |
|---|---|
| ProFil | Direct anterior & posterior restorations |
| Core Build ups | |
| Splinting | |
| ProFil Flow | Class III, V & smaller Class IV restorations |
| Base/liner in Class I & Class II restorations | |
| Repair resin, porcelain & acrylic temporary materials | |
| Pit & fissure sealant | |
| Undercut blockout | |
| Restoration of minimally invasive cavity preparations |
Contraindications
Patients with allergies to methacrylate monomers
1 See IFU curing time table
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2
Image /page/2/Picture/0 description: The image shows the word "SILMET" in bold, black letters. To the right of the word, there are two squares filled with a grainy, speckled pattern. The pattern in the first square is lighter and more sparse, while the pattern in the second square is darker and more dense.
Table 1: Technological characteristics
| Components | Function | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Fillers | |||||||||||||
| Barium aluminosilicate | |||||||||||||
| Fumed silica | Reduces thermal expansion coefficient and overall shrinkage. | ||||||||||||
| ProFil ProFil Flow Weight of filler: 78% 60% Volume of filler: 59% 42% Particle size 0.01-3µm 0.01-2.5µm | Improves handling and aesthetic results2 | ||||||||||||
| Provides radio-opacity | |||||||||||||
| Resin matrix | |||||||||||||
| BIS-GMA (bisphenol glycidylmethacrylate) | These form highly cross linked polymer structures that results in a rigid resin matrix that is highly resistant to softening/degradation by heat and solvents. | ||||||||||||
| TEDGMA (Triethyleneglycol | |||||||||||||
| dimethacrylate) | Diluent - Increases flow and handling characteristics or provide cross linking for improved strength | ||||||||||||
| Butylated hydroxytoluence | Stabilizer:Controls the reaction of activators and resin mixtures, added to avoid spontaneous polymerization | ||||||||||||
| Extend storage lifetime | |||||||||||||
| Ensure sufficient working time | |||||||||||||
| Camphoroquinone | Photochemical initiator: interact with the amine to form free radicals that initiate polymerization |
Summary of Physical Tests
This 510(k) submission includes data from bench testing to evaluate the performance of the ProFil Composites compared to predicate devices GrandiO, Unifil Flow and Filtek Supreme Ultra Flowable. Properties evaluated include:
Compressive Strength Flexural Strength Surface Hardness Water sorption Polymerization shrinkage Diametral Tensile Strength Flexural Modulus Radiopacity Water solubility
2 The clinical choice of a composite must consider priority should be given to mechanical or aestheic requirements: if mechanical considerations are paramount the material with the greatest volume of fiesthetic considerations predominate, particle size will be the nost important factor.
3
Substantial Equivalence
The information provided in this 510(k) submission shows that the ProFil Composites are substantially equivalent to:
GrandiO (K051867, VOCO America)
Unifil Flow (K020342, GC America)
Filtek Supreme Ultra Flowable (K100235, 3M ESPE Dental Products)
The equivalence is in terms of intended use, indications for use, composition, physical properties and technological characteristics. A comparison of technological characteristics is provided below.
| Table 2: Similarity of Technological properties to predicate devices | ||
|---|---|---|
| Technological property | ProFil
Composites | GrandiO
(VOCO)
K051867 | UniFil Flow
(GC America)
K020342 | Filtek Supreme
Ultra Flowable
(3M ESPE)
K100235 |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|------------------------------|----------------------------------------|----------------------------------------------------------|
| Camphorquinone/amine photoinitiator system | X | X | X | X |
| Mehtacrylate-based resin matrix | X | X | X | X |
| Silane treated fillers | X | X | X | X |
| Bonded with a permanent dental adhesive | X | X | X | X |
| When irradiated by light, the mehtacrylate
functionalities of the resins and surface
treated fillers undergo, in conjunction with
the photointitiator system, a light induced
polymerization to form a hard composite
that is bonded to the tooth structure with a
permanent dental adhesive | X | X | X | X |
The prior use of all the components in the legally marketed predicate devices supports our decision that additional testing for bio-compatibility with the final formulation are not necessary.
We believe that the prior use of these components in legally marketed devices and the performance data and results support the safety and effectiveness of ProFil Composites for the intended use.
Conclusion
In accordance with 21 C.F.R. part 807 and FDA's " Guidance for the preparation of Premarket Notifications for Dental Composites" and based on the information provided in this premarket notification, Silmet Ltd. concludes that ProFil Composites are safe and effective and substantially equivalent to the predicate devices described herein.
SILMET LTD.
24 January 2011
CEO: Moshe Zalsman
Signature
Image /page/3/Picture/17 description: This image shows a rectangular shape with the number '#2' written on the left side. To the right of the number is an oval shape with a star inside. There is a line that goes through the number and the oval shape.
- Section of the consisted by the first
・・・・
3 may be man and the became the contraction the titler canom and the subscription of the submit of the submit of the county of stress and the superior and sound to comments
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609. Silver Spring, MD 20993-0002
Mr. Moshe Zalsman CEO SILMET Limited 12 Hasadna Or Yehuda ISRAEL 60200
FEB - 2 201
Re: K103190
Trade/Device Name: ProFil Composites (ProFil, ProFil Flow) Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin, Material Regulatory Class: II Product Code: EBF Dated: January 31, 2011 Received: January 31, 2011
Dear Mr. Zalsman:
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.
5
Page 2- Mr. Zalsman
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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Wh 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
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Image /page/6/Picture/0 description: The image shows the word "SILMET" in bold, black letters. To the right of the word is a square that is divided into two smaller squares. The square on the left is lightly shaded, while the square on the right is more darkly shaded.
- Indications for Use Statement
510(k) Number (if known): | (ס3196
Device Name: ProFil Composites (ProFil, ProFil Flow)
| Products | Indications for Use |
|---|---|
| ProFil | Direct anterior & posterior restorations |
| Core Build ups | |
| Splinting | |
| ProFil Flow | Class III, V & smaller Class IV restorations |
| Base/liner in Class I & Class II restorations | |
| Repair resin, porcelain & acrylic temporary materials | |
| Pit & fissure sealant | |
| Undercut blockout | |
| Restoration of minimally invasive cavity preparations |
Prescription Use _ V ("pri /i CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page of
Susan Pinson
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Devices Division of Anesthesion 97.
Infection Control, Dental Devices
510(k) Number: