(244 days)
No
The summary describes a physical dental implant system and its components, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is indicated for oral rehabilitation and to restore chewing function, which are therapeutic purposes as they improve a health condition (edentulism) and restore a lost physiological function.
No
The provided text explicitly states that the devices are "Straumann® dental implants" which are "indicated for the functional and esthetic oral rehabilitation" and "can be used following the extraction or loss of natural teeth to restore chewing function." This describes a therapeutic and restorative function, not a diagnostic one.
No
The device description clearly states that the subject devices are "endosseous dental implants" which are physical, hardware components. The summary also details physical characteristics like diameter, length, and surface treatments.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "functional and esthetic oral rehabilitation" and to "restore chewing function." This describes a therapeutic and restorative purpose within the body.
- Device Description: The description details a physical implant designed to be surgically placed in the jawbone. It discusses materials, dimensions, and connections for prosthetic parts.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
IVD devices are used to perform tests on samples like blood, urine, or tissue to diagnose diseases or conditions. This device is a physical implant used for treatment and restoration.
N/A
Intended Use / Indications for Use
Straumann® dental implants are indicated for the functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients. They can be used for immediate, early or late implantation following the extraction or loss of natural teeth. The implants can be placed with immediate function for single-tooth restorations when good primary stability is achieved and with appropriate occlusal loading to restore chewing function.
Product codes
DZE
Device Description
The subject devices are part of the Straumann® Dental Implant System, which is an integrated system of endosseous dental implants with corresponding abutments and healing components as well as instruments and prosthetic parts. Straumann® dental implants are solid screw implants with a bone anchorage surface that is large-grit sandblasted and acid-etched. In addition, SLActive® is in a chemically activated state, which is preserved by storage in a saline solution (NaCI). Straumann® dental implants can be used following the extraction or loss of natural teeth to restore chewing function. The prosthetic restorations supported are single crowns, bridges and partial or full dentures, which are connected to the implants using the corresponding abutments.
The BLC and TLC implants features the TorcFit connection and are available in the maximum endosteal outer diameters ø 3.3 mm, ø 3.75 mm, ø 5.5 mm and Ø 6.5 mm.
The BLC implants are available with the following length options:
- L 8 mm to L 18 mm for the maximum endosteal outer diameter Ø 3.3 mm.
- L 6 mm to L 18 mm for diameters Ø 3.75 mm and Ø 4.5 mm
- L 6 mm to L 16 mm for diameter Ø 5.5 mm
- L 6 mm to 14 mm for diameter Ø 6.5 mm.
The subject BLC implants are presented with RB (Reqular Base) and WB (Wide Base) prosthetic platform.
The TLC implants are available with the following length options:
- L 8 mm to L 18 mm for the maximum endosteal outer diameter Ø 3.3 mm,
- L 6 mm to L 18 mm for diameters ø 3.75 mm and ø 4.5 mm
- L 6 mm to L 12 mm for diameter Ø 5.5 mm
- L 6 mm to 10 mm for diameter Ø 6.5 mm.
The subject TLC implants are presented with the NT (Narrow TorcFit) RT (Regular TorcFit) WT (Wide TorcFit) prosthetic platform. The implant neck is available either as Standard (2.8 mm height) or Standard Plus (1.8 mm height) option.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper or 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)
Sterilization Validation and Shelf-life: The subject devices are sterilized via gamma irradiation at 25 kGy to a sterility assurance level (SAL) of 10^-6, validated according to ISO 11137-1:2006 and ISO 11137-2:2013 using the VDmax25 method. No changes to sterilization procedures from predicate devices (K150938), and subject devices do not pose a higher challenge. Shelf life is 5 years. Pyrogenicity testing meets limits via LAL Endotoxin Analysis (20 EU/device).
Biocompatibility Testing: Performed according to ISO 10993-1 and FDA Guidance for contact with the body. Subject devices are equivalent to reference device K210855 in material, surface, manufacturing, sterilization, body contact, and duration, raising no new biocompatibility issues.
Electromagnetic Compatibility: No significant changes in materials or dimensions from marketed predicate devices. The subject implants have obtained the status of MR Conditional per K180540, with tests conducted according to FDA's "Testing and Labeling Medical Devices for Safety in Magnetic Resonance (MR) Environment" Guidance.
Performance Testing – Bench:
- Dynamic fatigue testing: Conducted per FDA guidance and ISO 14801 in saline (2 Hz, 37°C) for 2 million cycles, demonstrating equivalence to predicate/reference devices for permanent restoration without failure.
