(234 days)
No
The summary describes a dental implant system and its components, focusing on materials, design, and mechanical properties. There is no mention of AI, ML, image processing, or any data-driven analytical capabilities.
Yes
The device, MyPlant II implant system, is surgically placed to enable prosthetic restorations in edentulous or partially edentulous patients, replacing tooth roots. This directly addresses and treats a medical condition (edentulism), thus serving a therapeutic purpose.
No
The device description indicates that the MyPlant II implant system serves as a tooth root substitute and is surgically placed in the maxilla or mandible to enable prosthetic restorations. It is a physical implant used for treatment, not for diagnosing conditions.
No
The device description clearly details physical components made of titanium and PEEK, which are hardware. The performance studies also focus on physical properties and sterilization of these hardware components.
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 surgically placed in the maxilla or mandible to enable prosthetic restorations. This is a surgical procedure and a medical device, not a diagnostic test performed in vitro (outside the body).
- Device Description: The description details the physical components of a dental implant system (implants and abutments) made of materials like titanium and PEEK. This aligns with a medical device used for structural support and restoration within the body.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health condition.
- Performance Studies: The performance studies focus on the physical and biological properties of the device (sterilization, biocompatibility, fatigue testing), which are relevant to a medical implant, not an IVD.
In summary, the MyPlant II implant system is a medical device used for dental restoration, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The MyPlant II implants are surgically placed in the maxilla or mandible to enable prosthetic restorations in edentulous or partially edentulous patients. The implants are to be used exclusively with MyPlant II abutments and prosthetic components. The abutments serve for prosthetic restorations and can include individual crowns, bridges, partial or full prostheses. Abutments can be used for single tooth restorations or for the restoration of several teeth. The implants are intended for delayed loading with two surgical interventions. In case of appropriate primary stability (35 Ncm), immediate temporary restoration with appropriate occlusal load can also be performed.
Product codes
DZE, NHA
Device Description
The MyPlant II implant system serves as a tooth root substitute and can be used in free jaw sections or edentulous jaws. The MyPlant II implant is made of pure titanium Grade 4 (3.7065). The implant surface is micro-structured. The surface structure is created by blasting with white corundum (> 99 % AlsO3 = aluminum oxide) and etching with acid. Prosthetic connection and thus force transmission is conveyed via an internal cone. A sterile cover screw of 1 mm height is enclosed with each implant to enable an immediate occlusion of the internal thread after successful insertion. The implants are supplied sterile and are intended for single use. MyPlant II Implant System includes variations in diameter (3.5 mm, 4.0 mm, 4.5 mm) and length (8.0 mm, 9.5 mm, 11.0 mm, 14.0 mm).
Dental abutments are used to support prosthetic reconstruction. Prosthetic applications can include individual crowns, bridges, partial or full prostheses. Abutments can be used for the replacement of one or more teeth. All components are made of a material suitable for the purpose of the application. The abutments are made of pure titanium Grade 4 (3.7065), titanium alloy Grade 5-ELI (Grade 23/3.7165), or PEEK. Except for the PEEK healing caps, the abutment surface is anodized. Connection to the implant is assured via an internal tapered connection as well as a metric thread. For Abutments 0° / 15° and Shoulder Abutments, the abutment screw is not anodized and undergoes laser welding to connect the threaded sleeves with the shaft. The system includes various abutment types such as Abutments 0°/15°, Shoulder Abutments, Ball Anchors, Healing Abutments, Healing Caps, Cover Screws, Occlusal Screws, and Screws for Ceramics, with specified dimensions.
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)
Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence include:
- Gamma sterilization validation according to ISO 11137-1 and 11137-2 (conducted on the subject device).
- Steam sterilization validation according to ISO 17665 and ST79 (referenced from K132214).
- Cleaning validation: LAL endotoxin test according to USP [85] and ANSI AAMI ST72 (referenced from K132214).
