3I LOCATER ABUTMENT SYSTEM

K012911 · Implant Innovations, Inc. · DZE · Sep 28, 2001 · Dental

Device Facts

• Record ID: K012911
• Device Name: 3I LOCATER ABUTMENT SYSTEM
• Applicant: Implant Innovations, Inc.
• Product Code: DZE · Dental
• Decision Date: Sep 28, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2

Intended Use

The 3i Locator Abutment System for endosseous dental implants is appropriate for use with overdentures retained in whole or in part by endosseous implants in the mandible or maxilla.

Device Story

The 3i Locator Abutment System is a dental attachment system providing snap-fit retention for overdentures. It consists of a titanium alloy socket attached to an endosseous dental implant and a nylon component attached to the denture. The system functions by mating the nylon component into the titanium socket. It is used by dental professionals in a clinical setting to stabilize overdentures for patients with missing teeth. The device is a modification of the predicate Zest Locator Anchor System, adapted for use with 3i's Osseotite implants. It benefits patients by providing secure retention for removable dental prostheses.

Clinical Evidence

Bench testing only. The device underwent fatigue testing to 5 million cycles, demonstrating a fatigue strength of at least 175 pounds for the attachment components. No clinical data was required or provided.

Technological Characteristics

Materials: Titanium alloy (socket), Nylon 101 (component). Principle: Mechanical snap-fit retention. Form factor: Abutment for endosseous dental implants. Connectivity: None. Sterilization: Not specified (nylon components sterilized).

Indications for Use

Indicated for tissue-supported overdentures on 2-4 implants, partially edentulous overdentures with one or more implants, overdentures with minimum 3.17mm interarch distance, and overdentures with up to 40° divergence between implants. Contraindicated for multiple implants with >40° divergence and overdentures with >4 implants.

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

• Zest Locator Anchor System

Submission Summary (Full Text)

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Implant Innovations, Inc. Implant Innovations, Inc.
510(k) Premarket Notification for Modification to Locator® Anchor System

Image /page/0/Picture/2 description: The image is a logo for Implant Innovations, Inc., a Biomet company. The logo features a stylized "3i" in bold, black font. Below the "3i" are the words "IMPLANT INNOVATIONS, INC." in a smaller, sans-serif font, and below that is the text "A BIOMET COMPANY".

KO/2911

# Summary of Safety & Effectiveness

COMPANY: Implant Innovations, Inc. 4555 Riverside Drive Palm Beach Gardens, FL 33410

### CONTACT:

Jacquelyn A. Hughes, RAC Tacqueryn A. Regulatory Affairs & Quality Assurance Telephone: [phone] FAX: [phone] E-mail: [e-mail]

DATE PREPARED: August 29, 2001

NAME OF THE DEVICE: 3i Locator@Abutment System Classification: DZE Classinonene: Abutment for Endosseous Implant

PREDICATE DEVICES:

Zest Locator® Anchor System

### DEVICE DESCRIPTION:

DEVICE DESCRIPTION:
The 3i Locator Abutment System consists of a titanium alloy socket that is attached to a The 31 Locator Abutilent System consisted on umplants having an internal threaded socket. Both devices have a nylon component hat has a shape on one end that mates into socket. Both devices nave a hylon componities mass artached to the denture. This arrangement provides snap-fit retention of the system is identical to the arrangement provides shap-in relemon or the allow use with 37's Ossectite implant,
predicate devices, except for a modification to allow use with 31's from by 31 predicate devices, except for a modification of the system prior to distribution by 3i.

### INTENDED USE:

INTENDED USE:
The 3i Locator Implant Anchor Abutment for Endosseous Dental Implants is appropriate The 31 Locator Imprain Anchor Abdulentures retained in whole or in part by endosseous implants in the mandible or maxilla.

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## INDICATIONS FOR USE:

- Tissue supported overdentures on 2 to 4 implants ●
- Partially edentulous overdentures with one or more implants .
- Farthany edentures with a minimum of 3.17mm of interarch distance .
- Overdentures with a milling greater than 40° of divergence between them .

### CONTRAINDICATIONS:

- INTRAINDICATIOND.
Multiple implants with greater than 40° of divergence between them ●
- Overdentures with more than 4 implants .

