(144 days)
No
The device description and performance studies focus on the material properties and biocompatibility of a dental composite, with no mention of AI or ML.
No.
The device is a restorative dental material used by dental professionals. It functions as a filling material, not a device that treats or prevents a disease or condition for therapeutic purposes.
No
Explanation: The device description clearly states its use as a restorative, base, and liner material, designed to release ions, and notes its physical properties for dental applications. There is no mention of it being used to diagnose conditions or diseases.
No
The device description clearly indicates it is a physical material (flowable composite) used for dental restoration, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is as a "restorative, base and liner" used by dental professionals. This describes a material used in the body to repair or fill a dental cavity, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details the composition and properties of a dental filling material. It doesn't mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
- Measuring biomarkers
The device is a dental restorative material, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
Pulpdent Solo Flowable Composite with MCP is a fluoride, calcium and phosphate-releasing flowable composite used by dental professionals as a restorative, base and liner.
Product codes (comma separated list FDA assigned to the subject device)
EBF
Device Description
Pulpdent Solo Flowable Composite with MCP is a light-cured, radiopaque, glass-filled resin with MCP (modified calcium phosphate filler) that releases calcium and phosphate ions into the oral environment and which may be formulated to release fluoride ions. Solo Flowable Composite with MCP contains no Bisphenol A, no BisGMA and no BPA derivatives. It is available in tooth shades, has low solubility, low water sorption and high physical properties.
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
Dental professionals
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)
Pulpdent Solo Flowable Composite with MCP was tested with a Cytotoxicity Test (ISO 10993-5.2009) and an Implantation Test (ANSI/ADA Specification 41 and ISO 7405) and found to be biocompatible.
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.
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/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are black against a white background.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 1, 2016
PULPDENT CORPORATION c/o Roger Mastrony MedTek LLC. 2516 Kettle Creek Court Lincolnton, North Carolina 28092
Re: K153249
Trade/Device Name: Pulpdent Solo Flowable Composite with MCP Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth-shade resin material Regulatory Class: Class II Product Code: EBF Dated: March 25, 2016 Received: March 28, 2016
Dear Mr. Roger Mastrony:
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.
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
1
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 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/Resourcesfor You/Industry/default.htm. 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 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 yours.
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: Pulpdent Solo Flowable Composite with MCP
Indications for Use:
Pulpdent Solo Flowable Composite with MCP is a fluoride, calcium and phosphate-releasing flowable composite used by dental professionals as a restorative, base and liner.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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PULPDENT CORPORATION
80 Oakland Street Watertown, MA 02472 USA
510(k) SUMMARY
DATE OF SUBMISSION: April 1, 2016
OWNER: Pulpdent Corporation 80 Oakland Street Watertown, MA 02472 USA
CONTACT: Roger S. Mastrony 2516 Kettle Creek Court Lincolnton NC 28092 Tel: 1 203 640 5047 Email: rogermastrony@gmail.com
TYPE OF SUBMISSION: Traditional 510(k).
DEVICE:
Trade Name: Pulpdent Solo Flowable Composite with MCP Device Class: II Classification Name: Tooth-shade resin material FDA Product Code: EBF
PREDICATE DEVICE:
Pulpdent ACTIVA BioACTIVE-RESTORATIVE, K130223 (Pulpdent RMGI Fill)
NOTE: Pulpdent RMGI Fill was the working name for ACTIVA BioACTIVE-RESTORATIVE that was used during the design and development of the product before a marketing name was decided upon. It is the same exact formula.
REFERENCE DEVICE:
Bosworth AEGIS V with ACP, K103585
DESCRIPTION:
Pulpdent Solo Flowable Composite with MCP is a light-cured, radiopaque, glass-filled resin with MCP (modified calcium phosphate filler) that releases calcium and phosphate ions into the oral environment and which may be formulated to release fluoride ions. Solo Flowable Composite with MCP contains no Bisphenol A, no BisGMA and no BPA derivatives. It is available in tooth shades, has low solubility, low water sorption and high physical properties.
INTENDED USE:
Pulpdent Solo Flowable Composite with MCP is a fluoride, calcium and phosphate-releasing flowable composite used by dental professionals as a restorative, base and liner.
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80 Oakland Street Watertown, MA 02472 USA
BIOCOMPATIBILITY EVALUATION:
Pulpdent Solo Flowable Composite with MCP was tested with a Cytotoxicity Test (ISO 10993-5.2009) and an Implantation Test (ANSI/ADA Specification 41 and ISO 7405) and found to be biocompatible.
