(252 days)
No
The device description and performance studies focus on the mechanical and biological properties of dental abutments, with no mention of AI or ML technology.
No.
This device, a multi-unit abutment, is designed to provide mechanical support for dental prosthetics and restore function and aesthetics, rather than to treat or cure a disease or medical condition.
No
The device, Multi-unit Abutments, is described as a dental abutment intended to support prosthetic suprastructures on dental implants. Its purpose is to reconstruct the function and aesthetics of lost teeth, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states that the device is a physical dental abutment, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used as a support for dental prosthetics (bridges and bars) in the mouth of a patient. This is a direct medical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a physical component (dental abutment) that is screwed onto a dental implant to support a prosthetic. This is a mechanical device used for structural support and restoration of function and aesthetics.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. The performance studies focus on mechanical strength, biocompatibility, and sterility, which are relevant to implantable medical devices, not IVDs.
Therefore, this device falls under the category of a medical device, specifically a dental abutment, and not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Multi-unit abutments are indicated for use with dental implants as a support for multi-unit screw retained bridges and bars in the maxilla or mandible of a partially or fully edentulous patient.
Multi-unit Abutments are used for the restoration of the following dental implant systems:
| Medentika
series | Implant system | Implant
diameter | Platform diameter |
|---|---|---|---|
| EV-Series | Dentsply® Implants - ASTRA TECH
OsseoSpeed® | 3.6, 4.2, 4.8 | 3.6, 4.2, 4.8 |
| F-Series | Nobel Biocare NobelActive -
NobelReplace Conical | 3.5, 4.3, 5.0 | NP 3.5, RP 4.3/5.0 |
| H-Series | Biomet 3i - Certain | 3.25, 4.0 | 3.4, 4.1 |
| L-Series | Straumann - Bone Level | 3.3, 4.1, 4.8 | 3.3, 4.1, 4.8 |
| N-Series | Straumann - Soft Tissue Level | 4.1, 4.8 | 4.8, 6.5 |
| R-Series | Zimmer Dental Tapered Screw-vent | 3.3, 3.7, 4.1, 4.7 | 3.5, 4.5 |
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The proposed Multi-unit Abutments are dental abutments, which are intended to be screwed onto osseointegrated dental implants to provide support for prosthetic suprastructures on the gingival level. Multi-unit abutments can be used in combination with screw-retained multi-unit dental prosthetics, e.g. bridges and bars, which are used to reconstruct the function and aesthetics of lost teeth. Multi-unit abutments are very similar to the already FDA-cleared Straumann Screw-Retained Abutment System. Multi-unit abutments are available as straight abutments, which have an integrated thread and can be screwed directly into the implant, or as angled abutments, which can be screwed onto the implant with the corresponding abutment screw. All models of Multi-unit abutments have a universal interface for a variety of prefabricated prosthetic parts, e.g. Multi-unit caps, which become part of the superstructure and ensure a low-tension screw connection of the multi-unit prosthetics.
The Multi-Unit caps or base are used in conjunction with the Multi-Unit Abutment. The Multi-Unit Abutment is considered the bottom half of a two-piece abutment and the Multi-Unit Caps or Multi-Unit Titanium base are considered the top half of the two-piece abutment.
Multi-unit Abutments exist in two model types: straight multi-unit abutments without rotational indexing with various gingival heights and platform diameters and angled multi-unit abutments with rotary indexing with various ginqival heights and platform diameters.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxilla or mandible
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)
Dynamic fatigue and static strength tests were conducted according to ISO 14801:2016 and the FDA guidance document "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" and demonstrated that the Multi-unit Abutments are equivalent to the predicate and reference devices. The tests were conducted in ambient air.
Cytotoxicity testing according to ISO 10993-5 was conducted to address a difference in the manufacturing process for the CoCr cap compared to the reference predicate (K172798).
Sterility assurance level (SAL) of 10^-6 had been validated in accordance with ISO 11137-1:2006, Sterilization of health care products – Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices, 2006-04-05.
LAL Endotoxin Analysis was used to determine that the device meets pyrogen limit specifications, with a testing limit of 20 EU/device.
The sterilization process for the multi-unit prosthetic components and bridge screws was validated according to applicable recommendations in the FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued on March 17, 2015".
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.
