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 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.

AI/ML Overview

The provided FDA 510(k) summary for the Juell OSI O-ball Abutment Dental Implant focuses on establishing Substantial Equivalence to legally marketed predicate devices, rather than performing a rigorous study to prove the device meets specific acceptance criteria with quantifiable metrics.

Therefore, many of the requested sections (e.g., sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies) are not applicable or cannot be extracted from this document as these types of studies are not typically required for 510(k) clearances focused on substantial equivalence through material and design comparison and existing test standards.

Here's a breakdown of the information that can be extracted, and where the requested information is not applicable:

Acceptance Criteria and Device Performance for Juell OSI O-ball Abutment Dental Implant (K110348)1

The primary "acceptance criterion" for this 510(k) clearance is Substantial Equivalence to existing predicate devices, particularly regarding materials, design, indications for use, and successful fatigue testing.

The study presented is a comparison to predicate devices and demonstration of compliance with an industry standard for mechanical performance.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit for Substantial Equivalence)	Reported Device Performance (Juell OSI O-ball)
Material Equivalence (to Predicate)	Manufactured from ASTM F136 Ti6Al4V.
Design Equivalence (to Predicate)	O-ball implant head shape. Available in 3.0mm, 3.5mm, 4.0mm, 4.5mm diameters; 10mm-18mm thread lengths. "Designs are similar."
Indications for Use Equivalence (to Predicate)	"Indications for use is similar to those of the predicate devices." (See detailed description in the document).
Fatigue Performance (Modified ISO 14801)	"Tested to modified ISO 14801 successfully."
Surface Treatment Equivalence	"Blasted and clean" (compared to "Sandblasted and acid etched" and "Blasted and etched" for predicates).
Sterilization	Delivered sterile.

2. Sample Size for Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated for fatigue testing. Fatigue testing according to ISO 14801 typically involves multiple samples (e.g., 10-20 per condition) to establish a statistically significant endurance limit, but the exact number is not provided in this summary.
Data Provenance: The fatigue testing was conducted by or for Juell Dental. The country of origin of the data is not specified, but the company is based in Ardmore, OK, USA. The testing is prospective for the device being submitted.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. This type of submission relies on engineering standards (ISO 14801) and comparison to predicate devices, not on expert-established ground truth for a test set in the clinical or diagnostic sense.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical or diagnostic "test set" requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC study is not relevant for this type of device (dental implant) and submission, which focuses on mechanical performance and substantial equivalence.

6. Standalone Performance Study (Algorithm Only)

Not applicable. This device is a physical medical device (dental implant), not a software algorithm.

7. Type of Ground Truth Used

The "ground truth" for the fatigue test was established by the ISO 14801 standard, which defines how dental implants should be subjected to cyclic loading to assess their durability. The outcome is whether the device successfully met the standard's criteria (i.e., did not fracture within a specified number of cycles at a given load).

8. Sample Size for the Training Set

Not applicable. There is no "training set" in the context of this device. The device design and materials are based on established engineering principles and comparison to existing, already "trained" (i.e., clinically proven) predicate devices.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there's no training set, there's no ground truth establishment for it.

Summary

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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 (580) 798-4414

Device Description

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(K102436)	Champion(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 Abutmentimplant is a self-tappingtitanium threaded screwindicated for long term intra-	The Nobel Active 3.0implant is indicated foruse in the treatment ofmissing lateral incisors orthe mandibular central	The ChampionsImplants MIMI 1-Piece PrecisionImplant is intendedto support single ormulti-unit

Substantial Equivalence

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	bony fixation of upper andlower dentures in edentulouscases. These devices willpermit immediate splintingand ability and short-termfixation of failing crown andbridge installations, for full orpartial edentulism. They canbe used in the anteriorregions of the maxillary andmandibular arches and areindicated for immediateloading when there is goodprimary stability andappropriate occlusal load.	and lateral incisors tosupport prostheticdevices, such as artificialteeth, in order to restorechewing function inpartially edentulouspatients. The NobelActive 3.0 Implants maybe put in immediatefunction provided thatstability requirementsdetailed in the manualare satisfied.	restorations in bothlong-term andtemrporaryapplicationsthroughout themaxillary andmandibulararches. The MIMI 1-Piece PrecisionImplant is indicatedfor immediateloading when thereis goodprimary stability andan appropriateocclusal load. TheMIMI 1-PiecePrecision Implantshave diametersfrom 4,0 to 4,5mmand are available inlength of 10 to16mm.
Material	Ti6Al4V	Ti6Al4V	Ti6Al4V
Sterilization	Delivered sterile	Delivered sterile	Delivered sterile
Procode	Dze	Dze	Dze
Screw pitch	Between Imtec fine andcoarse	Self-tapping compressionthreads	Microthreads withcutting flute andcoarse compressionthreads
Screw surface	Blasted and clean	Sandblasted and acidetched	Blasted and etched
Fatigue testing	Tested to modified ISO 14801successfully	Tested according to theguidance documentsuccessfully	No testinginformation in the510k 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 (800) 638-2041 or (301) 796-7100 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:

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

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
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.(b)
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.