ZIMMER CONTOUR PROVISIONAL COPING

K113092 · Zimmer Dental, Inc. · NHA · Jan 23, 2012 · Dental

Device Facts

• Record ID: K113092
• Device Name: ZIMMER CONTOUR PROVISIONAL COPING
• Applicant: Zimmer Dental, Inc.
• Product Code: NHA · Dental
• Decision Date: Jan 23, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2

Intended Use

The Zimmer Contour Provisional Coping is for use with a Hex-Lock Contour Abutment or a Zimmer One-Piece Implant to prevent irritation of soft tissue due to rubbing against the restorative area of the abutment or implant, to prevent material from lodging in any undercuts or openings, and for fabricating a cement-retained provisional restoration. Use of the provisional coping is not to exceed 180 days. The Short Provisional Coping 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, to prevent material from lodging in any undercuts or openings, and for fabricating a cement-retained provisional restoration. Use of the provisional coping is not to exceed 180 days.

Device Story

Provisional copings are plastic caps designed to fit over dental abutments or implants. Clinicians affix the cap to the abutment/implant cone using dental adhesive. The device serves as a protective barrier to prevent soft tissue irritation from the restorative area and to block material from entering undercuts or openings during the fabrication of cement-retained provisional restorations. Used in dental clinics by licensed professionals. The device is intended for temporary use, not exceeding 180 days. The transition from Ultem/PMMA to PEEK material provides improved functional performance.

Clinical Evidence

No clinical testing was performed. Safety and effectiveness were supported by non-clinical mechanical property analysis and clinical literature, which indicated the device is strong enough to withstand anticipated forces and offers performance improvements over predicate materials.

Technological Characteristics

Materials: PEEK (polyether ether ketone). Design: Passive fit plastic cap with indexing/anti-rotation features. Function: Mates with specific abutment/implant geometries. Energy source: None (mechanical). Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for patients requiring cement-retained provisional dental restorations on Hex-Lock Contour Abutments, Zimmer One-Piece Implants, or Short Hex-Lock Abutments. Used to prevent soft tissue irritation and debris lodging in undercuts. Duration of use limited to 180 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® Contour Provisional Coping (K061043)
• Zimmer® Short Provisional Coping (K090723)
• Zimmer® Plastic Temporary Abutment (K092377)
• Zimmer® Contour Healing Cap (K061043)
• Zimmer® Short Healing Cap (K090723)

Submission Summary (Full Text)

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### Zimmer Dental

510k No.: K1130

1900 Aston Avenue Carlsbad, CA 92008 760.431.7811 (fax)

JAN 2 3 2012

A.5

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

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

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

#### 1. Submitter's Information:

Zimmer Dental Inc. Name:

Address: 1900 Aston Ave. Carlsbad, CA 92008

760-929-4300 Phone:

Contact: Jeremy Markovich

Date Prepared: October 17, 2011

- 2. New Device(s):
New Device No. 1 Trade Name: Zimmer® Contour Provisional Coping Regulation Number: 872.3630 Classification Code: NHA Device Classification Name: Endosseous Dental Implant Abutment

New Device No. 2 Zimmer® Short Provisional Coping Trade Name: Regulation Number: 872.3630 NHA Classification Code: Device Classification Name: Endosseous Dental Implant Abutment

- క. Predicate Device(s):
Predicate Device No. 1 Zimmer® Contour Provisional Coping Trade Name: K061043 510(k) Number: Regulation Number: 872.3630 Classification Code: NHA Device Classification Name: Endosseous Dental Implant Abutment

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| | Zimmer Dental | 510k No.: | |
|--|--------------------|-----------|-----|
| | 1900 Aston Avenue | Page No.: | A.5 |
| | Carlsbad, CA 92008 | | |
| | 760.929.4300 (ph) | | |
| | 760.431.7811 (fax) | | |

Predicate Device No. 2

| Trade Name: | Zimmer® Short Provisional Coping |
|-----------------------------|------------------------------------|
| 510(k) Number: | K090723 |
| Regulation Number: | 872.3630 |
| Classification Code: | NHA |
| Device Classification Name: | Endosseous Dental Implant Abutment |

Predicate Device No. 3

| Trade Name: | Zimmer® Plastic Temporary Abutment |
|-----------------------------|------------------------------------|
| 510(k) Number: | K092377 |
| Regulation Number: | 872.3630 |
| Classification Code: | NHA |
| Device Classification Name: | Endosseous Dental Implant Abutment |

Predicate Device No. 4

| Trade Name: | Zimmer® Contour Healing Cap |
|-----------------------------|------------------------------------|
| 510(k) Number: | K061043 |
| Regulation Number: | 872.3630 |
| Classification Code: | NHA |
| Device Classification Name: | Endosseous Dental Implant Abutment |

Predicate Device No. 5

| Trade Name: | Zimmer® Short Healing Cap |
|-----------------------------|------------------------------------|
| 510(k) Number: | K090723 |
| Regulation Number: | 872.3630 |
| Classification Code: | NHA |
| Device Classification Name: | Endosseous Dental Implant Abutment |

4. Device Description:

The Contour Provisional Coping is a smooth plastic cap that fits passively over the cone of a Hex-Lock Contour Abutment or a Zimmer One-Piece Implant and mates with the margin of the abutment or implant abutment

Implant and mates with the margin of the abutment or implant abutment section. Each passive fit cap is affixed to the abutment/implant cone with appropriate dental adhesive material selected by the clinician.

The Short Provisional Coping is a tan, textured, plastic cap that fits passively over the cone of a Hex-Lock® Short Abutment and mates with the margin of the abutment.

