OSI O-BALL ABUTMENT HEAD IMPLANTS

K110548 · Juell Dental · DZE · Jul 29, 2011 · Dental

Device Facts

• Record ID: K110548
• Device Name: OSI O-BALL ABUTMENT HEAD IMPLANTS
• Applicant: Juell Dental
• Product Code: DZE · Dental
• Decision Date: Jul 29, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The OSI O-ball Abutment implant is a self-tapping titanium threaded screw indicated for long term intra-bony fixation of upper and lower dentures in edentulous cases. These devices will permit immediate splinting and ability and short-term fixation of failing crown and bridge installations, for full or partial edentulism. They can be used in the anterior regions of the maxillary and mandibular arches and are indicated for immediate loading when there is good primary stability and appropriate occlusal load.

Device Story

Self-tapping titanium threaded screw implant; used for long-term fixation of dentures or short-term stabilization of failing crown/bridge installations. Implant features o-ball head; available in 3.0mm-4.5mm diameters and 10mm-18mm lengths. Manufactured from ASTM F136 Ti6Al4V; threaded surface blasted to increase surface area. Used by dental clinicians in clinical settings. Provides mechanical support for prosthetic devices; enables immediate loading when primary stability and occlusal load conditions are met. Benefits patient by restoring chewing function and stabilizing dental prosthetics.

Clinical Evidence

Bench testing only. Fatigue testing conducted according to a modified ISO 14801 standard on the 3.0mm implant variant. Testing successfully demonstrated mechanical integrity under specified loading conditions.

Technological Characteristics

Material: ASTM F136 Ti6Al4V. Design: Self-tapping threaded screw with o-ball head. Surface: Blasted with particulate media. Diameters: 3.0, 3.5, 4.0, 4.5mm. Lengths: 10-18mm. Sterilization: Delivered sterile.

Indications for Use

Indicated for edentulous or partially edentulous patients requiring long-term intra-bony fixation of dentures or short-term fixation of failing crown/bridge installations. Suitable for anterior maxillary and mandibular arches. Contraindicated without good primary stability or appropriate occlusal load.

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

• Nobel Active o-ball (K102436)
• Champion (K091182)

Submission Summary (Full Text)

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K110348

510k Summary

JUL 2 9 2011

# July 22, 2011

# Trade Name: Juell OSI O-ball Abutment Dental Implant

Common Name: o-ball implant

Material: ASTM F136 Ti6Al4V

## Company Contact:

ﻟ

John Roderick, Operations Manager Juell Dental 2401 N. Commerce Ardmore, OK 73401 [phone]

## Device Description

The JUELL OSI O-Ball Abutment Dental Implant is available with a gingival collar in four diameters: 3.0mm, 3.5mm, 4.0mm and 4.5mm. The JUELL OSI O-Ball Abutment Dental Implant is available in thread lengths ranging from 10mm to 18mm. The implant is manufactured from ASTM F136 Ti6Al4V. The threaded surface is blasted with particulate media to increase the surface area.

## Indications for Use

The OSI O-ball Abutment implant is a self-tapping titanium threaded screw indicated for long term intrabony fixation of upper and lower dentures in edentulous cases. These devices will permit immediate splinting and ability and short-term fixation of failing crown and bridge installations, for full or partial edentulism. They can be used in the anterior regions of the maxillary and mandibular arches and are indicated for immediate loading when there is good primary stability and appropriate occlusal load.

