FRIADENT ESTHETICAP

K050208 · Dentsply International · NHA · Jun 14, 2005 · Dental

Device Facts

• Record ID: K050208
• Device Name: FRIADENT ESTHETICAP
• Applicant: Dentsply International
• Product Code: NHA · Dental
• Decision Date: Jun 14, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

FRIADENT® EsthetiCap is an anatomically shaped abutment used for fabrication of screw-retained or cementable temporary crowns or bridges The FRIADENT® EsthetiCap is a short-term provisional abutment for esthetic shaping of soft tissue.

Device Story

FRIADENT® EsthetiCap is a plastic dental implant abutment; used for fabrication of screw-retained or cementable temporary crowns or bridges; provides esthetic peri-implant gingival contouring. Available in five diameters (3.4 mm - 6.5 mm) and two shapes (oval, triangular) to replicate tooth cross-section at the cementum-enamel junction. Used by dental professionals in clinical settings to support temporary restorations and shape soft tissue during the healing phase.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and material similarity to legally marketed predicate devices.

Technological Characteristics

Plastic dental implant abutment; available in 3.4 mm - 6.5 mm diameters; oval and triangular shapes; non-metallic; intended for short-term provisional use.

Indications for Use

Indicated for patients requiring temporary crowns or bridges and soft tissue esthetic shaping via an anatomically shaped dental implant abutment.

Regulatory Classification

Identification

An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.

Special Controls

*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)

Predicate Devices

• FRIADENT® ProTect Abutment (K974628, K013867)
• Nobel Biocare Temp Abut Plastic Engaging Select NP (K023113)

Submission Summary (Full Text)

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# 510(k) SUMMARY

DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York. PA 17405-0872

CONTACT: Helen Lewis

DATE PREPARED: June 6, 2005

TRADE OR PROPRIETARY NAME:

FRIADENT® EsthetiCap

CLASSIFICATION NAME: Endosseous dental implant abutment (872.3630)

PREDICATE DEVICES: FRIADENT® ProTect Abutment cleared under 510(k) premarket notification K974628 on March 11, 1998 and K013867 on March 15, 2002 as well as to the Nobel Biocare Temp Abut Plastic Engaging Select NP cleared under 510(k) premarket notification K023113 on September 26, 2002

#### DEVICE DESCRIPTION:

The FRIADENT® EsthetiCap abutments create anatomic, esthetic peri-implant gingival contours by simple customization. FRIADENT® EsthetiCap abutments are available in five diameters (3.4 mm - 6.5 mm) and two shapes (oval and triangular) that reproduce the crosssection of the tooth at the cementum-enamel junction (CEJ).

#### INTENDED USE:

The FRIADENT® EsthetiCap is an anatomically shaped abutment used for fabrication of screw-retained or cementable temporary crowns or bridges The FRIADENT® EsthetiCap is a short-term provisional abutment for esthetic shaping of soft tissue.

### TECHNOLOGICAL CHARACTERISTICS:

The FRIADENT® EsthetiCap and the predicate devices are similar in design and technological characteristics. The FRIADENT® EsthetiCap and the predicate devices are made of plastic materials. Both the FRIADENT® EsthetiCap and the predicate device FRIADENT® ProTect are available in the corresponding implant diameters and use similar laboratory components. The predicate device, Nobel Biocare Temp Abut Plastic Engaging Select NP is available in only one diameter.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines representing the branches of government. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 4 2005

Ms. Helen Lewis DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17405-0872

Re: K050208

Trade/Device Name: FRIADENT® EsthetiCap Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: May 18, 2005 Received: May 19, 2005

Dear Ms. Lewis:

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.

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 - Ms. Lewis

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 imited 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]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97)) You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its to to free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Qesnite Y. Michie Oms.

Chiu Lin, Ph.D. 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 (if known): Krozo

Device Name: FRIADENT® EsthetiCap

Indications for Use:

FRIADENT® EsthetiCap is an anatomically shaped abutment used for fabrication of screw-retained or cementable temporary crowns or bridges. The FRIADENT® EsthetiCap is a short-term provisional abutment for esthetic shaping of soft tissue.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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)

Jenite y. Michain D m-D.

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

Division of Anesthouters of Anfection Control.

510(k) Number: K050208