K142167, K172798, K170838, K162890, K180564
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 shows the logo of 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 6, 2020
Medentika GmbH % Jennifer Jackson Director, Regulatory Affairs Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01801
Re: K191123
Trade/Device Name: Multi-unit Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: December 4, 2019 Received: December 5, 2019
Dear Jennifer Jackson:
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.
Srinivas Nandkumar, Ph.D. for Director DHT1B: Division of Dental 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)
K191123
Device Name:
Multi-unit Abutments
Indications for Use (Describe)
Multi-unit abutments are indicated for use with dental implants as a support for multi-unit screw retained bridges and bars in the maxilla or mandible of a partially or fully edentulous patient.
Multi-unit Abutments are used for the restoration of the following dental implant systems:
| Medentika
series | Implant system | Implant
diameter | Platform diameter |
|---------------------|-----------------------------------------------------|---------------------|--------------------|
| EV-Series | Dentsply® Implants - ASTRA TECH
OsseoSpeed® | 3.6, 4.2, 4.8 | 3.6, 4.2, 4.8 |
| F-Series | Nobel Biocare NobelActive -
NobelReplace Conical | 3.5, 4.3, 5.0 | NP 3.5, RP 4.3/5.0 |
| H-Series | Biomet 3i - Certain | 3.25, 4.0 | 3.4, 4.1 |
| L-Series | Straumann - Bone Level | 3.3, 4.1, 4.8 | 3.3, 4.1, 4.8 |
| N-Series | Straumann - Soft Tissue Level | 4.1, 4.8 | 4.8, 6.5 |
| R-Series | Zimmer Dental Tapered Screw-vent | 3.3, 3.7, 4.1, 4.7 | 3.5, 4.5 |
Type of Use (Select one or both, as applicable)
区Prescription Use (Part 21 CFR 801 Subpart D)
□Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Medentika Multi-unit Abutments
510(k) Summary
510(k) Summary
Submitter's Contact Information
| Submitter: | Straumann USA, LLC
60 Minuteman Road
Andover, MA 01810
Registration No.: 1222315 Owner/Operator No.: 9005052 | | | |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------|--|--|--|
| | On the behalf of: | | | |
| | Medentika GmbH | | | |
| | Hammweg 8-10
76549 Hügelsheim, Germany | | | |
| Contact Person: | Jennifer M. Jackson, MS
Director of Regulatory Affairs
Phone Number: +1-978-747-2509
Fax Number: +1-978-747-0023 | | | |
| Prepared By &
Alternate Contact: | Olivier Russo
Regulatory Affairs and Compliance Manager
Institut Straumann AG
Phone number : +41 61 965 1260 | | | |
| Date of Submission: | January 6, 2020 | | | |
Name of the Device
| Trade Names: | Multi-unit Abutments |
|---|---|
| Common Name: | Endosseous dental implant abutment |
| Classification Name: | Endosseous dental implant abutment |
| Regulation Number: | 21 CFR 872.3630 |
| Device Classification: | II |
| Product Code(s): | NHA |
| Classification Panel: | Dental |
4
Medentika Multi-unit Abutments
510(k) Summary
Predicate Device(s)
Primary Predicate:
-
K171757 Straumann Screw Retained Abutments .
Reference Devices: -
K142167 Medentika Abutment System .
-
K172798 Straumann CARES Abutments CoCr .
-
. K170838 – Medentika CAD/CAM TiBases
-
K162890 BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and . Healing Abutments, SC Temporary Abutments, SC Variobase Abutments, SC CARES Abutment
-
K180564 Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika . CAD/CAM TiBases
Device Description
The proposed Multi-unit Abutments are dental abutments, which are intended to be screwed onto osseointegrated dental implants to provide support for prosthetic suprastructures on the gingival level. Multi-unit abutments can be used in combination with screw-retained multi-unit dental prosthetics, e.g. bridges and bars, which are used to reconstruct the function and aesthetics of lost teeth. Multi-unit abutments are very similar to the already FDA-cleared Straumann Screw-Retained Abutment System. Multi-unit abutments are available as straight abutments, which have an integrated thread and can be screwed directly into the implant, or as angled abutments, which can be screwed onto the implant with the corresponding abutment screw. All models of Multi-unit abutments have a universal interface for a variety of prefabricated prosthetic parts, e.g. Multi-unit caps, which become part of the superstructure and ensure a low-tension screw connection of the multi-unit prosthetics.