- Sterile barrier system validation according to ISO 11607, ASTM F88/F88M-15 and ASTM F1929-15 (conducted on the subject device).
- Biocompatibility assessment according to ISO 10993-1 and cytotoxicity testing according to ISO 10993-5 (proposed implants: referenced from K143539, proposed abutments: conducted on the subject device).
- Fatigue testing according to ISO 14801 and FDA Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments (conducted on the subject device).
No animal testing or human clinical trials have been conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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.
August 9, 2018
Hager & Meisinger GmbH Adam Tomczak Regulatory Affairs Hansemannstrasse 10 Neuss, 41468 GERMANY
Re: K173819
Trade/Device Name: MyPlant II Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: July 2, 2018 Received: July 9, 2018
Dear Adam Tomczak:
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.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 medical devices and radiation-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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K173819
Device Name MyPlant II Implant System
Indications for Use (Describe)
The MyPlant II implants are surgically placed in the maxilla or mandible to enable prosthetic restorations in edentulous or partially edentulous patients. The implants are to be used exclusively prith MyPlason and and prosthetic components. The abutments serve for prosthetic restorations and can include individual crowns, bridges, partial or full prostheses. Abutments can be used for single tooth restorations or for the restoration of several teeth. The implants are intended for delayed loading with two surgical interventions. In castof oppriate primary stability (35 Ncm), immediate temporary restoration with appropriate occlusal load can also be appriverad.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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."
FORM FDA 3881 (7/17)
3
1. Applicant's Name and Address:
| Hager & Meisinger GmbH | |
|---|---|
| Hansemannstrasse 10 | |
| 41468 Neuss | |
| Germany | |
| Phone: | 0049 2131 2012 293 |
| Fax: | 0049 2131 2012 223 |
| Contact Person: | Dr. Adam Tomczak, Regulatory Affairs |
2. Date prepared:
Date prepared:
9 August 2018
3. Name of the Device:
| Trade Name: | MyPlant II Implant System |
|---|---|
| Common Name: | Dental Implants, Dental Implant Abutments |
| Classification Name: | Root-form Endosseous Dental Implants, Endosseus Dental Implant |
| Abutment Devices | |
| Product Code: | DZE |
| Subsequent Product Code: | NHA |
| Regulation No: | 872.3640 |
| Class: | II |
| Panel: | Dental |
4. Primary Predicate Device:
| 510(k) No. | Manufacturer | Trade Name |
|---|---|---|
| K143539 | Hager & Meisinger GmbH. | Dental Implant System OKTAGON® Bone Level |
Reference Devices:
| 510(k) No. | Manufacturer | Trade Name |
|---|---|---|
| K083805 | Dentsply International, Inc | ANKYLOS® C/X Dental Implant System |
| K132214 | Hager & Meisinger GmbH | Dental Implant Abutment OKTAGON® |
| K172505 | MIS Implants Technologies Ltd | MIS C1 Narrow Platform Conical Connection |
| Implant System MIS C1 Wide Platform Conical |
Connection Abutments
4
5. Device Description:
Implants
