(165 days)
No
The 510(k) summary describes mechanical dental implants and abutments. There is no mention of software, algorithms, image processing, or any other technology that would typically incorporate AI/ML. The performance studies are focused on mechanical and sterilization testing.
Yes
The device is described as "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 masticatory function," which is a therapeutic purpose.
No
Explanation: The device described is a dental implant system, including implants and abutments, which are surgically placed to support prosthetic devices. Its intended use is to restore masticatory function, not to diagnose a condition.
No
The device description clearly details physical components (titanium abutments, ball attachments, OT-Equators) and mechanical testing, indicating it is a hardware device. There is no mention of software as the primary or sole component.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the device is surgically placed in the bone to support prosthetic devices and restore masticatory function. This is a direct interaction with the patient's body for a therapeutic purpose.
- Device Description: The device description details dental implants and abutments, which are physical components implanted into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVDs are used outside the body to analyze samples and provide diagnostic information. This device is used inside the body for structural support and functional restoration.
N/A
Intended Use / Indications for Use
MIS dental implant systems are 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 masticatory function. When a one-stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and the occlusal load is appropriate.
Narrow implants (Ø3.3mm & UNO) are indicated for use in surgical and restorative applications for placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another.
The long MIS (18 & 20 mm) implants can be used in a tilted manner.
MIS short implants are to be used only with straight abutments.
M4 short implants are indicated for delayed loading only.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
a. MIS LOCKiT Abutments System
MIS LOCKiT abutments system contains titanium abutments coated with titanium nitride (TiN). MIS LOCKIT abutments system is intended to be used in completely edentulous jaws and connects to an overdenture to allow its insertion and removal.
MIS LOCKiT abutments connect directly to the implant by their threading. MIS LOCKiT abutments are available in three different platforms (narrow platform (NP), standard platform (SP) and wide platform (WP)) and two connection types (conical connection and internal hex connection). LOCKiT abutments system contains straight abutments only.
MIS LOCKiT abutments are provided in the following gingival heights:
- Narrow platform: 1, 2, 3, 4, 5 mm
- Standard platform: 1, 2, 3, 4, 5 mm
- Wide platform: 1, 3, 5 mm
MIS LOCKIT internal hex connection abutments are compatible with MIS internal hex implants cleared under K040807 and K180282 (M4, LANCE and SEVEN Systems).
MIS LOCKiT conical connection abutments are compatible with MIS implants cleared under K112162, K163349 and K172505 (C1 and V3 Systems).
b. OT-Equators and Ball Attachments
Ball Attachments and OT-Equators are used to connect to an overdenture bar to allow its insertion and removal. They are connected directly to the implant by their distal threading, and are mostly used in complete edentulous jaws. The main difference between them is that ball attachments have a higher profile and ball shaped head, while the OT-equators have a lower profile and a truncated head. Both are made from Titanium 6Al-4V ELI and feature a Titanium Nitride (TiN) coating for increased resistance to wear.
Internal hex OT-Equators and Ball Attachments are available in three different platforms (narrow platform (NP), standard platform (SP) and wide platform (WP) and are available in the following gingival heights:
- Narrow platform: 1, 2, 3, 4, 5 mm
- Standard platform: 1, 2, 3, 4, 5 mm
- Wide platform: 1, 3, 5 mm.
MIS Internal hex OT-Equators and Ball Attachments are compatible with MIS internal hex implants cleared under K040807 and K180282 (M4, LANCE and SEVEN Systems).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper or lower jaw arches, mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws.
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)
Non-Clinical Performance Data
- Biocompatibility: The subject device is manufactured using identical manufacturing methods, in the same manufacturing facility, and using the same raw material as the previously cleared predicate, K040807. The subject device is packaged using identical materials and processing as the predicate. Finally the subject device has the same intended use, patient contact duration and type as the predicate. For these reasons, biocompatibility testing was not required to support the substantial equivalence of the subject device.
- Mechanical testing:
- Fatigue testing of MIS Internal Hex LOCKiT abutments was conducted in accordance with ISO 14801:2016. The worst case implants and abutments chosen for the tests were the narrowest implants loaded with the abutments which have the maximum gingival height for both narrow and standard platforms. The test articles were able to withstand 5,000,000 cycles without failure at a substantially equivalent load to the cited predicates. The fatigue test conducted on the standard platform worst case implant-abutment assembly supports the wide platform implants as the SP is a worst case in terms of diameter and wall thickness, and both SP and WP implants are made of the same material.
