(105 days)
No
The summary describes a dental implant system and its components, with no mention of AI or ML technology in the intended use, device description, or performance studies.
Yes.
The device is a dental implant system used for restoring chewing function and supporting crowns, bridges, and overdentures, which are therapeutic interventions.
No
This device is described as an endosseous dental implant and associated abutments used for restoring chewing function and supporting crowns, bridges, and overdentures. Its purpose is mechanical and structural support, not diagnosis.
No
The device description clearly states it is a "self-tapping, root form, endosseous dental implant made of commercially pure titanium," which is a physical hardware component. While it mentions digitally designed abutments, the core device is a physical implant.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a dental implant system used for restoring chewing function and supporting dental prosthetics (crowns, bridges, overdentures). This is a surgical and prosthetic device, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details the physical components of the implant system (implant, healing cap, gingiva former, abutments) and their materials (titanium). This aligns with a medical device used for implantation and support, not for in vitro testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, calibrators, controls, or any other elements typically associated with in vitro diagnostic devices.
- Performance Studies: The performance studies focus on mechanical strength, sterilization, biocompatibility, and packaging integrity, which are relevant to implantable medical devices, not IVDs.
Therefore, the ELEMENT PF 3.0, VARIOunite PF 3.0, and VARIOunite are classified as dental implant systems and associated components, not IVDs.
N/A
Intended Use / Indications for Use
Implant:
The ELEMENT PF 3.0 is suitable for use in one-stage or two-stage surgical techniques for restoring chewing function. The ELEMENT PF 3.0 is suitable for immediate implantation in case of replacement of several teeth; prerequisites are good primary stability and appropriate occlusal loading. The ELEMENT PF 3.0 must only be used for replacement of the lateral incisors of the upper jaw and lateral incisors of the lower jaw.
VARIOunite PF 3.0:
Thommen Medical VARIOunite abutments PF 3.0 are only used in conjunction with the ELEMENT PF 3.0 and are for fabrication of provisional and final crowns in the anterior maxilla and mandible (upper lateral incisors, lower anterior teeth).
Digitally designed abutments for use with Thommen VARIOunite are intended to be sent to a Thommen validated milling center for manufacture.
VARIOunite:
Thommen Medical VARIOunite abutments are intended to be used in conjunction with Thommen System dental implants in the maxillary and/or mandibular arch to provide support for crowns, bridges and overdentures. Digitally designed abutments for use with Thommen VARIOunite are intended to be sent to a Thommen validated milling center for manufacture.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
ELEMENT Ø 3.0 is a self-tapping, root form, endosseous dental implant made of commercially pure titanium. It is provided in two surfaces (TST and INICELL) and five lengths (8.0, 9.5, 11.0, 12.5, and 14 mm). Subject device components available for the ELEMENT Ø 3.0 implant are the healing cap, gingiva former and VARIOunite abutments. VARIOunite abutments can be used for temporary restorations, permanent restorations, or CAD/CAM zirconia superstructures. The indications for previously cleared VARIQunite abutments have been expanded to include angulation of the CAD/CAM zirconia superstructures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillary and/or mandibular arch
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 testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included: radiation sterilization validation to an SAL of 10to according to ISO 11137-1, ISO 11137-2; Steam sterilization validation to an SAL of 106 according to ISO 17665-1 and ISO 17665-2; biocompatibility evaluation according to ISO 10993-1 by reference to K093615, K160244, K102804 and K121334; Limulus amebocyte lysate (LAL) endotoxin testing in accordance with FDA Guidance documents Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile; shelf life testing for detecting seal leaks according to ASTM F88/F88M, seal strength testing according to ASTM F1886/1886M, seal integrity testing according to ASTM F1929, dye penetration testing according to ASTM F3039, testing for packaging of terminally sterilized medical devices according to ISO 11607-1, and ISO 11607-2, and mechanical testing according to ISO 14801 to ensure that the subject device is strong enough for its intended use.
No clinical data were included in this submission.
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.