The MyPlant II implant system serves as a tooth root substitute and can be used in free jaw sections or edentulous jaws. The MyPlant II implant is made of pure titanium Grade 4 (3.7065). The implant surface is micro-structured. The surface structure is created by blasting with white corundum (> 99 % AlsO3 = aluminum oxide) and etching with acid. Prosthetic connection and thus force transmission is conveyed via an internal cone. A sterile cover screw of 1 mm height is enclosed with each implant to enable an immediate occlusion of the internal thread after successful insertion. The implants are supplied sterile and are intended for single use. MyPlant II Implant System includes the following implant variations:
| Article No. | Diameter [mm] | Length [mm] |
|---|---|---|
| A3580 | 3.5 | 8.0 |
| A3595 | 3.5 | 9.5 |
| A3511 | 3.5 | 11.0 |
| A3514 | 3.5 | 14.0 |
| M4080 | 4.0 | 8.0 |
| M4095 | 4.0 | 9.5 |
| M4011 | 4.0 | 11.0 |
| M4014 | 4.0 | 14.0 |
| B4580 | 4.5 | 8.0 |
| B4595 | 4.5 | 9.5 |
| B4511 | 4.5 | 11.0 |
| B4514 | 4.5 | 14.0 |
Abutments
Dental abutments are used to support prosthetic reconstruction. Prosthetic applications can include individual crowns, bridges, partial or full prostheses. Abutments can be used for the replacement of one or more teeth. Depending on the indication and the anatomical conditions, the user will use several components for the specific prosthetic purpose. All components are made of a material suitable for the purpose of the application. The abutments are made of pure titanium Grade 4 (3.7065), titanium alloy Grade 5-ELI (Grade 23/3.7165), or PEEK. Except for the PEEK healing caps, the abutment surface is anodized. Connection to the implant is assured via an internal tapered
5
connection as well as a metric thread. In the case of Abutments 0° / 15° and Shoulder Abutments, the abutment screw is not anodized and undergoes laser welding to connect the threaded sleeves with the shaft. The subject abutments are listed in the table below.
| Article No. | Description | Specifications [mm] |
|---|---|---|
| GH=gingiva height, H=height, L=length | ||
| PAB01 | Abutment 0° | GH 1.5 H 4.0 |
| PAB02 | Abutment 0° | GH 1.5 H 6.0 |
| PAB03 | Abutment 0° | GH 3.0 H 4.0 |
| PAB04 | Abutment 0° | GH 3.0 H 6.0 |
| PAB51 | Abutment 15° | GH 1.5 H 4.0 |
| PAB52 | Abutment 15° | GH 1.5 H 6.0 |
| PAB53 | Abutment 15° | GH 3.0 H 4.0 |
| PAB54 | Abutment 15° | GH 3.0 H 6.0 |
| PSA01 | Shoulder Abutment 0° | GH 1.5 H 6.0 |
| PSA02 | Shoulder Abutment 0° | GH 3.0 H 6.0 |
| PSA51 | Shoulder Abutment 15° | GH 1.5 H 6.0 |
| PSA52 | Shoulder Abutment 15° | GH 3.0 H 6.0 |
| PKA01 | Ball Anchor | GH 1.5 |
| PKA02 | Ball Anchor | GH 3.0 |
| PKA03 | Ball Anchor | GH 4.5 |
| PGF15 | Healing Abutment | GH 1.5 |
| PGF30 | Healing Abutment | GH 3.0 |
| PGF45 | Healing Abutment | GH 4.5 |
| PHK01 | Healing Cap | H 4.0 |
| PHK02 | Healing Cap | H 6.0 |
| PVS00 | Cover Screw 0 mm | L 5.5 |
| PVS01 | Cover Screw 1 mm | L 6.5 |
| Article No. | Description | Specifications [mm] |
| GH=gingiva height, H=height, L=length | ||
| PVS02 | Cover Screw 2 mm | L 7.5 |
| POS01 | Occlusal Screw | L 4.5 |
| PSVK1 | Screw for Ceramics | L 4.5 |
6
6. Indications for Use:
The MyPlant II implants are surgically placed in the maxilla or mandible to enable prosthetic restorations in edentulous or partially edentulous patients. The implants are to be used exclusively with MyPlant II abutments and prosthetic components. The abutments serve for prosthetic restorations and can include individual crowns, bridges, partial or full prostheses. Abutments can be used for single tooth restorations or for the restoration of several teeth. The implants are intended for delayed loading with two surgical interventions. In case of appropriate primary stability (35 Ncm), immediate temporary restoration with appropriate occlusal load can also be performed.
