(314 days)
No
The summary describes a standard dental implant system made of titanium, focusing on its physical components, materials, and surgical procedures. There is no mention of AI, ML, image processing, or any data-driven analytical capabilities.
No.
The device is for supporting prosthetic devices and restoring chewing function, not for treating a disease or condition directly.
No
This device is a dental implant system designed to provide support for prosthetic devices (like artificial teeth) and restore chewing function in patients who are partially or fully edentulous. Its purpose is to physically replace missing teeth and support restorations, not to diagnose medical conditions or diseases.
No
The device description explicitly states it is made of titanium and consists of physical components (fixtures, abutments, and screws) intended for surgical placement.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease or congenital abnormality.
- Chaorum Implant System's Function: The Chaorum Implant System is a surgically implanted device made of titanium. Its purpose is to provide structural support for artificial teeth and restore chewing function. It is placed directly into the bone of the jaw.
- Lack of Specimen Examination: The description of the Chaorum Implant System does not involve the examination of any specimens derived from the human body. It is a physical implant.
Therefore, based on the provided information, the Chaorum Implant System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Chaorum Implant System is intended for use in partially or fully edentulous mandibles and maxilla, in support of single of multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. Chaorum Implant System is for single stage and two stage surgical procedures. This system is intended for delayed loading.
Product codes
DZE, NHA
Device Description
Chaorum Implant System are devices made of titanium 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, and to restore the patients chewing function. Chaorum Implant System consists of fixtures, abutments, and screws. Its material, structure and intended use are substantially equivalent to the predicate devices. It offers three different implants in RBM treatment and SLA treatment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
partially or fully edentulous mandibles and maxilla
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
Non-Clinical Testing:
- Physical tests including visual test, packaging test, packaging seal efficacy test, dimension test, and sterility test (direct transfer method)
- RBM/SLA Surface treatment tests including roughness average test, developed surface area ration test, surface characteristics test (SEM), and surface composition analysis test (EDX)
- TiN coating tests including surface roughness and abrasion testing
- Mechanical properties test including adaptation accuracy test (Implant to abutment compatibility), 35° compressive loads test, torsional breaking force test, removal torque force test, and fatigue test
- Sterilization validation and shelf life tests
- Biocompatibility tests performed in accordance with ISO10993 series: Cytotoxicity Test (ISO10993-5:2009), Acute Systemic Toxicity Test (ISO10993-11:2006), Intracutaneous Reactivity Test (ISO10993-10:2010), Pyrogen Test (ISO10993-11:2006), Local Lymph Node Assay, LLNA Test (ISO10993-10:2010), Bone Implantation Test (ISO10993-6:2007).
Key Metrics
Not Found
Predicate Device(s)
K131682, K143353, K143142, K081806, K142260, K063341
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 5, 2017
Medimecca Co., Ltd. % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 800 Roosevelt Ste 417 Irvine, California 92606
Re: K160536
Trade/Device Name: Chaorum Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: December 6, 2016 Received: December 8, 2016
Dear Priscilla Chung:
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.
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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 contact the Division of Industry and Consumer Education 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.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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.htm.
Sincerely yours,
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name Chaorum Implant System
Indications for Use (Describe)
Chaorum Implant System is intended for use in partially or fully edentulous mandibles and maxilla, in support of single of multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. Chaorum Implant System is for single stage and two stage surgical procedures. This system is intended for delayed loading.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
3
510(k) Summary
This summary of 510(K) information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: 12/06/2016
1. Applicant / Submitter
| Submitter | |
|---|---|
| Name | Medimecca Co., Ltd. |
| Address | Daeryung Techno town 3-cha 104, 105, 109, 110 Gasan- |
| dong,115, GasanDigital 2-ro, Geumcheon-gu, | |
| Seoul, Republic of Korea 153-772 | |
| Phone | +82-2-856-8282 |
| Fax | +82-2-856-0238 |
| Contact | Park Young Wan, QMR |
2. U.S Agent/Contact Person
Priscilla Chung LK Consulting Group USA, Inc. 800 Roosevelt Ste 417, Irvine CA 92606 Phone: 714.202.5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com
3. Device
- Trade Name: Chaorum Implant System
- Common Name: Dental Implant System .