- Insertion tests: Performed to prove adequate insertion torque in different bone classes when inserted according to the surgical procedure.
- Bone-to-implant contact (BIC) and pull-out force:
- BIC evaluation: Nominal endosseous surface area of subject devices was calculated and compared to reference devices. Conclusion: acceptance criterion met; subject devices have larger endosseous surface area and thus more bone-to-implant contact.
- Pull-out force: Implants inserted in bone substitute material and resistance measured during pull-out. Conclusion: acceptance criterion met; subject devices have higher pull-out force compared to reference device.
- Scanning electron microscopy and light microscopy: Analyzed apical end of implant body after removal from packaging. All inspected implants showed a uniform breaking surface with no residual metal fragments at the broken tip area.
- Surface treatments: Identical to primary predicate and reference devices cleared under K150938, K173961, K210855, K200586, and K153758 (SLA® and SLActive®). Routinely tested by roughness measurement or scanning electron microscopy.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K173961, K210855, K212533, K200586, K153758
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 logos of the U.S. Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
9/14/23
Institut Straumann AG % Jennifer Jackson Sr. Director, Regulatory Affairs and Ouality StraumannUSA, LLC 60 Minuteman Road Andover, Massachusetts 01810
Re: K230108
Trade/Device Name: Straumann® BLC and TLC Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: August 10, 2023 Received: August 11, 2023
Dear Jennifer Jackson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Sherrill Lathrop Blitzer
for Andrew Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality 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: 06/30/2023 See PRA Statement below.
510(k) Number:
Device Name
Straumann® BLC and TLC Implants
Indications for Use (Describe)
Straumann® dental implants are indicated for the functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients. They can be used for immediate, early or late implantation following the extraction or loss of natural teeth. The implants can be placed with immediate function for single-tooth restorations when good primary stability is achieved and with appropriate occlusal loading to restore chewing function.
Type of Use (Select one or both, as applicable) 図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."
3
Straumann® BLC and TLC Implants
510(k) Summary
510(k) Summary – K230108 5
5.1 Submitter's Contact Information
| Submitter: | Straumann USA, LLC (on behalf of Institut Straumann AG)
60 Minuteman Road
Andover, MA 01810
Registration No.: 1222315 Owner/Operator No.: 9005052
On the behalf of:
Institut Straumann AG
Peter Merian-Weg 12
4052 Basel, Switzerland |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jennifer M. Jackson, MS, RAC
Sr. Director, Regulatory Affairs and Quality
Phone Number: +1-978-747-2509
Fax Number: +1-978-747-0023 |
| Prepared By &
Alternate Contact: | Corinne Arimatea
Regulatory Affairs and Compliance Manager
Institut Straumann AG
Phone number: +41 61 965 1217 |
| Date of Submission: | September 14, 2023 |
5.2 Name of the Device
| Trade Names: | Straumann® BLC and TLC Implants |
|---|---|
| Common Name: | Endosseous Dental Implant |
| Classification Name: | Endosseous Dental Implant |
| Regulation Number: | §872.3640 |
| Device Classification: | II |
| Product Code(s): | DZE |
| Classification Panel: | Dental |
4
Straumann® BLC and TLC Implants
510(k) Summary
Predicate Device(s) 5.3
Primary Predicate:
-
K150938 Straumann® Dental Implant System Roxolid® SLA Implants .
Reference Devices: -
K173961 Straumann BLX Implant System .
-
K210855 Straumann BLX Implant System .
-
K212533 BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants .
-
K200586 Straumann TLX Implant System .
-
K153758 Straumann Bone Level Tapered Implants .
Device Description 5.4
The subject devices are part of the Straumann® Dental Implant System, which is an integrated system of endosseous dental implants with corresponding abutments and healing components as well as instruments and prosthetic parts. Straumann® dental implants are solid screw implants with a bone anchorage surface that is large-grit sandblasted and acid-etched. In addition, SLActive® is in a chemically activated state, which is preserved by storage in a saline solution (NaCI). Straumann® dental implants can be used following the extraction or loss of natural teeth to restore chewing function. The prosthetic restorations supported are single crowns, bridges and partial or full dentures, which are connected to the implants using the corresponding abutments.
The BLC and TLC implants features the TorcFit connection and are available in the maximum endosteal outer diameters ø 3.3 mm, ø 3.75 mm, ø 5.5 mm and Ø 6.5 mm.