7. Basis for substantial equivalence
The tables below compare the Indications for Use Statements and the technological characteristics of the subject device system and the predicate/reference devices.
| | Indications for Use Statement | | MyPlant II
Implant System
(subject device) | Dental Implant
System
OKTAGON® Bone
Level (primary
predicate) | ANKYLOS® C/X
Dental Implant
System
(reference device) | MIS C1 Narrow
Platform Conical
Connection Implant
System MIS C1 Wide
Platform Conical
Connection
Abutments
(reference device) |
|--------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|-------------------------------------------------------|---------------------------------------------------------------------------|----------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Subject Device | | 510(k) No. | K173819 | K143539 | K083805 | K172505 |
| K173819
MyPlant II Implant System | The MyPlant II implants are surgically placed in the maxilla or mandible to
enable prosthetic restorations in edentulous or partially edentulous patients.
The implants are to be used exclusively with MyPlant II abutments and
prosthetic components. The abutments serve for prosthetic restorations and
can include individual crowns, bridges, partial or full prostheses. Abutments
can be used for single tooth restorations or for the restoration of several
teeth. The implants are intended for delayed loading with two surgical
interventions. In case of appropriate primary stability (35 Ncm), immediate
temporary restoration with appropriate occlusal load can also be performed. | Implant
Type | Bone-level | Bone-level | Bone-level | Bone-level |
| Primary Predicate | | Material | Titanium Grade 4 | Titanium Grade 4 | Titanium Grade 2 | Ti6Al4V Grade 5-EL |
| K143539
Dental Implant System | The implants are surgically placed in the maxillary and/ or mandibular
arches to provide support for prosthetic restorations in edentulous or | Endosseous
Surface | Micro-structured
(grit blasted and
acid-etched) | Micro-structured
(grit blasted and acid-
etched) | Micro-structured
(grit blasted and
acid-etched) | Micro-structured
(grit blasted and
acid-etched) |
| OKTAGON® Bone Level | partially edentulous patients. The implants are intended to be used with
OKTAGON® Bone Level abutments and prosthetic parts. Dental Implant
Abutments Bone Level are intended to provide support for prosthetic
reconstructions. Prosthetic applications can include individual crowns,
bridges, partial or total prostheses. Abutments can be used in single tooth
replacements and multiple tooth restorations. The Abutments are intended
to be compatible to OKTAGON® Bone Level implants with diameters
3.3mm, 4.1mm and 4.8mm and with the lengths 8mm, 10mm, 12mm and
14mm. The Oktagon Bone Level System is intended for delayed loading,
or for immediate loading when good primary stability is achieved and
with appropriate occlusal load. | Thread
Design | Progressive | Consistent | Progressive | Progressive |
| Reference Devices | | Implant-
abutment
connection | Tapered, without
indexation | Octagonal | Tapered, available
with and without
indexation | Tapered, with
indexation |
| K083805
ANKYLOS® C/X
Dental Implant System | The ANKYLOS® C/X Implant System is for single-stage or two-stage surgical
procedures and cemented or screw retained restorations. The ANKYLOS®
C/X Implant System is intended for immediate placement and function on
single tooth and/or multiple tooth applications when good primary stability is
achieved, with appropriate occlusal loading, in order to restore chewing
function. Multiple tooth applications may be splinted with a bar. | Implant
Length | 8.0 / 9.5 / 11.0 /
14.0 mm | 8.0 / 10.0 / 12.0 /
14.0 mm | 8.0 / 9.5 / 11.0 /
14.0 / 17.0 mm | 10.0 / 11.5 / 13.0 /
16.0 mm |
| K132214
Dental Implant Abutment
OKTAGON® | Dental Implant Abutments are intended to provide support for prosthetic
reconstructions. Prosthetic applications can include individual crowns, bridges,
partial or total prostheses.
Abutments can be used in single tooth replacements and multiple tooth
restorations.