- . Classification Name: Endosseous Dental Implant System
- Product Code: DZE, NHA
- . Classification regulation: 21CFR872.3640
4. Predicate Device:
- Primary Predicate Device: . UD Implant System by MEDIMECCA Co., Ltd. (K131682)
- . Reference Predicate Device: Hahn Tapered Implant System by PRISMATIK DENTALCRAFT, INC (K143353) JDentalCare Implant System by J DENTAL CARE S.r.l.. (K143142)
4
IDI Implant Systems by IDI BIOMEDICAL LLC (K081806) NobelActive® by NOBEL BIOCARE USA, LLC (K142260) 31 OSSEOTITE CERTAIN DENTAL IMPLANTS by IMPLANT INNOVATIONS, INC. (K063341)
5. Description:
Chaorum Implant System are devices made of titanium 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, and to restore the patients chewing function. Chaorum Implant System consists of fixtures, abutments, and screws. Its material, structure and intended use are substantially equivalent to the predicate devices. It offers three different implants in RBM treatment and SLA treatment.
5.1. Fixtures -RBM (Titanium 6AL4V, ASTM F136)
| Shape | Size |
|---|---|
| Image: SFB Model Series | NP (Narrow Platform) Connection Type Fixture |
| 3.25mm Dia. x 8.0mm(L) / 8.5mm (L) / 10.0mm(L) / / 12.0mm(L) | |
| /14.0mm(L) / 15.0mm(L) | |
| 3.89mm Dia. x 8.0mm(L) /10.0mm(L) / 12.0mm(L) / 14.0mm(L) | |
| RP (Regular Platform) Connection Type Fixture | |
| 3.89mm Dia. x 8.0mm(L) /10.0mm(L) / 12.0mm(L) / 14.0mm(L) | |
| 4.28mm Dia. x 8.0mm(L) /10.0mm(L) / 12.0mm(L) / 14.0mm(L) | |
| 4.78mm Dia. x 8.0mm(L) /10.0mm(L) / 12.0mm(L) / 14.0mm(L) | |
| 5.28mm Dia. x 8.0mm(L) /10.0mm(L) / 12.0mm(L) / 14.0mm(L) | |
| 6.28mm Dia. x 8.0mm(L) /10.0mm(L) / 12.0mm(L) / 14.0mm(L) | |
| Image: ASFS Model Series | NP (Narrow Platform) Connection Type Fixture |
| 3.25mm Dia. x 8.0mm(L) / 8.5mm (L) / 10.0mm(L) / / 12.0mm(L) | |
| /14.0mm(L) | |
| 3.89mm Dia. x 8.0mm(L) /10.0mm(L) / 12.0mm(L) / 14.0mm(L) | |
| RP (Regular Platform) Connection Type Fixture | |
| 3.89mm Dia. x 8.0mm(L) /10.0mm(L) / 12.0mm(L) / 14.0mm(L) | |
| 4.28mm Dia. x 8.0mm(L) / 10.0mm(L) / 12.0mm(L) / 14.0mm(L) | |
| 4.78mm Dia. x 8.0mm(L) /10.0mm(L) / 12.0mm(L) / 14.0mm(L) | |
| 5.28mm Dia. x 8.0mm(L) /10.0mm(L) / 12.0mm(L) / 14.0mm(L) | |
| 6.28mm Dia. x 8.0mm(L) /10.0mm(L) / 12.0mm(L) / 14.0mm(L) | |
| Image: MSF Model | NP (Narrow Platform) Connection Type Fixture |
| 3.25mm Dia. x 8.5mm (L) / 10.0mm(L) / 11.50mm(L) /13.0mm(L) | |
| 3.75mm Dia. x 8.5mm (L) / 10.0mm(L) / 11.50mm(L) /13.0mm(L) / | |
| 15.0mm(L) | |
| RP (Regular Platform) Connection Type Fixture | |
| 4.30mm Dia. x 7.3mm(L) /8.5mm(L) / 10.0mm(L) / 11.5mm(L)/ | |
| 13.0mm(L) / 15.0mm(L) | |
| 4.50mm Dia. x 7.3mm(L) /8.5mm(L) / 10.0mm(L) / 11.5mm(L)/ | |
| 13.0mm(L) / 15.0mm(L) |
510(k) Submission.