The BLC implants are available with the following length options:
- L 8 mm to L 18 mm for the maximum endosteal outer diameter Ø 3.3 mm.
- L 6 mm to L 18 mm for diameters Ø 3.75 mm and Ø 4.5 mm
- L 6 mm to L 16 mm for diameter Ø 5.5 mm
- L 6 mm to 14 mm for diameter Ø 6.5 mm.
The subject BLC implants are presented with RB (Reqular Base) and WB (Wide Base) prosthetic platform.
A summary of the diameter/length implant body combinations is given in Table 1.
5
Straumann® BLC and TLC Implants
| Implant Diameter | ø 3.3mm | ø 3.75mm | ø 4.5mm | ø 5.5mm | ø 6.5mm |
|---|---|---|---|---|---|
| Implant Length | - | 6 mm | 6 mm | 6 mm | 6 mm |
| 8 mm | 8 mm | 8 mm | 8 mm | ||
| 10 mm | 10 mm | 10 mm | 10 mm | ||
| 12 mm | 12 mm | 12 mm | 12 mm | ||
| 14 mm | 14 mm | 14 mm | 14 mm | ||
| 16 mm | 16 mm | 16 mm | 16 mm | ||
| 18 mm | 18 mm | 18 mm | - | ||
| Prosthetic platforms | RB | RB | WB | WB | WB |
510(k) Summary
Table 1 – Overview of diameter/length implant body combinations for BLC implants
The TLC implants are available with the following length options:
- L 8 mm to L 18 mm for the maximum endosteal outer diameter Ø 3.3 mm,
- L 6 mm to L 18 mm for diameters ø 3.75 mm and ø 4.5 mm
- L 6 mm to L 12 mm for diameter Ø 5.5 mm
- L 6 mm to 10 mm for diameter Ø 6.5 mm.
The subject TLC implants are presented with the NT (Narrow TorcFit) RT (Regular TorcFit) WT (Wide TorcFit) prosthetic platform. The implant neck is available either as Standard (2.8 mm height) or Standard Plus (1.8 mm height) option.
A summary of the diameter/length implant body combinations is given in Table 2.
| Implant Diameter | ø 3.3mm | ø 3.75mm | ø 4.5mm | ø 5.5mm | ø 6.5mm |
|---|---|---|---|---|---|
| Implant Length | - | 6 mm | 6 mm | 6 mm | 6 mm |
| 8 mm | 8 mm | 8 mm | 8 mm | 8 mm | |
| 10 mm | 10 mm | 10 mm | 10 mm | 10 mm | |
| 12 mm | 12 mm | 12 mm | 12 mm | - | |
| 14 mm | 14 mm | 14 mm | - | - | |
| 16 mm | 16 mm | 16 mm | - | - | |
| 18 mm | 18 mm | 18 mm | - | - | |
| Prosthetic platforms | NT / RT | NT / RT | RT / WT | WT | WT |
Table 2 – Overview of diameter/length implant body combinations for TLC implants
6
Straumann® BLC and TLC Implants
510(k) Summary
Intended Use 5.5
Straumann® dental implants and abutments are intended for oral implantation to provide a support structure for connected prosthetic devices.
5.6 Indications for Use
Straumann® dental implants are indicated for the functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients. They can be used for immediate, early or late implantation following the extraction or loss of natural teeth. The implants can be placed with immediate function for single-tooth and/or multiple-tooth restorations when good primary stability is achieved and with appropriate occlusal loading to restore chewing function.
