(84 days)
No
The 510(k) summary describes a line extension of dental implants with a different length. There is no mention of AI, ML, image processing, or any data-driven algorithms. The performance studies are bench studies focused on mechanical and biological properties, not algorithmic performance.
Yes
The device is indicated for "functional and esthetic oral rehabilitation" and to "restore chewing function," which are therapeutic purposes.
No
The device is a dental implant intended for oral rehabilitation, not for diagnosing a condition. Its function is to restore chewing function by supporting prosthetic restorations.
No
The device description clearly states it is a line extension of previously cleared Bone Level Tapered Implants, which are physical implants made of Ti-13Zr. The performance studies also describe bench studies on physical implants.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device for oral endosteal implantation to restore chewing function and provide support for prosthetic restorations. This is a surgical and restorative procedure performed directly on the patient's body.
- Device Description: The description details the physical characteristics of dental implants (diameters, interfaces, material, surface finishes, lengths). These are physical devices implanted into bone.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a medical implant.
N/A
Intended Use / Indications for Use
Straumann® Bone Level Tapered Implants are indicated for oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients. Straumann Bone Level Tapered Implants can also be used for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants by the corresponding elements (abutments).
Product codes
DZE
Device Description
The subject devices represent a line extension of the previously cleared Bone Level Tapered Implants of the Straumann Dental Implant System (K140878 and K150938). The subject devices have the same diameters (3.3, 4.1 and 4.8 mm), the same implant-to-abutment interfaces (NC, RC), the same material (Ti-13Zr) and the same surface finishes (SLA, SLActive) as the identified primary predicate devices. The subject devices differ in that the lengths are 18 mm versus a maximum length for the primary predicate devices of 16 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper and lower jaw
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
Per Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments dated May 12, 2004, the substantial equivalence of the subject device(s) are satisfactorily addressed via bench studies. The following studies are incorporated into this submission by reference to the submission for the primary predicate (K140878): Dynamic fatigue test data consistent with FDA guidance and ISO 14801 Biological compatibility per the ISO 10993 series standards Sterilization validation per the ISO 11137 series standards Shelf life (stability) per ASTM F1980.
In order to confirm that the reduced minimum implant diameter between the subject device (Ø3.3 mm) and the Neodent CM Drive reference device (Ø3.5 mm) does not result in a new failure mode, the following additional bench study was performed on all three diameters of the subject device: Peak insertion torque was measured while driving the implants to a clinically appropriate position relative to the surface of simulated bone material (polyurethane foam) having densities of between 10 and 40 pounds per cubic foot that had been prepared per the instructions for use.
Key Metrics
Not Found
Predicate Device(s)
Straumann Bone Level Tapered Implants (K140878)
Reference Device(s)
Straumann Roxolid SLA Implants (K150938), Neodent CM Drive Line Extension (K150182)
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
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 23, 2016
Institut Straumann AG c/o Ms. Jennifer Jackson. M.S. Head of Regulatory Affairs and Quality Straumann USA. Inc. 60 Minuteman Road Andover, Massachusetts 01810
Re: K153758
Trade/Device Name: Straumann® Bone Level Tapered Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: December 29, 2015 Received: December 30, 2015
Dear Ms. 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. 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.
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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 (QS) 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 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 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 yours,
Tina Kiang -S
for Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K153758
Device Name
Straumann® Bone Level Tapered Implants
Indications for Use (Describe)
Straumann® Bone Level Tapered Implants are indicated for oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients. Straumann Bone Level Tapered Implants can also be used for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants by the corresponding elements (abutments).
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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| 5. | 510(k) Summary | K153758 |
|---|---|---|
| Submitter: | Straumann USA, LLC (on behalf of Institut Straumann AG) | |
| 60 Minuteman Road | ||
| Andover, MA 01810 | ||
| Registration No.: 1222315 Owner/Operator No.: 9005052 | ||
| Contact Person: | Jennifer Jackson, MS | |
| Head of Regulatory Affairs and Quality | ||
| (978) 747-2509 | ||
| Prepared By: | Christopher Klaczyk | |
| Head of North American Regulatory Affairs | ||
| +41 79 915 8367 | ||
| Date Prepared: | March 7, 2016 | |
| Product Code(s): | DZE (21 CFR 872.3640) | |
| Device Class: | II (21 CFR 872.3640) | |
| Classification Panel: | Dental | |
| Classification Name: | Endosseous dental implant (21 CFR 872.3640) | |
| Proprietary Name: | Straumann® Bone Level Tapered Implant | |
| Predicate Device:: | Straumann Bone Level Tapered Implants (K140878) | |
| Reference Device(s): | Straumann Roxolid SLA Implants (K150938) | |
| Neodent CM Drive Line Extension (K150182) | ||
| Device Description: | The subject devices represent a line extension of the previously | |
| cleared Bone Level Tapered Implants of the Straumann Dental | ||
| Implant System (K140878 and K150938). The subject devices | ||
| have the same diameters (3.3, 4.1 and 4.8 mm), the same | ||
| implant-to-abutment interfaces (NC, RC), the same material | ||
| (Ti-13Zr) and the same surface finishes (SLA, SLActive) as the | ||
| identified primary predicate devices. The subject devices differ | ||
| in that the lengths are 18 mm versus a maximum length for the | ||
| primary predicate devices of 16 mm. | ||
| Intended Use: | ||
| Bone Level Tapered | ||
| Implants | Straumann® Bone Level Tapered Implants are indicated for oral | |
| endosteal implantation in the upper and lower jaw and for the | ||
| functional and esthetic oral rehabilitation of edentulous and | ||
| partially dentate patients. Straumann Bone Level Tapered | ||
| Implants can also be used for immediate or early implantation | ||
| following extraction or loss of natural teeth. Implants can be | ||
| placed with immediate function on single-tooth and/or multiple | ||
| tooth applications when good primary stability is achieved and | ||
| with appropriate occlusal loading, to restore chewing function. | ||
| The prosthetic restorations used are single crowns, bridges and | ||
| partial or full dentures, which are connected to the implants by | ||
| the corresponding elements (abutments). | ||
| Materials: | Versions of the subject devices will be produced from a | |
| titanium-13zirconium alloy, trade named Roxolid®, as | ||
| previously reviewed and cleared to market per premarket | ||
| notification submission K140878. |
The transfer piece is produced from titanium-6aluminum-
7niobium alloy (TAN). This is the same material as for the
predicate transfer pieces cleared to market per premarket
notification submission K140878. | |
| Technological
Characteristics: | The subject devices are identical in every respect to the
identified Bone Level Tapered predicate devices with the
exception of overall length; the subject device is 18 mm in
length where the longest previously cleared Bone Level
Tapered devices previously cleared to market per K140878 and
K150938 is 16 mm in length.