- Mechanical performance of MIS Conical Connection LOCKiT abutments is supported by fatigue testing that was conducted on MIS conical connection CONNECT abutments (cleared under K173326) which represent a worst-case in terms of mechanical properties due to geometric design.
- Mechanical performance of MIS internal hex OT-Equators and Ball Attachments is supported by the fatigue testing that was conducted on MIS Internal Hex LOCKIT abutments, which are a worst case in terms of mechanical strength as they have a narrower emergence profile than the OT-Equators and Ball Attachments.
- Sterilization testing (steam sterilization by the user): The steam sterilization parameters were validated according to ANSI/AAMI/ISO 17665-1:2006 and ANSI/AAMI/ISO 17665-2:2009 for two methods: gravity displacement steam sterilization and pre vacuum steam sterilization.
- Disinfection validation: the disinfection procedure was validated in accordance with ANSI/AAMI/ISO 11737-1:2006 (R) 2011, AAMI TIR 30:2011 and AAMI TIR 12:2010 by demonstrating a reduction of at least 10^6 of the microbiological challenge.
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.
MIS Conical Connection Equators cleared under K163349, K172505, MIS Internal Hex Connection Equators cleared under K180282, Zest Locator® Implants Attachments K072878, MIS CONNECT Conical Connection Abutment K173326
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.
Zest Locator® Implants Attachments cleared under K072878, MIS Conical Connection Equators cleared under K172505, MIS Internal Hex Connection Equators cleared under K180282, MIS CONNECT Conical Connection Abutment cleared under K173326, MIS Conical Connection Implants cleared under K112162, MIS Dental Implant System cleared under K040807
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
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)
0
Image /page/0/Picture/0 description: The image contains the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 28, 2019
MIS Implants Technologies Ltd. Arbel Shezaf RA Coordinator P.O. Box 7 Bar Lev Industrial Park, 2015600 ISRAEL
Re: K18228
Trade/Device Name: MIS LOCKiT Abutments System, OT-Equators and Ball Attachments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: January 3, 2019 Received: January 3, 2019
Dear Arbel Shezaf:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Andrew I. Steen -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
Indications for Use
510(k) Number (if known)
Device Name
MIS LOCKiT Abutments System, OT-Equators and Ball Attachments
Indications for Use (Describe)
MIS dental implant systems are 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 masticatory function. When a one-stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and the occlusal load is appropriate.
Narrow implants (03.3mm & UNO) are indicated for use in surgical and restorative applications for placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another.
The long MIS (18 & 20 mm) implants can be used in a tilted manner.
MIS short implants are to be used only with straight abutments.
M4 short implants are indicated for delayed loading only.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
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:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"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."
3
Image /page/3/Picture/1 description: The image shows the logo for MIS Implants Technologies Ltd. The logo consists of the letters "MIS" in blue, with the "M" and "I" connected and the "S" stylized as a curved line. To the right of the letters, the words "Implants Technologies Ltd." are written in a smaller font size.
510(k) Summary
1. Submitter
MIS Implants Technologies Ltd. P.O. Box 7, Bar Lev Industrial Park 2015600 ISRAEL
Telephone: +972-4-9016802 Fax: +972-4-9918623
Contact: Arbel Shezaf Date Prepared: January 22, 2019
2. US Agent: Motti Weisman - VP Marketing
MIS Implants Technologies Inc. 18-00 Fair Lawn Ave Fair Lawn NJ 07410 Phone: (201) 797-9144 Fax: (201) 797-9145
3. Device Identification
| Trade/Proprietary Name: | MIS LOCKIT Abutments System, OT-Equators and Ball Attachments |
|---|---|
| Common/Usual Name: | Dental implant abutment |
| Classification Name: | Endosseous dental implant abutment |
| Regulation Number: | 872.3630 |
| Product Code: | NHA |
| Device Class: | Class II |
| Classification Panel: | Dental Devices Panel |
4. Predicate Device(s)
Primary predicate device:
-
. MIS Conical Connection Equators cleared under K163349
Reference devices: -
. Zest Locator® Implants Attachments cleared under K072878
-
MIS Conical Connection Equators cleared under K172505
-
MIS Internal Hex Connection Equators cleared under K180282 ●
-
MIS CONNECT Conical Connection Abutment cleared under K173326 ●
4
Image /page/4/Picture/0 description: The image shows the logo for MIS Implants Technologies Ltd. The logo features the letters "MIS" in a stylized, connected font, with the "I" appearing as a vertical line. To the right of the logo is the text "Implants Technologies Ltd." in a smaller, sans-serif font.
