(135 days)
Not Found
No
The device description and performance studies focus on the physical and chemical properties of the denture resins, with no mention of AI or ML technology.
No
These resins are used for creating and repairing dental prosthetic devices, not for directly treating a medical condition or ailment.
No
The device is a material (resin) used for manufacturing and repairing dental prosthetics, not for diagnosing medical conditions.
No
The device description clearly states it is composed of acrylic and polyamide resins, which are physical materials, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the resins are for manufacturing, relining, repairing, and rebasing dental prosthetics and appliances. This is a mechanical and structural application, not a diagnostic one.
- Device Description: The description details the composition and application methods of the resins, which are materials used to build or repair physical structures.
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue, etc.) or to provide information about a patient's health status or disease.
- Performance Studies: The performance studies focus on the physical and mechanical properties of the resins (flexural strength, bonding strength, water sorption, etc.), which are relevant to their use as a structural material in the mouth. They do not involve diagnostic accuracy metrics.
IVD devices are specifically designed to perform tests on biological samples to diagnose, monitor, or screen for diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
Dentsoll High Dental Denture Resins are intended for manufacturing, relining, repairing, and rebasing of partial or full removable dentures, dental plates, bite plates, personal trays, appliances, occlusal splints and night guards.
Product codes
EBI
Device Description
Dentsoll High Dental Denture Resins are acrylic and polyamide resins for use in creating, relining, repairing, and rebasing denture bases. They are available in clear or pink colors. The Rezen NF and Acrytone resin granules can be used for injection molding and the ISO FAST self curing resin is mixed and applied as a liquid for repairs.
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 results of non-clinical testing demonstrated that the devices are safe and effective. Device testing of the Dentsoll High Dental Denture Resins was conducted in accordance with ISO ISO 20795-1 Denture Base Polymers. Testing included physical appearance, surface property, hue stability, transparency, presence of air bubbles, flexural strength, flexural elasticity, bonding strength with a dental implant, presence of residuals, water sorption, and solubility.
Biocompatibility: Dentsoll High Dental Denture Resins are formed into surface contacting dental devices with limited (less than 24 hours) contact duration. Biocompatibility of the resins was analyzed in accordance with ISO 10993. Testing included the following:
ISO 10993-5 Cytotoxicity - pass
ISO 10993-10 Sensitization - pass
ISO 10993-11 Systemic Toxicity - pass
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.
0
Appendix 1
JUL 2 6 2013
510(k) Summary
K130680 510(k) Summary Pursuant to 21 CFR 807.92
General Company Information
| Company Name: | Dentsoll, Inc. |
|---|---|
| Company Address: | 5836 Buford Hwy. #A, |
| Norcross, GA 30071 |
Company Telephone:
Contact:
Contact Address:
770-314-5226
May 8, 2013
David C. Furr, MS FDC Services, LLC
8708 Capehart Cove Austin, Texas 78733 (512) 906-9654
Date:
Device Trade Names:
Classification Name and Reference:
Predicate Devices:
ACRYTONE, REZEN NF, and
ISO FAST denture resins
Resin, Denture, Relining, Repairing, Rebasing Product Code EBI 21 CFR§872.3760
PalaXpress ultra Heraeus Kulzer, LLC K110037, Cleared 04/29/2011
1
DEFLEX NUXEN S.R.L. K113608, Cleared 04/10/2012
Dentsoll High Dental Denture Resins are acrylic and polyamide resins for use in creating, relining, repairing, and rebasing denture bases. They are available in clear or pink colors. The Rezen NF and Acrytone resin granules can be used for injection molding and the ISO FAST self curing resin is mixed and applied as a liquid for repairs.
Intended Use:
Device Description:
Dentsoll High Dental Denture Resins are intended for manufacturing, relining, repairing, and rebasing of partial or full removable dentures, dental plates, bite plates, personal trays, appliances, occlusal splints and night guards.
Performance Data:
(Nonclinical and/or Clinical): The results of non-clinical testing demonstrated that the devices are safe and effective. Device testing of the Dentsoll High Dental Denture Resins was conducted in accordance with ISO ISO 20795-1 Denture Base Polymers. Testing included physical appearance, surface property, hue stability, transparency, presence of air bubbles, flexural strength, flexural elasticity, bonding strength with a dental implant, presence of residuals, water sorption, and solubility.
Biocompatibility:
Dentsoll High Dental Denture Resins are formed into surface contacting dental
2
devices with limited (less than 24 hours) contact duration. Biocompatibility of the resins was analyzed in accordance with ISO 10993. Testing included the following:
ISO 10993-5 Cytotoxicity - pass ISO 10993-10 Sensitization - pass ISO 10993-11 Systemic Toxicity - pass
There are no significant differences between the Dentsoll High Dental Denture Resins and the predicate devices. All devices are tested to meet ISO 20795 and ISO 10993. Formulations, presentation, and colors are very similar. The devices are substantially equivalent.
Conclusion:
5
3
Image /page/3/Picture/12 description: The image shows the logo of the Department of Health & Human Services (HHS). The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or body. To the left of the graphic, there is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-0002
July 26, 2013
Dentsoll, Incorporated C/O Mr. David C. Furr, MS FDC Services, Limited Liability Company 8708 Capehart Cove . Austin, Texas 78733
Re: K130680
Trade/Device Name: Dentsoll - High Dental Denture Resins Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, or Rebasing Resin Regulatory Class: 11 Product Code: EBI Dated: March 12, 2013 Received: May 14, 2013
Dear Mr. Furr:
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.
4
Page 2 - Mr. Furr
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 (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/McdicalDevices/Safety/ReportalProblem/dcfault.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,
Mary S. Runner -S
Kwame Ulmer. M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Premarket Notification Dentso!! - High Dental Denture Resins
Indications for Use Statement
130680
510(k) Number:
Device Name: Dentsoll - High Dental Denture Resins
Indications For Use:
Dentsoll High Dental Denture Resins are intended for manufacturing, relining, repairing, and rebasing of partial or full removable dentures, dental plates, bite plates, personal trays, appliances, occlusal splints and night guards.
Prescription Use X (per CFR 801.109)
or
Over-the-counter use
Concurrence of CDRH
Sheena A. Greet 2013.07.26 11 138 00 000
for M. Susan Runner, DDS, MA
(Division Sign-Off) Islon of Anesthestology, General Hospital Infection Control, Dental Device 510(k) Number: