GRANDTEC

K102347 · Voco GmbH · EBI · Oct 29, 2010 · Dental

Device Facts

• Record ID: K102347
• Device Name: GRANDTEC
• Applicant: Voco GmbH
• Product Code: EBI · Dental
• Decision Date: Oct 29, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3760
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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

Device Story

GrandTEC is a dental material used for splinting and stabilization. It functions as a reinforcement component for provisional bridges and temporary tooth replacements. Used in clinical dental settings by licensed practitioners. The material is applied to immobilize teeth following trauma, periodontal, or orthodontic procedures, or to support temporary tooth spaces during implant healing. It provides structural support to composite or provisional crown and bridge materials, aiding in patient recovery and functional maintenance during temporary treatment phases.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Denture relining, repairing, or rebasing resin (21 CFR 872.3760). Product code EBI. Class II device.

Indications for Use

Indicated for patients requiring dental stabilization or splinting, including post-orthodontic or periodontal treatment, trauma management (avulsed/loosened teeth, fracture anchoring), provisional bridge reinforcement, temporary tooth replacement (using plastic or natural teeth), and temporary stabilization during implant osseointegration.

Regulatory Classification

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.

Submission Summary (Full Text)

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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.

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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 [phone] or [phone] 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

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## 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: _______________________________________________________________________________________________________________________________________________________________