Technological Characteristics 5.7 -
The technological characteristics of the subject devices are compared to the primary predicate and reference devices in the following tables:
7
Straumann® BLC and TLC Implants
510(k) Summary
| FEATURE | PROPOSED
DEVICE | PRIMARY
PREDICATE
DEVICE | REFERENCE
DEVICE | REFERENCE
DEVICE | REFERENCE
DEVICE | REFERENCE
DEVICE | | PROPOSED
DEVICE | PRIMARY
PREDICATE DEVICE | REFERENCE
DEVICE | REFERENCE DEVICE |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K Number | K230108 | K150938 | K173961 | K210855 | K212533 | K153758 | K Number | K230108 | K150938 | K200586 | K153758 |
| Indications
for Use | Straumann®
dental implants
are indicated
for the
functional and
esthetic oral
rehabilitation of
the upper or
lower jaw of
edentulous or
partially
edentulous
patients. They
can be used for
immediate,
early or late
implantation
following the
extraction or
loss of natural
teeth. The
implants can be
placed with
immediate
function for
single-tooth
and/or multiple-
tooth
restorations
when good
primary stability
is achieved and
with appropriate
occlusal loading
to restore
chewing
function. | 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®
BLX Implants
are suitable for
endosteal
implantation in
the upper and
lower jaw and
for the
functional and
esthetic oral
rehabilitation of
edentulous and
partially
edentulous
patients. BLX
Implants can
be placed with
immediate
function on
single-tooth
applications
when good
primary stability
is achieved and
with
appropriate
occlusal
loading to
restore
chewing
function. The
prosthetic
restorations are
connected to
the implants
through the
corresponding
abutment
components. | Straumann BLX
Implants are
suitable for
endosteal
implantation in
the upper and
lower jaw and
for the
functional and
esthetic oral
rehabilitation of
edentulous and
partially
edentulous
patients. BLX
implants can
be placed with
immediate
function on
single-tooth and
multi-unit
restorations
when good
primary stability
is achieved and
with appropriate
occlusal
loading, to
restore chewing
function. The
prosthetic
restorations
used are
connected to
the implants
through the
corresponding
abutment
components. | Straumann®
dental implants
are indicated
for the
functional and
esthetic oral
rehabilitation of
the upper or
lower jaw of
edentulous or
partially
edentulous
patients. They
can be used for
immediate,
early or late
implantation
following the
extraction or
loss of natural
teeth. The
implants can be
placed with
immediate
function for
single-tooth
and/or multiple-
tooth
restorations
when good
primary stability
is achieved and
with appropriate
occlusal loading
to restore
chewing
function. | 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
primary
predicate 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). | Indications
for Use | Straumann® dental
implants are indicated
for the functional and
esthetic oral
rehabilitation of the
upper or lower jaw of
edentulous or partially
edentulous patients.
They can be used for
immediate, early or late
implantation following
the extraction or loss of
natural teeth. The
implants can be placed
with immediate function
for single-tooth and/or
multiple-tooth
restorations when good
primary stability is
achieved and with
appropriate occlusal
loading to restore
chewing function. | 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 TLX Implants
are suitable for endosteal
implantation in the upper
and lower jaws and for
the functional and
esthetic oral rehabilitation
of edentulous and
partially edentulous
patients. TLX Implants
can be placed with
immediate function on
single-tooth and multi-
unit restorations when
good primary stability is
achieved and with
appropriate occlusal
loading to restore
chewing function. The
prosthetic restorations
are connected to the
implants through the
corresponding abutment
components. | 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 primary predicate
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). |
| FEATURE | PROPOSED
DEVICE | PRIMARY
PREDICATE
DEVICE | REFERENCE
DEVICE | REFERENCE
DEVICE | REFERENCE
DEVICE | REFERENCE
DEVICE | Material | Titanium-13 Zirconium
alloy (Roxolid®) | Titanium-13 Zirconium
alloy
(Roxolid®) | Titanium-13 Zirconium
