(97 days)
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.
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.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria in a dedicated table format with corresponding reported performance values. Instead, it describes a "Summary of Physical Tests" and then presents a "Similarity of Technological properties to predicate devices" table to establish substantial equivalence.
However, based on the context, the implicit acceptance criteria for the ProFil Composites are that their physical properties and technological characteristics are comparable to or within acceptable ranges of the predicate devices.
Implicit Acceptance Criteria and Reported Device Performance (as inferred from the document):
| Physical / Technological Property | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Physical Tests | Comparable to predicate devices (GrandiO, Unifil Flow, Filtek Supreme Ultra Flowable) | Bench testing data was included in the 510(k) submission to evaluate performance. (Specific values are not provided in the summary.) |
| Compressive Strength | ||
| Flexural Strength | ||
| Surface Hardness | ||
| Water Sorption | ||
| Polymerization Shrinkage | ||
| Diametral Tensile Strength | ||
| Flexural Modulus | ||
| Radiopacity | ||
| Water Solubility | ||
| Technological Properties | Present in predicate devices | Present ("X") in ProFil Composites |
| Camphorquinone/amine photoinitiator system | Present | X |
| Methacrylate-based resin matrix | Present | X |
| Silane treated fillers | Present | X |
| Bonded with a permanent dental adhesive | Present | X |
| Light-induced polymerization mechanism | Operates as described | X |
2. Sample Size Used for the Test Set and the Data Provenance
The document mentions "data from bench testing" but does not provide specific details on the sample sizes used for these tests. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective) for these bench tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable and not provided in the document. The study described is bench testing of material properties, not a clinical study requiring expert assessment of outcomes or images for ground truth establishment.
4. Adjudication Method for the Test Set
This information is not applicable and not provided in the document. As stated above, this was bench testing of material properties, not a study involving human readers or clinical outcomes requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This information is not applicable and not provided in the document. The device in question is a dental composite material, not an AI-powered diagnostic or assistive device for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable and not provided in the document. The device is a dental material, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the bench tests would be the measured physical and chemical properties of the materials themselves, determined by standardized laboratory methods, and then compared to the established properties of the predicate devices. It is not expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
This information is not applicable and not provided in the document. There is no mention of a "training set" as this is not a machine learning or AI-driven device.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided in the document, as there is no training set mentioned or implied.
Summary of the Study Proving Substantial Equivalence:
The study proving the device meets its implicit acceptance criteria is a series of bench tests that evaluated various physical properties of the ProFil Composites (Compressive Strength, Flexural Strength, Surface Hardness, Water sorption, Polymerization shrinkage, Diametral Tensile Strength, Flexural Modulus, Radiopacity, Water solubility). The results of these bench tests were compared to those of three predicate devices: GrandiO, Unifil Flow, and Filtek Supreme Ultra Flowable.
The document emphasizes that "the information provided in this 510(k) submission shows that the ProFil Composites are substantially equivalent" to the predicate devices in terms of intended use, indications for use, composition, physical properties, and technological characteristics. The table comparing technological properties (Table 2) highlights the shared components and mechanisms (e.g., photoinitiator system, resin matrix type, silane-treated fillers, bonding method, polymerization process) as a key part of establishing this equivalence. The prior use of these components in legally marketed predicate devices is cited to support the safety and effectiveness without requiring additional biocompatibility testing of the final formulation.
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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 ParkOr 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
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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 restorationsCore Build upsSplinting |
| ProFil Flow | Class III, V & smaller Class IV restorationsBase/liner in Class I & Class II restorationsRepair resin, porcelain & acrylic temporary materialsPit & fissure sealantUndercut blockoutRestoration of minimally invasive cavity preparations |
Contraindications
Patients with allergies to methacrylate monomers
1 See IFU curing time table
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Table 1: Technological characteristics
| Components | Function | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Fillers | |||||||||||||
| Barium aluminosilicateFumed 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 results2Provides 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 (Triethyleneglycoldimethacrylate) | 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 polymerizationExtend storage lifetimeEnsure 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.
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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 | ProFilComposites | GrandiO(VOCO)K051867 | UniFil Flow(GC America)K020342 | Filtek SupremeUltra 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 mehtacrylatefunctionalities of the resins and surfacetreated fillers undergo, in conjunction withthe photointitiator system, a light inducedpolymerization to form a hard compositethat is bonded to the tooth structure with apermanent 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
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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.
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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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- 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:
§ 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.