MIRUSCONE ABUTMENT SYSTEM

K961728 · Nobelpharma USA, Inc. · NHA · Jul 10, 1996 · Dental

Device Facts

• Record ID: K961728
• Device Name: MIRUSCONE ABUTMENT SYSTEM
• Applicant: Nobelpharma USA, Inc.
• Product Code: NHA · Dental
• Decision Date: Jul 10, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Nobelpharma MirusCone Abutment System is intended to be used in edentulous patients as an anchor to support a prosthesis.

Device Story

MirusCone Abutment System is an endosseous dental implant abutment. Device serves as an anchor for dental prostheses in edentulous patients. System consists of abutments and associated screws implanted into the upper or lower jaw bone. Modifications include adjusted base and external diameters to accommodate varying fixture sizes and provide a lower vertical profile option. Device is used by dental professionals in a clinical setting. Output is a mechanical interface supporting prosthetic restoration, aiding in patient oral function and rehabilitation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Endosseous dental implant abutment. Mechanical device consisting of abutment and screw components. Dimensional modifications to base and external diameters. No software or electronic components.

Indications for Use

Indicated for edentulous patients requiring an anchor to support a dental prosthesis.

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

• MirusCone Abutment System (K944964)

Submission Summary (Full Text)

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Pre-Market Notification
May 1, 1996
Page 2
K961728
JUL 10 1996

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

### A. Name and Address

This Summary of Safety and Effectiveness is being submitted by Nobelpharma USA, Inc., 777 Oakmont Lane, Suite 100, Westmont, IL 60559. Their telephone number is [phone]. The contact person will be the Director, Regulatory Affairs. This summary was prepared on May 1, 1996.

### B. Name of the Device

This device is known as an abutment to an endosseous implant with the trade name BRÄNEMARK SYSTEM® MirusCone Abutment System. This submission is a modification to a previously cleared device, K944964.

### C. The Predicate Product

The predicate product used in this Premarket Notification is the previous version of the same device, MirusCone Abutment System, K944964.

### D. Description of the Device

The Nobelpharma MirusCone Abutment System is an abutment used with an endosseous implant which is implanted in the upper or lower jaw bone. The abutment has a lower profile (vertical height) for use when the dentist desires a lower profile abutment. The only modifications to the device are the broadening and narrowing of the base and external diameters of the abutments; and broadening and narrowing of the diameters of the abutment screws, adding two series of abutments fitting the larger and smaller diameters of fixture previously cleared.

### E. Intended Use of the Device

The Nobelpharma MirusCone Abutment System is intended to be used in edentulous patients as an anchor to support a prosthesis.

### F. Comparison of Technological Characteristics

The technological characteristics between the modified version of the MirusCone Abutment and the earlier version are identical. The only changes are minor dimensional changes to the diameters of the abutment, the abutment screw and the prosthetic screw.

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service

SEP 17 2010

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

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

Re: K961728
Trade/Device Name: MirusCone 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,


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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J(k) Number (if known): K961728

Device Name: MirusCone Abutment System

Indications For Use:
Intended to be used in edentulous patients as an anchor to support a prosthesis.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Surg. Purvo
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number K961728

Option Use ☑
or 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

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