STRAUMANN GUIDED INSTRUMENTS

K082532 · Straumann USA · DZI · Oct 21, 2008 · Dental

Device Facts

• Record ID: K082532
• Device Name: STRAUMANN GUIDED INSTRUMENTS
• Applicant: Straumann USA
• Product Code: DZI · Dental
• Decision Date: Oct 21, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4120
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Bone cutting instruments are intended for use during oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin or screw.

Device Story

Straumann Guided Instruments are surgical drill bits used during oral surgery. Operated by dental surgeons, these instruments facilitate the preparation of the upper or lower jaw bone for the placement of dental implants, wires, pins, or screws. The device functions as a mechanical cutting tool. By enabling precise bone preparation, the instruments assist in the surgical workflow for restoring edentulous patients.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Mechanical bone cutting instrument (drill bit). Materials and design are consistent with standard dental surgical instruments regulated under 21 CFR 872.4120.

Indications for Use

Indicated for use during oral surgery to drill or cut into the upper or lower jaw to prepare bone for the insertion of wires, pins, or screws in patients requiring dental implant procedures.

Regulatory Classification

Identification

A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.

Predicate Devices

• Bone Cutting Instruments (K894844)

Submission Summary (Full Text)

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K082532

OCT 2 1 2008

## Section I 510(k) Summary

### 1. Applicant's Name and Address

Straumann US (on behalf of Institut Straumann AG) 60 Minuteman Rd. Andover, MA 01810 Telephone Number: 800-448-8168, ext 2513 Fax Number: 978-747-0023 Contact Person: Elaine Alan Regulatory Affairs Specialist Date of Submission: August 29, 2008

#### 2. Name of the Device

| Trade Name: | Straumann Guided Instruments |
|----------------------|-----------------------------------------|
| Common Name: | Drill Bits |
| Classification Name: | Bone Cutting Instrument and Accessories |
| Regulation Number: | §872.4120 |

### 3. Legally Marketed Device to which Equivalence is Claimed (Predicate Device)

Bone Cutting Instruments, K894844

#### 4. Description of the Device

The Straumann P.004 Dental Implant System is an integrated system of endosseous dental implants, which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants, abutments and surgical and prosthetic parts and instruments.

#### 5. intended Use of the Device

Bone cutting instruments are intended for use during oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin or screw.

#### 6. Technological Characteristics

The proposed Straumann Guided Instruments are substantially equivalent to the currently marketed devices. The intended use is identical to the predicate devices. The proposed drill bits have the same material composition, basic design and fundamental operating principles to the currently marketed devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# OCT 21 2008

Ms. Elaine Alan Regulatory Affairs Specialist Straumann USA 60 Minuteman Road Andover, Massachusetts 01810

Re: K082532

Trade/Device Name: Straumann Guided Instruments Regulation Number: 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: II Product Code: DZI Dated: August 29, 2008 Received: September 2, 2008

Dear Ms. Alan:

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. Alan

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 vours,

J.N. Samuels-Lendry frey

Chiu S. Lin, Ph. D Division 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 Statement

Device Name: Straumann Guided Instruments

Indications for Use:

Bone cutting instruments are intended for use during oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin or screw.

× Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Susan Runner

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

510(k) Number: K081532

510(k) Submission: Straumann Guided Instruments August 29, 2008 Proprietary and Confidential

Straumann US Page 5