(161 days)
No
The device description and performance studies focus on the mechanical properties, sterilization, and biocompatibility of physical dental implant components (abutments and cementing caps). There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes
The device is described as dental implant systems and abutments intended to "restore masticatory function" and "provide support for prosthetic devices, such as artificial teeth," which are therapeutic purposes.
No
Explanation: This device, consisting of dental implants and abutments, is intended for prosthetic rehabilitation and providing support for artificial teeth to restore masticatory function. Its purpose is to physically support prosthetic devices, not to diagnose a condition.
No
The device description clearly states that the device is composed of physical components made of Titanium, such as abutments, screws, and a gripping bar. It also mentions sterilization and shelf-life testing, which are relevant to physical devices, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a dental implant system intended for surgical placement in the bone to support prosthetic devices and restore masticatory function. This is a surgical and restorative procedure performed directly on the patient's body.
- Device Description: The device description details the physical components of the dental implant system (implants, abutments, screws, cementing caps) made of titanium. These are physical devices implanted into the body.
- Lack of IVD Characteristics: An IVD is a medical device intended for use in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The provided text does not mention any of these activities. There is no mention of analyzing biological samples, providing diagnostic information, or being used for monitoring or compatibility testing of biological materials.
Therefore, the device described is a surgical implant and prosthetic component, not an In Vitro Diagnostic device.
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 (Ø3.30mm) 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 & 20mm) 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
The proposed MIS Angulated multi-unit abutments are endosseous dental implant abutments that are connected to MIS dental implants and used as an aid in prosthetic rehabilitation, for anchoring screw retained multiple-unit restorations.
MIS Angulated multi-unit abutments consist of a one-piece abutment and a prosthetic multi-unit screw, both made of Titanium complying with ASTM F136-13 (Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (USN R56401). The proposed abutments are available in 17° and 30° angulations and connected to the implant by a prosthetic multi-unit screw supplied with the proposed abutments. The proposed abutments are also supplied with a titanium gripping bar used to position the multi-unit abutment on the implant. The proposed abutments are supplied sterile to the user.
The proposed MIS cementing cap is a superstructure that has a standard connection design intended to be directly connected to all MIS straight and angulated multi-unit abutments with a prosthetic screw. The proposed cementing cap and prosthetic screw are made of Titanium complying with ASTM F136-13. Multi-unit cementing caps are delivered non-sterile, and are intended to be cleaned and steamsterilized by a professional user according to the instructions before use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone of the upper or lower jaw arches
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Fatigue Testing: Mechanical testing of representative worst-case MIS Angulated multi-unit abutment-implant combinations were included. The test articles were able to withstand 5,000,000 cycles without failure at a substantially equivalent load or better, compared with the reference device (K122268).
- Sterilization: Sterilization validation of sterile devices (gamma irradiation) and non-sterile devices (steam sterilization) was submitted.
- Shelf life: Test results support a 5-year shelf life.
- Biocompatibility: No new biocompatibility testing was required as the device uses identical materials and manufacturing processes as the primary predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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 logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Dentsply Sirona Courtney Clark Sr. Director of Regulatory Affairs 221 West Philadelphia Street, Suite 60W York, Pennsylvania 17401
Re: K213432
Trade/Device Name: MIS Angulated multi-unit abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: March 3, 2022 Received: March 4, 2022
Dear Courtney Clark:
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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 Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K213432
Device Name MIS Angulated multi-unit abutments
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 (Ø3.30mm) 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 & 20mm) 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)
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3
Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401
Image /page/3/Picture/1 description: The image shows the logo for Dentsply Sirona. The logo consists of a stylized, abstract shape on the left, resembling a curved leaf or a stylized "S". To the right of the shape are the words "Dentsply" stacked on top of "Sirona". The logo is simple and modern, with a focus on the company's name.
510(k) SUMMARY for MIS Angulated multi-unit abutments - K213432
1. Submitter Information:
Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401
Primary Contact Person: Courtney Clark Telephone Number: 248-895-4379 Fax Number: 717-849-4343
Date Prepared: April 1, 2022
2. Device Name:
.
