PROCERA IMPLANT BRIDGE, MODELS 15-1001, 15-1002, 15-1051, 15-1052

K041236 · Nobel Biocare AB · NHA · May 26, 2004 · Dental

Device Facts

• Record ID: K041236
• Device Name: PROCERA IMPLANT BRIDGE, MODELS 15-1001, 15-1002, 15-1051, 15-1052
• Applicant: Nobel Biocare AB
• Product Code: NHA · Dental
• Decision Date: May 26, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Procera® Implant Bridge is indicated for use as a bridge framework in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function. The Procera® Implant Bridge can be used at the implant or abutment level of the following implant systems: Nobel Biocare Brånemark System Nobel Biocare Replace Select The Procera® Implant Bridge can be used at the implant level of the following implant systems: Nobel Biocare Replace Nobel Biocare Steri-Oss HL Nobel Biocare Novum Nobel Biocare Novum Straumann Dental Implants Straumann Dental Implant System Regular neck 4.8 Straumann Dental Implant System Wide neck 6,5 The Procera® Implant Bridge can be used at abutment level of the following implant systems: Nobel Biocare ARK abutment for Teeth-in-Hour concept

Device Story

Procera® Implant Bridge is a custom-fabricated titanium bridge framework; designed to attach to specific dental implants or abutments to restore chewing function in edentulous patients. Device is manufactured individually based on patient-specific instructions and models. Framework serves as a substructure to be finished by dental laboratories using standard materials like resin composite or porcelain veneer. Used in clinical dental settings by dental professionals. Interfaces are modeled after established predicate implant systems to ensure compatibility. Benefits include patient-specific fit and restoration of masticatory function.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Titanium. Form factor: Custom-fabricated bridge framework. Interfaces: Modeled after existing Nobel Biocare and Straumann implant/abutment systems. Connectivity: None. Energy source: None. Sterilization: Not specified.

Indications for Use

Indicated for partially or totally edentulous patients requiring restoration of chewing function via a bridge framework supported by specific Nobel Biocare or Straumann dental implant/abutment systems.

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

• Nobel Biocare - Replace TiUnite Endosseous Implant (K023113)
• Nobel Biocare - Branemark System Implants (K022562)
• Steri-Oss - Steri-Oss Implants for Single Stage Placement (K963224)
• Straumann - ITI synOcta Meso Abutments (K033243)

Submission Summary (Full Text)

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MAY 2 6 2004

Image /page/0/Picture/1 description: The image shows a sequence of handwritten characters and numbers. The sequence starts with the letter 'K', followed by the number '041236'. The characters are written in a simple, clear style, making them easily readable.

#### 1.4 510(k) Summary of Safety and Effectiveness

| Submitted by: | Elizabeth J. Mason, Sr. Regulatory Affairs Specialist |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | Nobel Biocare USA Inc.<br>22715 Savi Ranch Parkway<br>Yorba Linda, CA 92887 |
| Telephone: | [phone], ext. 7830 |
| Facsimile: | [phone] |
| Date of Submission: | May 10, 2004 |
| Classification Name: | Endosseous Dental Implant (21 CFR 872.3640) |
| Trade or Proprietary<br>or Model Name: | Procera® Implant Bridge |
| Legally Marketed Devices: | Nobel Biocare - Replace TiUnite Endosseous Implant (K023113)<br>Nobel Biocare - Branemark System Implants (K022562)<br>Steri-Oss - Steri-Oss Implants for Single Stage Placement (K963224)<br>Straumann - ITI synOcta Meso Abutments (K033243) |

### Device Description:

Nobel Biocare's Procera® Implant Bridge is a bridge framework that attaches to implants or abutments. The Procera® Implant Bridge framework is intended to be finished into a dental prosthesis using standard laboratory dental materials such as resin composite or porcelain veneer.

Procera® Implant Bridges are made individually following instructions and models specific to each patient. The Procera® Implant Bridge is made entirely of titanium.

The Procera® Implant Bridge implant and abutment interfaces are modeled after similar interfaces currently available for the predicate devices listed.

### Indications for Use:

The Procera® Implant Bridge is indicated for use as a bridge framework in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function.

The Procera® Implant Bridge can be used at the implant or abutment level of the following implant systems:

Nobel Biocare Brånemark System Nobel Biocare Replace Select

The Procera® Implant Bridge can be used at the implant level of the following implant systems:

Nobel Biocare Replace

Nobel Biocare Steri-Oss HL Nobel Biocare Novum

Nobel Biocare Novum
Straumann Dental Implants

Straumann Dental Implant System Regular neck 4.8 Straumann Dental Implant System Wide neck 6,5

The Procera® Implant Bridge can be used at abutment level of the following implant systems: Nobel Biocare ARK abutment for Teeth-in-Hour concept

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#### 1.5 Performance Standards

The Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Abutments; Draft Guidance for Industry and FDA was identified as applicable to this submission.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAY 2 6 2004

Nobel Biocare AB C/O Ms. Elizabeth J. Mason Senior Regulatory Affairs Specialist Nobel Biocare USA, Incorporated 22715 Savi Ranch Parkway Yorba Linda, California 92887

Re: K041236

Trade/Device Name: Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051 Regulation Number: 372.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: NHA Dated: May 10, 2004 Received: May 11, 2004

Dear Ms. Mason:

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. Mason

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 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 toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Carls

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

510(k) Number (if known):

Device Name: Procera Implant Bridge

Indications For Use:

The Procera Implant Bridge is indicated for use as a bridge framework in the treatment of partially edentulous jaws for the purpose of restoring chewing function.

The Procera Implant Bridge can be used at the implant or abutment level of the following implant systems:

41236

•Nobel Biocare Brånemark System

·Nobel Biocare Replace Select

The Procera Implant Bridge can be used at the implant level of the following implant systems:

·Nobel Biocare Replace

· Nobel Biocare Steri-Oss HL

•Nobel Biocare Novum

·Straumann Dental Implant System Regular neck 4.8

·Straumann Dental Implant System Wide neck 6.5

The Procera Implant Bridge can be used at abulment level of the following implant systems: •Nobel Biocare ARK abutment for Teeth-in-Hour concept

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Sue Funnes

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

510(k) Number:

000007