The Dental Implant Abutments OKTAGON® are intended to be compatible
to OKTAGON® implants (Dental Implant OKTAGON®) with diameters
3.3mm, 4.1mm and 4.8mm in the variation Regular Platform, Wide Platform
and Tapered Design with the lengths 8mm, 10mm, 12mm and 14mm. | | | | | |
| K172505
MIS C1 Narrow Platform
Conical Connection Implant
System
MIS C1 Wide Platform
Conical Connection
Abutments | 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. | | | | | |
Comparison of Indications for Use Statements:
7
The comparison of Indications for Use Statements shows that the subject device and the primary predicate have the same intended use. Both implant systems are surgically placed in the maxilla or the
8
mandible to provide support for single tooth or multiple tooth restorations. The surgical procedure may be two-stage or single-stage, with the possibility of immediate prosthetic restoration with appropriate occlusal load (in case of good primary stability). K143539 Indications for Use Statement additionally states that "The Abutments are intended to be compatible to OKTAGON® Bone Level implants with diameters 3.3mm, 4.1mm and 4.8mm and with the lengths 8mm, 10mm, 12mm and 14mm". This information about implant-abutment compatibility does not change the intended use. Further small differences in wording do not change the intended use.
Comparison of technological characteristics - implants:
9
| Endosseous
| Diameter | 3.5 / 4.0 / 4.5 mm | 3.3 / 4.1 / 4.8 mm | 3.5 / 4.5 / 5.5 / 6.5 mm | 3.3 mm |
|---|---|---|---|---|
| Sterility | Provided sterile; | |||
| irradiation | Provided sterile; | |||
| irradiation | Provided sterile; | |||
| irradiation | Provided sterile; | |||
| irradiation |
As compared to the primary predicate K143539, the subject implants use the same materials and manufacturing methods. With regard to length and diameter, the subject implants lie within the range of the predicate device. The sterilization method is the same. However, the thread design and the implant-abutment connection are different. This gap is closed by K083805 implants, which have the same thread design and implant-abutment connection type (self-locking inner cone + retention screw). The main design difference between the subject device system and K083805 reference device is the extension of the inner cone connection which provides the implant-abutment interface. The effects of this design change have been evaluated by fatigue testing and FEM analysis, supporting substantial equivalence.
| | MyPlant II
Implant
System
(subject
device) | Dental Implant
System
OKTAGON®
(primary
predicate) | ANKYLOS®
C/X Dental
Implant System
(reference
device) | Dental Implant
Abutment
OKTAGON®
(reference
device) | MIS C1 Narrow
Platform Conical
Connection
Implant System
MIS C1 Wide
Platform Conical
Connection
Abutments
(reference device) |
|------------------------------------|--------------------------------------------------------|----------------------------------------------------------------|-------------------------------------------------------------------|-----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) No. | K173819 | K143539 | K083805 | K132214 | K172505 |
| Material | Ti6Al4V
Gr.5 - ELI
Titanium Gr. 4
PEEK | Ti6Al4V
Gr.5 - ELI
Titanium Gr. 4
POM-C | Ti6Al4V
POM | Ti6Al4V
Gr.5 – ELI
Titanium Gr. 4
POM-C | Ti6Al4V - ELI
PEEK
POM
Gold alloy |
| Angulation | 0° / 15° | 0° | 0° - 22.5° | 0° - 20° | 0° - 30° |
| Implant-
abutment
connection | Tapered,
without
indexation | Octagonal | Tapered,
available with
and without
indexation | Octagonal | Tapered, with
indexation |
| Sterility | Non-sterile | Non-sterile | Non-sterile | Non-sterile | Non-sterile |
Comparison of technological characteristics abutments:
10
The subject abutments are intended to enable various single-tooth and multiple tooth restorations. With respect to the predicate, the main differences are the angulation (the predicate does not include angled abutments), and the implant-abutment connection. This gap is bridged by K083805 abutments, which are very similar to the subject abutments in terms of design. Below the intended use and the technological characteristics have been compared with predicate/reference device for each abutment type included in this submission, and the most similar predicate/reference abutment has been identified. Regarding indexation of the implant-abutment connection, the reference device K083805 allows the user to choose between indexed (/X) and unindexed connection (/C). The subject device system will be made available without indexation, so substantial equivalence to the /C variation is claimed.