alloy (Roxolid®) | Titanium-13 Zirconium
alloy (Roxolid®) |
| K Number | K230108 | K150938 | K173961 | K210855 | K212533 | K153758 | Surface
Treatment | Hydrophilic SLActive®
and SLA® | Hydrophilic SLA® | Hydrophilic SLActive® | Hydrophilic SLActive® |
| Material | Titanium-13
Zirconium alloy
(Roxolid®) | Titanium-13
Zirconium alloy
(Roxolid®) | Titanium-13
Zirconium alloy
(Roxolid®) | Titanium-13
Zirconium alloy
(Roxolid®) | Titanium-13
Zirconium alloy
(Roxolid®) | Titanium-13
Zirconium alloy
(Roxolid®) | Implant to
Abutment
Connection | TorcFit
(with conical fitting) | Narrow CrossFit (NC)
Regular CrossFit (RC)
Narrow Neck CrossFit
(NNC)
Regular Neck (RN)
Wide Neck (WN) | TorcFit
(with conical fitting) | Narrow CrossFit® (NC)
Regular CrossFit® (RC) |
| Surface
Treatment | Hydrophilic
SLActive® and
SLA® | Hydrophilic
SLA® | Hydrophilic
SLActive® | Hydrophilic
SLActive® and
SLA® | Hydrophilic
SLActive® and
SLA® | Hydrophilic
SLActive® | Implant
Diameter | $Ø 3.3, 3.75, 4.5, 5.5, 6.5 mm$ | $Ø 3.3, 4.1, 4.8 mm$ | $Ø 3.75, 4.5, 5.5, 6.5 mm$ | $Ø 3.3, 4.1, 4.8 mm$ |
| Implant to
Abutment
Connection | TorcFit
(with conical
fitting) | Narrow
CrossFit (NC)
Regular
CrossFit (RC)
Narrow Neck
CrossFit (NNC)
Regular Neck
(RN)
Wide Neck
(WN) | TorcFit
(with conical
fitting) | TorcFit
(with conical
fitting) | TorcFit
(with conical
fitting) | Narrow
CrossFit® (NC)
Regular
CrossFit® (RC) | Implant
Length | $Ø 3.3: 8, 10, 12, 14, 16,18 mm$
$Ø 3.75 and 4.5:6, 8, 10, 12, 14, 16,18 mm$
$Ø 5.5: 6, 8, 10, 12 mm$
$Ø 6.5: 6, 8, 10 mm$ | $6, 8, 10, 12, 14, 16 mm$ | $Ø 3.75, 4.0, 4.5, 5.0 mm:6, 8, 10, 12, 14, 16,18 mm$
$Ø 5.5 and 6.5 mm:6, 8, 10, 12 mm$ | $18 mm$ |
| Implant
Diameter | Ø 3.3, 3.75, 4.5,
5.5, 6.5 mm | Ø 3.3, 4.1, 4.8
mm | Ø 4.5, 5.5,
6.5 mm | Ø 3.75 and 4.0
mm | Ø 5.0, 5.5, 6.5
mm | Ø 3.3, 4.1, 4.8
mm | Implant
Design | Apically tapered Tissue
Level implant | Parallel wall and
Apically tapered Bone
Level implant | Fully tapered Tissue
Level implant | Apically tapered Bone
Level implant |
| Implant
Length | Ø 3.3: 8, 10, 12,
14, 16, 18 mm
Ø 3.75 and 4.5:
6, 8, 10, 12, 14,
16, 18 mm
Ø 5.5: 6, 8, 10,
12, 14, 16 mm
Ø 6.5: 6, 8, 10,
12, 14 mm | 8, 10, 12, 14
and 16 mm | Ø 4.5: 6 to 18
mm
Ø 5.5 and 6.5:
6 to 12 mm | 6 mm | Ø 5.0: 18 mm
Ø 5.5 and 6.5:
14 and 16 mm | 18 mm | | | | | |
| Implant
Design | Apically tapered
Bone Level
implant | Parallel wall
and
Apically tapered
Bone Level
implant (BLT) | Fully tapered
Bone Level
implant | Fully tapered
Bone Level
implant | Fully tapered
Bone Level
implant | Apically tapered
Bone Level
implant (BLT) | | | | | |
| Thread
Pitch | 0.8, 0.9, 1 and
1.15 mm | 0.8 and 1.25
mm | 2.0 to 2.8 mm | 1.7 to 1.8 mm | 2.5 to 3.1 mm | 0.8 mm | | | | | |
| Sterilization
Method | Irradiation | Irradiation | Irradiation | Irradiation | Irradiation | Irradiation | | | | | |
8
Straumann® BLC and TLC Implants
510(k) Summary
Table 3 – Comparison of subject device versus primary predicate and reference device –
BLC implant
9
Straumann® BLC and TLC Implants
510(k) Summary
10
Straumann® BLC and TLC Implants
| | PROPOSED
DEVICE | PRIMARY
PREDICATE DEVICE | REFERENCE
DEVICE | REFERENCE DEVICE |
|-------------------------|-------------------------|---------------------------------|---------------------------------------------|------------------|
| K Number | K230108 | K150938 | K200586 | K153758 |
| Implant
neck | Tulip shape | Tulip shape
n/a (bone level) | Tulip shape | n/a (bone level) |
| Prosthetic
platform | NT, RT and WT | NC, RC, NNC, RN, and
WN | NT, RT and WT | NC and RC |
| Thread
Pitch | 0.8, 0.9, 1 and 1.15 mm | 0.8 and 1.25 mm | 1.7, 2.0, 2.1, 2.2, 2.5,
2.6, and 2.8 mm | 0.8 mm |
| Sterilization
Method | Irradiation | Irradiation | Irradiation | Irradiation |
510(k) Summary
Table 4 - Comparison of subject device versus primary predicate and reference device - TLC implant
The Indications for Use of the primary predicate and subject devices are identical. Both devices are indicated for the functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients, with identical use. The Indications for Use of the primary predicate device includes details of prosthetic restoration, whereas for the subject devices, those details are provided in the Product Description section.