K160244, K102804, K151984, K121334, K120414
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
§ 872.3640 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Thommen Medical AG % Linda Schulz Regulatory Affairs PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130
September 29, 2017
Re: K171795
Trade/Device Name: Thommen Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: August 31, 2017 Received: September 1, 2017
Dear Linda Schulz:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Mary S. Runner -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Thommen Implant System
Indications for Use (Describe)
Implant:
The ELEMENT PF 3.0 is suitable for use in one-stage or two-stage surgical techniques for restoring chewing function. The ELEMENT PF 3.0 is suitable for immediate implantation in case of replacement of several teeth; prerequisites are good primary stability and appropriate occlusal loading. The ELEMENT PF 3.0 must only be used for replacement of the lateral incisors of the upper jaw and lateral incisors of the lower jaw.
VARIOunite PF 3.0:
Thommen Medical VARIOunite abutments PF 3.0 are only used in conjunction with the ELEMENT PF 3.0 and are for fabrication of provisional and final crowns in the anterior maxilla and mandible (upper lateral incisors, lower anterior teeth).
Digitally designed abutments for use with Thommen VARIOunite are intended to be sent to a Thommen validated milling center for manufacture.
VARIOunite:
Thommen Medical VARIQunite abutments are intended to be used in conjunction with Thommen System dental implants in the maxillary and/or mandibular arch to provide support for crowns, bridges and overdentures. Digitally designed abutments for use with Thommen VARIOunite are intended to be sent to a Thommen validated milling center for manufacture.
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) |
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3
510(k) Summary
Thommen Medical AG
Thommen Implant System K171795
September 29, 2017
ADMINISTRATIVEINFORMATION
| Manufacturer Name | Thommen Medical AG
Neckarsulmstrasse 28
2540 Grenchen, Solothurn, Switzerland
Telephone: +41 61 965 90 20
Fax: +41 61 965 90 21 |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact | Daniel Snetivy, PhD
Chief Technology Officer |
| Representative/Consultant | Linda K. Schulz, BSDH, RDH
Kevin A. Thomas, PhD
PaxMed International, LLC
12264 El Camino Real, Suite 400
San Diego, CA 92130
Telephone: +1-858-792-1235
Fax: +1-858-792-1236
Email: lschulz@paxmed.com |
DEVICE NAME AND CLASSIFICATION
| Thommen Implant System |
|---|
| Dental implant |
| Dental implant abutment |
| Implant, endosseous, root form |
| Endosseous dental implant abutment |
| 21 CFR 872.3640, Class II |
| DZE, NHA |
| Dental Products Panel |
| Dental Devices Branch |
PREDICATE DEVICE INFORMATION
Primary Predicate K093615, SP1® Dental Implant ELEMENT, Thommen Medical AG
Reference Predicates K160244, VARIOunite, Thommen Medical AG K102804, SPI® Titanium Base for CAD/CAM, Thommen Medical AG K151984, Milling Abutment for CAD/CAM, Thommen Medical AG K121334, VARIOeco, Thommen Medical AG K120414, OsseoSpeed™ Plus, Astra Tech AB
4
INDICATIONS FOR USE
Implant:
The ELEMENT PF 3.0 is suitable for use in one-stage surgical techniques for restoring chewing function. The ELEMENT PF 3.0 is suitable for immediate implantation and restoration in case of replacement of several teeth; prerequisites are good primary stability and appropriate occlusal loading. The ELEMENT PF 3.0 must only be used for replacement of the lateral incisors of the upper jaw and the central and lateral incisors of the lower jaw.
VARIOunite PF 3.0:
Thommen Medical VARIOunite abutments PF 3.0 are only used in conjunction with the ELEMENT PF 3.0 and are for fabrication of provisional and final crowns in the anterior maxilla and mandible (upper lateral incisors, lower anterior teeth).
Digitally designed abutments for use with Thommen VARIOunite are intended to be sent to a Thommen validated milling center for manufacture.
VARIOunite:
Thommen Medical VARIOunite abutments are intended to be used in conjunction with Thommen System dental implants in the maxillary and/or mandibular arch to provide support for crowns, bridges and overdentures.
Digitally designed abutments for use with Thommen VARIOunite are intended to be sent to a Thommen validated milling center for manufacture.