| | MyPlant II
Implant System
(subject device) | ANKYLOS® C/X
Implant System
(reference device) | ANKYLOS® C/X
Implant System
(reference device) |
|--------------------------|------------------------------------------------------------------------------------------|------------------------------------------------------|------------------------------------------------------|
| K Number | K173819 | K083805 | K083805 |
| Product Name | Abutments 0° / 15° | Standard C/Abutments | SynCone C/ Abutments |
| Intended Use | Support screw-retained
restorations or
overdentures on
prefabricated taper caps | Support cemented or screw-
retained restorations | Support overdentures on
prefabricated taper caps |
| Material | Ti6Al4V Gr.5 - ELI | Ti6Al4V | Ti6Al4V |
| Diameter | 3.5 mm | 3.3 / 4.5 mm | 4.0 mm |
| Gingiva height | 1.5 / 3.0 mm | 1.5 / 3.0 / 4.5 / 6.0 mm | 1.5 / 3.0 / 4.5 mm |
| Post height | 4.0 / 6.0 mm | 4.0 / 6.0 mm | 4.0 mm |
| Angulation | 0° / 15° | 0°/ 15° | 0° / 15° / 22.5° |
| Connection to
implant | Tapered + metric thread,
without indexation | Tapered + metric thread,
without indexation | Tapered + metric thread,
without indexation |
| Sterility | Non-sterile | Non-sterile | Non-sterile |
Abutments 0° / 15° (PAB01-04, PAB52-54)
The subject abutments are substantially equivalent to the reference device in all features. There is a small difference in the abutment diameter, but the subject device lies within the range of the predicate. The SynCone C/ Abutment has been included in the comparison because, as in the case of
11
the subject abutment, the abutment body is tapered to enable prosthetic restoration with overdentures on taper caps (this form of restoration is not possible on K083805 Standard C/ abutment).
Shoulder Abutments (PSA01-02, PSA51-52)
| | MyPlant II Implant System
(subject device) | ANKYLOS® C/X Implant System
(reference device) |
|-----------------------|-----------------------------------------------------|-----------------------------------------------------|
| K Number | K173819 | K083805 |
| Product Name | Shoulder abutments | Regular C/Abutments |
| Intended Use | Support cemented or screw-
retained restorations | Support cemented or screw-
retained restorations |
| Material | Ti6Al4V Gr.5 - ELI | Ti6Al4V |
| Diameter | 5.0 mm | 5.7 mm |
| Gingiva height | 1.5 / 3.0 mm | 0.75 / 1.5 / 3.0 / 4.5 mm |
| Post height | 6.0 mm | 6.6 / 7.0mm |
| Angulation | 0°/15° | 0° / 15° / 22.5° |
| Connection to implant | Tapered + metric thread,
without indexation | Tapered + metric thread, without
indexation |
| Sterility | Non-sterile | Non-sterile |
The subject shoulder abutments are substantially equivalent to the reference device in all features despite small differences in dimensions. In the subject device, the post height is shorter, and the abutment diameter is slightly narrower. However, these differences do not represent a new worstcase within this submission.