- MIS Conical Connection Implants cleared under K112162 .
- MIS Dental Implant System cleared under K040807 ●
5. Device Description
a. MIS LOCKiT Abutments System
MIS LOCKiT abutments system contains titanium abutments coated with titanium nitride (TiN). MIS LOCKIT abutments system is intended to be used in completely edentulous jaws and connects to an overdenture to allow its insertion and removal.
MIS LOCKiT abutments connect directly to the implant by their threading. MIS LOCKiT abutments are available in three different platforms (narrow platform (NP), standard platform (SP) and wide platform (WP)) and two connection types (conical connection and internal hex connection). LOCKiT abutments system contains straight abutments only.
MIS LOCKiT abutments are provided in the following gingival heights:
- . Narrow platform: 1, 2, 3, 4, 5 mm
- . Standard platform: 1, 2, 3, 4, 5 mm
- Wide platform: . 1, 3, 5 mm
MIS LOCKIT internal hex connection abutments are compatible with MIS internal hex implants cleared under K040807 and K180282 (M4, LANCE and SEVEN Systems).
MIS LOCKiT conical connection abutments are compatible with MIS implants cleared under K112162, K163349 and K172505 (C1 and V3 Systems).
b. OT-Equators and Ball Attachments
Ball Attachments and OT-Equators are used to connect to an overdenture bar to allow its insertion and removal. They are connected directly to the implant by their distal threading, and are mostly used in complete edentulous jaws. The main difference between them is that ball attachments have a higher profile and ball shaped head, while the OT-equators have a lower profile and a truncated head. Both are made from Titanium 6Al-4V ELI and feature a Titanium Nitride (TiN) coating for increased resistance to wear.
Internal hex OT-Equators and Ball Attachments are available in three different platforms (narrow platform (NP), standard platform (SP) and wide platform (WP) and are available in the following gingival heights:
- . Narrow platform: 1, 2, 3, 4, 5 mm
- . Standard platform: 1, 2, 3, 4, 5 mm
- Wide platform: 1, 3, 5 mm .
MIS Internal hex OT-Equators and Ball Attachments are compatible with MIS internal hex implants cleared under K040807 and K180282 (M4, LANCE and SEVEN Systems).
5
s Technologies Ltd.
6. Indications for Use
MIS dental implant systems are 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 masticatory function. When a one-stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and the occlusal load is appropriate.
Narrow implants (Ø3.3mm & UNO) are indicated for use in surgical and restorative applications for placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another.
The long MIS (18 & 20 mm) implants can be used in a tilted manner.
MIS short implants are to be used only with straight abutments.
M4 short implants are indicated for delayed loading only.
7. Substantial Equivalence Discussion
a. MIS LOCKiT Abutments System:
The predicate device for the Conical Connection MIS LOCKiT abutments is MIS Conical Connection Equators cleared under K163349 and K172505, while the predicate device for the Internal Hex Connection MIS LOCKiT abutments is the MIS Internal Hex Connection Equators recently cleared under K180282. Two reference devices for MIS LOCKIT abutments are also included, specifically, the Zest Locator® Implants Attachments (K072878) and MIS CONNECT Concal Connection Abutment (K173326). All devices have identical intended use. The indications listed for the LOCKiT are identical to the indications for MIS Equators and do not meaningfully differ from the Zest Locator.
All abutments are made from titanium or its alloy, and undergo TiN coating. In regards to the distal geometry, the conical implant connection geometry for the Conical Connection MIS LOCKIT is identical to the MIS Conical Connection Equators while the internal hex connection is equivalent to MIS Internal Hex Connection Equators. The subject and the predicate devices are available in the same gingival heights - 1, 2, 3, 4, 5 mm (both conical and internal hex connection, narrow and standard platform) and 1, 3, 5 mm (both conical and internal hex connections, wide platform).
MIS CONNECT Conical Connection Abutments and Zest Locator® Implants Attachments were chosen as a reference device in terms of fatigue limit. MIS LOCKIT abutment (internal hexagon connection, NP and SP) were tested in order to determine the fatigue limit value of an implant-abutment assembly. The endurance limit for the LOCKiT assembly was compared with the corresponding worst case for CONNECT and Zest Locator® systems.
