PROCERA PREPARABLE ABUTMENT SYSTEM

K974150 · Nobel Biocare Uas, Inc. · NHA · Jan 23, 1998 · Dental

Device Facts

• Record ID: K974150
• Device Name: PROCERA PREPARABLE ABUTMENT SYSTEM
• Applicant: Nobel Biocare Uas, Inc.
• Product Code: NHA · Dental
• Decision Date: Jan 23, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Nobel Biocare's Procera® Preparable Abutment System is a set of screw retained preparable abutments that are secured to an endosseous implant and are intended to function as an anchor to which prosthetic devices, such as artificial teeth, may be attached using dental cement to restore a patient's chewing function.

Device Story

Procera® Preparable Abutment System consists of titanium abutments, abutment screws, counter torque devices, adaptors, and impression copings. System functions as anchor for single crowns or multi-unit bridges; secured to Branemark System® dental implants via gold abutment screw. Used by dental professionals in clinical settings to restore patient chewing function. Components facilitate attachment of prosthetic devices using dental cement. System includes manual instrumentation for installation and torque management.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and design similarity to predicate devices.

Technological Characteristics

Titanium abutments; gold abutment screws; manual instrumentation (counter torque device, screwdrivers). System is designed for use with Branemark System® endosseous dental implants. Components are autoclavable.

Indications for Use

Indicated for patients requiring restoration of chewing function via prosthetic devices (artificial teeth) attached to endosseous dental implants using dental cement.

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

• TiAdapt Abutments (K971706)

Submission Summary (Full Text)

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K974150

Pre-market Notification Page -3-*****************************************************************************************************************************************************************************

JAN 2 3 1998

#### 510(k) Summary of Safety and Effectiveness VII.

A. Name and Address

This Summary of Safety and Effectiveness is being submitted by Nobel Biocare USA, Inc., 777 Oakmont Lane, Suite 100, Westmont, IL 60559. The telephone number is: [phone], extension 2002, and the contact person will be Betsy Brown, the Vice President, Regulatory Affairs.

#### B. Name of the Device

This device system consists of various preparable titanium abutments, abutment screws, a counter torque device with handle, adaptors, machine Uni-grip screwdrivers with autoclavable box, temporary cylinders, temporary tubes, laboratory screws and impression copings.

### C. The Predicate Product

The predicate products used in this Pre-market Notification are similar components marketed by Nobel Biocare which include the TiAdapt Abutments (K971706). However, the following devices are existing products that have been "cleared" for their indicated use under 510K #971706 for TiAdapt. These components are to be used as specified in the "Clinical Procedure" which is presented in Exhibit B. The components include the following: Abutment Screws Uni-Grip, Laboratory-Screws, Counter Torque Device, Counter Torque Device Adaptors, Counter Torque Instrument Tray, Temporary Cylinders, Temporary Tubes, Impression Copings, Impression Coping Screws, Plastic Impression Coping and Machine Uni-Grip Screwdriver.

D. Description of Device

The Nobel Biocare Procera® Preparable Abutment System is comprised of a titanium abutment which is secured to the Branemark System® dental implants with a gold abutment screw. This system functions as an anchor to which a single crown can be cemented. When more than one preparable abutment is used, a multi-unit bridge can be cemented to the abutments. The Procera® Preparable Abutment also includes a counter torque device and adaptors, temporary cylinders, impression copings and machine Uni-grip screwdrivers.

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### E. Intended Use of the Device

Nobel Biocare's Procera® Preparable Abutment System is a set of screw retained preparable abutments that are secured to an endosseous implant and are intended to function as an anchor to which prosthetic devices, such as artificial teeth, may be attached using dental cement to restore a patient's chewing function.

## F. Comparison of Technological Characteristics

The technological characteristics between the components of the Procera® Preparable Abutment and the corresponding predicate products found in the Branemark System® are identical.

### Summary Of Safety And Effectiveness Concerns

Safety and effectiveness problems that have been encountered with similar Abutment Systems used with endosseous implants that are currently being marketed include:

- 1. occasional fractures of the screw attaching the abutment to the fixtures usually due to functional overload from masticastory forces;
- loose (usually because torque force below 2. screws working recommended values was applied when the abutment was attached to the fixture) may lead to the formation of granulation tissue at the level of the fixture and abutment connection which may, in turn, result in infection;
- initial seating of abutments resulting in gingival 3. improper inflammation and fistulae formation, both conditions resolve when proper seating of the abutment is accomplished.
- 4. occasional fracture of the abutment screw which is usually caused by poorly designed and/or fabricated restorations that creates overloads or cause's metal fatigue.

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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 stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol. The logo is presented in black and white.

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

SEP 1 7 2010

Ms. Phuong Nguyen Son Regulatory Affairs Manager Nobel Biocare USA, LLC 22715 Savi Ranch Way Parkway Yorba Linda, California 92887

Re: K974150

Trade/Device Name: Procera Preparable Abutment System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: July 28, 2010 Received: July 29, 2010

Dear Ms. Nguyen Son:

This letter corrects our substantially equivalent letter of July 28, 2010.

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 (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 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. Nguyen Son

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,

Susan Kuares

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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510(k) Number (if known):

K974150

Device Name: Procera® Abutment System

### Indications For Use:

Nobel Biocare's Procera Abutment System is a set of screw retained preparable abutments which are secured to an endosseous implant and is intended to function as an anchor to which prosthetic devices, such as artificial teeth, may be attached using dental cement to restore a patient's chowing function.

# (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEED

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | <div align="left"><i>Susan Praser</i></div> |
|---------------------------------------------------------------------|---------------------------------------------|
| (Division Sign-Off) | |
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K974150 |

| Prescription Use | OR | Over-The-Counter Use |
|----------------------|----|----------------------|
| (Per 21 CFR 801.109) | | |

(Optional Format 1-2-96)