The subject devices have identical or equivalent technological characteristics compared to the primary predicate and reference devices. The material, surface treatment, sterilization method, and implant characteristics (length, diameter & connection) are identical to the primary predicate and reference devices. The device performance demonstrates substantial equivalence between subject devices and primary predicate/reference devices.
11
Traditional 510(k) Submission Straumann® BLC and TLC Implants
Appendix 5-9
5.8 Performance Testing
Sterilization Validation and Shelf-life
The subject devices are provided sterile via gamma irradiation at a dose of 25 kGy and will be sterilized after final packaging. The sterilization process for the subject devices as recommended in the labeling was validated to a sterility assurance level (SAL) of 10° in accordance with ISO 11137-1:2006, "Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices, 2006-04-05". The validation method used was the over kill bioburden (or VDmax25) method in accordance with ISO 11137- 2:2013, "Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose". There are no changes to the sterilization procedures or processes from those of the Straumann primary predicate devices (K150938), the subject devices do not represent a higher challenge to the sterilization process in comparison to the validated worst-case product and validated irradiation sterilization process.
The packaging of the subject device is equivalent to the packaging of the primary predicate and reference device. The shelf life for devices provided sterile is 5 years.
The devices will not be marketed as non-pyrogenic. Pyrogenicity information provided is based on FDA Guidance on "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submission for Devices Labeled as Sterile, issued on 21 January 2016." The method used to determine the device meets pyrogen limit specifications is LAL Endotoxin Analysis with testing limit of 20 EU/device, based on a blood contacting and implanted device.
Biocompatibility Testing
Biological assessment has been performed according to ISO 10993-1 "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" and to the FDA Guidance document "Use of International Standard ISO 10993- 1, 'Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process', Guidance for Industry and Food and Drug Administration Staff, Document issued on: June 16, 2016" for each of the subject devices.
The subject devices are equivalent in material, surface, manufacturing processes, sterilization process, body contact and contact duration to the reference device K210855 therefore, no new issues regarding biocompatibility were raised.
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Straumann® BLC and TLC Implants
Appendix 5-10
Electromagnetic Compatibility
There are no significant changes to the materials and dimensions from the currently marketed predicate devices. Therefore, no new issues of electromagnetic compatibility are raised for the subject devices and they can be considered MR Conditional.
The subject implants have obtained the status of MR Conditional per K180540. The MR Conditional tests were conducted according to FDA's Guidance "Testing and Labeling Medical Devices for Safety in Magnetic Resonance (MR) Environment".
Performance Testing – Bench
Dynamic fatigue testing was conducted according to the FDA guidance document "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" and ISO 14801 "Dentistry — Implants — Dynamic loading test for endosseous dental implants" and demonstrated the subject devices are equivalent to the primary predicate and reference devices. The test was conducted in saline (2 Hz and 37°C) at 2 million cycles covering permanent restoration of the implant without failure.
Insertion tests were performed for the subject implants and it could be proven that there is an adequate insertion torque in different bone classes when the implant is inserted according to the surgical procedure.
A comparison of the bone-to-implant contact (BIC) and pull-out force between the subject implants and previously cleared devices (K150938) was performed.
-
As part of the BIC evaluation, the nominal endosseous surface area of the subject devices was calculated and then compared to the contact surface area of the reference devices. The analysis concludes that the acceptance criterion is met; the subject devices have a larger endosseous surface area, and therefore, more area of bone-to-implant contact compared to the corresponding reference device.
-
To determine the pull-out force, the implants were inserted in bone substitute material and then pulled-out while the resistance was measured. The analysis concludes that the acceptance criterion is met; the subject devices have a higher pull-out force compared to the corresponding reference device.
13
Straumann® BLC and TLC Implants
Appendix 5-11
The subject devices were analyzed using scanning electron microscopy and light microscopy to investigate the apical end of the implant body after removal from the packaging. All the inspected implants showed a uniform breaking surface, with no residual metal fragments at the broken tip area.
The subject device surface treatments are identical to the surface treatments of the primary predicate and reference devices cleared under K150938. K173961. K210855. K200586 and K153758. The SLA® surface treatment is a sand-blasted, large grit, acid etched surface. The SLActive® surface treatment is a sand-blasted, large grit, acid etched, chemically active and hydrophilic surface. The surface is routinely tested by roughness measurement or scanning electron microscopy.
Conclusion
The documentation submitted in this premarket notification demonstrates the subject devices are substantially equivalent to the primary predicate and reference devices.