6
Image /page/6/Picture/0 description: The image shows the word "mis" in blue. The letters are connected and stylized, with the "m" having a wavy appearance, the "i" having a dot above it, and the "s" having a curved shape. The text is simple and clean, with a focus on readability.
Implants Technologies Ltd.
| Trade Name | MIS LOCKIT
Abutments (conical
and internal hex
connection)
New device | MIS Equators
(conical and internal
hex connection)
Primary predicate | MIS CONNECT
Conical Connection
Abutments
Reference device
(fatigue strength) | ZEST Locator ®
Implants Attachments
Reference device
(proximal connection) |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | Subject | Conical
Connection:
K163349, K172505
Internal Hex
Connection:
K180282 | K173326 | K072878 |
| Manufacturer | MIS Implants
Technologies Ltd. | MIS Implants
Technologies Ltd. | MIS Implants
Technologies Ltd. | Zest Anchors LLC. |
| Device Class | Class II | Class II | Class II | Class II |
| Product Code(s) | NHA | NHA | NHA | NHA |
| Regulation | Endosseous dental | Endosseous dental | Endosseous dental | Endosseous dental |
| Description | implant abutment | implant abutment | implant abutment | implant abutment |
| Regulation | 872.3630 | 872.3630 | 872.3630 | 872.3630 |
| Number | | | | |
| Intended use: | Dental implant
abutments are
intended to be used
in the upper or lower
jaw and used for
supporting tooth
replacements to
restore chewing
function. The
abutments in
combination with
endosseous implants
are used as the
foundation for
anchoring tooth
replacements in
either jaw. Intended
for fully edentulous
jaw retaining a tissue
supported
overdenture. | Dental implant
abutments are
intended to be used
in the upper or lower
jaw and used for
supporting tooth
replacements to
restore chewing
function. The
abutments in
combination with
endosseous implants
are used as the
foundation for
anchoring tooth
replacements in
either jaw. Intended
for fully edentulous
jaw retaining a tissue
supported
overdenture. | Dental implant
abutments are
intended to be used
in the upper or lower
jaw and used for
supporting tooth
replacements to
restore chewing
function. The
abutments in
combination with
endosseous implants
are used as the
foundation for
anchoring tooth
replacements in
either jaw. Intended
for fully edentulous
jaw retaining a tissue
supported
overdenture. | Dental implant
abutments are intended
to be used in the upper
or lower jaw and used
for supporting tooth
replacements to restore
chewing function. The
abutments in
combination with
endosseous implants are
used as the foundation
for anchoring tooth
replacements in either
jaw. Intended for fully
edentulous jaw
retaining a tissue
supported overdenture. |
| Indications for
use: | MIS dental implant
systems are 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
masticatory function.
When a one-stage
surgical procedure is | MIS dental implant
systems are 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
masticatory function. | MIS Dental Implant
Systems are 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
masticatory function. | The Locator® Implant
Attachment System is
designed for use with
overdentures or partial
dentures, retained in
whole or in part, by
endosseous implants in
the mandible or
maxilla. |
| Trade Name | MIS LOCKIT
Abutments (conical
and internal hex
connection)
New device | MIS Equators
(conical and internal
hex connection)
Primary predicate | MIS CONNECT
Conical Connection
Abutments
Reference device
(fatigue strength) | ZEST Locator ®
Implants Attachments
Reference device
(proximal connection) |
| | applied, the implant
may be immediately
loaded when good
primary stability is
achieved and the
occlusal load is
appropriate.
Narrow implants
(Ø3.3mm & UNO)
are indicated for use
in surgical and
restorative
applications for
placement only in the
mandibular central,
lateral incisor and
maxillary lateral
incisor regions of
partially edentulous
jaws, to provide
support for prosthetic
devices such as
artificial teeth.
Mandibular central
and lateral incisors
must be splinted if
using two or more
narrow implants
adjacent to one
another.
The long MIS (18 &
20 mm) implants can
be used in a tilted
manner.
MIS short implants
are to be used only
with straight
abutments.
M4 short implants
are indicated for
delayed loading only. | When a one-stage
surgical procedure is
applied, the implant
may be immediately
loaded when good
primary stability is
achieved and the
occlusal load is
appropriate.
