(71 days)
Not Found
Not Found
No
The provided text describes a dental stabilization device and does not mention any AI or ML components or functionalities.
Yes
The device is described as stabilizing, immobilizing, and splinting teeth, which are therapeutic actions aimed at treating or alleviating conditions related to dental trauma or recovery.
No
The intended uses described for GrandTEC primarily involve stabilization, reinforcement, and temporary treatment of teeth and are therapeutic or supportive in nature, not diagnostic.
No
The provided text describes a device intended for dental applications involving the physical stabilization and splinting of teeth. The intended uses clearly indicate a physical material or structure is being used, not a software application. There is no mention of software, data processing, or any digital component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are all related to the mechanical stabilization and support of teeth and dental structures within the patient's mouth. This is a direct interaction with the patient's body, not the examination of samples taken from the body.
- Device Description: While the description is "Not Found," the intended uses clearly point to a device used for physical support and stabilization in a dental context.
- No mention of biological samples: There is no indication that this device is used to test or analyze biological samples (like blood, urine, tissue, etc.) outside of the body.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health. This device's function is entirely different.
N/A
Intended Use / Indications for Use
GrandTEC is intended for the following applications:
- Stabilisation of teeth:
- After orthodontic treatment
- After periodontal treatment
- For support in treating trauma:
- For immobilising and splinting avulsed and loosened teeth
- Fragment anchoring after fracture
- For the reinforcement/fabrication of provisional bridges made from composite and provisional C & B material
- For temporary treatment after extraction and replacement of a missing tooth with the use of a plastic tooth
- For the temporary or semi-permanent treatment of a tooth space with the use of an extracted natural tooth
- For temporary treatment after placing an implant during the osseointegration of the implant
Product codes
EBI
Device Description
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
Image /page/0/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all caps. The text is written in a simple, sans-serif font and is horizontally aligned. The words are evenly spaced, and the overall appearance is clean and professional.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Contro} Room -WO66-G609 Silver Spring. MD 20993-0002
Dr. T. Gerkensmeier Regulatory Affairs Voco GMBH Anton-Flettner-Strasse 1-3 Cuxhaven Germany D-27472
001 2 9 2010
Re: K102347
Trade/Device Name: GrandTEC Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, or Rebasing Resin Regulatory Class: II Product Code: EBI Dated: August 13, 2010 Received: August 19, 2010
Dear Dr. Gerkensmeier:
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
Page 2- Dr. Gerkensmeier
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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.
for
Anthony D. Watson, B.S., M.S., M.B.A. Director Director of Anesthesiology, General Hospital,
Infection Control and Dental Devices Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
2
Indications for Use Statement
| 510(k) Number: | K10-2347 | OCT 29 2010 |
|---|---|---|
| Device Name: | GrandTEC |
Indications for Use:
GrandTEC is intended for the following applications:
- Stabilisation of teeth:
- After orthodontic treatment
- After periodontal treatment
- For support in treating trauma:
- For immobilising and splinting avulsed and loosened teeth
- Fragment anchoring after fracture
- For the reinforcement/fabrication of provisional bridges made from composite and provisional C & B material
- For temporary treatment after extraction and replacement of a missing tooth with the use of a plastic tooth
- For the temporary or semi-permanent treatment of a tooth space with the use of an extracted natural tooth
- For temporary treatment after placing an implant during the osseointegration of the implant
| Prescription Use X | OR | Over-The-Counter Use _ |
|---|---|---|
| ---------------------- | ---- | ------------------------ |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Rusper
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Significal Canadael, Dontal Devices Division of Anesthesions go
Infection Control, Dental Devices
1702347 510(k) Number: _______________________________________________________________________________________________________________________________________________________________