(107 days)
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No
The device description and performance studies focus on the physical and mechanical properties of a dental composite material, with no mention of AI or ML capabilities.
No
The device is a restorative composite material used to repair tooth defects, not designed to treat a disease or health condition.
No
Explanation: The device description and intended uses clearly state that REVEAL Bulk is a restorative composite used for repairing and restoring teeth, not for diagnosing conditions. Its performance studies focus on physical and mechanical properties, not diagnostic accuracy.
No
The device description clearly states it is a "light-activated restorative composite," which is a physical material, not software. The performance studies also focus on physical and mechanical properties of the material.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses are all related to direct dental restorations and procedures performed on the patient's teeth (anterior and posterior restorations, core build-ups, splinting, etc.). IVDs are used to examine specimens from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The description clearly states it's a "light-activated restorative composite," which is a material used to fill cavities and restore tooth structure. This is a therapeutic device, not a diagnostic one.
- Anatomical Site: The anatomical sites are teeth, which are the target of the treatment, not the source of a diagnostic specimen.
- Performance Studies: The performance studies focus on physical and mechanical properties of the material (strength, wear, depth of cure, etc.) and biocompatibility, which are relevant for a restorative material, not a diagnostic test.
In summary, the device is a dental restorative material used for treatment, not a diagnostic tool used to analyze specimens from the body.
N/A
Intended Use / Indications for Use
-
- Direct anterior and posterior restorations (including occlusal surfaces)
-
- Base/liner under direct restorations
-
- Core build-ups
-
- Splinting
-
- Indirect restorations including inlays, onlays and veneers
-
- Restorations of deciduous teeth
-
- Extended fissure sealing in molars and premolars
-
- Repair of defects in porcelain restorations, enamel, and temporaries
Product codes
EBF
Device Description
REVEAL Bulk is a light-activated restorative composite, optimized to allow for simpler and faster posterior restorations. REVEAL Bulk is intended to combine superior levels of handling, depth of cure, and polishability to perform as an optimum functional and aesthetic bulk fill composite.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 following physical/mechanical properties of REVEAL Bulk were tested:
- Diametral Tensile Strength: REVEAL Bulk is equivalent to the predicates.
- Flexural Strength / Flexural Modulus (ISO 4049:2009): REVEAL Bulk meets the requirements of ISO 4049:2009 for Flexural Strength. REVEAL Bulk is equivalent to the predicate for Flexural Modulus.
- Radiopacity (ISO 4049:2009): REVEAL Bulk meets the requirements of ISO 4049:2009 for Radiopacity.
- Water Sorption and Solubility (ISO 4049:2009): REVEAL Bulk meets the requirements of ISO 4049:2009 for Water Sorption and Solubility.
- Depth of Cure (ISO 4049:2009): Predicate: 4 mm, REVEAL Bulk: 5 mm
- Volumetric Shrinkage: REVEAL Bulk is equivalent to the predicate.
- Compressive Strength: REVEAL Bulk is equivalent to the predicate.
- Wear: REVEAL Bulk is equivalent to the predicate.
- Polish Retention: REVEAL Bulk is equivalent to the predicate.
- Surface Hardness: REVEAL Bulk is equivalent to the predicate.
- Cusp Deflection: REVEAL Bulk is equivalent to the predicate.
Biocompatibility: An evaluation of biocompatibility was conducted using ISO 7405:2008 and ISO 10993-1 to determine the biocompatibility of REVEAL Bulk. It is concluded from the evaluation and the results of the Cytotoxicity testing that REVEAL Bulk meets the requirements of the testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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Image /page/0/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized image of three faces in profile, stacked on top of each other. The faces are facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 4, 2017
Bisco. Inc. Rvan Hobson Regulatory Affairs Product Registration Coordinator 1100 West Irving Park Road Schaumburg, Illinois 60193
Re: K171147
Trade/Device Name: REVEAL Bulk Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: May 10, 2017 Received: May 11, 2017
Dear Ryan Hobson:
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.
1
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 devicerelated 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Andrew I. Steen -S
for Lori Wiggins, MPT, CLT Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K171147
Device Name REVEAL Bulk
Indications for Use (Describe)
-
- Direct anterior and posterior restorations (including occlusal surfaces)
-
- Base/liner under direct restorations
-
- Core build-ups
-
- Splinting
-
- Indirect restorations including inlays, onlays and veneers
-
- Restorations of deciduous teeth
-
- Extended fissure sealing in molars and premolars
-
- Repair of defects in porcelain restorations, enamel, and temporaries
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the BISCO company logo. The logo consists of five three-dimensional hexagons in a row, alternating between red and blue. The word "BISCO" is written in large, bold letters below the hexagons, with the top half of the letters in gray and the bottom half in black.
510 (k) SUMMARY
Applicant:
Bisco, Inc. 1100 W. Irving Park Road Schaumburg IL, 60193
Contact Person:
Ryan Hobson Tel: 847-534-6143 Fax: 847-534-6143
Date Prepared: 10 May 2017
Trade Name: Common Name: Product Code: Classification/Name: REVEAL Bulk Light-Cured Bulk Fill Composite EBF Tooth Shade Resin Material Class II per 21 CFR 872.3690
Predicate Devices:
REVEAL Bulk is substantially equivalent to:
Filtek Bulk Fill Posterior Restorative, by 3M ESPE, K141081
Indications for Use:
-
- Direct anterior and posterior restorations (including occlusal surfaces)
-
- Base/liner under direct restorations
-
- Core build-ups
-
- Splinting
-
- Indirect restorations including inlays, onlays and veneers
-
- Restorations of deciduous teeth
-
- Extended fissure sealing in molars and premolars
-
- Repair of defects in porcelain restorations, enamel, and temporaries
4
Image /page/4/Picture/0 description: The image shows the logo for BISCO. The logo consists of a series of connected hexagons in red and blue colors. Below the hexagons, the word "BISCO" is written in a bold, sans-serif font, with the top half of the letters in gray and the bottom half in black.