#### Indication for Use: 5.

The Zimmer Contour Provisional Coping is for use with a Hex-Lock Contour Abutment or a Zimmer One-Piece Implant to prevent irritation of soft tissue due to rubbing against the restorative area of the abutment or

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| 510k No.: | |
|-----------|-----|
| Page No.: | A.5 |

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

implant, to prevent material from lodging in any undercuts or openings, and for fabricating a cement-retained provisional restoration. Use of the provisional coping is not to exceed 180 days.

The Short Provisional Coping 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, to prevent material from lodging in any undercuts or openings, and for fabricating a cement-retained provisional restoration. Use of the provisional coping is not to exceed 180 days.

#### 6. · Device Comparison:

Zimmer Dental Inc. believes the Zimmer® Contour Provisional Coping and Zimmer® Short Provisional Coping to be substantially equivalent to their respective predicates as listed below. The modified devices are not subject to geometry modification and will be manufactured using the same process. The modified devices are equivalent in intended use, design. and materials. PEEK (polyether ether ketone) material demonstrates an improvement in functional performance compared to Ultem and PMMA. The modifications affect product labeling; however, these changes do not bring up new concerns regarding safety and efficacy and no new risks have been identified.

| Feature: | New Device 1: | Predicate No. 1: | Predicate No. 2: | Predicate No. 3: |
|-------------------|------------------------------------------------------|------------------------------------------------------|---------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| | Contour Provisional<br>Coping | Contour Provisional<br>Coping | Zimmer Plastic<br>Temporary<br>Abutment | Zimmer Contour<br>Healing Cap |
| Material | PEEK (polyether<br>ether ketone) | Ultem 1010-1101<br>(polyetherimide) | PEEK (polyether<br>ether ketone) | PMMA Acrylic<br>CP-1000-IG |
| Fit | Mates uniquely with<br>shape of Contour<br>abutment. | Mates uniquely with<br>shape of Contour<br>abutment. | Hexagon<br>connection | Mates uniquely<br>with shape of<br>Contour<br>abutment. |
| Design<br>Feature | Has indexing / anti<br>rotation feature | Has indexing / anti<br>rotation feature | Straight or angled,<br>collar heights in 1<br>or 4mm. Grooves<br>for retention,<br>defined margin | Has indexing /<br>anti rotation<br>feature |
| Feature: | New Device 2: | Predicate No. 1: | Predicate No. 2: | Predicate No. 3: |
| | Short Provisional<br>Coping | Short Provisional<br>Coping | Zimmer Plastic<br>Temporary<br>Abutment | Short Healing Cap |
| Material | PEEK (polyether<br>ether ketone) | Ultem 1010-1101<br>(polyetherimide) | PEEK (polyether<br>ether ketone) | PMMA Acrylic<br>CP-1000-IG |
| Fit | Mates uniquely with<br>shape of short<br>abutment. | Mates uniquely with<br>shape of short<br>abutment. | Hexagon<br>connection | Mates uniquely<br>with shape of<br>Short abutment. |

#### 7. Technological Characteristics

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| Design<br>Feature | Has indexing / anti<br>rotation feature | Has indexing / anti<br>rotation feature | Straight or angled,<br>collar heights in 1<br>or 4mm. Grooves<br>for retention,<br>defined margin | Has indexing /<br>anti rotation<br>feature |
|-------------------|-----------------------------------------|-----------------------------------------|---------------------------------------------------------------------------------------------------|--------------------------------------------|
|-------------------|-----------------------------------------|-----------------------------------------|---------------------------------------------------------------------------------------------------|--------------------------------------------|

#### Non-Clinical Testing: 8.

Non-clinical test data was not used to support the decision of safety and effectiveness. Clinical literature and material mechanical prosperities indicated that the device is strong enough to withstand the anticipated forces and demonstrated improvements over the predicate devices.

#### 9. Clinical Testing

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

#### Conclusion 10.

Based on our analysis, the device is substantially equivalent to the predicates and it is considered that the new device is as safe and effective for its intended use and performs as well or better than the predicate device(s).

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines forming the wings and a snake winding around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

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

Mr. Jeremy Markovich Regulatory Affairs Zimmer Dental Incorporated 1900 Aston Avenue Carlsbad. California 92008

JAN 2 3 2012

Re: K113092

Trade/Device Name: Zimmer® Contour Provisional Coping Zimmer® Short Provisional Coping Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: January 11, 2012 Received: January 17, 2012

Dear Mr. Markovich:

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. Markovich

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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Nr 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

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Image /page/6/Picture/0 description: The image shows a logo for Zimmer Dental. The logo consists of a stylized letter "Z" inside a circle, with the word "zimmer" written in lowercase letters below it. Underneath "zimmer" is the word "dental" in a smaller font size. The logo appears to be for a dental-related company or service.

510k No.: A4-1 Page No .:

Zimmer® Contour Provisional Coping Zimmer® Short Provisional Coping

# Indications for Use

510(k) Number (if known): _

Device Name: Zimmer® Contour Provisional Coping Zimmer® Short Provisional Coping

Indications For Use:

The Zimmer Contour Provisional Coping is for use with a Hex-Lock Contour Abutment or a Zimmer One-Piece Implant to prevent irritation of soft tissue due to rubbing against the restorative area of the abutment or implant, to prevent material from lodging in any undercuts or openings, and for fabricating a cement-retained provisional restoration. Use of the provisional coping is not to exceed 180 days.

The Short Provisional Coping 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, to prevent material from lodging in any undercuts or openings, and for fabricating a cement-retained provisional restoration. Use of the provisional coping is not to exceed 180 days.

1 Prescription Use (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)

Swear Puane

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

510(k) Number: K113092