GRANDIO

K030915 · Voco GmbH · EBF · May 30, 2003 · Dental

Device Facts

• Record ID: K030915
• Device Name: GRANDIO
• Applicant: Voco GmbH
• Product Code: EBF · Dental
• Decision Date: May 30, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Fillings of class I to V Reconstruction of traumatically affected anteriors Facetting of discolored anteriors Correction of shape and shade for better aesthetic appearance Locking, splinting of loose anteriors Repair of veneers Filling of deciduous teeth Core-build-up under crowns Composite inlays

Device Story

Grandio is a tooth shade resin material used by dental professionals for restorative procedures. It functions as a composite restorative material for filling cavities (Class I-V), reconstructing traumatized anterior teeth, correcting tooth shape/shade, splinting loose teeth, repairing veneers, filling deciduous teeth, and performing core build-ups. The device is applied by a dentist in a clinical setting. It provides a structural and aesthetic replacement for natural tooth tissue, aiding in the restoration of dental function and appearance.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use.

Technological Characteristics

Tooth shade resin material; Class II device; Product Code EBF; 21 CFR 872.3690.

Indications for Use

Indicated for patients requiring dental restorations including Class I-V fillings, reconstruction of traumatized anterior teeth, aesthetic correction of discolored or misshapen teeth, splinting of loose anterior teeth, veneer repair, deciduous tooth fillings, and core build-ups.

Regulatory Classification

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 3 0 2003

VOCO GmbH C/O Mr. Gerald W. Shipps Regulatory Affairs Consultant Cascades Device Consulting Associates 19379 Blue Lake Loop Bend, Oregon 97702

Re: K030915

Trade/Device Name: Grandio® Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: March 22, 2003 Received: March 24, 2003

Dear Mr. Shipps:

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 incications 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 Aniendments, 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.

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## Page 2 - Mr. Gerald W. Shipps

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on vour responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html

Sincerely yours.

Susan Renner

Susan Runner, DDS, MA Interim Director Division 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: | K030915 |
|----------------------|---------|
| Device Name: Grandio | ✓ |

Indications for Use:

Fillings of class I to V Reconstruction of traumatically affected anteriors Facetting of discolored anteriors Correction of shape and shade for better aesthetic appearance Locking, splinting of loose anteriors Repair of veneers Filling of deciduous teeth Core-build-up under crowns Composite inlays

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _____________________________________________________________________________________________________________________________________________________________

OR

Over-The-Counter Use

Roberts Betz DDS for Dr. K. Mulhern
(Division Sign Off)

hesiology, General Hospital,

510(k) Number: K030915