### PERFORMANCE DATA:

PERFORMANCE DATA.
All previously submitted bench testing of the Zest Locator Anchor System has All previously submitted belief tosting of an essess in retention and withstanding occlusal forces. The system was also fatigue tested to 5 million cycles, and demonstrated that the fatigue strength of the attachment components is still at least 175 pounds. There are no modifications to the system in the 31 Locator Abutment System that would demonstrate modifications to the system in the St Locations (replacement males) were fatigue different results. Stermized Nyfon 101 components (2001) of non-sterilized components.

In conclusion, this 510(k) supports the substantial equivalence of the 3i Locator In Concrusion, this 510(x) Seppedicate, the Zest Locator Anchor System.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus consists of a staff with two snakes coiled around it and a pair of wings at the top.

Public Health Service

SEP 2 8 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Jacqueline A. Hughes Director of R/A & Q/A Implant Innovations, Incorporated 4555 Riverside Drive Palm Beach Gardens, Florida 33410

Re: K012911

K012911
Trade/Device Name: 31 Locater Abutment System Regulation Number: 872.3640 Regulation Names Endosseous Dental Implant Regulatory Class: III Product Code: DZE Dated: August 29, 2001 Received: August 30, 2001

Dear Ms. Hughes:

We have reviewed your Section 510(k) premarket notification of intent to market the device the We have reviewed your Section 310(x) pendice is substantially equivalent (for the referenced above and have determined the device to legally marketed predicate devices marketed in
indications for use stated in the enclosure was an anteger dies of the Meal indications for use stated in the enclosules to the enactment date of the Medical Device interstate commerce prior to May 20, 1970, the condance with the provisions of
Amendments, or to devices that have been recorders approval of a premarket Amendments, or to devices that have occi receive approval of a prematice approval of a premarket
the Federal Food, Drug, and Cosmetic Act (Act) that douice, subject to the ge the Federal Food, Drug, and Cosment Act (100) market the device, subject to the general
approval application (PMA). You may, therefore, market the device, subject to the ge approval application (FMA). Tou may, and controls provisions of the Act include controls provisions of the Act. The general of devices, good manufacturing practice,
requirements for annual registration, listing of devices, good manufacturing practice, requirements for annual regional misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III
ns affect If your device is classined (see above) into entrols. Existing major regulations affecting (PMA), it may be subject to such additional controllations, Title 21, Parts 800 to 898. In
your device can be found in the Code of Federal Regulations, Title 21, Federal your device can be found in the Code of Peacharies, would been and one in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA S Issualice of a savice complies with other requirements
mean that FDA has made a determination that your device complies with other Federal agenc mean that FDA has made a delemination that your as a secures and regulations and registes.

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#### Page 2 - Ms. Hughes

You must comply with all the Act's requirements, including, but not limited to: registration and I ou must comply while an labeling (21 CFR Part 801); good manufacturing practice nstilly (21 CFR Part 807), accems (QS) regulation (21 CFR Part 820); and if requirements as set form in the quality by examp (section 531-542 of the Act, 21); CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your 510(k) premated notification. The FDA finding of substantial equivalence of your device to a legally marketed nounceaton. The PDA income of succeantary vour 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 11 you desire specific advice for your do to contact the Office of Compliance at additionally 809.10 for m vito diagnestions on the promotion and advertising of your device, [phone]. entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Information on your responsional Assistance at its toll-free number [phone] or Manufacturers, International ant ediress http://www.fda.gov/cdrh/dsma/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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Implant Innovations, Inc. Implant Innovations, Inc.
510(k) Premarket Notification for Modification to Locator® Anchor System

510(k) Number (if known): K012291

Device Name: _________________________________________________________________________________________________________________________________________________________________

### Intended Use

The 3i Locator Abutment System for endosseous dental implants is appropriate for use The 3i Locator Abutment System for endosseous denar mipans in 1-11-11-11 in the mandible or maxilla.

#### Indications for Use

- Tissue supported overdentures on 2 to 4 implants .
- I issue supported ous overdentures with one or more implants �
- Partially edentureds overseinm of 3.17mm of interarch distance .
- Overdentures with a minimum of STFAMIL to advergence between them ●

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

| | Concurrence of CDRH, Office of Device Evaluation (ODE) |
|--|--------------------------------------------------------|
|--|--------------------------------------------------------|

*Susan Runner*

(Division Sign-Off)

Division of Dental, Infection Control,

and General Hospital Devices

| 510(k) Number | K012911 |
|---------------|---------|
|---------------|---------|

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

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