## Testing

Fatigue was conducting according to a mofified ISO 14801 on the 3.0mm implant with the exception of the angle the implant was held being adjusted to 15° and the loading point being on the o-ball causing the length from the bone level to be 5mm and the length from the holding line to be 8mm.

| | OSI o-ball | Nobel Active o-ball<br>(k102436) | Champion<br>(k091182) |
|---------------------|-------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Diameter (mm) | 3.0,3.5,4.0,4.5 | 3.3 | 4, 4.5 |
| Length (mm) | 10,13,15,17,18 | 10, 11.5, 13,15 | 10 to 16 |
| Implant head shape | o-ball | o-ball | o-ball |
| Indications for use | The OSI O-ball Abutment<br>implant is a self-tapping<br>titanium threaded screw<br>indicated for long term intra- | The Nobel Active 3.0<br>implant is indicated for<br>use in the treatment of<br>missing lateral incisors or<br>the mandibular central | The Champions<br>Implants MIMI 1-<br>Piece Precision<br>Implant is intended<br>to support single or<br>multi-unit |

#### Substantial Equivalence

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| | bony fixation of upper and<br>lower dentures in edentulous<br>cases. These devices will<br>permit immediate splinting<br>and ability and short-term<br>fixation of failing crown and<br>bridge installations, for full or<br>partial edentulism. They can<br>be used in the anterior<br>regions of the maxillary and<br>mandibular arches and are<br>indicated for immediate<br>loading when there is good<br>primary stability and<br>appropriate occlusal load. | and lateral incisors to<br>support prosthetic<br>devices, such as artificial<br>teeth, in order to restore<br>chewing function in<br>partially edentulous<br>patients. The Nobel<br>Active 3.0 Implants may<br>be put in immediate<br>function provided that<br>stability requirements<br>detailed in the manual<br>are satisfied. | restorations in both<br>long-term and<br>temrporary<br>applications<br>throughout the<br>maxillary and<br>mandibular<br>arches. The MIMI 1-<br>Piece Precision<br>Implant is indicated<br>for immediate<br>loading when there<br>is good<br>primary stability and<br>an appropriate<br>occlusal load. The<br>MIMI 1-Piece<br>Precision Implants<br>have diameters<br>from 4,0 to 4,5mm<br>and are available in<br>length of 10 to<br>16mm. |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Material | Ti6Al4V | Ti6Al4V | Ti6Al4V |
| Sterilization | Delivered sterile | Delivered sterile | Delivered sterile |
| Procode | Dze | Dze | Dze |
| Screw pitch | Between Imtec fine and<br>coarse | Self-tapping compression<br>threads | Microthreads with<br>cutting flute and<br>coarse compression<br>threads |
| Screw surface | Blasted and clean | Sandblasted and acid<br>etched | Blasted and etched |
| Fatigue testing | Tested to modified ISO 14801<br>successfully | Tested according to the<br>guidance document<br>successfully | No testing<br>information in the<br>510k summary |

The materials, surface treatment, and design are similar and show Juell o-ball abutments to be substantially equivalent to the predicate devices. The indications for use is similar to those of the predicate devices so the Juell o-ball abutments are substantially equivalent to the predicate devices. Both Juell o-ball abutment implants and the predicate devices tested in fatigue successfully, so Juell oball abutment implants are substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol. The text is in all caps and is in a sans-serif font.

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

Jucil Dental C/O Ms. Angela Blackwell Senior Consultant Biologics Consulting Group 2401 North Commerce Ardmore, Oklahoma 73401

JUL 2 9 2011

Re: K110548

Trade/Device Name: OSI o-Ball Abutment Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous dental Implant Regulatory Class: II Product Code: DZE Dated: July 22, 2011 Received: July 25, 2011

Dear Ms. Blackwell:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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. Blackwell

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 (OS) 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Susan Purnan

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

# Enclosure

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# Indications for Use

510(k) Number (if known): K | 1 05 48

Device Name: OSI o-ball abutment implants

Indications for Use:

The OSI O-ball Abutment implant is a self-tapping titanium threaded screw indicated for long term intra-bony fixation of upper and lower dentures in edentulous cases. These devices will permit immediate splinting and ability and short-term fixation of failing crown and bridge installations, for full or partial edentulism. They can be used in the anterior regions of the maxillary and mandibular arches and are indicated for immediate loading when there is good primary stability and appropriate occlusal load.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

# Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Knox

Page Page of

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

510(k) Number: K110548