(105 days)
Not Found
No
The document describes a dental implant system and its physical characteristics, intended use, and performance testing. There is no mention of software, algorithms, or any technology related to AI or ML.
Yes
The device is a dental implant system indicated for long-term intra-bony applications to provide stability and fixation for crown and bridge installations, which serves a therapeutic purpose by restoring dental function and aesthetics.
No
Explanation: The device described is a dental implant system used for long-term intra-bony applications and supporting restorations. Its function is to provide fixation and stability, not to diagnose a condition.
No
The device description clearly states the device is a physical implant made of titanium alloy, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the LEW O-ball implant system is a "self-tapping titanium threaded screw indicated for long-term intra-bony applications." It is a physical implant designed to be placed directly into bone to support dental restorations.
- Lack of Biological Sample Analysis: There is no mention of this device being used to analyze biological samples or provide diagnostic information based on such analysis.
Therefore, the LEW O-ball implant system falls under the category of a surgical implant or dental device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Park Dental Research Corporation's LEW O-ball implant system is a self-tapping titanium threaded screw indicated for long-term intra-bony applications. Additionally, the LEW Mini O-ball Implant may be used for inter-radicular transitional applications.
These devices will permit immediate splinting stability and long-term fixation of new and bridge installations, for full or partial edentulism, and employing minimally invasive surgical intervention.
The 2.0mm , 2.5 mm, and 3.0 mm diameter are intended to support single or multi-unit restorations in both long-term and temporary applications throughout the maxillary and mandibular arches.
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
The LEW Mini O-ball implant (MD)) is available with a 1.5 mm gingival collar in three diameters: 2.0mm, and 3.0mm. The LEW Mini O-ball implant (MDI) is also available without a gingival collar in two diameters; 2.0mm and 2.5mm. The implant is made of Titanium alloy (Ti6A4V ELI per ASTM F 136-02), The thread surface is ablated with 50 micron aluminum oxide to remove shiny machined surface. The LEW Mini O-ball implant (MDI) is available in thread lengths ranging from 10mm to 18mm allowing for maximum bone engagement. The system consists of the major component, a root-form, screw type, self-tapping implant, and accessories designed to facilitate placing and using the implant. The accessories contact tissues for less than 1 hour and therefore are exempt from 510(k) requirements are described generally but are of course subject to general controls and are covered by the Quality System documents.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Fatigue testing was conducted according to ISO 14801 on both models of 2.0mm implant.
The LEW Mini O-Ball implant is substantially equivalent or stronger* than IMTEC’s K031106 MDI implant. The same titanium alloy, a SE of thread pitch, form and depth, a SE of threaded lengths. *Tthe IMTEC MDI 1.8mm diameter is approved, when calculated has a lower fatigue properties than a SE 2.0mm diameter implant
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.
IMTEC MDI K031106, Intra-Lock MDL K070601, Intra-Lock MILO K050970, Prizmatics Inclusive K100932
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
Image /page/0/Picture/0 description: The image is a circular logo with the words "PARK DENTAL" in the center. The text is white and the background is black. The logo is simple and easy to read.
510(k) Summary
Submitter: Owner - Park Dental Research Corporation, 2401N. Commerce, Ardmore, OK. Office 212.736.3765, Fax 214.233.7279. Point of Contact - Ron Bulard. Submitted 5/18/2012
Proprietary Name: LEW Mini O-Ball Implant
Common/Usual Name : Implants, endosseous implants, SDI's, Small diameter implants
Classification Name and Number : Endosseous Dental Implant (21 CFR 872.3640 DZE)
Devices for Substantial Equivalence: IMTEC MDI K031106, Intra-Lock MDL K070601, Intra-Lock MILO K050970, Prizmatics Inclusive K100932
Device Description
The LEW Mini O-ball implant (MD)) is available with a 1.5 mm gingival collar in three diameters: 2.0mm, and 3.0mm. The LEW Mini O-ball implant (MDI) is also available without a gingival collar in two diameters; 2.0mm and 2.5mm. The implant is made of Titanium alloy (Ti6A4V ELI per ASTM F 136-02), The thread surface is ablated with 50 micron aluminum oxide to remove shiny machined surface. The LEW Mini O-ball implant (MDI) is available in thread lengths ranging from 10mm to 18mm allowing for maximum bone engagement. The system consists of the major component, a root-form, screw type, self-tapping implant, and accessories designed to facilitate placing and using the implant. The accessories contact tissues for less than 1 hour and therefore are exempt from 510(k) requirements are described generally but are of course subject to general controls and are covered by the Quality System documents.