COMPARISON WITH PREDICATE AND REFERENCE PRODUCTS:
| | Pulpdent Solo Flowable
Composite
K153249 / EBF | Predicate Product:
Pulpdent ACTIVA BioACTIVE
RESTORATIVE (RMGI Fill)
K130223 / EMA | Reference Product:
Bosworth AEGIS V with ACP
K103585 / EBF, EMA | |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| DESCRIPTION /
TECHNOLOGY | Light-cured, glass-filled resin
with modified calcium
phosphate | Dual-cure, resin-modified glass ionomer
with ion releasing resins and glass | Light-cured, glass-filled resin
with amorphous calcium
phosphate | |
| INTENDED USE | Dental restorative, base and
liner | Dental restorative* | Dental restorative and liner | |
| COMPOSITION | Diurethane dimethacrylate
Bis (2-(Methacryloyloxy) Ethyl)
Phosphate
Barium glass
Strontium glass
Camphorquinone
Sodium fluoride (optional)
MCP (Modified calcium
phosphate)
Colorants | Diurethane dimethacrylate
Bis (2-(Methacryloyloxy) Ethyl)
Phosphate
Barium glass
lonomer glass
Polyacrylic acid/maleic acid copolymer
Dual-cure chemistry
Sodium fluoride
Colorants. | BisGMA (Bis [4-2 (hydroxy-3-
methacryloxy propyl) phenyl]
propane-2)
Barium glass
Camphorquinone
ACP (Amorphous Calcium
phosphate) | |
| PHYSICAL PROPERTIES | | | | |
| Light cure set time | 20 seconds | 20 seconds | 20 seconds | |
| Depth of cure | 2.84 mm | 2.80 mm | | |
| Appearance | Tooth-shade paste | Tooth-shade paste | Paste | |
| Odor | Mild, characteristic | Mild, characteristic | Mild, characteristic | |
| Specific gravity | 1.810 ± 0.03 g /ml | Part A: 1.580 ± 0.02 g/mL
Part B: 1.620 ± 0.02 g/mL | 1.46 g/ml | |
| Flexural strength (MPa) | 129 ± 18.7 | 108.4 ± 14.7 | | |
| Flexural modulus GPa | 8.0 | ---- | | |
| Compressive strength
(MPa) | 330 ± 47.9 | 270 ± 14 | | |
| Diametral tensile
strength | 46.5 MPa | 44.4 ± 2.7 | | |
| | Pulpdent Solo Flowable
Composite
K153249 / EBF | Predicate Product:
Pulpdent ACTIVA BioACTIVE
RESTORATIVE (RMGI Fill)
K130223 / EMA | Reference Product:
Bosworth AEGIS V with ACP
K103585 / EBF, EMA | |
| Polymerization
shrinkage | 2.1 % | 1.7 % | | |
| Water absorption | 1.73% | 1.77% | | |
| Water solubility | 0.09 % | 0.25 % | | |
| Fluoride releasing | Yes (optional) | Yes | No | |
| Calcium releasing | Yes | Yes | Yes | |
| Phosphate releasing | Yes | Yes | Yes | |
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PULPDENT CORPORATION
80 Oakland Street Watertown, MA 02472 USA
- Note: Although the intended use of Solo Flowable and ACTIVA RESTORATIVE are not identical, in dentistry, products are often used for multiple purposes. The inclusion of the indications for use does not change the intended use of the device because placing a "base' is one step in the process of cavity restoration. The device is placed in the same location for the purpose of filling a dental cavity and restoring function. The difference between a 'base' and a 'restorative' is the amount of the device material used.
Similarities
Pulpdent Solo Flowable Composite, ACTIVA BioACTIVE-RESTORATIVE and Bosworth Aeqis V with ACP are all glass-filled resin composites that release ions into the oral environment. All the devices have the same basic structure, i.e., glass-filled resin.
Solo Flowable Composite, ACTIVA BioACTIVE-RESTORATIVE and Bosworth Aegis V with ACP are all intended to be used as dental restoratives; Solo Flowable Composite and AEGIS may also be used as a base and/or liner under cavity restorations.
Solo Flowable Composite, ACTIVA and AEGIS all release calcium and phosphate ions. Solo Flowable may be formulated to release fluoride ions like ACTIVA does.
Solo Flowable Composite and ACTIVA contain the same monomers, i.e., diurethane dimethacrylate and Bis (2-(methacryloyloxy) ethyl) phosphate.
Solo Flowable Composite and AEGIS are one-part light-cured materials. Solo Flowable Composite, ACTIVA and AEGIS all light cure in 20 seconds.
The predicate and reference medical devices have been found substantially equivalent under the 510(k) Premarket Notification process as Class II Dental Devices under CFR 872.3690 and 872.3275.
Differences
Solo Flowable Composite and ACTIVA are formulated with urethane dimethacrylate and Bis(2-(Methacryloyloxy) Ethyl) Phosphate. Bosworth Aegis V with ACP is formulated with BisGMA (Bis [4-2 (hydroxy-3-methacryloxy propyl) phenyl] propane-2). The difference is not significant because both monomers have an established history of use in dental materials and no substantial history of adverse reactions.
ACTIVA is a two-part, resin-modified glass ionomer composite that has three setting mechanisms: light cure, self-cure resin chemistry, and acid-base glass ionomer reaction. Solo Flowable Composite and AEGIS are one-part, light-cured materials. This difference in curing chemistry is not significant because they are both used extensively in dental composites, have no substantial history of adverse events, and give the dentists a choice of curing method based on the clinical situation.
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80 Oakland Street Watertown, MA 02472 USA
Conclusion
Taking into account the above similarities and differences, Pulpdent Solo Flowable Composite with MCP is substantially equivalent in design, composition, performance and intended use to ACTIVA BioACTIVE-RESTORATIVE and Bosworth Aegis V with ACP.