DEVICE DESCRIPTION
ELEMENT Ø 3.0 is a self-tapping, root form, endosseous dental implant made of commercially pure titanium. It is provided in two surfaces (TST and INICELL) and five lengths (8.0, 9.5, 11.0, 12.5, and 14 mm). Subject device components available for the ELEMENT Ø 3.0 implant are the healing cap, gingiva former and VARIOunite abutments. VARIOunite abutments can be used for temporary restorations, permanent restorations, or CAD/CAM zirconia superstructures. The indications for previously cleared VARIQunite abutments have been expanded to include angulation of the CAD/CAM zirconia superstructures.
PERFORMANCE DATA
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included: radiation sterilization validation to an SAL of 10to according to ISO 11137-1, ISO 11137-2; Steam sterilization validation to an SAL of 106 according to ISO 17665-1 and ISO 17665-2; biocompatibility evaluation according to ISO 10993-1 by reference to K093615, K160244, K102804 and K121334; Limulus amebocyte lysate (LAL) endotoxin testing in accordance with FDA Guidance documents Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile; shelf life testing for detecting seal leaks according to ASTM F88/F88M, seal strength testing according to ASTM F1886/1886M, seal integrity testing according to ASTM F1929, dye penetration testing according to ASTM F3039, testing for packaging of terminally sterilized medical devices according to ISO 11607-1, and ISO 11607-2, and mechanical testing according to ISO 14801 to ensure that the subject device is strong enough for its intended use.
No clinical data were included in this submission.
5
EQUIVALENCE TO MARKETED DEVICE
The subject device is substantially equivalent in indications and design principles to the predicate devices shown above. Below are summary tables comparing the Indications for Use and the technological characteristics of the subject device and the predicate devices.
| Indications for Use Statement | |
|---|---|
| Subject Device | |
| Thommen Implant | |
| System | |
| Thommen Medical | |
| AG | Implant: |
| The ELEMENT PF 3.0 is suitable for use in one-stage or two-stage surgical techniques for restoring chewing function. | |
| The ELEMENT PF 3.0 is suitable for immediate implantation and restoration in case of replacement of several teeth; | |
| prerequisites are good primary stability and appropriate occlusal loading. The ELEMENT PF 3.0 must only be used for | |
| replacement of the lateral incisors of the upper jaw and the central and lateral incisors of the lower jaw. | |
| VARIOunite PF 3.0: | |
| Thommen Medical VARIOunite abutments PF 3.0 are only used in conjunction with the ELEMENT PF 3.0 and are for | |
| fabrication of provisional and final crowns in the anterior maxilla and mandible (upper lateral incisors, lower anterior | |
| teeth). | |
| Digitally designed abutments for use with Thommen VARIOunite are intended to be sent to a Thommen validated | |
| milling center for manufacture. | |
| VARIOunite: | |
| Thommen Medical VARIOunite abutments are intended to be used in conjunction with Thommen System dental | |
| implants in the maxillary and/or mandibular arch to provide support for crowns, bridges and overdentures. | |
| Digitally designed abutments for use with Thommen VARIOunite are intended to be sent to a Thommen validated | |
| milling center for manufacture. | |
| Primary Predicate | |
| K093615 | |
| SPI® Dental Implant | |
| ELEMENT | |
| Thommen Medical | |
| AG | SPI® Dental Implant, ELEMENT is for one-stage or two-stage surgical procedures. SPI Dental Implant, ELEMENT is |
| intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary | |
| stability is achieved and with appropriate occlusal loading, to restore chewing function. Multiple tooth applications may | |
| be rigidly splinted. In the case of edentulous patients, four or more implants must be used in immediately loaded cases. | |
| Contraindications for the use of SPI ELEMENT implant Ø 3.5 mm: These implants are not suitable for applications in | |
| areas where pronounced rotation and translation movements occur, causing the implant to be subjected to large bending | |
| movements. | |