Ball Anchors (PKA01-03)
| | MyPlant II
Implant System
(subject device) | ANKYLOS® C/X
Implant System
(reference device) | Dental Implant Abutment
OKTAGON®
(reference device) |
|----------|--------------------------------------------------|------------------------------------------------------|-----------------------------------------------------------|
| K Number | K173819 | K083805 | K132214 |
12
| Product Name | Ball Anchor | Snap Attachment C/ | Retentive Anchor |
|---|---|---|---|
| Intended Use | Support retentively-fixated | ||
| overdentures | Support retentively-fixated | ||
| overdentures | Support retentively-fixated | ||
| overdentures | |||
| Material | Titanium Grade 4 | Ti6Al4V | Titanium Grade 4 |
| Diameter (snap | |||
| attachment | |||
| sphere) | 2.25 mm | 2.7 mm | 2.25 mm |
| Gingiva height | 1.5 / 3.0 /4.5 mm | 1.5 / 3.0 /4.5 mm | Non-applicable (to be used |
| with a tissue-level implant) | |||
| Height | 3.5 mm | 3.5 mm | 3.4 mm |
| Angulation | Straight | Straight | Straight |
| Connection to | |||
| implant | Tapered + metric thread, | ||
| without indexation | Tapered + metric thread, | ||
| without indexation | Octagonal | ||
| Sterility | Non-sterile | Non-sterile | Non-sterile |
The subject ball anchors are substantially equivalent to the reference devices in almost all features. In the subject device the snap sphere is narrower. This gap is closed by the reference device K132214, which uses an attachment sphere of the same size.
Healing abutments (PGF15, PGF30, PGF45)
| | MyPlant II Implant System
(subject device) | ANKYLOS® C/X Implant
System (reference device) |
|--------------|----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| K Number | K173819 | K083805 |
| Product Name | Healing abutment | Standard C/ Sulcus Former |
| Intended Use | Closing the implant and shaping of
the peri-implant soft tissue during
transgingival healing | Closing the implant and shaping of
the peri-implant soft tissue during
transgingival healing |
| Material | Titanium Grade 4 | Ti6Al4V |
| Diameter | Compatible with planned abutment
of 3.5 mm diameter | Compatible with planned abutment
of 3.3 / 4.5 mm diameter |
13
| Height | Non-applicable | Non-applicable |
|---|---|---|
| Gingiva height | 1.5 / 3.0 / 4.5 mm | 1.5 / 3.0 / 4.5 / 6.0 mm |
| Angulation | Straight | Straight |
| Connection to implant | Tapered + metric thread, without indexation | Tapered + metric thread, without indexation |
| Sterility | Non-sterile | Non-sterile |
The subject healing abutments are substantially equivalent to the reference device in all features. There is a minimal difference in the planned abutment diameter, but the subject device lies within the range of the predicate.
Healing caps (PHK01-02)
| | MyPlant II Implant System
(subject device) | ANKYLOS® C/X
Implant System
(reference device) | MIS C1 Narrow Platform
Conical Connection
Implant System MIS C1
Wide Platform Conical
Connection Abutments
(reference device) |
|--------------------------|--------------------------------------------------------------------------|--------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| K Number | K173819 | K080385 | K172505 |
| Product Name | Healing Caps | Standard Temporary Cap | Plastic Healing Caps |
| Intended Use | Cover the abutment and
provide interface for
temporary restoration | Cover the abutment and
provide interface for
temporary restoration | Cover the abutment until
permanent restoration is
ready |
| Material | PEEK | POM | PEEK |
| Diameter | 3.5 mm | 3.3 / 4.5 mm | No public data available |
| Height | 4.0 / 6.0 mm | 4.0 / 6.0 mm | 4.0 / 6.0 / 8.0 mm |
| Gingiva height | - | - | - |
| Angulation | - | - | - |
| Connection to
Implant | Non-applicable (the healing
cap is mounted on the | Non-applicable (the healing
cap is mounted on the | Non-applicable (the healing
cap is mounted on the |
14
| abutment) | abutment) | abutment) | |
|---|---|---|---|
| Sterility | Non-sterile | Non-sterile | Non-sterile |
The subject healing caps are substantially equivalent to the reference devices in almost all features. The subject device uses a different material. This gap is closed by the reference device K172505, which includes a healing cap made of the same material.
