SYNOCTA ANGLED ABUTMENTS

K994119 · Straumann USA · DZE · Mar 17, 2000 · Dental

Device Facts

• Record ID: K994119
• Device Name: SYNOCTA ANGLED ABUTMENTS
• Applicant: Straumann USA
• Product Code: DZE · Dental
• Decision Date: Mar 17, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2

Indications for Use

The synOcta® angled abutments are indicated for use in cases where the placement of the implant requires an angled reconstruction for an aesthetic result. The abutment can be used to restore crowns for single tooth replacements and bridges for bound situations. The angled abutment is not to be used in conjunction with the ITI 15° angled implant as the total degree of angulation is 30 degrees or above.

Device Story

The synOcta® Angled Abutment is a dental implant accessory used to correct angulation of dental implants to achieve aesthetic prosthetic results. It is a single-piece component made of Grade 4 titanium, featuring an 8° conical taper for connection to the dental implant and an occlusal thread for impression coping. The device is available in 15° and 20° angles. It is placed by a dental professional into the dental implant and secured with a titanium alloy screw. The device provides a foundation for crowns or bridges. It is supplied non-sterile and requires clinical handling for integration into the patient's dental restoration.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, material, and intended use comparisons to legally marketed predicate devices.

Technological Characteristics

Material: Commercially pure Grade 4 titanium (ASTM F67) and titanium alloy screw. Design: Single-piece abutment with 8° conical taper. Angles: 15° and 20°. Connectivity: Mechanical interface to dental implant. Sterilization: Provided non-sterile.

Indications for Use

Indicated for patients requiring dental implant reconstruction where implant placement necessitates angulation correction for aesthetic outcomes. Supports single tooth crowns and bound bridges. Contraindicated for use with ITI 15° angled implants due to excessive total angulation (≥30°).

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® synOcta® Abutment (K990342)
• ITI® Angled Abutment (K962647)
• Calcitek Angled Abutment
• Nobel Biocare Angled Abutment (K905434)
• Implant Innovations Angled Abutment

Submission Summary (Full Text)

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## MAR 17 2000

K994119

## ATTACHMENT 7 - 510(k) Summary

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

Straumann USA (on behalf of Institut Straumann AG) Reservoir Place 1601 Trapelo Road Waltham, MA 02451 781-890-0001 Telephone Number: 781-890-6464 Fax Number: Linda Jalbert, Director of Regulatory Affairs Contact Person:

#### 2. Name of the Device

Trade Name: Common Name: Classification Name: synOcta® Angled Abutment Dental Implant Abutment Accessories to Endosseous Dental Implant (21 CFR 872.3640)

### Legally Marketed Devices to which Equivalence is Claimed (Predicate Devices) 3. ITI® synOcta® Abutment (K990342) ITI® Angled Abutment (K962647)

Calcitek Angled Abutment (K number unknown) Nobel Biocare Angled Abutment (K905434) Implant Innovations Angled Abutment (K number unknown)

#### 4. Description of the Device

The subject device of this 510(k) is the ITI® synOcta® Angled Abutment which is placed into the dental implant to provide support for a prosthetic reconstruction. The angled abutment is used for angulation correction in cases where the angle of placement of the dental implant requires an angled reconstruction for an aesthetic result.

The synOcta® abutment is available in 15° and 20° angles and is made from commercially pure Grade 4 titanium (cold worked) which conforms to ASTM Standard Specification F67. The abutment is provided non-sterile in medical grade heat-sealed packaging.

The basal portion of the modified angled abutment has an 8° conical taper which fits into the coronal portion of the ITI implants. The abutment is held in place with a screw located in the basal portion of the abutment. This screw is composed of titanium alloy. The abutment is manufactured out of a single piece of titanium. The screw and suspension ring are mounted into the basal portion of the abutment. The coronal aspect of the abutment has an occlusal thread for the impression coping and a lateral screwdriver access hole.

#### న్. Intended Use of the Device

The synOcta® angled abutment is indicated to be used in cases where the angle of placement of the implant requires an angled reconstruction for an aesthetic result. The abutment can be used to restore both crowns for single tooth replacements and bridges for bound situations.

#### Basis for Substantial Equivalence 6.

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The ITI® synOcta® angled abutment and accessories are substantially equivalent in intended use, material and design to devices marketed by ITI® (Straumann), Nobel Biocare, Implant Innovations, and Calcitek.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 7 2000

Ms. Linda Jalbert Director, Regulatory Affairs Straumann USA Reservoir Place 1601 Trapelo Road Waltham, Massachusetts 02451

Re : K994119 SynOcta® Angled Abutments Trade Name: Regulatory Class: III Product Code: DZE December 3, 1999 Dated: Received: December 6, 1999

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, Druq, 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. ਰ 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

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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 findinq 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 and additionally 809.10 for in vitro diaqnostic 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

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

Enclosure

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# મુલવવાયા છ

## Indications for Use Statement

Device Name:

SynOcta® Angled Abutments

## Indications for Use:

The synOcta® angled abutments are indicated for use in cases where the placement of the implant requires an angled reconstruction for an aesthetic result. The abutment can be used to restore crowns for single tooth replacements and bridges for bound situations.

The angled abutment is not to be used in conjunction with the ITI 15° angled implant as the total degree of angulation is 30 degrees or above.

Susan Runno

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital De O 510(k) Number _

.