(135 days)
Not Found
No
The document describes a line extension of dental implants with modifications to the physical design and materials. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is a dental implant that restores chewing function and rehabilitates patients, which constitutes a therapeutic effect.
No
Explanation: The device description and intended use clearly state that this is a dental implant system used for oral rehabilitation, not for diagnosing medical conditions.
No
The device description clearly describes physical implants made of materials like CP Ti and Ti-13Zr, with specific dimensions and features, indicating it is a hardware device.
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 and functional/esthetic oral rehabilitation. This involves surgical placement within the body.
- Device Description: The description details physical characteristics of dental implants (diameters, lengths, materials, surface finishes, thread forms, cutting flutes). These are components designed to be surgically implanted.
- Lack of IVD Indicators: 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) for structural support and rehabilitation.
N/A
Intended Use / 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). In cases of fully edentulous patients, 4 or more implants must be used in immediately loaded cases.
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
The subject devices represent a line extension of the previously cleared Bone Level implants of the Straumann Dental Implant System (K062129, K083550 and K121131). 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 lengths (8 to 14 mm), the same materials (CP Ti and Ti-13Zr) and the same surface finishes (SLA, SLActive) as the identified predicate devices. The subject devices differ in that the apical aspect of the implants incorporate a tapering thread form, the apical aspect of the implants incorporate three cutting flutes, an additional length of 16mm and the transfer piece is of a new design.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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. Dynamic fatigue test data consistent with FDA guidance and ISO 14801 have been referenced in support of this submission. This data shows that the subjects devices provide performance that is substantially equivalent to the identified predicate devices.
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.
K062129, K083550, K121131, K123784, K130222, K983742, K071357, K081005, K050406, K071370
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.
Not Found
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with three human profiles incorporated into its design. The profiles are facing to the right and are stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 20, 2014
Straumann USA, LLC Mr. Christopher Klaczyk Director of Regulatory Affairs and Clinical Research 60 Minuteman Road Andover, MA 01810
Re: K140878
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: July 22, 2014 Received: July 23, 2014
Dear Mr. Klaczyk:
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
Page 2 - Mr. Klaczyk
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 device-related 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,
Mary S. Runner -S
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
2
4. Indications For Use
510(k) Number (if known): K140878
Straumann® Bone Level Tapered Implant Device Name: Roxolid SLActive
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).
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
3
510(k) Number (if known): K140878 Straumann® Bone Level Tapered Implant Device Name: Titanium SLA
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). In cases of fully edentulous patients, 4 or more implants must be used in immediately loaded cases.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
4
5. 510(k) Summary
| 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: | Christopher Klaczyk
Director of Regulatory Affairs and Clinical Research |
| Date Prepared: | April 22, 2014 |
| 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 Implants |
| Predicate Device(s): | ● Straumann P.004 Implants – Ti Bone Level implants (K062129)
● Straumann Dental Implant System – 3.3mm NC TiZr Bone Level implants (K083550)
● Straumann Dental Implant System – 4.1& 4.8mm TiZr Bone Level implants (K121131)
● Straumann Dental Implant System (K123784)
● Straumann Dental Implant System (K130222)
● Straumann Tissue Level Titanium Implants (K983742)
● Straumann NC Anatomic Abutment (K071357)
● Straumann NC Cares Abutments (K081005)
● Nobel Biocare, NobelSpeedy (K050406)
● Nobel Biocare, NobelActive (K071370) |
| Device Description: | The subject devices represent a line extension of the previously
cleared Bone Level implants of the Straumann Dental Implant
System (K062129, K083550 and K121131). 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 lengths
(8 to 14 mm), the same materials (CP Ti and Ti-13Zr) and the
same surface finishes (SLA, SLActive) as the identified
predicate devices. The subject devices differ in that the apical
aspect of the implants incorporate a tapering thread form, the |
5
apical aspect of the implants incorporate three cutting flutes, an additional length of 16mm and the transfer piece is of a new design.
| Intended Use:
Roxolid SLActive | 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). |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use:
Titanium SLA | 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). In cases of fully
edentulous patients, 4 or more implants must be used in
immediately loaded cases. |
| Materials: | Versions of the subject devices will be produced from either
grade 4 commercially pure titanium conforming with ISO 5832-
2 or a titanium-13zirconium alloy, trade named Roxolid®, as
previously reviewed and cleared to market per premarket
notification submissions K083550 and K121131 for the
predicate devices, as well as K081419, K111357 and K122855. |
| | The transfer piece is produced from titanium-6aluminum-
7niobium alloy (TAN) conforming with ISO 5832-11. This is
the same material as for the predicate transfer pieces cleared to
market per premarket notification submissions K062129,
K083550 and K121131. |
6
| Technological | The subject devices have the same Indications For Use, |
|---|---|
| Characteristics: | diameters (3.3, 4.1 and 4.8 mm), lengths (8 to 14 mm), implant- |
| to-abutment connections (NC, RC), materials (CP Ti and Ti- | |
| 13Zr), surface finishes (SLA, SLActive), coronal thread form, | |
| packaging, sterilization process and dynamic fatigue | |
| performance as the identified Bone Level predicate devices (see | |
| comparison below). |
The subject devices have an equivalent apical tapered thread form with cutting flutes as the identified Nobel predicates.
| Feature | Predicate Devices
Bone Level Implants
(K062129, K083550, K121131) | Subject Devices
Bone Level Tapered Implants |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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, 14mm | 8, 10, 12, 14, 16mm |
| 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 |
| Apical Thread Form | Constant major and minor thread diameters
(i.e., parallel wall)
0.8mm thread pitch | Angled major and minor thread diameters
(i.e., tapered wall), with the major and
minor diameters have differing angles such
that the depth increases toward the apical
end of the implant and the addition of
cutting flutes.
0.8mm thread pitch |
| Surface Finish | SLA, SLActive | SLA, SLActive |
| Transfer Piece | Thread mount transfer piece
Intended to support the implant while in the
primary package, to aid in the removal of
the implant from the primary package, and
to aid in placement of the implant into the
osteotomy site. | Snap fit mount Loxim™ transfer piece
Intended to support the implant while in the
primary package, to aid in the removal of
the implant from the primary package, and
to aid in placement of the implant into the
osteotomy site. |
| Material | Commercially pure grade 4 titanium &
Titaniun-13Zirconium alloy (Roxolid®) | Commercially pure grade 4 titanium &
Titaniun-13Zirconium alloy (Roxolid®) |
| Primary Package
SLActive | Vial of styrene-butadiene block copolymer
(Styrolux), vial cap of LDPE and an
implant holder of Grilamid TR70
polyamide.
As delivered, the package is filled with
aqueous NaCl solution. | Vial of styrene-butadiene block copolymer
(Styrolux), vial cap of LDPE and an
implant holder of Grilamid TR70
polyamide.
As delivered, the package is filled with
aqueous NaCl solution. |
| Sterilization | Gamma Irradiation, 25 kGy minimum
Validated per ISO 11137-1 and ISO 11137-
2 to an SAL of 1 x 10-6 | Gamma Irradiation, 25 kGy minimum
Validated per ISO 11137-1 and ISO 11137-
2 to an SAL of 1 x 10-6 |
7
| 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. Dynamic fatigue test
data consistent with FDA guidance and ISO 14801 have been
referenced in support of this submission. This data shows that
the subjects devices provide performance that is substantially
equivalent to the identified predicate devices. |
|-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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.
- Straumann USA, LLC