Indications for Use
The Park Dental Research Corporation's LEW O-ball implant system is a self-tapping titanium threaded screw indicated for long-term intra-bony applications. Additionally, the LEW Mini O-ball Implant may be used for inter-radicular transitional applications.
These devices will permit immediate splinting stability and long-term fixation of new and bridge installations, for full or partial edentulism, and employing minimally invasive surgical intervention.
The 2.0mm , 2.5 mm, and 3.0 mm diameter are intended to support single or multi-unit restorations in both long-term and temporary applications throughout the maxillary and mandibular arches.
Testing
Fatigue testing was conducted according to ISO 14801 on both models of 2.0mm implant.
Compliance with Performance Standards No performance standards are applicable, however we followed "Class II Special Controls Guidance - Document: Root-form Endosseous Dental Implant Abutments" issued May 12, 2004. The Ti6AlAV-EU titanium used in these implants meet ASTM F-136 "Standard Specifications for Wrought Titanium-6aluminum-4Vanadium Allow for Surgical Implant Applications"
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1
Substantial Equivalence
Summary : The LEW Mini O-Ball implant system is substantially equivalent to several small diameter implants systems currently on the market. We have listed five 510(k) implants systems. A detailed chart of more implant systems is included in Section 12
| Element of
Comparison | LEW Mini O-Ball
Implant | IMTEC K031106 | IMTEC K081653 | Intra-Lock K070601 | Intra-Lock
K050970 | Prismatic
K100932 |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Diameter
(mm) | 2.0, 2.5, 3.0 | 1.8, 2.1, 2.4 | 2.9 | 2.0, 2.5 | 3.0 | 2.2, 2.5, 3.25 |
| Length (mm) | 10,13,15,17,18 | 10,13,15,18 | 10,13,15,18 | 10,11.5,13,15,18 | 10,11.5,13,15,18 | 10, 13, 15 |
| Implant head
shape | O-ball Connection
compatible/SE to
IMTEC K031106 and
Intra-Lock K070601.
SE | O-ball Connection
compatible to an
o-ring metal
housing | O-ball
Connection
compatible to an
o-ring metal
housing | O-ball Connection
compatible/SE to
IMTEC K031106 | O-ball Connection
compatible/SE to
IMTEC K031106 | O-Ball Connection
SE to IMTEC
K031106 |
| Indications for
use | The Park Dental
Research
Corporation's LEW
O-ball implant
system is a self-
tapping titanium
threaded screw
indicated for long-
term intra-bony
applications.
Additionally, the
LEW Mini O-ball
Implant may be
used for inter-
radicular
transitional
applications.
These devices will
permit immediate
splinting stability
and long-term
fixation of new or
existing crown and
bridge installations,
for full or partial
edentulism, and
employing
minimally invasive
surgical
intervention.
The 2.0mm , 2.5
mm, and 3.0 mm
diameter are
intended to support
single or multi-unit
restorations in both
long-term and
temporary
applications | The MDI and MDI
Plus are self-
tapping titanium
threaded screws
indicated for
long-term intra-
bony applications.
Additionally, the
MDI may be used
for inter-radicular
transitional
applications.
These devices will
permit immediate
splinting stability
and long-term
fixation of new or
existing crown
and bridge
installations, for
full or partial
edentulism, and
employing
minimally
invasive surgical
intervention. | The MII Implant
is intended to
support single or
multi-unit
restorations in
both long-term
and temporary
applications
throughout the
maxillary and
mandibular
arches. The MII
implant is
indicated for
immediate
loading when
good primary
stability is
achieved.
Additionally, this
device will permit
stability and long
term fixation of
upper and lower
dentures in
edentulous cases. | 3. Mini Drive-Lock™
Dental Implants are
intended for use as a
self-tapping titanium
screw for
transitional or intra-
bony long-term
applications.
4. Mini Drive-Lock™
Dental Implants are
indicated for long-
term maxillary and
mandibular tissue
supported denture
stabilization.
Multiple implants
should be used and
may be restored
after a period of
time or placed in
immediate function. | MILO ™ Implants
are indicated for
long-term
maxillary and
mandibular
tissue-supported
denture
stabilization.
Multiple implants
may be restored
after a period of
time or placed in
immediate
function. | Inclusive® Mini
Implants are self-
tapping threaded
titanium screws
indicated for long-
term applications.
Inclusive® Mini
Implants may also
be used for
provisional
applications.