510(k) summary , 2 / 10 page
5
Series
5.00mm Dia. x 7.3mm(L) /8.5mm(L) / 10.0mm(L) / 11.5mm(L)/ 13.0mm(L) / 15.0mm(L) 6.00mm Dia. x 7.3mm(L) /8.5mm(L) / 10.0mm(L) / 11.5mm(L)/ 13.0mm(L) / 15.0mm(L)
5.2. Fixtures --SLA(Titanium Gr 4, ASTM F67)
| Shape | Size |
|---|---|
| Image: ASF Model Series | NP (Narrow Platform) Connection Type Fixture |
| 3.25mm Dia. x 8.0mm(L) / 8.5mm (L) / 10.0mm(L) / 12.0mm(L) / | |
| 14.0mm(L) / 15.0mm(L)/15.5mm(L) | |
| 3.89mm Dia. x 8.0mm(L)/10.0mm(L) / 12.0mm(L) / 14.0mm(L) | |
| RP (Regular Platform) Connection Type Fixture | |
| 3.89mm Dia. x 8.0mm(L) /10.0mm(L) / 12.0mm(L) / 14.0mm(L) | |
| 4.28mm Dia. x 8.0mm(L) /10.0mm(L) / 12.0mm(L) / 14.0mm(L) | |
| 4.78mm Dia. x 8.0mm(L) /10.0mm(L) / 12.0mm(L) / 14.0mm(L) | |
| 5.28mm Dia. x 8.0mm(L) /10.0mm(L) / 12.0mm(L) / 14.0mm(L) | |
| 6.28mm Dia. x 8.0mm(L) /10.0mm(L) / 12.0mm(L) / 14.0mm(L) | |
| Image: ATF Model Series | NP (Narrow Platform) Connection Type Fixture |
| 3.89mm Dia. x 8.0mm(L) /10.0mm(L) / 12.0mm(L) / 14.0mm(L) | |
| RP (Regular Platform) Connection Type Fixture | |
| 3.89mm Dia. x 8.0mm(L) /10.0mm(L) / 12.0mm(L) / 14.0mm(L) | |
| 4.28mm Dia. x 8.0mm(L) /10.0mm(L) / 12.0mm(L) / 14.0mm(L) | |
| 4.78mm Dia. x 8.0mm(L) /10.0mm(L) / 12.0mm(L) / 14.0mm(L) | |
| 5.28mm Dia. x 8.0mm(L) /10.0mm(L) / 12.0mm(L) / 14.0mm(L) | |
| 6.28mm Dia. x 8.0mm(L) /10.0mm(L) / 12.0mm(L) / 14.0mm(L) | |
| Image: PSF Model Series | NP (Narrow Platform) Connection Type Fixture |
| 3.75mm Dia. x 8.5mm (L) / 10.0mm(L) / 11.50mm(L) /13.0mm(L) / | |
| 15.0mm(L) | |
| RP (Regular Platform) Connection Type Fixture | |
| 4.30mm Dia. x 7.3mm(L) /8.5mm(L) / 10.0mm(L) / 11.5mm(L)/ | |
| 13.0mm(L) / 15.0mm(L) | |
| 4.50mm Dia. x 7.3mm(L) /8.5mm(L) / 10.0mm(L) / 11.5mm(L)/ | |
| 13.0mm(L)/15.0mm(L) | |
| 5.00mm Dia. x 7.3mm(L) /8.5mm(L) / 10.0mm(L) / 11.5mm(L)/ | |
| 13.0mm(L) / 15.0mm(L) | |
| 6.00mm Dia. x 7.3mm(L) /8.5mm(L) / 10.0mm(L) / 11.5mm(L)/ | |
| 13.0mm(L) / 15.0mm(L) |
6
5.3. Abutments
- · NP (Narrow Platform) Connection Type Two Piece Abutments
| Abutments | Material | Dia(mm) |
|---|---|---|
| Dual Abutment | 3.5/4.0/4.5 | |
| Combi Abutment | 3.5/4.0/4.5 | |
| Angled | ||
| Abutment | ||
| (15°,17°, 25°) | MSAA-- | |
| CSAA-- | ||
| Titanium Gr 4 ASTM F | ||
| 67 / TiN Coating | 3.5/4.0/4.5 | |
| Billow Abutment | 3.5/4.0/4.5 | |
| Temporary Abutment | 3.5/4.0/4.5 | |
| Ball Abutment | 3.5/4.0 | |
| Healing Abutment | Ti6AL4V ELI, ASTM F | |
| 136 | 3.5/4.0/4.5 |
- · RP (Regular Platform) Connection Type Two Piece Abutments
| Abutments | Material | Dia(mm) |
|---|---|---|
| Dual Abutment | 4.5/5.0/5.5/6.0/6.5 | |
