HEX-LOCK SHORT ABUTMENT, MODEL SA341, SA342, SA451, SA452, SA561, SA562 SHORT HEALING CAP, MODEL SAHEAL4, SAHEAL5,

K090723 · Zimmer Dental, Inc. · NHA · Apr 7, 2009 · Dental

Device Facts

• Record ID: K090723
• Device Name: HEX-LOCK SHORT ABUTMENT, MODEL SA341, SA342, SA451, SA452, SA561, SA562 SHORT HEALING CAP, MODEL SAHEAL4, SAHEAL5,
• Applicant: Zimmer Dental, Inc.
• Product Code: NHA · Dental
• Decision Date: Apr 7, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3630
• Device Class: Class 2

Intended Use

The Hex-Lock Short Abutment is used as a terminal or intermediate abutment for a cemented prosthesis. It can be used for a single or multiple-unit restoration. The Short Healing Cap is for use with a Short Hex-Lock Abutment to prevent irritation of soft tissue due to rubbing against the restorative area of the abutment or implant, and to prevent material from lodging in any undercuts or openings. The Short Provisional Coping is used for fabricating a cement-retained provisional restoration for a Short Hex-Lock Abutment. Use of the provisional cap is not to exceed 28 days.

Device Story

Hex-Lock Short Abutment system consists of abutments, healing caps, and provisional copings; designed for dental implant restoration. Abutments feature prepared margin, 3-degree cone taper, and hex-configuration apex with anti-rotation flat. Healing caps protect soft tissue during healing; provisional copings facilitate temporary cement-retained crowns. Used in dental clinics by dentists/prosthodontists. Device provides structural interface between endosseous implant and final or temporary prosthesis. Benefits include soft tissue protection and support for cemented restorations. Dimensional modifications (shorter height) compared to predicate devices.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Endosseous dental implant abutment system. Features: prepared margin, 3-degree cone taper, hex-configuration apex with anti-rotation flat. Materials and general structure consistent with predicate devices. Mechanical interface for cemented prostheses.

Indications for Use

Indicated for patients requiring single or multiple-unit cemented dental prostheses supported by endosseous implants. The Short Healing Cap is indicated for soft tissue protection during healing. The Short Provisional Coping is indicated for fabrication of temporary cement-retained restorations (duration ≤ 28 days).

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

• Zimmer Dental 3.5mm Hex-Lock Abutment (HLA3/3) (K953101, K061043)
• Zimmer Contour Healing Cap (e.g., ZOCHEAL4S) (K953101, K061043)
• Zimmer Contour Provisional Coping (e.g., ZOCPROV4S) (K953101, K061043)

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 letter Z inside. Below the circle, the word "zimmer" is written in a bold, sans-serif font, with a line underneath it. Below "zimmer", the word "dental" is written in a smaller, cursive font.

Zimmer Dental

1900 Aston Avenue Carlsbad, CA 92008 760.929.4300 (ph) 760.431.7811 (fax)

510k No .:

Attachment 12.8 1 of 2

K090723

### Special 510(k): Device Modification PRE-MARKET NOTIFICATION 510(k) APR - 7 2009

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

- 1. Submitter's Information:
Name: Zimmer Dental Inc. Address: Zimmer 1900 Aston Ave. dental Carlsbad, CA 92008 Phone: [phone] Contact: William Fisher Date Prepared: March 4, 2009

2. Device Name: Hex-Lock Short Abutment, Short Healing Cap, Short Provisional Coping (cat no. SA341, SA342, SA451, SA452, SA561, SA562, SAHEAL4, SAHEAL5, SAHEAL6, SAPROV4, SAPROV5, SAPROV6)

Device Classification Name: Endosseous Dental Implant Abutment

- Predicate Device(s): Zimmer® Dental 3.5mm Hex-Lock Abutment (HLA3/3) 3. Zimmer® Contour Healing Cap (e.g.: ZOCHEAL4S) Zimmer Contour Provisional Coping (e.g. ZOCPROV4S)
- 4. Device Description:

The new abutments have a prepared margin and cone shape. A prepared margin and cone shape top portion and an apex with a hex configuration with 1 degree tapered flats. . The taper on the cone of the abutment is 3 degrees. The cone of the abutment has a flat section for anti-rotation.

The Healing Cap is made to precisely fit the abutment for placement on the Abutment at the time of placement to protect the soft tissue during the healing process.

The provisional coping is made to precisely fit the abutments to allow for the placement of a provision crown on the abutment.

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Attachment 12.8 2 of 2

#### ട. Intended Use:

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The Hex-Lock Short Abutment is used as a terminal or intermediate abutment for a cemented prosthesis. It can be used for a single or multiple-unit restoration.

The Short Healing Cap is for use with a Short Hex-Lock Abutment to prevent irritation of soft tissue due to rubbing against the restorative area of the abutment or implant, and to prevent material from lodging in any undercuts or openings.

The Short Provisional Coping is used for fabricating a cement-retained provisional restoration for a Short Hex-Lock Abutment. Use of the provisional cap is not to exceed 28 days.

#### 6. Device Comparison:

The new devices are equivalent in design with Predicates. The new devices are dimensional modifications to the Predicates cleared in K953101 and K061043. They differs from the Predicate in that they are shorter in overall height. The materials, general structure, and function in the endosseous implant system remains the same as the Predicate Devices.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three wing segments. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. William Fisher Regulatory Affairs Associate Zimmer Dental Incorporated 1900 Aston Avenue Carlsbad, California 92008

APR - 7 2009

Re: K090723

> Trade/Device Name: Hex-Lock Short Abutment, Short Healing Cap. Short Provisional Coping Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: March 4, 2009 Received: March 9, 2009

Dear Mr. Fisher:

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 - Mr. Fisher

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely yours,

Shule H. Murphy, MD for Susan Rummer DDS

Susan Runner, D.D.S., MA Acting 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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K090723

| Zimmer Dental Inc.<br>Hex-Lock Short Abutment | 510(k) No. | | Attachment 12.13<br>1 of 1 | |
|-------------------------------------------------|------------------------------------------------------------------------------------------|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | | Indications for Use | | |
| | 510(k) Number (if known): | | | |
| | Device Name: Hex-Lock Short Abutment,<br>Short Healing Cap,<br>Short Provisional Coping | | | |
| Indications For Use: | | | | |
| | multiple-unit restoration. | | The Hex-Lock Short Abutment is used as a terminal or intermediate<br>abutment for a cemented prosthesis. It can be used for a single or | |
| | any undercuts or openings. | | The Short Healing Cap is for use with a Short Hex-Lock Abutment to<br>prevent irritation of soft tissue due to rubbing against the restorative<br>area of the abutment or implant, and to prevent material from lodging in | |
| | | provisional coping is not to exceed 28 days. | The Short Provisional Coping is used for fabricating a cement-retained<br>provisional restoration for a Short Hex-Lock Abutment. Use of the | |
| Prescription Use<br>(Part 21 CFR 801 Subpart D) | X | AND/OR | Over-The-Counter Use<br>(21 CFR 801 Subpart C) | |
| NEEDED) | | | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF | |
| | | | Concurrence of CDRH, Office of Device Evaluation (ODE) | |
| | | | | |
| | | | | |
| | | | | |
| | (Division Sign-Off) | Division of Anesthesiology, General Hospital | | |

Infection Control, Dental Devices

510(k) Number: K090723