The Multi-Unit caps or base are used in conjunction with the Multi-Unit Abutment. The Multi-Unit Abutment is considered the bottom half of a two-piece abutment and the Multi-Unit Caps or Multi-Unit Titanium base are considered the top half of the two-piece abutment.
5
Medentika Multi-unit Abutments
510(k) Summary
Multi-unit Abutments exist in two model types: straight multi-unit abutments without rotational indexing with various gingival heights and platform diameters and angled multi-unit abutments with rotary indexing with various ginqival heights and platform diameters.
Intended Use
The Multi-unit Abutments are directly screwed into the implant and have a universal mounting on the face side for various additional prosthetic parts. The bridge or bar elements are produced to fit to the prosthetic parts by which they are screwed onto the Multi-unit Abutments.
Indications for Use
Multi-unit abutments are indicated for use with dental implants as a support for multi-unit screw retained bridges and bars in the maxilla or mandible of a partially or fully edentulous patient. Multi-unit Abutments are used for the restoration of the following dental implant systems:
| Medentika
series | Implant system | Implant
diameter | Platform diameter |
|---------------------|-----------------------------------------------------|---------------------|--------------------|
| EV-Series | Dentsply® Implants - ASTRA TECH
OsseoSpeed® | 3.6, 4.2, 4.8 | 3.6, 4.2, 4.8 |
| F-Series | Nobel Biocare NobelActive -
NobelReplace Conical | 3.5, 4.3, 5.0 | NP 3.5, RP 4.3/5.0 |
| H-Series | Biomet 3i - Certain | 3.25, 4.0 | 3.4, 4.1 |
| L-Series | Straumann - Bone Level | 3.3, 4.1, 4.8 | 3.3, 4.1, 4.8 |
| N-Series | Straumann - Soft Tissue Level | 4.1, 4.8 | 4.8, 6.5 |
| R-Series | Zimmer Dental Tapered Screw-vent | 3.3, 3.7, 4.1, 4.7 | 3.5, 4.5 |
Technological Characteristics
The technological characteristics of the subject devices are compared to the primary predicate and reference devices in Table 1. The reference device K162890 is included for adoption of the sterilization validation. K180564 is referenced in the submission to support the MRI compatibility of the subject devices.
6
Medentika Multi-unit Abutments
| Feature | Subject Device | Predicate Device | Reference Devices | | | Equivalence
discussion |
|----------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Medentika Multi-unit
Abutments | K171757 -
Straumann Screw
Retained Abutments | K142167- Medentika
Abutment System | K172798 -
Straumann CARES
Abutments CoCr | K170838 -
Medentika
CAD/CAM TiBases | |
| Indications for use | Multi-unit abutments are
indicated for use with
dental implants as a
support for multi-unit
screw retained bridges
and bars in the maxilla
or mandible of a partially
or fully edentulous
patient.
Multi-unit Abutments are
used for the restoration
of the following dental
implant systems
(Implant System / Series
/ Implant diameter /
Platform diameter):
Dentsply® Implants -
ASTRA TECH
OsseoSpeed® / EV-
Series / Diameter 3.6,
4.2, 4.8 / Platform 3.6,
4.2, 4.8
Nobel Biocare
NobelActive -
NobelReplace Conical /
F-Series / Diameter 3.5,
4.3, 5.0 / Platform NP
3.5, RP 4.3/5.0
Biomet 3i - Certain / H-
Series / Diameter 3.25,
4.0 / Platform 3.4, 4.1
Straumann - Bone Level
/ L-Series / Diameter
3.3, 4.1, 4.8 / Platform
3.3, 4.1, 4.8
Straumann - Soft Tissue
Level / N-Series / | The Straumann® Screw
Retained Abutments
are indicated to be
placed into the implants
of the Straumann®
Dental Implant System
to provide support for
prosthetic
reconstructions such as
crowns, bridges and
bars.
The final processed
devices have the
purpose of restoring
chewing function.
Straumann® Screw
Retained Abutments
are indicated for screw-
retained restorations. | Medentika abutments
are intended for use
with dental implants as
a support for single or
multiple tooth
prostheses in the
maxilla or mandible of
a partially or fully
edentulous patient.