Narrow implants
("3.3mm & UNO)
are indicated for use
in surgical and
restorative
applications for
placement only in the
mandibular central,
lateral incisor and
maxillary lateral
incisor regions of
partially edentulous
jaws, to provide
support for prosthetic
devices such as
artificial teeth.
Mandibular central
and lateral incisors
must be splinted if
using two or more
narrow implants
adjacent to one
another.
For the internal hex
connection MIS
Equators, there is a
following addition to
the indications for
use:
The long MIS (18 &
20 mm) implants can
be used in a tilted
manner.
MIS short implants
are to be used only
with straight
abutments.
M4 short implants
are indicated for | When a one-stage
surgical procedure is
applied, the implant
may be immediately
loaded when good
primary stability is
achieved and the
occlusal load is
appropriate.
Narrow implants
(Ø3.3mm) are
indicated for use in
surgical and
restorative
applications for
placement only in the
mandibular central,
lateral incisor and
maxillary lateral
incisor regions of
partially edentulous
jaws, to provide
support for prosthetic
devices such as
artificial teeth, in
order to restore the
patient chewing
function. Mandibular
central and lateral
incisors must be
splinted if using two
or more narrow
implants adjacent to
one another. | |
| Trade Name | MIS LOCKIT
Abutments (conical
and internal hex
connection)
New device | MIS Equators
(conical and internal
hex connection)
Primary predicate | MIS CONNECT
Conical Connection
Abutments
Reference device
(fatigue strength) | ZEST Locator ®
Implants Attachments
Reference device
(proximal connection) |
| | | delayed loading only. | | |
| Material(s) | Ti 6A1 4V ELI | Ti 6A1 4V ELI | Ti 6A1 4V ELI | Ti 6A1 4V ELI |
| Surface
Treatment | TiN coating, SP and
WP also color
anodized | TiN coating, SP and
WP also color
anodized | Anodized | TiN coating |
| Connection of the
Abutment to the
Implant | • Conical
Connection
without indexes
• Internal Hex
Connection | • Conical
Connection
without indexes
• Internal Hex
Connection | • Conical
Connection
without indexes | • Conical
Connection
without indexes
• Internal Hex
Connection |
| Gingival height | NP / SP (both
connections): 1, 2, 3,
4, 5 mm
WP (both
connections): 1, 3, 5
mm | NP / SP: 1, 2, 3, 4, 5
mm
WP: 1, 3, 5 mm | NP: 2, 3 mm
SP: 1.5, 2, 3, 4 mm
WP: 1.5, 2, 3, 4 mm | NP / SP (conical
connection ): 1, 2, 3, 4,
5 mm
NP / SP / WP (internal
hex connection ): 0, 1,
2, 3, 4, 5, 6 mm |
| Platform | NP / SP / WP (both
connections) | NP / SP / WP | NP / SP / WP | Conical Connection:
NP / SP
Internal Hex
Connection: NP / SP /
WP |
| Abutment
Angulation | 0° | 0° | 0° | 0° |
| Maximum
Implant
Angulation
Allowed | 20 degrees of
divergence (40
degrees between
implants) | Conical
Connection:
15 degrees of
divergence (30
degrees between
implants)
Internal Hex
Connection:
No angulation is
allowed | 20 degrees of
divergence (30
degrees between
implants) | 20 degrees of
divergence (40 degrees
between implants) |
| Sterilization
Method | Product provided
non-sterile | Product provided
non-sterile | Product provided
non-sterile | Product provided non-
sterile |
7
Image /page/7/Picture/0 description: The image shows the word "mis" in blue. The letters are stylized and connected. The "m" is a curvy line, the "i" has a dot above it, and the "s" is a rounded shape with a flat bottom.
Implants Technologies Ltd.
8
Image /page/8/Picture/0 description: The image shows a logo that spells out the letters 'mis' in a stylized, blue font. The 'm' is represented by two connected, angled lines, while the 'i' is a simple vertical line with a dot above it. The 's' is a curved line that resembles a backwards 'c' shape. The logo has a clean and modern design.
mplants Technologies Ltd.
b. OT-Equators and Ball Attachments
OT-Equators and Ball Attachments were cleared under K180282. No changes have been made since the clearance, as shown in the following table.
They were cleared with the following instructions:
"OT-Equators and straight Ball Attachments are not to be used with implants placed at an angle."