Cover Screws (PVS00-02)
| | MyPlant II Implant System
(subject device) | ANKYLOS® C/X Implant
System (reference device) |
|------------------------------------|--------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| K Number | K173819 | K083805 |
| Product Name | Cover Screw | C/X Cover Screw |
| Intended Use | Closing the implant during
subgingival healing | Closing the implant during
subgingival healing |
| Material | Titanium Grade 4 | Ti6Al4V |
| Diameter | 2.7 / 3.0 / 3.5 mm | 2.5 - 3.5 mm |
| Height
(above implant shoulder) | 0.0 / 1.0 / 2.0 mm | 0.0 / 1.0 / 2.0 mm |
| Gingiva height | Non-applicable | Non-applicable |
| Angulation | Non-applicable | Non-applicable |
| Connection to implant | Tapered + metric thread, without
indexation | Tapered + metric thread, without
indexation |
| Sterility | Sterile when delivered in the
implant package; Non-sterile as
spare part | Sterile when delivered in the
implant package; Non-sterile as
spare part |
The subject cover screws are substantially equivalent to the reference device in all features.
Occlusal Screw (POS01), Screw for Ceramics (PVSK01)
| MyPlant II Implant System | ANKYLOS® C/X Implant | |
|---|---|---|
15
| (subject device) | System (reference device) | |
|---|---|---|
| K Number | K173819 | K083805 |
| Product Name | Occlusal Screw, Screw for | |
| Ceramics | Fixation screw | |
| Intended Use | Fixation of screw-retained | |
| restorations | Fixation of screw-retained | |
| restorations | ||
| Material | Ti6Al4V Gr. 5 -ELI | Ti6Al4V |
| Thread acc. to ISO 1502 | M2 | M1.4 / M1.6 |
| Height | Non-applicable | Non-applicable |
| Gingiva height | Non-applicable | Non-applicable |
| Angulation | Non-applicable | Non-applicable |
| Connection to implant | Non-applicable | Non-applicable |
| Sterility | Non-sterile | Non-sterile |
The subject screws for screw-retained restorations are substantially equivalent to the reference device in all features. There is a small difference in the thread size, but using a slightly larger thread for screw-retained restorations does not raise new performance or safety issues.
In summary, the above comparison shows that the subject abutments are substantially equivalent to the legally marketed predicate/reference devices. The intended use is identical, the used materials are the same or very similar, and the design parameters fall into the range of predicate/reference devices. Except for the healing caps made of PEEK, the manufacturing methods are shared with the predicate device K143539, albeit with a difference in the manufacturing process of the abutment screw used for Abutments 0° / 15° (PAB01-04, PAB52-54) and Shoulder Abutments (PSA01-02, PSA51-52). K143539 screws are manufactured as one part and are anodized, whereas the proposed screws use laser welding to connect the threaded sleeve with the shaft and are not anodized.
8. Performance tests and used standards
Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence include:
16
· Gamma sterilization validation according to ISO 11137-1 and 11137-2 (conducted on the subject device).
· Steam sterilization validation according to ISO 17665 and ST79 (referenced from K132214).
· Cleaning validation: LAL endotoxin test according to USP [85] and ANSI AAMI ST72 (referenced from K132214).
• Sterile barrier system validation according to ISO 11607, ASTM F88/F88M-15 and ASTM F1929-15 (conducted on the subject device).
• Biocompatibility assessment according to ISO 10993-1 and cytotoxicity testing according to ISO 10993-5 (proposed implants: referenced from K143539, proposed abutments: conducted on the subject device).
· Fatigue testing according to ISO 14801 and FDA Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments (conducted on the subject device).
No animal testing or human clinical trials have been conducted.
9. Conclusion
The subject device and the legally marketed predicate device have identical intended use. The technological characteristics are the same or very similar, as shown by the predicate/reference device comparison. Based on the assessment of applicable performance data, the subject device system does not raise new performance or safety issues. Thus, we concluded that the subject device is substantially equivalent to the legally marketed predicate device listed above.