Abutments are
compatible with the
following implant
systems:
Implant
System/Series/Implant
Diameters (mm)
Nobel Biocare Replace
Select/E-Series/3.5,
4.3, 5.0, 6.0
Nobel Biocare Nobel
Active/F-Series/3.5,
4.3, 5.0
Biomet 3i Osseotite
Certain/H-Series/3.25,
4.0, 5.0
Biomet 3i Osseotite/ I-
Series/3.25, 3.75, 4.0,
5.0
Nobel Biocare
Branemark/K-
Series/3.3, 3.75, 4.0,
5.0
Straumann Bone
Level/L-Series/3.3, 4.1,
4.8 | The Straumann®
CARES® Abutments
CoCr are indicated for
single tooth
replacement and
multiple tooth
restorations. The
prosthetic restoration
can be cemented or
directly
veneered/screw-
retained. | Medentika CAD/CAM
Abutments are
intended for use with
dental implants as a
support for single or
multiple tooth
prostheses in the
maxilla or mandible of
a partially or fully
edentulous patient.
Implant System
Compatibility/Series/Im
plant Diameter
(mm)/Platform
Diameter (mm)
Nobel Biocare Replace
Select/E-Series/3.5,
4.3, 5.0, 6.0/3.5, 4.3,
5.0, 6.0
Dentsply
Implants/ASTRA TECH
OsseoSpeed EV/EV-
Series/3.6, 4.2, 4.8,
5.4/3.6, 4.2, 4.8, 5.4
Nobel Biocare Nobel
Active/F-Series/3.5,
4.3, 5.0/3.5, 3.9 (4.3),
3.9 (5.0)
Biomet 3i Osseotite
Certain/H-Series/3.25,
4.0, 5.0/3.4, 4.1, 5.0
Biomet 3i Osseotite/ I-
Series/3.25, 3.75, 4.0,
5.0/3.4, 4.1, 5.0
Nobel Biocare
Branemark/K- | Equivalent
The subject device has
similar indications for
use as the predicate
and reference devices
which is to give a
support for multi-unit
prosthetic
reconstructions such as
bridges and bars.
The compatible implant
systems are a
combination of the
previously cleared
compatibilities under
K142167 and K170838. |
| Feature | Subject Device | Predicate Device | Reference Devices | | | Equivalence discussion |
| | Medentika Multi-unit
Abutments | K171757 -
Straumann Screw
Retained Abutments | K142167- Medentika
Abutment System | K172798 -
Straumann CARES
Abutments CoCr | K170838 -
Medentika
CAD/CAM TiBases | |
| | Diameter 4.1, 4.8 /
Platform 4.8, 6.5
Zimmer Dental Tapered
Screw-vent / R-Series /
Diameter 3.3, 3.7, 4.1,
4.1, 4.7 / Platform 3.5,
4.5 | | Straumann
Standard/N-Series/3.3,
4.1, 4.8
Zimmer Tapered
Screw-Vent/R-
Series/3.3, 3.7, 4.1,
4.7, 6.0
Astra Tech
OsseoSpeed/S-
Series/3.5, 4.0, 4.5, 5.0
Dentsply Friadent
Frialit/Xive/T-
Series/3.4, 3.8, 4.5, 5.5
Dentsply Friadent
Ankylos/Y-Series/3.5,
4.5, 5.5, 7.0 | | Series/3.3, 3.75, 4.0,
5.0/3.5, 4.1, 4.1, 5.1
Straumann Bone
Level/L-Series/3.3, 4.1,
4.8/3.3, 4.1, 4.8
Straumann Soft Tissue
Level/N-Series/3.3, 4.1,
4.8/3.5 (NNC), 4.8, 6.5
Zimmer Tapered
Screw-Vent/R-
Series/3.3, 3.7, 4.1,
4.7, 6.0/3.5, 4.5, 5.7
Astra Tech
OsseoSpeed/S-
Series/3.5, 4.0, 4.5,
5.0/3.5, 4.0, 4.5, 5.0
Dentsply Friadent
Frialit/Xive/T-
Series/3.4, 3.8, 4.5,
5.5/3.4, 3.8, 4.5, 5.5
Dentsply Friadent
Ankylos/Y-Series/3.5,
4.5, 5.5, 7.0/3.5, 4.5,
5.5, 7.0
Medentika TiBase is
intended for use with
the Straumann CARES
System.