Due to fatigue tests provided in this submission, the instruction is changed to:
9
Image /page/9/Picture/0 description: The image shows the logo for MIS Implants Technologies Ltd. The logo features the letters "MIS" in a stylized blue font, with a vertical line separating the letters from the company name. The company name, "Implants Technologies Ltd.," is written in a smaller, lighter font to the right of the vertical line.
"OT-Equators and straight Ball Attachments allow a maximum 30 divergence between two implant constructs, with each implant/abutment construct having no more than 15°correction."
| Trade Name | MIS internal hex OT-Equators and Ball Attachments | MIS internal hex OT-Equators and Ball Attachments |
|---|---|---|
| 510(k) Number | Subject | K180282 |
| Manufacturer | MIS Implants Technologies Ltd. | MIS Implants Technologies Ltd |
| Device Class | Class II | Class II |
| Product Code(s) | NHA | NHA |
| Regulation Description | Endosseous dental implant abutment | Endosseous dental implant abutment |
| Regulation Number | 872.3630 | 872.3630 |
| Intended use: | Dental implant abutments are intended to | |
| be used in the upper or lower jaw and used | ||
| for supporting tooth replacements to restore | ||
| chewing function. The abutments in | ||
| combination with endosseous implants are | ||
| used as the foundation for anchoring tooth | ||
| replacements in either jaw. For fully | ||
| edentulous jaw retaining a tissue-supported | ||
| overdenture. | Dental implant abutments are intended to be | |
| used in the upper or lower jaw and used for | ||
| supporting tooth replacements to restore | ||
| chewing function. The abutments in | ||
| combination with endosseous implants are | ||
| used as the foundation for anchoring tooth | ||
| replacements in either jaw. For fully | ||
| edentulous jaw retaining a tissue-supported | ||
| overdenture. | ||
| Indications for use: | MIS dental implant systems are 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 | ||
| masticatory function. When a one-stage | ||
| surgical procedure is applied, the implant | ||
| may be immediately loaded when good | ||
| primary stability is achieved and the | ||
| occlusal load is appropriate. | ||
| Narrow implants (Ø3.3mm & UNO) are | ||
| indicated for use in surgical and restorative | ||
| applications for placement only in the | ||
| mandibular central, lateral incisor and | ||
| maxillary lateral incisor regions of partially | ||
| edentulous jaws, to provide support for | ||
| prosthetic devices such as artificial teeth. | ||
| Mandibular central and lateral incisors must | ||
| be splinted if using two or more narrow | ||
| implants adjacent to one another. | ||
| The long MIS (18 & 20 mm) implants can | ||
| be used in a tilted manner. | ||
| MIS short implants are to be used only with | ||
| straight abutments. | ||
| M4 short implants are indicated for delayed | ||
| loading only | MIS dental implant systems are 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 masticatory function. When a | ||
| one-stage surgical procedure is applied, the | ||
| implant may be immediately loaded when | ||
| good primary stability is achieved and the | ||
| occlusal load is appropriate. | ||
| Narrow implants (Ø3.3mm & UNO) are | ||
| indicated for use in surgical and restorative | ||
| applications for placement only in the | ||
| mandibular central, lateral incisor and | ||
| maxillary lateral incisor regions of partially | ||
| edentulous jaws, to provide support for | ||
| prosthetic devices such as artificial teeth. | ||
| Mandibular central and lateral incisors must | ||
| be splinted if using two or more narrow | ||
| implants adjacent to one another. | ||
| The long MIS (18 & 20 mm) implants can be | ||
| used in a tilted manner. | ||
| MIS short implants are to be used only with | ||
| straight abutments. | ||
| M4 short implants are indicated for delayed | ||
| loading only | ||
| Instruction for use | OT-Equators and straight Ball Attachments | |
| allow a maximum 30° divergence between | ||
| two implant constructs, with each implant/ | ||
| abutment construct having no more than | ||
| 15° correction | OT-Equators and straight Ball Attachments | |
| are not to be used with implants placed at an | ||
| angle. | ||
| Material(s) | Ti 6A1 4V ELI per ASTM F136 | Ti 6A1 4V ELI per ASTM F136 |
| Surface Treatment | TiN coating after machined | TiN coating after machined |
| Trade Name | MIS internal hex OT-Equators and Ball | |
| Attachments | MIS internal hex OT-Equators and Ball | |
| Attachments | ||
| Connection Type | Internal hexagon | Internal hexagon |
| Platform | NP, SP, WP | NP, SP, WP |
| Abutment angulation | 0° | 0° |
| Maximum Implant | ||
| Angulation Allowed | 15 degrees of divergence (30 degrees | |
| between implants) | 0 degrees of divergence | |
| Abutment Diameters | NP: ball 4.0, equator 4.1 mm | |
| SP: ball & equator 4.1 mm | ||
| WP: ball & equator 5.0 mm | NP: ball 4.0, equator 4.1 mm | |
| SP: ball & equator 4.1 mm | ||
| WP: ball & equator 5.0 mm | ||
| Gingival height | 1, 2, 3, 4, 5 mm | 1, 2, 3, 4, 5 mm |
| Sterilization Method | Product provided non sterile | Product provided non sterile |
10
Image /page/10/Picture/0 description: The image shows the logo for MIS Implants Technologies Ltd. The logo consists of the letters "MIS" in blue, with the "M" and "I" connected and the "S" slightly offset to the right. To the right of the letters is the text "Implants Technologies Ltd." in a smaller font size.
