GRANDIO SO

K102351 · Voco GmbH · EBF · Nov 2, 2010 · Dental

Device Facts

• Record ID: K102351
• Device Name: GRANDIO SO
• Applicant: Voco GmbH
• Product Code: EBF · Dental
• Decision Date: Nov 2, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Grandio SO is intended for use as: - class I to V fillings - reconstruction of traumatically affected anteriors - facetting of discolored anteriors - correction of shape and shade for improved aesthetic appearance - locking, splinting of loose anteriors - repairing veneers - restoration of deciduous teeth - core-build-up under crowns - composite inlays

Device Story

Grandio SO is a condensable, methacrylate-based dental filling composite; used by dental professionals in clinical settings for restorative procedures. Device functions as a light-cured material applied to tooth cavities or structures; provides structural support, color stability, and durability. Material is applied to prepared tooth surfaces and cured using standard dental light-curing procedures. Output is a hardened, polished dental restoration; benefits patient by restoring tooth function and aesthetics. No complex processing or software involved.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing and the established safety profile of components used in legally marketed predicate devices.

Technological Characteristics

Nanohybrid dental composite; methacrylate-based resin matrix with inorganic fillers. Light-cured; condensable consistency. No software, electronics, or connectivity. Sterilization not applicable (material is supplied for clinical use).

Indications for Use

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

Predicate Devices

• Grandio (K051867)

Submission Summary (Full Text)

{0}------------------------------------------------

| FDA CDRH DMC |
|--------------|
|--------------|

K102351

OCT 1 5 2010

Received

#### 510(k) SUMMARY

| Contact: | M. Th. Plaumann |
|----------------------------|-----------------------------------------|
| Date prepared: | August 16, 2010 |
| | NOV - 2 2010 |
| Trade or proprietary name: | Grandio SO |
| Classification name: | Material, Tooth Shade, Resin (872.3690) |
| Predicate device: | Grandio, K051867, VOCO GmbH |

# Device description:

Grandio SO is a condensable, methacrylate based dental filling composite for all cavity Grandro So is a contential features excellent physical properties Classes with the morganie strength, color stability and durability in the mouth. e.g. Wear resistance, oomprocerve birgin, edes of optimal opacity and can be easily polished. It is therefore highly qualified for long lasting, esthetic restorations.

Grandio SO is processed according to current state of the art procedures for light curing condensable dental composites, thus, Grandio SO can be applied by any dental condensable domported, "that" of materials. Like the predicate device Grandio it profosoional who

#### Intended use:

Grandio SO is intended for use as:

- class I to V fillings a
- reconstruction of traumatically affected anteriors ﺖ
- facetting of discolored anteriors .
- faceting of dioblored antonomic for improved aesthetic appearance -
- locking, splinting of loose anteriors ـــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ
- repairing veneers -
- restoration of deciduous teeth -
- core-build-up under crowns -
- composite inlays -

{1}------------------------------------------------

#### Technological characteristics:

Grandio SO and the legally marketed device Grandio, K051867 (VOCO GmbH) share the same indications but have improved physical features. Grandio SO has been optimized with regard-to-several-physical-parameters.

Grandio SO based on nanohybrid technology just like the predicate device Grandio. This technology relies on the optimal mixture of inorganic filler diameters.

The components of Grandio SO serve the same purpose as the ingredients of the predicate device Grandio.

The prior use of all of the components of Grandio SO in legally marketed devices supports our decision that additional testing for cytotoxicity and mutagenicity as well as additional biocompatibility studies with the final formulation are not necessary.

We believe that the prior use of the components of Grandio SO in legally marketed devices and the performance data and results.also provided support the safety and effectiveness of Grandio SO for the intended use.

VOCO GmbH, Qctober 13th, 2010

Dr. Thorsten Gorkensmeier

Dr. Thorsten Gerkensmeier (Regulatory Affairs)

{2}------------------------------------------------

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The logo also includes the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the caduceus symbol.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Manfred T. Plaumann Managing Board Voco GMBH Anton-Flettner-Strasse 1-3 Cuxhaven Germany D-27472

Re: K102351

Trade/Device Name: Grandio SO Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: October 13, 2010 Received: October 15, 2010

Dear Mr. Plaumann:

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.

NOV - 2 2010

{3}------------------------------------------------

# Page 2- Mr. Plaumann

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,

Nh fo

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

# Indications for Use Statement

| 510(k) Number: | K102351 |
|----------------|------------|
| Device Name: | Grandio SO |

NOV - 2 2010
Indications for Use:

Grandio SO is intended for use as:

- class I to V fillings
- reconstruction of traumatically affected anteriors
- facetting of discolored anteriors
- correction of shape and shade for improved aesthetic appearance
- locking, splinting of loose anteriors
- repairing veneers
- restoration of deciduous teeth
- core-build-up under crowns
- composite inlays

| 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 Ruaner

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K160235