- Proprietary Name: ● MIS Angulated multi-unit abutments
- Classification Name: ● Endosseous dental implant abutment
- CFR Number: 872.3630
- Device Class: II
- Product Code: . NHA
-
- Predicate Device:
The primary predicate and reference devices identified relating to the substantial equivalence for the MIS Angulated multi-unit abutments are:
| Primary Predicate Device Name | 510(k) | Company Name |
|---|---|---|
| MIS V3 Conical Connection | ||
| Dental Implant System | K163349 | MIS Implants Technologies Ltd. |
| (Dentsply Sirona) | ||
| Reference Device Name | 510(k) | Company Name |
| MIS C1 Wide Platform Conical | ||
| Connection Abutment | K172505 | MIS Implants Technologies Ltd. |
| (Dentsply Sirona) | ||
| MIS Internal Hex Dental Implant | ||
| System | K180282 | MIS Implants Technologies Ltd. |
| (Dentsply Sirona) | ||
| Ankylos Balance Base Abutments | K122268 | Dentsply Sirona Implants |
| (Dentsply Sirona) |
4
4. Description of Device:
The proposed MIS Angulated multi-unit abutments are endosseous dental implant abutments that are connected to MIS dental implants and used as an aid in prosthetic rehabilitation, for anchoring screw retained multiple-unit restorations.
MIS Angulated multi-unit abutments consist of a one-piece abutment and a prosthetic multi-unit screw, both made of Titanium complying with ASTM F136-13 (Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (USN R56401). The proposed abutments are available in 17° and 30° angulations and connected to the implant by a prosthetic multi-unit screw supplied with the proposed abutments. The proposed abutments are also supplied with a titanium gripping bar used to position the multi-unit abutment on the implant. The proposed abutments are supplied sterile to the user. Table 4.1 below summarizes the main specifications of the proposed MIS Angulated multi-unit abutments and the modifications made.
| Element | Specifications | Modifications/Changes |
|---|---|---|
| Connection | -Conical (C1, V3) | |
| -Internal-hex Connection (SEVEN, Lance +, M4) | Same connections | |
| Proposed abutments are compatible with multiple conical and internal-hex connections | ||
| Platform | -Narrow Platform (NP) | |
| -Standard Platform (SP) | ||
| -Wide Platform (WP) | New NP for angulated multi-unit abutments | |
| Implant platform | ||
| diameter | -NP: Ø3.3 mm | |
| -SP: Ø 3.75, 3.9, 4.2, 4.3, 5.0 mm | ||
| -WP: Ø 5.0, 6.0 mm | New NP | |
| Other platform diameters remain the same. | ||
| Gingival height | -1 and 2 mm for NP | |
| -3 mm for SP and WP | New gingival height of 3 mm for SP and WP | |
| Angulations | 17° and 30° for all platforms | Same angulations |
| Prosthetic screw | ||
| Implant to | ||
| abutment | -Multi-unit screw for SP and WP: | |
| MU-SOP01A (cleared in K163349) | ||
| -Screw for NP: | ||
| New, MU-SOPN1A | Same materials and same screw for SP and WP. | |
| New multi-unit screw to fit the NP abutments |
Table 4.1: Specifications of the Proposed MIS Angulated multi-unit abutments
The proposed MIS cementing cap is a superstructure that has a standard connection design intended to be directly connected to all MIS straight and angulated multi-unit abutments with a prosthetic screw. The proposed cementing cap and prosthetic screw are made of Titanium complying with ASTM F136-13. Multi-unit cementing caps are delivered non-sterile, and are intended to be cleaned and steamsterilized by a professional user according to the instructions before use.
5. 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 (03.30mm) 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
5
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 & 20mm) 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.
6. Substantial Equivalence:
The design of the proposed MIS Angulated multi-unit abutments is based on the design of angulated multi-unit abutments cleared under primary predicate (K163349) and reference devices (K172505, K180282). The abutment diameter, implant-abutment-superstructure connection, and angulations are identical. The proposed MIS Angulated multi-unit abutments include a higher gingival height for Standard and Wide Platforms and are also available in a Narrow Platform.