| Combi Abutment | 4.5/5.0/5.5/6.0/6.5 | |
| Angled | ||
| Abutment | ||
| (15°,17°, 25°) | MSAA-- | 4.5/5.0/5.5/6.0 |
| CSAA-- | ||
| Billow Abutment | 4.5/5.0/5.5/6.0/6.5 | |
| Temporary Abutment | 4.5/5.0/5.5 | |
| Ball Abutment | 3.5/4.0 | |
| Healing Abutment | Ti6AL4V ELI, ASTM F | |
| 136 | 4.0/4.5/5.0/5.5/6.0/ | |
| 6.5/7.5/8.5 |
- 5.4. Cover Screws (Ti6AL4V ELI, ASTM F 136)
1.95mm Dia. x 5.8mm (L) / 6.5mm(L)
6. Indication for use:
Chaorum Implant System is intended for use in partially or fully edentulous mandibles and maxilla, in support of single of multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. Chaorum Implant System is for single stage and two stage surgical procedures. This system is intended for delayed loading.
7
7. Basis for Substantial Equivalence
The Chaorum Dental Implant System has the identified predicate devices. They are similar in fundamental scientific technology in that they are all threaded, root form implants constructed of titanium with RBM or SLA roughened surfaces. The subject and predicate devices are both bone-level implants that shape design such as straight walled neck and tapered body design.
The subject and predicate devices are similar in size, materials, surface treatment, and are sterlized via gamma irradiation for fixtures.
| Item | Subject
Device | Primary
Predicate
Device | Reference Predicate Devices | | | | | |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 510(K) Number | - | K131682 | K143353 | K143142 | K081806 | K142260 | K063341 | |
| Device Name | Chaorum
Implant
System | UD Implant
System | Hahn Tapered
Implant System | JDentalCare
Implant
System | IDI Implant
Systems | NobelActive® | 3I OSSEOTITE
CERTAIN
DENTAL
IMPLANTS | |
| Manufacturer | MEDIMECCA
Co., Ltd. | MEDIMECCA
Co., Ltd. | PRISMATIK
DENTALCRAFT,
INC | J DENTAL
CARE S.r.l. | IDI
BIOMEDICAL
LLC | NOBEL
BIOCARE
USA, LLC | IMPLANT
INNOVATIONS,
INC | |
| Indications for Use | Chaorum
Implant
System is
intended for
use in partially
or fully
edentulous
mandibles and
maxilla, in
support of
single of
multiple-unit
restorations
including;
cemented | UD Implant
System is
intended for
use in partially
or fully
edentulous
mandibles and
maxilla, in
support of
single of
multiple-unit
restorations
including; | Hahn Implants
are indicated for
use in maxillary
and mandibular
partially or fully
edentulous cases,
to support single,
multiple-unit, and
overdenture
restorations. The
implants are to be
used for
immediate
loading only in
the presence of | JDentalCare®
implant
system is
intended for
surgical
placement in
the upper or
lower jaw.
