ANAXBLEND MODEL 20XXX (SEVERAL), ANAXGUM MODEL 25XXX (U), MOCK-UP DIRECT MODEL 240XXX (U), MOCK-UP DIRECT FLOW MODEL 24A

K112044 · Anaxdent GmbH · EBF · Jan 26, 2012 · Dental

Device Facts

• Record ID: K112044
• Device Name: ANAXBLEND MODEL 20XXX (SEVERAL), ANAXGUM MODEL 25XXX (U), MOCK-UP DIRECT MODEL 240XXX (U), MOCK-UP DIRECT FLOW MODEL 24A
• Applicant: Anaxdent GmbH
• Product Code: EBF · Dental
• Decision Date: Jan 26, 2012
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

anaxBLEND: full or partial facing of fixed metal-based crowns and bridges; anterior and posterior crowns; inlays, onlays; facing of removable combined restorations (telescopic/conical crowns and attachment retained dentures); Characterization of dentures. anaxGUM: Esthetic rehabilitation of gingival parts in case of dental restorations with severe bone loss; Facing of the gingival area of removable combined restorations (telescopic/conical crowns and attachment-retained dentures); Characterization of dentures. mock-up direct / mock-up direct flow: mock-ups; direct anterior and posterior fillings of the classes 1, 11, 111, and V (Black); indirect restorations as inlays, onlays and veneers; extended fissure sealing of molars and premolars; core build-ups; splinting of loose teeth; shape and color corrections to improve the esthetic appearance.

Device Story

Light-curing resin materials used by dental professionals for restorative and esthetic procedures. Devices include anaxBLEND (crown/bridge/denture facing), anaxGUM (gingival esthetics), and mock-up direct/flow (fillings, inlays, onlays, veneers, fissure sealing, core build-ups, splinting). Materials applied chairside by dentists; cured using standard dental light-curing units. Output is a hardened, tooth-colored or gingival-colored restorative structure. Benefits include improved esthetics, structural support for damaged teeth, and functional restoration of dental anatomy.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Light-curing resin materials; dental restorative composites; supplied in various shades for tooth and gingival matching; form factor includes pastes and flowable resins; polymerization via dental light-curing units.

Indications for Use

Indicated for dental patients requiring restorative or esthetic dental procedures, including crown and bridge facing, gingival rehabilitation, cavity fillings (Black classes I-V), inlay/onlay/veneer fabrication, fissure sealing, core build-ups, tooth splinting, and denture characterization.

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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

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

anaxDENT C/O Mr. John Balistreri Manager Director FDA- Agents 14500 Fim 470 Tarpley, Texas 78883

JAN 2 6 2012

Re: K112044

Trade/Device Name: anaxBLEND anaxGUM Mock-up direct / mock-up direct flow Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: January 18, 2012 Received: January 23, 2012

Dear Mr. Balistreri:

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 - Mr. Balistreri

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,

es for Anthony D. Watson

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

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## Indications for use

K 112044 510(k) Number (if known):

anaxBLEND Device Name:

Indications For Use:

- full or partial facing of fixed metal-based crowns and bridges; -
- anterior and posterior crowns; -
- inlays, onlays; -
- facing of removable combined restorations (telescopic/conical ー crowns and attachment retained dentures);
- Characterization of dentures ー

Prescription Use No (Part 21 CFR 801 Subpart D) AND/OR

No . Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Supen Rume

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

Page 1 of 3

510(k) Number:

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## Indications for use

510(k) Number (if known): K 112044

Device Name: anaxGUM

Indications for use:

- Esthetic rehabilitation of gingival parts in case of dental restorations with severe bone loss;
- Facing of the gingival area of removable combined restorations -(telescopic/conical crowns and attachment-retained dentures);
- Characterization of dentures -

Prescription Use No (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use No (21 CFR 801 Subpart C)

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

Concurrence of CDRH Office of Device Evaluation (ODE)

Suran Kumar

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

510(k) Number: K112044 Page 2 of 3

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## Indications for use

K 112044 510(k) Number (if known):

Device Name:

mock-up direct / mock-up direct flow

Indications for use:

- mock-ups; -
- direct anterior and posterior fillings of the classes 1, 11, 111, and V -(Black);
- indirect restorations as inlays, onlays and veneers; -
- extended fissure sealing of molars and premolars; -
- core build-ups; -
- splinting of loose teeth; -
- shape and color corrections to improve the esthetic appearance -

Prescription Use No (Part 21 CFR 801 Subpart D) AND/OR

No Over-The-Counter Use (21 CFR 801 Subpart C)

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|--|
|--------------------------------------------------------|--|

Susan Kumar

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

510(k) Number: K112044

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