The 18 mm length subject devices have the same length as the
Neodent CM Drive device cleared to market per K150182,
however the Neodent CM Drive devices have a minimum
diameter of Ø3.5 mm where the subject device has a minimum
diameter of Ø3.3 mm. | |
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5
| Feature | Primary Predicate Device
Bone Level Tapered Implants
(K140878) | Subject Devices
Bone Level Tapered Implants |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications For Use | Straumann® dental implants are indicated
for oral endosteal implantation in the
upper and lower jaw and for the
functional and esthetic oral rehabilitation
of edentulous and partially dentate
patients. Straumann dental implants can
also be used for immediate or early
implantation following extraction or loss
of natural teeth. Implants can be placed
with immediate function on single-tooth
and/or multiple tooth applications when
good primary stability is achieved and
with appropriate occlusal loading, to
restore chewing function. The prosthetic
restorations used are single crowns,
bridges and partial or full dentures, which
are connected to the implants by the
corresponding elements (abutments). | Straumann® Bone Level Tapered Implants
are indicated for oral endosteal
implantation in the upper and lower jaw
and for the functional and esthetic oral
rehabilitation of edentulous and partially
dentate patients. Straumann Bone Level
Tapered Implants can also be used for
immediate or early implantation
following extraction or loss of natural
teeth. Implants can be placed with
immediate function on single-tooth and/or
multiple tooth applications when good
primary stability is achieved and with
appropriate occlusal loading, to restore
chewing function. The prosthetic
restorations used are single crowns,
bridges and partial or full dentures, which
are connected to the implants by the
corresponding elements (abutments). |
| Implant-to-Abutment
Connection | Narrow CrossFit® (NC)
Regular CrossFit® (RC) | Narrow CrossFit® (NC)
Regular CrossFit® (RC) |
| Implant Diameter | Ø3.3mm, Ø4.1mm, Ø4.8mm | Ø3.3mm, Ø4.1mm, Ø4.8mm |
| Implant Length | 8, 10, 12, 14, 16 mm | 18 mm |
| Coronal Thread Form | Constant major and minor thread
diameters (i.e., parallel wall)
0.8mm thread pitch | Constant major and minor thread
diameters (i.e., parallel wall)
0.8mm thread pitch |
| Material | Titanium Grade 4
Titanium zirconium alloy Ti-13Zr | Titanium zirconium alloy Ti-13Zr |
| Surface Finish | SLA
SLActive | SLA
SLActive |
6
| Performance Data: | Per Guidance for Industry and FDA Staff - Class II Special
Controls Guidance Document: Root-form Endosseous Dental
Implants and Endosseous Dental Abutments dated May 12,
2004, the substantial equivalence of the subject device(s) are
satisfactorily addressed via bench studies. The following
studies are incorporated into this submission by reference to the
submission for the primary predicate (K140878):
Dynamic fatigue test data consistent with FDA guidance
and ISO 14801Biological compatibility per the ISO 10993 series standardsSterilization validation per the ISO 11137 series standardsShelf life (stability) per ASTM F1980 |
|-------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | In order to confirm that the reduced minimum implant diameter
between the subject device (Ø3.3 mm) and the Neodent CM
Drive reference device (Ø3.5 mm) does not result in a new
failure mode, the following additional bench study was
performed on all three diameters of the subject device:
Peak insertion torque was measured while driving the
implants to a clinically appropriate position relative to the
surface of simulated bone material (polyurethane foam)
having densities of between 10 and 40 pounds per cubic
foot that had been prepared per the instructions for use. |
| Conclusions: | Based upon our assessment of the design and applicable
performance data, the subject devices have been determined to
be substantially equivalent to the identified predicate devices. |