ANGLED TAPERED ABUTMENT

K111853 · Zimmer Dental, Inc. · NHA · Dec 8, 2011 · Dental

Device Facts

• Record ID: K111853
• Device Name: ANGLED TAPERED ABUTMENT
• Applicant: Zimmer Dental, Inc.
• Product Code: NHA · Dental
• Decision Date: Dec 8, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2

Intended Use

The Angled Tapered Abutment is used for a terminal or intermediate abutment for screw-retained multiple-unit restorations. The 30°Angled Tapered Abutment must be used within 45 degree of parallelism for a splinted restoration. The 15°Angled Tapered Abutment must be used within 30 degrees of parallelism for a splinted restoration.

Device Story

Angled Tapered Abutment serves as terminal or intermediate component for screw-retained multiple-unit dental restorations; provides angulation correction for off-angle implant placement. Device features external hex engaging Tapered Screw-Vent and Screw-Vent implants; includes preassembled abutment retaining screw and tapered cone with internal screw access for coping screw attachment. Available in 15° and 30° configurations; fabricated from titanium 6Al-4V. Packaged with metal delivery tool for placement/orientation. Used by dental professionals in clinical settings to facilitate multi-unit restorations where straight abutments are insufficient. Enables angled restoration, expanding functionality of screw-retained systems.

Clinical Evidence

No clinical testing was performed. Safety and effectiveness supported by non-clinical bench testing, specifically fatigue and compression testing conducted in accordance with FDA guidance for Root-form Dental Implants and Endosseous Dental Implant Abutments.

Technological Characteristics

Material: Titanium 6Al-4V. Configuration: 15° and 30° angled abutments. Attachment: Internal screw threaded through internal hex into implant. Dimensions: 1.2mm tall cone. Packaging: Includes metal delivery tool. Mechanical device; no software or energy source.

Indications for Use

Indicated for patients requiring terminal or intermediate abutments for screw-retained multiple-unit dental restorations. 30° abutments require 45° parallelism; 15° abutments require 30° parallelism for splinted restorations.

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

• NobelActive Multi Unit Abutment
• Tapered Abutment

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Zimmer Dental. The logo consists of a circle with a stylized "Z" inside it. Below the circle, the word "zimmer" is written in a bold, sans-serif font, and the word "dental" is written in a smaller, serif font below a horizontal line.

| Zimmer Dental | |
|---------------|--|
|---------------|--|

1900 Aston Avenue

Carlsbad, CA 92008 760.929.4300 (ph)

760.431.7811 (fax)

< 111 857 510k No .:

A5-1 Page No .:

DEC - 8 2011

## Traditional 510(k) PRE-MARKET NOTIFICATION 510(k)

## 510(k) SUMMARY (21CFR807.92(a))

#### Submitter's Information: 1.

| Name: | Zimmer-Dental-Inc. |
|----------|------------------------------------|
| Address: | 1900 Aston Ave. Carlsbad, CA 92008 |
| Phone: | 760-929-4300 |
| Contact: | Melissa Burbage |

Date Prepared: June 27, 2011

| 2. Device Name: |
|-----------------|
|-----------------|

| Trade Name: | Angled Tapered Abutment |
|-----------------------------|------------------------------------|
| Regulation Number: | 872.3630 |
| Classification Code: | NHA |
| Device Classification Name: | Endosseous Dental Implant Abutment |

- 3. Predicate Device(s):
Predicate Device No. 1 NobelActive Multi Unit Abutment Trade Name: Requlation Number: 872.3630 Classification Code: NHA Endosseous Dental-Implant Abutment Device Classification-Name:

Predicate Device No. 2 Tapered Abutment Trade Name: 872.3630 Regulation Number: NHA Classification Code: Endosseous Dental Implant Abutment Device Classification Name:

#### Device Description: 4.

The Angled Tapered Abutment has an external hex which engages the hex of the Tapered Screw-Vent and Screw-Vent implant. The abutments are available in multiple cuff heights and in both 15° and 30° configurations to provide angulation correction for off-angle implant placement. The abutment is secured to the implant with an abutment retaining screw. The abutment screw is preassembled in the abutment

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Angled Tapered Abutment

510(k) No. K111853
Page No. A5-2

and is not removable from the abutment. The abutment has a tapered cone with an internal screw access for the attachment of various restorative components using a separate coping screw. The abutment cone has a 15° taper and is 1.2mm tall. Abutments are packaged with a metal delivery tool to assist with the placement and orientation of the abutment into the implant. The abutment and abutment retaining screw are fabricated from titanium allov.