| Restoration of posterior teeth in the upper and lower jaw Single-tooth restoration of canines and central incisors in the upper jaw Any application involving retentive anchors | |
| Reference | |
| Predicates | |
| K160244 | |
| VARIOunite | |
| Thommen Medical | |
| AG | VARIOflex: Thommen Medical VARIOflex abutments are intended to be used in conjunction with Thommen System |
| dental implants in the maxillary and/or mandibular arch to provide support for crowns, bridges and overdentures. | |
| K102804 | |
| SPI® Titanium Base | |
| for CAD/CAM | |
| Thommen Medical | |
| AG | VARIOtemp: Thommen Medical VARIOtemp abutments are intended to be used in conjunction with Thommen System |
| dental implants in the maxillary and/or mandibular arch to provide support for crowns, bridges and overdentures. | |
| K151984 | |
| Milling Abutment for | |
| CAD/CAM | |
| Thommen Medical | |
| AG | Thommen Titanium Base for CAD/CAM abutments are intended to be used in conjunction with Thommen implants and |
| the 3M ESPE Lava™ System in the maxillary and/or mandibular arch to provide support for crowns and bridges. | |
| K121334 | |
| VARIOeco | |
| Thommen Medical | |
| AG | Thommen Milling abutments for CAD/CAM are intended to be used in conjunction with Thommen System dental |
| implants in the maxillary and /or mandibular arch to provide support for crowns, bridges and overdentures. | |
| All digitally designed abutments for use with Thommen Milling abutments for CAD/CAM are intended to be sent to a | |
| Thommen validated milling center for manufacture. | |
| Thommen VARIOeco dental implant abutments are intended to be used in conjunction with Thommen System dental | |
| implants in the maxillary and/or mandibular arch to provide support for crowns, bridges and overdentures. |
| Comparison of Indications for Use Statements | |
|---|---|
| ---------------------------------------------- | -- |
6
| Indications for Use Statement | |
|---|---|
| 120414 | |
| OsseoSpeed™ Plus | |
| Astra Tech AB | Implants: |
| The Astra Tech Dental Implants are intended for both one- and two-stage surgical procedures in the following situations | |
| and with the following clinical protocols: | |
| replacing single and multiple missing teeth in the mandible and maxilla, immediate placement in extraction sites and in situations with a partially or completely healed alveolar ridge, especially indicated for use in soft bone applications where implants with other implant surface treatments may be less effective, immediate loading in all indications, except in single tooth situations on implants shorter than 8 mm, or in soft bone (type IV) where implant stability may be difficult to obtain and immediate loading may not be appropriate. The intended use for OsseoSpeedTM Plus 3.0S is limited to replacement of maxillary lateral incisors and mandibular incisors. | |
| Abutments: | |
| Astra Tech Implant System Plus abutments are intended to be used in conjunction with Astra Tech Implant System Plus in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for crowns, bridges or overdentures. | |
| Atlantis Abutments: | |
| The Atlantis™ Abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous; patient. It is intended for use to support single and multiple tooth prostheses, in the mandible or maxilla. The prosthesis can be cemented, screw retained or friction fit to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant. | |
| The Atlantis™ Crown Abutment in Zirconia is intended for use with an endosseous; implant to function as a substructure that also serves as the final restoration, in partially or completely edentulous; patients. The prosthesis is screw retained. The abutment screw is intended to secure the crown abutment to the endosseous implant. |
Comparison of Technological Characteristics
| | Subject
Device | Primary
Predicate
Device | Reference Predicate Devices | | | | | |
|----------------------------------|------------------------------------|----------------------------------------------|-----------------------------|----------------------------------------------------|-----------------------------------------------|----------------------------|------------------------------------|--|
| | Thommen
Implant
System | K093615
SPI® Dental
Implant
ELEMENT | K160244
VARIOunite | K102804
SPI®
Titanium
