(154 days)
Not Found
No
The description focuses on the mechanical properties and intended use of a dental implant, with no mention of AI or ML capabilities.
Yes
The device is an implant used for long-term intra-bony fixation of dentures, which addresses a medical condition (edentulism) by restoring function.
No
Explanation: The device is an implant for long-term intra-bony fixation of dentures and for splinting and short-term fixation of failing crown and bridge installations. It is a treatment device, not a diagnostic one.
No
The device description clearly describes a physical dental implant made of titanium, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- Device Description and Intended Use: The provided text clearly describes a dental implant, a device surgically placed into bone to support a prosthesis (like a denture). Its function is mechanical fixation within the body, not the analysis of biological samples outside the body.
The information provided about the device's material, dimensions, surface treatment, and performance testing (fatigue) are all consistent with a surgically implanted medical device, not an IVD.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DZE
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior regions of the maxillary and mandibular arches
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
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
(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 Abutment
implant is a self-tapping
titanium threaded screw
indicated for long term intra- | The Nobel Active 3.0
implant is indicated for
use in the treatment of
missing lateral incisors or
the mandibular central | The Champions
Implants MIMI 1-
Piece Precision
Implant is intended
to support single or
multi-unit |
Substantial Equivalence
1
| | 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. | and lateral incisors to
support prosthetic
devices, such as artificial
teeth, in order to restore
chewing function in
partially edentulous
patients. The Nobel
Active 3.0 Implants may
be put in immediate
function provided that
stability requirements
detailed in the manual
are satisfied. | restorations in both
long-term and
temrporary
applications
throughout the
maxillary and
mandibular
arches. The MIMI 1-
Piece Precision
Implant is indicated
for immediate
loading when there
is good
primary stability and
an appropriate
occlusal load. The
MIMI 1-Piece
Precision Implants
have diameters
from 4,0 to 4,5mm
and are available in
length of 10 to
16mm. |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Material | Ti6Al4V | Ti6Al4V | Ti6Al4V |
| Sterilization | Delivered sterile | Delivered sterile | Delivered sterile |
| Procode | Dze | Dze | Dze |
| Screw pitch | Between Imtec fine and
coarse | Self-tapping compression
threads | Microthreads with
cutting flute and
coarse compression
threads |
| Screw surface | Blasted and clean | Sandblasted and acid
etched | Blasted and etched |
| Fatigue testing | Tested to modified ISO 14801
successfully | Tested according to the
guidance document
successfully | No testing
information in the
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.
2
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.
3
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
4
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