The current tapered abutments facilitate multiple-unit, screw-retained restoration. These abutments do not engage the internal hex.connection. and are not for use in single-unit. While the current tapered abutments are somewhat limited to straight restoration, the new device will expand the functionality of our screw retained restoration by permitting angled restoration. It will be available in titanium 6Al-4V and will provide an angulation up to 30°.

#### ട. Indications for Use:

The Angled Tapered Abutment is used for a terminal or intermediate abutment for screw-retained multiple-unit restorations. The 30°Angled Tapered Abutment must be used within 45 degree of parallelism for a splinted restoration. The 15°Angled Tapered Abutment must be used within 30 degrees of parallelism for a splinted restoration.

#### 6. Device Comparison:

The Angled Tapered Abutment is substantially equivalent to the predicate NobelActive Multi Unit Abutment in the material, implant/abutment connection, abutment platforms and angulations. The Angled Tapered Abutment is substantially equivalent to the predicate Tapered Abutment in the material, implant/abutment connection, abutment platforms, and mating of prosthetic components.

#### Technological Characteristics 7.

| Feature | New Device 1<br>Angled Tapered Abutment | Predicate No. 1<br>Nobel Active Multi Unit Abutment | Predicate No. 2<br>Tapered Abutment |
|-------------------------|-----------------------------------------------------------------|-----------------------------------------------------------------|-----------------------------------------------------------------|
| Material | Titanium 6Al-4V | Titanium 6Al-4V | Titanium 6Al-4V |
| Abutment<br>angles | Up to 30° | Up to 30° | 0° |
| Platforms | 3.5, 4.5mm | 3.5, 3.9mm | 3.5, 4.5, 5.7mm |
| Method of<br>Attachment | Internal screw threaded<br>through internal hex into<br>implant | Internal screw threaded<br>through internal hex into<br>implant | Internal screw threaded<br>through internal hex into<br>implant |

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| 510(k) No. | K111853 |
|------------|---------|
| Page No. | A5-2 |

#### 8. Non-Clinical Testing:

Non-clinical test data was used to support the decision of safety and effectiveness. Non-clinical testing consisted of performance of fatigue and compression testing in accordance with the FDA guidance Class II Special Controls Guidance Document: Root-form Dental Implants and Endosseous Dental Implant Abutments. The testing indicates that the device is strong enough to withstand the anticipated forces and demonstrated improvements-over-the-predicate-device.--------------------------------------------------------------------------------------------------------------------------

#### ல் Clinical Testing

No clinical testing was performed. Non-clinical testing was used to support the decision of safety and effectiveness.

#### 10. Conclusion

Based on our analysis, the device is substantially equivalent to the predicate and considers the new device is as safe and effective for its intended use and performs as well or better than the predicate device.

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Image /page/3/Picture/0 description: The image shows a partial logo for the Department of Health and Human Services - USA. The logo includes the department's emblem, which features a stylized human figure embracing a sphere. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is partially visible, with only "DEPARTMENT" fully legible. The image appears to be a close-up or cropped section of a document or publication featuring the department's logo.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

# DEC - 8 2011

Ms. Melissa Burbage Regulatory Affairs Manager Zimmer Dental Incorporated 1900 Aston Avenue Carlsbad, California 92008

Re: K111853

Trade/Device Name: Angled Tapered Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: October 14, 2011 Received: December 1, 2011

Dear Ms. Burbage:

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 - Ms. Burbage

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.

hh for

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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Image /page/5/Picture/0 description: The image shows a logo for Zimmer Dental. The logo consists of a circle with a stylized letter "Z" inside it. Below the circle, the word "Zimmer" is written in a bold, sans-serif font, and below that, the word "dental" is written in a smaller, sans-serif font.

Indications for Use

510(k) Number (if known): << < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < > > > > > > > > > > > > > > > > > > > > > > > > > > > > >

Device Name: Angled Tapered Abutment

Indications For Use:

The Angled Tapered Abutment is used for a terminal or intermediate abutment for screw-retained multiple-unit restorations. The 30°Angled Tapered Abutment must be used within 45 degree of parallelism for a splinted restoration. The 15°Angled Tapered Abutment must be used within 30 degrees of parallelism for a splinted restoration.

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)

Susan Rurr
Division Sign Off)

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

510(k) Number: K-111853