Base for
CAD/CAM | K151984
Milling
Abutment for
CAD/CAM | K121334
VARIOeco | K120414
OsseoSpeed™
Plus | |
| | Thommen
Medical AG | Thommen
Medical AG | Thommen
Medical AG | Thommen
Medical AG | Thommen
Medical AG | Thommen
Medical AG | Astra Tech
AB | |
| Design | | | | | | | | |
| Implant Body
Diameter
(mm) | 3.0 | 3.5, 4.0, 4.5,
5.0, 6.0 | NA | NA | NA | NA | 3.0, 3.6, 4.2,
4.8, 5.4 | |
| Implant
Length (mm) | 8, 9.5, 11,
12.5, 14 | 6.5, 8.0, 9.5,
11, 12.5 | NA | NA | NA | NA | 6.0, 8.0, 9.0,
11, 13, 15, 17 | |
| Abutment
Diameter
(mm) | 3.0, 3.5, 4.0,
4.5, 5.0, 6.0 | 6.0 | 3.5, 4.0, 4.5,
5.0, 6.0 | 3.5, 4.0, 4.5,
5.0, 6.0 | 3.5, 4.0, 4.5,
5.0, 6.0 | 3.5, 4.0, 4.5,
5.0, 6.0 | 3.0, 3.6, 4.2,
4.8, 5.4 | |
| Abutment
Design | Straight or
Angled
(max 20°) | Straight | Straight | Straight or
Angled
(max 20°) | Straight or
Angled
(max 20°) | Straight | Straight or
Angled
(max 30°) | |
| Restoration | Single or
multi-unit | Single or
multi-unit | Single or
multi-unit | Single or
multi-unit | Single or
multi-unit | Single or
multi-unit | Single or
multi-unit | |
| Implant
Connection | Internal | Internal | Internal | Internal | Internal | Internal | Internal | |
| Material | | | | | | | | |
| Implant | CP Titanium | CP Titanium | NA | NA | NA | NA | CP Titanium | |
7
| | Subject
Device | Primary
Predicate
Device | Reference Predicate Devices | | | | |
|----------|-----------------------------------------------------------|---------------------------------------------------------------------------|----------------------------------------------------|---------------------------------------------------------------------------------|----------------------------------------------------------------------------|--------------------------------------------------|--------------------------------------------------------|
| | Thommen
Implant
System
Thommen
Medical AG | K093615
SPI® Dental
Implant
ELEMENT
Thommen
Medical AG | K160244
VARIOunite
Thommen
Medical AG | K102804
SPI®
Titanium
Base for
CAD/CAM
Thommen
Medical AG | K151984
Milling
Abutment for
CAD/CAM
Thommen
Medical AG | K121334
VARIOeco
Thommen
Medical AG | K120414
OsseoSpeed™
Plus
Astra Tech
AB |
| Abutment | CP Titanium
Titanium
Alloy | CP Titanium | CP Titanium | CPTitanium | CPTitanium | CP Titanium | Titanium
Alloy
Zirconia,
Gold, PEEK |
| Screw | Titanium
Alloy | Titanium
Alloy | Titanium
Alloy | Titanium
Alloy | Titanium
Alloy | Titanium
Alloy | Titanium
Alloy |
Subject device implants and healing caps are substantially equivalent to K093615 implants and healing caps in body and cover design, connection design, material, surface, and intended use. The subject device ELEMENT Ø 3.0 mm implant is 0.5 mm narrower than the predicate ELEMENT Ø 3.5 mm implant. The hex interface remains the same. The ELEMENT Ø 3.0 mm implant is substantially equivalent to the OsseoSpeed™ Plus Ø 3.0 mm implant (K120414) in diameter, length, and intended use.
Subject device VARIOunite and Gingiva Former abutments are substantially equivalent to K160224 and K120414 abutments in material, design and function. The expanded indication for VARIOunite to be used as a TiBase with CAD/CAM zirconia superstructure is substantially equivalent to that of SP1® Titanium Base for CAD/CAM (K102804) using the same materials and processes. The subject device is substantially equivalent to K151984 in that all digitally designed abutments for use with Thommen VARIOunite are intended to be sent to a Thommen validated milling center for manufacture.
Small differences in language in the Indications for Use Statements among the subject device, the predicate devices do not change the intended use. All are implant systems placed in the maxilla or mandible to support single or multi-unit prostheses and restore chewing function.
CONCLUSION
The subject device and the predicate devices have intended use, have similar technological characteristics, and are made of similar materials. The subject device and predicate devices encompass the same range of physical dimensions, including diameter and angle of the abutments. The subject and predicate devices are packaged in similar materials and are to be sterilized using similar methods.
The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.