All digitally designed
copings and/or crowns
are intended to be sent
to Straumann for
manufactures at a
validated milling center. | |
| Abutment Design | Straight and angled | Straight and angled | Straight and angled | Straight and angled | Straight | Identical |
| Feature | Subject Device | Predicate Device | Reference Devices | | | |
| | Medentika Multi-unit
Abutments | K171757 -
Straumann Screw
Retained Abutments | K142167- Medentika
Abutment System | K172798 -
Straumann CARES
Abutments CoCr | K170838 -
Medentika
CAD/CAM TiBases | Equivalence
discussion |
| Interface | Engaging /
Non engaging | Engaging | Engaging /
Non engaging | Engaging | Engaging | Identical to reference
device K142167 |
| Abutment
angulation to
Engagement
feature | Straight, 17°, 30° | 0°, 17°, 30° | Straight, 15°,
16°, 18°, 21° | Straight | Straight | Equivalent
The subject device has
the identical range of
angulation as the
primary predicate
devices. |
| Compatible
Abutment/Implant
Interface Series /
Implant systems
Diameter(s) | Dentsply® Implants -
ASTRA TECH
OsseoSpeed® / EV-
Series / Diameter 3.6,
4.2, 4.8
Nobel Biocare
NobelActive -
NobelReplace Conical /
F-Series / Diameter 3.5,
4.3, 5.0
Biomet 3i - Certain / H-
Series / Diameter 3.25,
4.0
Straumann - Bone Level
/ L-Series / Diameter
3.3, 4.1, 4.8
Straumann - Soft Tissue
Level / N-Series /
Diameter 4.1, 4.8
Zimmer Dental Tapered
Screw-vent / R-Series /
Diameter 3.3, 3.7, 4.1,
4.7 | Straumann Bone Level
NC (Narrow CrossFit) /
Diameter 3.3
Straumann Bone Level
RC (Regular CrossFit)
/ Diameter 4.1, 4.8 | Nobel Biocare Replace
Select / E-Series /
Diameter 3.5, 4.3, 5.0,
6.0
Nobel Biocare
NobelActive /
NobelReplace conical /
F-Series / Diameter
3.5, 4.3, 5.0
Biomet 3i - Certain / H-
Series / Diameter 3.25,
4.0, 5.0
Biomet 3i Osseotite/ I-
Series / Diameter 3.25,
3.75, 4.0, 5.0
Nobel Biocare
Branemark - K Series /
Diameter 3.3, 3.75, 4.0,
5.0
Straumann - Bone
Level / L-Series /
Diameter 3.3, 4.1, 4.8
Straumann - Soft
Tissue Level / N-Series
/ Diameter 3.3, 4.1, 4.8 | Straumann Bone Level
NC (Narrow CrossFit),
and RC (Regular
CrossFit)
Straumann Soft Tissue
Level RN (Regular
Neck), WN (Wide
Neck) | Abutments are
compatible with the
following implant
systems:
Nobel Biocare
Replace™ Select E-
Series 3.5, 4.3, 5.0, 6.0
Dentsply® Implants/AST
RA TECH
OsseoSpeed® EV EV-
Series
3.6, 4.2, 4.8, 5.4
Nobel Biocare
NobelActive™/NobelR
eplace conical F-Series
3.5, 4.3, 5.0
Biomet 3i Osseotite®
Certain® H-Series
3.25, 4.0, 5.0
Biomet 3i Osseotite® I-
Series
3.25, 3.75, 4.0, 5.0
Nobel Biocare
Brånemark K-Series
3.3, 3.75, 4.0, 5.0
Straumann Bone Level
L-Series | Equivalent
The compatible implant
systems are a
combination of the
previously cleared
compatibilities under
K142167 and K170838.