An overview of the similarities and differences between the proposed and the primary predicate device (K163349) is given in Table 6.1. below. A discussion of the similarities and differences follows Table 6.1.
6
Table 6.1: Comparison between the proposed MIS Angulated multi-unit abutments and primary predicate device and reference devices
| Element | Proposed devices
MIS angulated multi-unit
abutments and cementing
cap | Primary predicate
MIS V3 conical
connection angulated
multi-unit abutments and
superstructure
(K163349) | Reference device
MIS Internal Hex
angulated multi-unit
abutment
(K180282) | Reference device
MIS C1 conical
connection angulated
multi-unit abutment
(K172505) | Reference device
Ankylos Balance Base
angulated multi-unit
abutment
(K122268) |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 (Ø3.30mm)
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 &
20mm) 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 V3 Conical Connection
Dental Implant System 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 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) 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. | 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 (Ø3.30mm &
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 &
20mm) 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 system 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 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,
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. | The angled ANKYLOS®
Balance Base Abutments are
indicated for use in prosthetic
restorations with Ankylos®
implants and bridges or bar
overdentures using a minimum
of 2 implants. In edentulous
jaws, immediate loading is
possible using a minimum of 4
implants. Implants may be
tilted up to 45°. When used
with angulations between 30°
and 45° in edentulous arch, a
minimum of four implants must
be used and splinted. |
| Manufacturer | MIS Implants Technologies
Ltd. (Dentsply Sirona) | MIS Implants
Technologies Ltd.
(Dentsply Sirona) | MIS Implants
Technologies Ltd.
(Dentsply Sirona) | MIS Implants
Technologies Ltd.
(Dentsply Sirona) | Dentsply Sirona |
| Device Class | Class II | Class II | Class II | Class II | Class II |
| Product code(s) | NHA, Endosseous dental
implant abutment | NHA, Endosseous dental
implant abutment | NHA, Endosseous dental
implant abutment | NHA, Endosseous dental
implant abutment | NHA, Endosseous dental
implant abutment |
| Element | Proposed devices
MIS angulated multi-unit
abutments and cementing
cap | Primary predicate
MIS V3 conical
connection angulated
multi-unit abutments and
superstructure
(K163349) | Reference device
MIS Internal Hex
angulated multi-unit
abutment
(K180282) | Reference device
MIS C1 conical
connection angulated
multi-unit abutment
(K172505) | Reference device
Ankylos Balance Base
angulated multi-unit
abutment
(K122268) |
| Material | Titanium | Titanium | Titanium | Titanium | Titanium |
| Surface treatment | Polished and anodized /
Only polished | Polished and anodized after
machined | Polished after machined | Polished and anodized after
machined | Polished after machined |
| Screw connection | One abutment screw for
connection of the multi-unit
to the implant. Prosthetic
screw for connection of the
superstructure (cementing
cap) to the multi-unit | One abutment screw for
connection of the multi-
unit to the implant.
Prosthetic screw for
connection of the
temporary superstructure to
the multi-unit | One abutment screw for
connection of the multi-
unit to the implant.
Prosthetic screw for
connection of the
temporary superstructure to
the multi-unit | One abutment screw for
connection of the multi-
unit to the implant.
Prosthetic screw for
connection of the
temporary superstructure to
the multi-unit | Abutment screw for
connection to the implant.
2-piece abutment,
abutment head screws into
main abutment body.
Prosthetic screw for
connection to the abutment |
| Abutment-
superstructure
interface | Screw secured, with a plate
to plate sealing surface | Screw secured, with a plate
to plate sealing surface | Screw secured, with a plate
to plate sealing surface | Screw secured, with a plate
to plate sealing surface | Screw secured, with a plate
to plate sealing surface |
| Restoration | Multiple-units | Multiple-units | Multiple-units | Multiple-units | Multiple-units |
| Restoration type | Screw-retained | Screw-retained | Screw-retained | Screw-retained | Screw-retained |
| Abutment diameter | Ø 4.80 | Ø 4.80 | Ø 4.80 | Ø 4.80 | Ø 4.20 |
| Implant to
abutment
connection | -MIS C1 Conical
Connection
-MIS V3 Conical
Connection
-MIS SEVEN Internal Hex
-MIS M4 Internal Hex
-MIS Lance+ Internal Hex | MIS V3 Conical
Connection | MIS M4 Internal Hex
MIS SEVEN Internal Hex | MIS C1 Conical
Connection | Ankylos A. B. C. D.