JDentalCare®
implant
system is
comprised of
dental implant
fixtures and
prosthetic | IDI Implant
Systems (IDI
Fixtures and IDI
Abutments with
screws) are
endosseous
implants
intended to be
surgically
placed in the
bone of the
upper or lower
jaw arches to
provide support
for prosthetic | NobelActive®
implants are
endosseous
implants
intended to be
surgically
placed in the
upper or lower
jaw bone for
anchoring or
supporting
tooth
replacements
to restore
patient | 3i dental
implants are
intended for
surgical
placement in the
upper or lower
jaw to
provide a means
for prosthetic
attachment in
single tooth
restorations and
in partially or
fully edentulous
spans with | |
510(k) Submission.
510(k) summary , 5 / 10 page
8
| retained, screw
retained, or
overdenture
restorations,
and terminal or
intermediate
abutment
support for
fixed
bridgework.
Chaorum
Implant
System
is for single
stage and two
stage surgical
procedures.
This system is
intended for
delayed
loading. | cemented
retained, screw
retained, or
overdenture
restorations,
and terminal or
intermediate
abutment
support for
fixed
bridgework.
UD Implant
System is for
single stage
and two stage
surgical
procedures.
This system is
intended for
delayed
loading. | primary stability
and appropriate
occlusal loading | devices.
JDentalCare®
implant
system
provides a
means
for prosthetic
attachment in
single tooth
restorations
and partially
or fully
edentulous
spans with
multiple single
teeth utilizing
delayed
or immediate
loading, or as
a terminal or
intermediary
abutment for
fixed or
removable
bridgework or
to retain
overdentures.
Prosthetic
devices
provide
support and
retention for
screwretained
or cemented
restorations in
mandible
and maxilla.
JDentalCare® | devices, such as
an artificial
tooth, in order to
restore patient
esthetics and
chewing
function.
Straight
abutments
indicated for
both screw
retained and
cemented
restorations are
included. The
implants are
indicated for
single or
multiple unit
restorations and
can be used in
splinted and
non-splinted
applications.
The device is
intended for
immediate
loading when
good primary
stability has
been achieved
and with
appropriate
occlusal
loading. | esthetics and
chewing
function.
NobelActive®
implants are
indicated for
single or
multiple unit
restorations in
splinted or
non-splinted
applications.
This can be
achieved by a
2-stage or 1-
stage surgical
technique in
combination
with
immediate,
early or
delayed
loading
protocols,
recognizing
sufficient
primary
stability and
appropriate
occlusal
loading for the
selected
technique.
NobelActive®
3.0 implants
are intended to
replace a
lateral incisor | multiple single
teeth, or as a
terminal or
intermediary
abutment for
fixed or
removable
bridgework, and
to retain
overdentures.
In addition,
when a
minimum of 4
implants,
IOmni in
length, are
placed in the
mandible and
splinted in the
anterior region,
immediate
loading is
indicated. | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| | | implant
system is
intended for
immediate
function on
single tooth
and/or
multiple tooth
applications
when good
primary
stability is
achieved, with
appropriate
occlusal
loading, in
order to
restore
chewing
function. | | in the maxilla
and/or a
central or
lateral incisor
in the
mandible.
