BONDING BASE

K973353 · Straumann USA · DZE · Dec 2, 1997 · Dental

Device Facts

• Record ID: K973353
• Device Name: BONDING BASE
• Applicant: Straumann USA
• Product Code: DZE · Dental
• Decision Date: Dec 2, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The bonding base serves as an attachment surface for the cementing of orthodontic brackets.

Device Story

Titanium bonding base; attaches to ITI Octa system via internal icositetrahedron (24 facets) for 15° angulation steps. Features eccentric bonding surfaces for variable distances between implant axis and bonding surface. Orthodontic bracket cemented to base; acts as anchor for orthodontic forces. Used in posterior oral cavity; removed post-treatment for standard prosthetic restoration. Physician-operated; facilitates orthodontic treatment in patients with dental implants.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Titanium. Design: 5.5 mm and 6.5 mm heights, 6.8 mm width. Internal icositetrahedron (24 facets) for seating on Octabutment. Axial screw channel for attachment. Mechanical device; no software or electronics.

Indications for Use

Indicated for use with a standard ITI implant placed in the posterior oral cavity, to serve as a base for orthodontic attachment during orthodontic treatment.

Regulatory Classification

Identification

An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.

Special Controls

*Classification.* (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2) *Classification.* Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use; (ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads; (iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system; (iv) The device must be demonstrated to be biocompatible; (v) Sterility testing must demonstrate the sterility of the device; (vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment; (vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians; (viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and (ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.

Predicate Devices

• ITI Titanium Transverse Screw Coping (K943720)
• ITI Octa Gold Coping (K894844)
• 3M Unitek orthodontic bands

Submission Summary (Full Text)

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DEC - 2 1997

KA73353

# ATTACHMENT 7

510(k) Summary

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## ATTACHMENT 7 - 510(k) Summary

#### Applicant's Name and Address 1.

Straumann USA (on behalf of Institut Straumann AG) Reservoir Place 1601 Trapelo Road Waltham, MA 02154 781-890-0001 Telephone Number: Fax Number: 781-890-6464 Linda Jalbert, Director of Regulatory Affairs Contact Person:

#### 2. Name of the Device

Trade Name: Bonding Base Orthodontic Bonding Base Common Name: Accessory to a dental implant (21 CFR 872.3640) Classification Name:

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

ITI Titanium Transverse Screw Coping (K943720) ITI Octa Gold Coping (K894844) 3M Unitek orthodontic bands

#### 4. Description of the Device

The orthodontic bonding base is screwed onto the ITI Octa system. The bonding base has an interior icositetetrahedron (24 facets) which allows a positioning in the desired angulation (15° steps). The bonding surfaces are eccentric to the implant axis such that four different distances are available between implant axis and bonding surface. An orthodontic bracket is cemented to the orthodontic bonding base and it acts as an anchor for the application of orthodontic forces during treatment. After orthodontic use, the bonding base is removed and a standard prosthetic restoration placed on the implant.

#### ട. Intended Use of the Device

The bonding base serves as an attachment surface for the cementing of orthodontic brackets.

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### Basis for Substantial Equivalence 6.

The Orthodontic Bonding Base is substantially equivalent to 3M Unitek Orthodontic The Orthodonitic Donaing Daos to babotantially oquivalism to on Children in the ITI Dands, the TTP Thankin Transverstooners on, material and design as follows:

| | Subject<br>Device | Predicate Devices | | | |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Features | Orthodontic<br>Bonding<br>Base | 3M Unitek<br>Orthodontic<br>Bands | ITI Titanium<br>Transverse<br>Screw<br>Coping | ITI Octa Gold<br>Coping | ITI<br>Transverse<br>Screw Gold<br>Coping |
| Intended<br>Use | Serve as a base<br>for orthodontic<br>attachment | Serve as a<br>base for<br>orthodontic<br>attachment | Serve as a base<br>for prosthetic<br>reconstruction | Serve as a base<br>for prosthetic<br>reconstruction | Serve as a<br>base for<br>prosthetic<br>reconstruction |
| Materials | Titanium | Stainless Steel | Titanium | gold alloy | gold alloy |
| Design | Heights of 5.5<br>mm and 6.5 mm.<br>Width of 6.8 mm.<br>Internal<br>icositetrahedron<br>(24 facets) for<br>seating on<br>Octabutment.<br>Axial screw<br>channel for<br>attachment to<br>abutment. | Tooth-shaped<br>circular bands<br>designed in a<br>range of sizes<br>to<br>accommodate<br>varying tooth<br>anatomies and<br>sizes. | Height of 8.0<br>mm.<br>Internal<br>icositetrahedro<br>n (24 facets) for<br>seating on<br>Octabutment.<br>Transverse<br>screw channel<br>for attachment<br>to abutment | Height of 4.0<br>mm.<br>Internal octagon<br>for seating on<br>Octabutment.<br>Axial screw<br>channel for<br>attachment to<br>abutment. | Height of 5.2<br>mm.<br>Internal<br>icositetrahedr<br>on (24 facets)<br>for seating on<br>Octabutment.<br>Transverse<br>screw channel<br>for attachment<br>to abutment. |

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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle's head and neck. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 2 1997

Ms. Linda Jalbert Director, Requlatory Affairs Straumann USA Reservoir Place 1601 Trapelo Road 02154 Waltham, Massachusetts

Re : K973353 Trade Name: Bonding Base Regulatory Class: III Product Code: DZE Dated: September 4, 1997 Received: September 5, 1997

Dear Ms. Jalbert:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Page 2 - Ms. Jalbert

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-20#1 or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Directbr Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

. Enclosure

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| 510(k) Number (if known): | K973353 |
|---------------------------|-------------|
| Device Name: | Bondin base |
| Indications For Use: | |

Page ofThe bonding base is indicated for use with a standard ITI implant placed in the posterior oral cavity, to serve as a base for orthodontic attachment during orthodontic treatment.

. .

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign Off)
Divi- Division of Reproductive, Abdominal, and Radiological Devices Control,
and Division of Reproductive, Abdominal, and Radiological Devices al Devices

| 510(k) Number | K973353 |
|---------------|---------|
|---------------|---------|

Prescription Use Vse (Per 21 CFR 801.109)

OR

Over-The-Counter Use_ ________________________________________________________________________________________________________________________________________________________

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(Optional Format 1-2-96)