510 (k) SUMMARY (continued)
The indications for use of REVEAL Bulk are identical to those for Filtek Bulk Fill (K141081) and are summarized in the table below:
| Filtek Bulk Fill (K141081) | REVEAL Bulk |
|---|---|
| Direct anterior and posterior restorations (including occlusal surfaces) Base/liner under direct restorations Core build-ups Splinting Indirect restorations including inlays, onlays and veneers Restorations of deciduous teeth Extended fissure sealing in molars and premolars Repair of defects in porcelain restorations, enamel, and temporaries | Direct anterior and posterior restorations (including occlusal surfaces) Base/liner under direct restorations Core build-ups Splinting Indirect restorations including inlays, onlays and veneers Restorations of deciduous teeth Extended fissure sealing in molars and premolars Repair of defects in porcelain restorations, enamel, and temporaries |
Description of Applicant Device:
REVEAL Bulk is a light-activated restorative composite, optimized to allow for simpler and faster posterior restorations. REVEAL Bulk is intended to combine superior levels of handling, depth of cure, and polishability to perform as an optimum functional and aesthetic bulk fill composite.
5
Image /page/5/Picture/0 description: The image shows the logo for BISCO. The logo consists of five connected hexagons, with the two outer hexagons being red, the middle hexagon being blue, and the two inner hexagons being white. Below the hexagons is the word "BISCO" in gray and black.
510 (k) SUMMARY (continued)
Technological Characteristics:
All components of REVEAL Bulk are based upon industry standard chemistry. The chemical composition of REVEAL Bulk is similar to Filtek Bulk Fill (K141081) summarized in the table below:
| Chemical Composition | Filtek Bulk Fill (K141081) | REVEAL Bulk |
|---|---|---|
| Filler | Inorganic glass fillers | |
| (Ceramic, Silica, Zirconia, Ytterbium | ||
| Fluoride) | Inorganic glass fillers | |
| (Barium and Ytterbium Fluoride) | ||
| Resin composition | Methacrylate based resin matrix | Methacrylate based resin matrix |
| Adhesion | Requires use of dental adhesive | Requires use of dental adhesive |
| Polymerization Method | Light induced polymerization to form | |
| a hard composite. | Light induced polymerization to form a | |
| hard composite. | ||
| Physical Mechanical Property | Filtek Bulk Fill (K141081) | Reveal Bulk |
|---|---|---|
| Radiographic Appearance | Radiopaque | Radiopaque |
| Depth of Cure | 4 mm | 5 mm |
| Delivery system | Syringe and unit-dose | Syringe and unit-dose |
The difference in filler is REVEAL Bulk's use of Barium Glass, an industry standard filler and is substantially equivalent in performance to Filtek Bulk Fill's fillers. Additionally, REVEAL Bulk's depth of cure, from a single point cure, is 5mm as determined by ISO 4049:2009(E), an improvement, and does not raise new questions of safety or efficacy. Both REVEAL Bulk and the predicate device are methacylate based light cured composite devices that require the use of a dental adhesive and are available in syringes and unit dose.
BISCO, Inc. 1100 W. Irving Park Road Schaumburg, IL 60193 U.S.A.
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Image /page/6/Picture/0 description: The image shows the BISCO company logo. The logo consists of a series of red and blue hexagons arranged in a row. Below the hexagons is the word "BISCO" in gray, block letters.
510 (k) SUMMARY (continued)
Performance Data:
The following physical/mechanical properties of REVEAL Bulk were tested:
| Physical / Mechanical Property | REVEAL Bulk |
|---|---|
| Diametral Tensile Strength | REVEAL Bulk is equivalent to the predicates. |
| Flexural Strength / Flexural | |
| Modulus | |
| (ISO 4049:2009) | REVEAL Bulk meets the requirements of ISO 4049:2009 for |
| Flexural Strength. REVEAL Bulk is equivalent to the predicate | |
| for Flexural Modulus. | |
| Radiopacity | |
| (ISO 4049:2009) | REVEAL Bulk meets the requirements of ISO 4049:2009 for |
| Radiopacity. | |
| Water Sorption and Solubility | |
| (ISO 4049:2009) | REVEAL Bulk meets the requirements of ISO 4049:2009 for |
| Water Sorption and Solubility. | |
| Depth of Cure (ISO | |
| 4049:2009) | Predicate: 4 mm, REVEAL Bulk: 5 mm |
| Volumetric Shrinkage | REVEAL Bulk is equivalent to the predicate. |
| Compressive Strength | REVEAL Bulk is equivalent to the predicate. |
| Wear | REVEAL Bulk is equivalent to the predicate. |
| Polish Retention | REVEAL Bulk is equivalent to the predicate. |
| Surface Hardness | REVEAL Bulk is equivalent to the predicate. |
| Cusp Deflection | REVEAL Bulk is equivalent to the predicate. |
Biocompatibility:
An evaluation of biocompatibility was conducted using ISO 7405:2008 and ISO 10993-1 to determine the biocompatibility of REVEAL Bulk. It is concluded from the evaluation and the results of the Cytotoxicity testing that REVEAL Bulk meets the requirements of the testing.
Conclusion:
It is concluded from review of the predicate device indications, chemical composition, biocompatibility, and physical properties that REVEAL Bulk is substantially equivalent in safety and effectiveness to the predicate device.