(98 days)
Not Found
No
The 510(k) summary describes a kit of dental restorative materials and bonding agents, with no mention of software, algorithms, or any technology that would typically incorporate AI/ML. The performance studies section refers to guidance documents for dental materials, not software validation.
No
The device is described as a restorative kit used for fillings, core build-up, and bonding materials to tooth structure, which are dental repair and restoration functions, not therapeutic.
No
The device is a restorative kit used for dental fillings, inlays, onlays, and bonding, which are treatment and material application procedures, not diagnostic ones.
No
The device description clearly states it consists of three materials (Nanocomposite, Nanocomposite Flowable, and MDP One Bottle Bond), which are physical substances, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The Nanocomposite Restorative Kit is used for the direct restoration of teeth, bonding materials to tooth structure, and other dental procedures performed directly on the patient's teeth. It is a material applied to the body, not a device used to analyze samples taken from the body.
- Intended Use: The intended uses listed are all related to dental restorative procedures performed within the mouth.
- Anatomical Site: The anatomical site is "Tooth structure (dentin and enamel)," which is part of the human body, not a specimen taken from it.
Therefore, this device falls under the category of a dental restorative material used directly on the patient, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Nanocomposite Restorative Kit consists of 2 types of nanocomposite restorative materials with a compatible bonding agent. The specific indications of each kit component are as follows:
- Nanocomposite is indicated for:
- Restorations of all cavity classes
- Fabrication of direct inlays, onlays and indirect veneers
- Core build-up after tooth preparation with the root canal post
- Machinable Composite for Restorations
- Indirect Inlays/Onlays
- Nanocomposite Flowable is indicated for:
- Small fillings of cavity classes III, IV and V
- Minimally invasive fillings for deciduous teeth (all cavity classes)
- Splinting of teeth
- MDP One Bottle Bond is indicated for:
- Bonding resin-based materials (especially light-cure composite / compomer materials) to tooth structure (dentin and enamel)
Product codes (comma separated list FDA assigned to the subject device)
EBF, KLE
Device Description
The Nanocomposite Restorative Kit consists of 3 materials: Nanocomposite, Nanocomposite Flowable, and MDP One Bottle Bond.
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)
This submission is an Abbreviated 510(k) as described in FDA's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications." In support of this 510(k), DMG-USA has provided information to demonstrate conformity with FDA's guidance document entitled Guidance for Industry and FDA Staff: Dental Cements - Premarket Notification (August 1998) and Guidance for Industry and FDA Staff: Dental Composite Resin Devices -Premarket Notification [510(k)] Submissions (October 2005).
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
510(k) Summarv
| MAY 30 2008 | ||
|---|---|---|
| Trade Name: | Nanocomposite Restorative Kit | |
| Sponsor: | DMG USA, Inc. | |
| 23 Frank Mossberg Drive | ||
| Attleboro, MA 02703 | ||
| Registration # not yet assigned | ||
| Owner/Operator No. 9005969 | ||
| Device Generic Name: | Nanocomposite Restorative Kit | |
| Classification: | According to Section 513 of the Federal Food, Drug, and | |
| Cosmetic Act, the device classification is Class II. |
Product Description:
The Nanocomposite Restorative Kit consists of 3 materials:
Nanocomposite is indicated for
- Restorations of all cavity classes .
- . Fabrication of direct inlays, onlays and indirect veneers
- Core build-up after tooth preparation with the root canal post .
- . Machinable Composite for Restorations
- . Indirect Inlays/Onlays
Nanocomposite Flowable is indicated for
- . Small fillings of cavity classes III, IV and V
- Minimally invasive fillings for deciduous teeth (all cavity classes) .
- Splinting of teeth .
MDP One Bottle Bond is indicated for:
- Bonding resin-based materials (especially light-cure composite / compomer . materials) to tooth structure (dentin and enamel)
Predicate Devices:
The components of the proposed Nanocomposite Restorative Kit materials are substantially equivalent to several currently marketed dental restorative materials including the following:
Nanocomposite:
| Product Name | Predicates |
|---|---|
| SternOmega Composite LC | K982692 (Sterngold / Implamed) |
1
Nanocomposite Flowable:
| Product Name | Predicates |
|---|---|
| SternOmega Composite LC | K982692 (Sterngold / Implamed) |
MDP One Bottle Bond:
| Product Name | Predicates |
|---|---|
| Clearfil tri-S bond | K042913 (Kuraray Medical inc.) |
Safety and Performance:
This submission is an Abbreviated 510(k) as described in FDA's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications." In support of this 510(k), DMG-USA has provided information to demonstrate conformity with FDA's guidance document entitled Guidance for Industry and FDA Staff: Dental Cements - Premarket Notification (August 1998) and Guidance for Industry and FDA Staff: Dental Composite Resin Devices -Premarket Notification [510(k)] Submissions (October 2005).
Conclusion:
Based on the indications for use, technological characteristics, and comparison to the predicate devices, the Nanocomposite Restorative Kit has been shown to be safe and effective for its intended use.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 30 2008
DMG USA, Incorporated C/O Ms. Pamela Papineau Regulatory Affairs Consultant Delphi Medical Device Consulting 5 Whitcomb Avenue Ayer, Massachusetts 01432
Re: K080480
Trade/Device Names: Nanocomposite Restorative Kit Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Codes: EBF and KLE Dated: May 5, 2008 Received: May 12, 2008
Dear Ms. Papineau:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
Page 2- Ms. Papineau
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Chin Liu, Ph.D.
Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
5 May 2008 Nanocomposite Restorative Kit
Page
0:0011
510(k) Number (if known): K080480
Device Name: Nanocomposite Restorative Kit
Product Indications for Use:
The Nanocomposite Restorative Kit consists of 2 types of nanocomposite restorative materials with a compatible bonding agent. The specific indications of each kit component are as follows:
-
- Nanocomposite is indicated for:
- . Restorations of all cavity classes
- Fabrication of direct inlays, onlays and indirect veneers .
- Core build-up after tooth preparation with the root canal post .
- Machinable Composite for Restorations .
- Indirect Inlays/Onlays .
-
- Nanocomposite Flowable is indicated for:
- Small fillings of cavity classes III, IV and V D
- Minimally invasive fillings for deciduous teeth (all cavity classes) ●
- Splinting of teeth .
-
- MDP One Bottle Bond is indicated for:
- Bonding resin-based materials (especially light-cure composite / compomer . materials) to tooth structure (dentin and enamel)
| Prescription Use | X |
|---|---|
| (Per 21 CFR 801 Subpart D) |
OR
| Over-the-Counter Use | |
|---|---|
| (Per 21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Anesthesiology, General Hospital- Infection Control, Dental Devices
510(k) Number: K080486