(89 days)
Not Found
No
The description focuses on the material composition and physical properties of a dental restorative composite, with no mention of AI or ML.
No
Mosaic is described as a restorative composite used for fillings (inlays, onlays, and veneers), not for treating or curing a disease or condition. It is a material used to replace missing tooth structure.
No
This device is a dental restorative material used for fillings and repairs, not for diagnosing medical conditions.
No
The device description clearly states it is a "light-cured, bisGMA-based universal restorative composite," which is a physical material, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Mosaic's Function: Mosaic is a dental restorative material used to repair teeth. It is applied directly to the tooth structure and is not used to analyze samples taken from the body.
The description clearly indicates that Mosaic is a material used for direct and indirect restorations in the mouth, which is a therapeutic and restorative function, not a diagnostic one.
N/A
Intended Use / Indications for Use
Mosaic is used for direct and indirect restorations (inlays, onlays, and veneers) in both the anterior and posterior regions.
Product codes (comma separated list FDA assigned to the subject device)
EBF
Device Description
Mosaic is a light-cured, bisGMA-based universal restorative composite. Mosaic is radiopaque and available in multiple shades. It has a nano-hybrid composite containing zirconia-silica glass ceramic and 20 nanometer silica. Filler load is 68% by volume for the dentin shades and 56% for the enamel shades. Mosaic is supplied in multi-use syringes (4.0 grams) and single compules (0.2 grams).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior and posterior regions (for dental restorations)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Licensed dentist
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 device design, delivery form(s) and intended use of Mosaic and the predicate devices are the same or very similar. Based on the technological characteristics and performance testing, Mosaic has demonstrated it is substantially equivalent to the identified predicate device(s).
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.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized human figure or a bird in flight. The symbol is composed of three interconnected profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 21, 2015
Ultradent Products, Inc. Ms. Karen Kakunes, RN Sr. Regulatory Affairs Associate 505 West 10200 South South Jordan, UT 84095
Re: K151094
Trade/Device Name: Mosaic™ Universal Composite Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Codes: EBF Dated: April 22, 2015 Received: April 23, 2015
Dear Ms. Kakunes:
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. Isting 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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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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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. lina Kiang -S
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) K151094
Device Name Mosaic Universal Composite
Indications for Use (Describe)
Mosaic is used for direct and indirect restorations (inlays, onlays, and veneers) in both the anterior regions.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Section 5: 510(k) Summary
This summary of the Traditional 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR 807.92.
l. Applicant's Name and Address
Ultradent Products, Inc. 505 West 10200 South South Jordan, UT 84095
| Contact Person: | Karen Kakunes, RN |
|---|---|
| Title: | Sr. Regulatory Affairs Associate |
| Telephone: | 800-552-5512 x4420, 801-553-4366 |
| FAX: | 801-553-4609 |
| Date Summary Prepared: | 17 Jul 2015 |
II. Name of the Device
| Trade Name: | Mosaic™ Universal Composite |
|---|---|
| Common Name: | Tooth Shade Resin Material |
| Device Classification: | II |
| Classification Product Code: | EBF |
| Regulation No. | 21 CFR 872.3690 |
lll. Legally Marketed Predicate Devices to Which Equivalence is Claimed
Mosaic is substantially equivalent to Filtek™ Supreme Ultra Universal Restorative (K083610) and 3M™ Dent II System (K981647), both of which have been cleared under dental device product code EBF (tooth shade resin material). Mosaic is substantially similar to the predicate devices in Indications for Use, chemical composition, mechanical and physical properties, and application.
IV. Device Description:
Mosaic is a light-cured, bisGMA-based universal restorative composite. Mosaic is radiopaque and available in multiple shades. It has a nano-hybrid composite containing zirconia-silica glass ceramic and 20 nanometer silica. Filler load is 68% by volume for the dentin shades and 56% for the enamel shades. Mosaic is supplied in multi-use syringes (4.0 grams) and single compules (0.2 grams).
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V. Statement of intended use:
Mosaic is used for direct and indirect restorations (inlays, onlays, and veneers) in both the anterior and posterior regions.
VI. Indication of Risk Analysis Method:
Risk Analysis was performed on Mosaic utilizing processes based on ISO 14971:2012. Risks associated to patient safety and product efficacy for Mosaic have been identified, assessed, and controlled to level that is as low as currently feasible. Any remaining residual risks are not considered to be hazardous to patients, customers, and/or end users. Ultradent considers Mosaic to be substantially equivalent in safety and effectiveness in its intended use as compared to the predicate device.
VII. Technological Characteristics and Testing Summary:
The technological characteristics of Mosaic are very similar to those of the predicate devices, 3M™ Dent II System (K981647) and Filtek™ Supreme Ultra Universal Restorative (K083610). Mosaic is a similar product, manufactured with similar or identical materials and used in the same way by the same types of users.
Mosaic has been tested and designed in accordance with ISO 4049:2009 Dentistry -Polymer-based restorative materials. Biocompatibility testing has been assessed according to EN ISO 10993-1:2009.
The device design, delivery form(s) and intended use of Mosaic and the predicate devices are the same or very similar. Based on the technological characteristics and performance testing, Mosaic has demonstrated it is substantially equivalent to the identified predicate device(s).
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| Characteristic | Comparison Product
(3M Dent II System
K981647) | Comparison Product
(Filtek Supreme Ultra
Universal Restorative
K083610) | Mosaic Universal Composite |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Direct anterior and posterior
restorations including:
• Class III, IV, V, and VI
• Veneers
• Incisal edge repair
Direct posterior restorations
including:
• Class I or II
• Sandwich technique with
glass ionomer resin material
• Cusp buildups
Core Buildups
Splinting
Indirect anterior and posterior
restoration including:
• Inlays
• Onlays
• Veneers | Filtek Supreme Ultra
universal restorative is
indicated for use in:
• Direct anterior and
posterior restorations
(including occlusal surfaces)
• Core Build-ups
• Splinting
• Indirect restorations
including inlays, onlays and
veneers | Mosaic is used for direct and
indirect restorations (inlays,
onlays, and veneers) in both
the anterior and posterior
regions. |
| Intended user | Licensed dentist | Licensed dentist | Licensed dentist |
| Chemical
Characteristics | Bis-GMA | Bis-GMA, UDMA, TEGDMA,
PEGDMA, and Bis-EMA resins | Bis-GMA based resin |
| Delivery system | Unknown | Capsule, syringe | Compule, syringe |
| Physical
properties | 36 month shelf life, room
temperature
Radiopaque
Light Cure System | 36 month shelf life, room
temperature
Available in a variety of VITA
Shades
Radiopaque
Enamel shade: 63.3% Filled
by Volume; Translucent
shade: 55.6% Filled by
Volume | 24 month shelf life, room
temperature
Available in a variety of VITA
Shades
Radiopaque
Dentin shade: 68% Filled by
Volume; Enamel shade: 56%
Filled by Volume
Light Cure System |
| | | Light Cure System | |
| Biocompatibility | ISO 10993 | ISO 10993 | Cytotoxicity, Genotoxicity,
Delayed-Type
Hypersensitivity, Irritation |
| Functional Testing | ISO 4049 | ISO 4049:2009 | ISO 4049:2009 |
Table 5-1: Substantial equivalence comparison
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