Conical connection |
| Element | Proposed devices
MIS angulated multi-unit
abutments and cementing
cap | Primary predicate
MIS V3 conical
connection angulated
multi-unit abutments and
superstructure
(K163349) | Reference device
MIS Internal Hex
angulated multi-unit
abutment
(K180282) | Reference device
MIS C1 conical
connection angulated
multi-unit abutment
(K172505) | Reference device
Ankylos Balance Base
angulated multi-unit
abutment
(K122268) |
| Implant platform
(diameter) | NP: Ø3.3 mm
SP: Ø 3.75, 3.9, 4.2, 4.3,
5.0 mm
WP: Ø 5.0, 6.0 mm | NP, WP: N/A
SP: Ø 3.75, 3.9, 4.2, 4.3,
5.0 mm | NP: N/A
SP: Ø 3.75, 3.9, 4.2, 4.3,
5.0 mm
WP: Ø 5.0, 6.0 mm | NP, SP: N/A
WP: Ø 5.0, 6.0 mm | A 3.5
B 4.5
C 5.5
D 7 |
| Angulation | NP - 17°, 30°
SP & WP - 17°, 30° | NP, WP: N/A
SP - 17°, 30° | NP: N/A
SP & WP - 17°, 30° | NP, SP: N/A
WP - 17°, 30° | 15°, 30° |
| Gingival Height
(mm) | NP: 1, 2
SP & WP: 3 | NP, WP: N/A
SP: 1, 2 | NP: N/A
SP, WP: 1, 2 | NP, SP: N/A
WP: 1, 2 | 3, 4.5 mm |
| Sterilization | Multi-unit provided sterile
by gamma irradiation.
Superstructures are
provided non-sterile. | Multi-unit provided sterile
by gamma irradiation.
Superstructures are
provided non-sterile. | Multi-unit provided sterile
by gamma irradiation.
Superstructures are
provided non-sterile. | Multi-unit provided sterile
by gamma irradiation.
Superstructures are
provided non-sterile. | Provided non-sterile. User
to sterilize via moist steam
sterilization |
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8
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The intended use of the proposed device and the primary predicate MIS V3 Conical Connection Dental Implant Abutment (K163349) is the same. The primary predicate device (K163349) indications for use statement is specific to V3 conical connection implants and is not available in short or long implants. The modifications to the indications for use are supported by the Indications for Use of prior clearances of the additional compatible implant bodies included in this submission. Besides these minor differences, the indications for use are the same.
The proposed MIS angulated multi-unit abutments and the primary predicate abutments (K 163349), share a similar design, are made from titanium and are identical in manufacturing processes and facility, packaging, sterilization, and intended use. Both the proposed and primary predicate device (K163349) are connected via a multi-unit screw to MIS Endosseous dental implants to aid in restoration of a partially or fully edentulous jaw and are to be used with angulated screw retained restorations. They are also designed to receive a superstructure as an interface for the final or temporary restoration via a prosthetic screw.
The proposed devices have the same conical standard platform as the primary predicate abutments (K163349) and compatible with MIS V3 Conical Connection implants (K163349). In addition, the proposed MIS angulated multi-unit abutments have the same internal-hex (MIS M4 Internal Hex and MIS SEVEN Internal Hex implants) and conical (MIS C1 Conical Connection wide platform) connection as the reference devices K180282 and K172505, respectively.