NobelActive®
3.0 implants
are indicated
for single unit
restorations
only. | | | |
| Design/Principle of
Operation | Image: dental implant | Image: dental implant | Image: dental implant | Image: dental implant
- Endomaxim
Internal
Connection - Implant
threads allow
self drilling | Image: dental implant - Internal
Hexagon
connection - Self-taping
cutting edge
threads | Image: dental implant - Internal
Hexagon
connection - Self-taping
cutting edge
threads | |
| | - Internal
Hexagon
connection - Self-taping
cutting edge
threads | - Internal
Hexagon
connection - Self-taping
cutting edge
threads | - Internal
Hexagon
connection - Self-taping
cutting edge
threads | | | | - Internal Hexa
gon connection - Self-taping
cutting edge
threads |
| Endosseous
Implant Material | Titanium
(ASTM F136,
ASTM F67) | Titanium
(ASTM F136,
ASTM F67) | Titanium
(ASTM F136,
ASTM F67) | Titanium
(ASTM F136,
ASTM F67)
Ti Gr. 5 for Ø
3,25mm | Titanium | CP Titanium | Titanium
(ASTM F136,
ASTM F67) |
| Surface Treatment | RBM,
SLA | RBM | RBM | SLA | RBM | TiUnite | SLA |
| Implant Sterilization
Method | Radiation
Sterile | Radiation
Sterile | Radiation Sterile | Radiation Ster
ile | - | Radiation
Sterile | - |
| Implant Diameters | 3.25-6.0mm | 3.5-6.0mm | 3.0-7.0mm | 3.25-6.0mm | 3.5-6.0mm | 3.0-5.5mm | 3.25-6.0mm |
| Implant Lengths | 7.3-15.0mm | 7.3-15.0mm | 8.0-16.0mm | 8.0-15.0mm | 8.8-16.0mm | 7.0-18.0mm | 7.0-20.0mm |
| Angulations of
Angled
abutments | 15°, 17°, 25° | 15°, 25° | 15° ~ 30° | 0° ~ 30° | 15° | 0°~30° | 0-25° |
| Abutments
Diameters | 3.5-6.0mm | 4.0-6.0mm | 3.0-7.0mm | 3.2-6.0mm | - | 3.6-6.0mm | 3.4-7.5 |
| Abutments
Materials | - Ti-6Al-4V
ELI - Titanium Gr | -Ti-6Al-4V
ELI - Titanium Gr 4 | Ti-6Al-4V ELI | Ti-6Al-4V
ELI | Ti-6Al-4V
ELI | Ti-6Al-4V
ELI | Ti-6Al-4V ELI |
510(k) Submission.
510(k) summary , 6 / 10 page
9
510(k) Submission.
510(k) summary , 7 / 10 page
10
510(k) Submission.
510(k) summary , 8 / 10 page
11
| 4 ASTM F 67 | ASTM F 67 | ||||||
|---|---|---|---|---|---|---|---|
| -- | ------------- | ----------- | -- | -- | -- | -- | -- |
12
8. Non-Clinical Testing
The following non-clinical testing was conducted to validate its safety.
-
Physical tests including visual test, packaging test, packaging seal efficacy test, dimension test, and sterility test (direct transfer method)
-
RBM/SLA Surface treatment tests including roughness average test, developed surface area ration test, surface characteristics test (SEM), and surface composition analysis test (EDX)
-
TiN coating tests including surface roughness and abrasion testing
-
Mechanical properties test including adaptation accuracy test (Implant to abutment compatibility), 35° compressive loads test, torsional breaking force test, removal torque force test, and fatigue test
-
Sterilization validation and shelf life tests
-
The following biocompatibility tests have been performed in accordance with ISO10993 series.
| No | Test Title | Test Standard |
|---|---|---|
| 1 | Cytotoxicity Test | ISO10993-5:2009 |
| 2 | Acute Systemic Toxicity Test | ISO10993-11:2006 |
| 3 | Intracutaneous Reactivity Test | ISO10993-10:2010 |
| 4 | Pyrogen Test | ISO10993-11:2006 |
| 5 | Local Lymph Node Assay, LLNA Test | ISO10993-10:2010 |
| 6 | Bone Implantation Test | ISO10993-6:2007 |
9. Conclusion
Based on the similarities and the test results of the validation activities, we conclude that the Chaorum Dental Implant System is substantially equivalent to the predicate device.