8. Non-Clinical Performance Data
As part of demonstrating the substantial equivalence of the MIS LOCKiT Abutments System, OT-Equators and Ball Attachments to the predicate devices listed in this 510(k) submission, MIS Implants Technologies completed a number of non-clinical performance tests:
- Biocompatibility The subject device is manufactured using identical manufacturing methods, in the . same manufacturing facility, and using the same raw material as the previously cleared predicate, K040807. The subject device is packaged using identical materials and processing as the predicate. Finally the subject device has the same intended use, patient contact duration and type as the predicate. For these reasons, biocompatibility testing was not required to support the substantial equivalence of the subject device.
- . Mechanical testing
- o Fatigue testing of MIS Internal Hex LOCKiT abutments was conducted in accordance with ISO 14801:2016. The worst case implants and abutments chosen for the tests were the narrowest implants loaded with the abutments which have the maximum gingival height for both narrow and standard platforms. The test articles were able to withstand 5,000,000 cycles without failure at a substantially equivalent load to the cited predicates. The fatigue test conducted on the standard platform worst case implant-abutment assembly supports the wide platform implants as the SP is a worst case in terms of diameter and wall thickness, and both SP and WP implants are made of the same material.
- Mechanical performance of MIS Conical Connection LOCKiT abutments is supported by о fatigue testing that was conducted on MIS conical connection CONNECT abutments (cleared
11
Image /page/11/Picture/0 description: The image shows the logo for MIS Implants Technologies Ltd. The logo consists of the letters "MIS" in a stylized font, with a curved line above the "M" and a horizontal line extending from the "S". To the right of the letters, the words "Implants Technologies Ltd." are written in a smaller, simpler font. The logo is in blue and white.
under K173326) which represent a worst-case in terms of mechanical properties due to geometric design.
- Mechanical performance of MIS internal hex OT-Equators and Ball Attachments is supported o by the fatigue testing that was conducted on MIS Internal Hex LOCKIT abutments, which are a worst case in terms of mechanical strength as they have a narrower emergence profile than the OT-Equators and Ball Attachments.
- Sterilization testing (steam sterilization by the user): The steam sterilization parameters were . validated according to ANSI/AAMI/ISO 17665-1:2006 and ANSI/AAMI/ISO 17665-2:2009 for two methods: gravity displacement steam sterilization and pre vacuum steam sterilization.
- Disinfection validation: the disinfection procedure was validated in accordance with ANSI/AAMI/ISO . 11737-1:2006 (R) 2011, AAMI TIR 30:2011 and AAMI TIR 12:2010 by demonstrating a reduction of at least 106 of the microbiological challenge.
9. Clinical Performance Data
There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.
10. Summary
The comparison between the subject device and the predicate devices has shown that the indications for use, principles of operation, technological characteristics and materials were similar, and that the differences did not raise new safety and effectiveness issues. Furthermore, performance testing showed that the predicate device is at least equivalent to the predicates by means of performance.
11. Conclusions
MIS LOCKiT Abutments System, OT-Equators and Ball Attachments have the same intended use, incorporate the same fundamental technology, and have similar indications for use as the predicate. Test data to verify the performance of the MIS LOCKIT Abutments System, OT-Equators and Ball Attachments has been provided including dynamic fatigue, pull-out tests and sterilization. The results of this testing. combined with the design and intended use comparison with the predicate device, support substantial equivalence.