The proposed MIS angulated multi-unit abutments are available in higher gingival height and narrower platforms. The reference devices, Ankylos Balance Base abutments (K122268), have a similar angulated screw retained design, are made from Titanium, and are available in angulation of 15° and 30° and gingival heights of 3 and 4.5 mm. The gingival height of the reference device (K122268) and that of the proposed device are nearly identical when measured on the same axis and therefore fatigue testing results of the reference device, Ankylos Balance Base abutments (K122268), was compared to that of the proposed device to demonstrate substantial equivalence. The introduction of the narrow platform was also verified via fatigue testing and it was confirmed that the results are substantially equivalent to the reference device Ankylos Balance Base abutments (K122268).
Both primary predicate temporary superstructure (K163349) and the proposed cementing cap share the same raw material, manufacturing process, surface treatment, and packaging. The difference between the two superstructures is that the proposed cementing cap is intended to be used for permanent restorations while the primary predicate temporary superstructure (K163349) is intended to be used for temporary restorations for up to 180 days. Both are attached to the multiunit using the same prosthetic screw, and share an identical interface to the multi-unit. The fatigue testing performed on the proposed MIS Angulated multi-unit abutments included the proposed cementing cap in the implant-abutment combination and the results show acceptable fatigue results that are substantially equivalent to the reference device Ankylos Balance Base abutment (K122268).
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7. Non-Clinical Performance Data
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence includes:
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Fatigue Testing: Guidance document "Root-form Endosseous Dental Implants and Endosseous Dental Abutments - Class II Special Controls" and ISO 14801:2016 (Dentistry -Implants-Dynamic fatigue tests for endosseus dental implants) was used for determining the performance testing required for the proposed device, MIS Angulated multi-unit abutments.
Mechanical testing of representative worst-case MIS Angulated multi-unit abutment-implant combinations were included. The test articles were able to withstand 5,000,000 cycles without failure at a substantially equivalent load or better, compared with the reference device (K122268). -
Sterilization: ●
- o Sterilization validation of sterile devices was submitted to demonstrate sterilization validation of existing worst-case challenge validations conducted according to ISO 11137-1:2006/(R)2013 (Sterilization of health care products – Radiation – Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices), ISO 11137-2:2013 (Sterilization of health care products, Radiation-Part 2: Establishing the sterilization dose), and ISO 11737-2:2009 (Sterilization of medical devices – Microbiological methods- Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process). The sterilization with a sterilization dose of 20 kGy provides a sterility assurance level (SAL) of 10-6.
- o Steam sterilization validation of non-sterile devices was submitted to demonstrate sterilization validation of gravity displacement and pre-vacuum methods according to ANSI/AAMI/ISO 17665-1:2006/(R)2013 (Sterilization of health care products – Moist Heat – Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices), ANSI/AAMI/ISO 17665-2:2009 (Sterilization of health care products - Moist heat- Part 2:Guidance on the application of ISO/ANSI/AAMI/ISO 17665-1), and ISO 11138-1:2017 (Sterilization of health care products – Biological indicators – Part 1 General requirements).
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Shelf life: Shelf life study of sterile devices is referenced by equivalence to real time aging . study performed (submitted in K180282) according to ISO 11607-1:2019 (Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems). Test results support a 5-year shelf life.
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Biocompatibility: The proposed MIS Angulated multi-unit abutment devices are . manufactured using identical manufacturing methods, in the same manufacturing facility, and
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using the same raw material and packaging materials as the primary predicate (K163349) devices. The proposed device has the same contact classification and duration as the primary predicate (K163349), which is direct contact, permanent duration (>30 days). It was determined that no new biocompatibility testing was required to support substantial equivalence of the proposed device.
8. Clinical Performance Data
No human clinical data was included to support substantial equivalence.
9. Conclusion Regarding Substantial Equivalence
The information included in this premarket notification supports the substantial equivalence of the proposed MIS Angulated multi-unit abutments with the primary predicate device MIS V3 conical connection angulated multi-unit abutments (K163349). The proposed devices have the same intended use, principles of operation, manufacturing and packaging processes, packaging materials, and sterilization, very similar indications for use, and similar performance characteristics as the legally marketed primary predicate device (K163349). The modification to add a narrow platform and additional gingiyal height was confirmed via fatigue performance testing and supports a conclusion that the proposed devices are substantially equivalent to the predicate devices.