Dentsply® Implants -
ASTRA TECH
OsseoSpeed® / EV-
Series is part of the
reference device
K170838,
complementary
performance testing
was performed and
demonstrated
equivalence. |
| Feature | Subject Device | Predicate Device | Reference Devices | | | Equivalence
discussion |
| | Medentika Multi-unit
Abutments | K171757 -
Straumann Screw
Retained Abutments | K142167- Medentika
Abutment System | K172798 -
Straumann CARES
Abutments CoCr | K170838 -
Medentika
CAD/CAM TiBases | |
| Material of
Abutment (bottom
half of two-piece
abutment) | Ti6Al4V, medical grade
5, conforming ASTM F
136 | Titanium-6aluminum-
7niobium alloy (TAN)
conforming to ISO
5832-11 | Ti6Al4V, medical grade
5, conforming ASTM F
136 | Cobalt-chromium alloy | Ti6Al4V, medical grade
5, conforming ASTM F
136 | Equivalent
The subject device uses
the type of material as
the reference devices
K142167 and K170838 |
| Gingival Heights | GH 0.6 to GH 5.5 mm | GH 1.0 to GH 5.5 mm | GH 0.5 to GH 5.5 mm | Not applicable Gingiva
Height is
defined/designed by
the dentist using
CARES Visual | Not applicable, Gingiva
Height is
defined/designed by
the dentist | Equivalent
The subject device has
a similar range of
Gingival Height as the
predicate and reference
devices |
| Feature | Subject Device | Predicate Device | Reference Devices | | | Equivalence
discussion |
| | Medentika Multi-unit
Abutments | K171757 -
Straumann Screw
Retained Abutments | K142167- Medentika
Abutment System | K172798 -
Straumann CARES
Abutments CoCr | K170838 -
Medentika
CAD/CAM TiBases | |
| Restoration | Multi-Unit restorations | Single and Multi-Unit
restorations | Single and Multi-Unit
restorations | Single and Multi-Unit
restorations | Single restorations | Identical
The subject device |
| Material of screws | Ti6Al4V, medical grade
5, conforming ASTM F
136 | Titanium-6aluminum-
7niobium alloy (TAN)
conforming to ISO
5832-11 | Ti6Al4V, medical grade
5, conforming ASTM F
136 | Titanium-6aluminum-
7niobium alloy (TAN)
conforming to ISO
5832-11 | Ti6Al4V, medical grade
5, conforming ASTM F
136 | Equivalent
The subject device uses
the type of material as
the reference devices
K142167 and K170838 |
| Material of Multi-
unit Base or Cap
(top half of two-
piece abutment) | Titanium
Gold
Cobalt Chromium | Titanium
Gold | Not applicable | Not applicable | Not applicable | Equivalent
The subject device uses
the type of material as
the reference devices
K171757 and K172798 |
| Sterility | Delivered sterile | Delivered sterile | Delivered non sterile | Delivered non sterile | Delivered non sterile | Identical
The subject device is
provided sterile which is
identical to the primary
predicate K171757 |
| Sterilization by end
user | No | No | Yes | Yes | Yes | Identical
Identical to primary
predicate K171757 |
| Packaging | Medical grade
polyethylene blister with
a sealing lid | Medical grade
polyethylene blister
with a sealing lid | Medical grade
polyethylene blister
with a sealing lid | Poly Bag for the
abutment and Medical
grade polyethylene
blister with a sealing lid
for the screw | Plastic box | Equivalent
The subject device uses
a similar type of
packaging as the
predicate device |
7
Medentika Multi-unit Abutments
8
Medentika Multi-unit Abutments
9
Medentika Multi-unit Abutments
10
Medentika Multi-unit Abutments
510(k) Summary
Table 1 – Technological Characteristics
11
Medentika Multi-unit Abutments
510(k) Summary
Performance Testing
Dynamic fatique and static strength tests were conducted according to ISO 14801:2016 and the FDA guidance document "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" and demonstrated that the Multi-unit Abutments are equivalent to the predicate and reference devices. The tests were conducted in ambient air.
According to the FDA guidance entitled "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"", dated June 16, 2016, the subject abutments will be in contact with tissue/bone/dentin and are external communicating devices intended for more than 30 days of patient contact. Most of the subject device materials are equivalent to the predicate and reference device materials (K171757 and K142167). There is a difference in the manufacturing process for the CoCr cap compared to the reference predicate (K172798) which was addressed through cytotoxicity testing according to ISO 10993-5.
The subject device Multi-unit Abutments are provided sterile via gamma irradiation. A sterility assurance level (SAL) of 10 6 had been validated in accordance with ISO 11137-1:2006, Sterilization of health care products – Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices, 2006-04-05.
The subject devices will not be marketed as non-pyrogenic. The method used to make the determination that the device meets pyrogen limit specifications is LAL Endotoxin Analysis. The testing limit is 20 EU/device.
The sterilization process for the multi-unit prosthetic components and bridge screws, as recommended in the labeling, was validated according to applicable recommendations in the FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued on March 17, 2015".
Conclusion
The documentation submitted in this premarket notification demonstrates the Multi-unit Abutments are substantially equivalent to the primary predicate and reference devices.