These devices will
allow immediate
loading and long-
term stabilization
of dentures and
provisional
stabilization of
dentures while
standard implants
heal. To be used
for immediate
loading only in the
presence of
primary stability
and appropriate
occlusal loading. |
| Element of
Comparison | LEW Mini O-Ball
Implant
throughout the
maxillary and
mandibular arches. | IMTEC K031106 | IMTEC K081653 | Intra-Lock K070601 | Intra-Lock
K050970 | Prismatic
K100932 |
| Material | Ti6Al4V ASTM F-136 | Ti6Al4V ASTM F-
136 | Ti6Al4V ASTM F-
136 | Ti6Al4V ASTM F-136 | Ti6Al4V ASTM F-
136 | Ti6Al4V ASTM F-
136 |
| Sterilization | Delivered sterile | Delivered sterile | Delivered sterile | Delivered sterile | Delivered sterile | Delivered sterile |
| Packaging | Vial in a pouch | Vial in a pouch | Vial in a pouch | Vial in a pouch | Vial in a pouch | Vial in a pouch |
| Product Code | dze | dze | dze | dze | dze | dze |
| Screw pitch &
depth of
thread | Thread pitch ranges
between IMTEC's
fine and coarse
pitch as well as
thread depth | Fine thread pitch
for 1.8,2.1
Diameters.
Ccoarser pitch for
2.4 | Coarse Pitch and
depth | Thread pitch ranges
between IMTEC's
fine and coarse pitch
as well as thread
depth | Coarse Pitch and
depth | Coarse Pitch and
depth |
| Bone Contact
Surface | Blasted and clean
(SLA equivalent),
machined surface,
SE to IMTEC
K031106 | Blasted and clean
(SLA equivalent),
machined surface | Blasted and clean
(SLA equivalent),
machined surface | Blasted and clean, ,
SE to IMTEC
K031106, In addiion
with embedded
CaPhos molecules | Blasted and clean,
, SE to IMTEC
K031106, In
addiion with
embedded
CaPhos molecules | Blasted Etched
Surface, SE to
IMTEC K031106 |
| Driver
Connection | Square 1.65mm SE
to IMTEC K031106 | Square 1.65mm | Square 1.65mm | Square 1.65mm SE
to IMTEC K031106 | Square 1.65mm
SE to IMTEC
K031106 | Square 1.65mm
SE to IMTEC
K031106 |
| Included
Prosthetic | Metal Housing(s)
with o-ring, SE to
IMTEC K031106 | Metal Housing(s)
with o-ring, | Metal Housing(s)
with o-ring, | Metal Housing(s)
with o-ring, SE to
IMTEC K031106 | Metal Housing(s)
with o-ring, SE to
IMTEC K031106 | Metal Housing(s)
with o-ring, SE to
IMTEC K031106 |
| Fatigue testing | Tested to ISO 14801
(results attached) .
The LEW Mini O-Ball
implant is
substantially
equivalent or
stronger* than
IMTEC's K031106
MDI implant. The
same titanium alloy,
a SE of thread pitch,
form and depth, a
SE of threaded
lengths. *Tthe
IMTEC MDI 1.8mm
diameter is
approved, when
calculated has a
lower fatigue
properties than a SE
2.0mm diameter
implant | In clinical use
since 1998 | In clinical use
since 2008 | SE to IMTEC
K031106 | SE to IMTEC
K081653 | SE to IMTEC
K031106 |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
2017
Park Dental Research Corporation Mr. Ronald Bulard President 2401 North Commerce Street, Suite B Ardmore, Oklahoma 73401
Re: K121707
Trade/Device Name: Lew Mini O-Ball Implant Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: August 27, 2012 Received: September 4, 2012
Dear Mr. Bulard:
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.
4
Page 2- Mr. Bulard
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 (QS) 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/ResourcesforYou/Industry/default.htm1.
Sincerely yours,
An for
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
5
Indications for Use
510(k) Number (if known): K121707
Device Name: LEW Mini O-Ball Implant
Indications for Use:
The Park Dental Research Corporation's LEW O-ball implant system is a self-tapping titanium threaded screw indicated for long-term intra-bony applications. Additionally, the LEW Mini O-ball Implant may be used for inter-radicular transitional applications.
These devices will permit immediate splinting stability and long-term fixation of new or existing crown and bridge installations, for full or partial edentulism, and employing minimally invasive surgical intervention.
The 2.0mm , 2.5 mm, and 3.0 mm diameter are intended to support single or multi-unit restorations in both long-term and temporary applications throughout the maxillary and mandibular arches.
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 Russo
(Division Sign-Off) (Division Sign-Off)
Division of Anestheslology, General Hospital Infection Control, Dental Devi
510(k) Number:
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