(286 days)
No
The device description and performance studies focus on mechanical properties, biocompatibility, and sterilization, with no mention of AI/ML or related concepts like image processing, training data, or performance metrics typically associated with AI/ML devices.
No
Explanation: The device is an abutment for attaching dentures to dental implants. It does not provide direct therapeutic action but rather supports a prosthetic device.
No
The device description indicates it is an abutment for dental implants used to support dentures, and the intended use specifies attachment of dentures. It does not perform any diagnostic function.
No
The device description clearly states it is a physical abutment made of TAV (Ti-6AI-4V) and TiN coated, intended to be placed onto dental implants. It is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the mechanical attachment of dentures to dental implants and bar constructs. This is a structural and mechanical function within the body.
- Device Description: The device is a physical abutment made of titanium, designed to be placed onto dental implants. It facilitates the connection of a denture.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies focus on sterilization, biocompatibility, and mechanical strength (fatigue and static strength), which are relevant to a surgically implanted or attached medical device, not an IVD.
IVDs are used in vitro (outside the body) to examine specimens and provide diagnostic information. This device is used in vivo (within the body) as a component of a dental restoration system.
N/A
Intended Use / Indications for Use
The Straumann® Retentive System is indicated for the attachment of full or partial dentures on Straumann dental implants and bar constructs.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The subject Novaloc TiN Abutments are intended to be placed onto Straumann dental implants to provide support for full or partial arch detachable restorations (over-denture). The coronal portion of the subject abutments are similar to the primary predicate devices, whereas the apical portion of the abutments has the appropriate implant-to-abutment interface geometry for each of the platforms of the Straumann Dental Implant System. The Novaloc abutments are manufactured from TAV (Ti-6AI-4V, Titanium-Aluminum-Vanadium). The restoration is connected to the Novaloc abutment through a snap-on fixture provided by a negative shape of Novaloc snap-on fixture embedded into the final restoration. The snap-on feature is TiN coated. The subject Novaloc TiN Abutments are provided in straight and anqulated models, in different heights. The subject Novaloc TiN Abutment is also provided in a bar attachment. The Novaloc TiN abutments are provided non-sterile with instructions for end user sterilization.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
dental implants
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)
Performance Testing included Sterilization Validation, Biocompatibility Testing, and Bench Testing.
- Sterilization Validation: The subject Novaloc TiN Abutments are provided non-sterile and need to be sterilized by moist heat (steam) by the end-user. The recommended sterilization method has been validated according to ISO 17665-1 and ISO 17665-2 applicable recommendations in the FDA quidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued on March 17, 2015".
- Biocompatibility Testing: Biological assessment has been performed according to ISO 10993-1:2009 "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.
- Bench Testing: Dynamic fatigue and static strength tests conducted according to the FDA guidance document "Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Rootform Endosseous Dental Implants and Endosseous Dental Abutments" and ISO 14801, Dentistry - Implants - Dynamic fatigue test for endosseous dental implants, demonstrated that the Straumann Novaloc TiN Abutments are equivalent to the predicate and reference devices.
No device specific clinical data has been submitted to demonstrate substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K033699, K151157, K171649, K190662
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
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the 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 includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
August 13, 2020
Institut Straumann AG % Jennifer Jackson Director, Regulatory Affairs Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01801
Re: K193046
Trade/Device Name: Straumann® Retentive System - Novaloc TiN Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: July 16, 2020 Received: July 17, 2020
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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to 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.
for Srinivas Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name:
Straumann® Retentive System - Novaloc TiN Abutments
Indications for Use (Describe)
The Straumann® Retentive System is indicated for the attachment of full or partial dentures on Straumann dental implants and bar constructs.
Type of Use (Select one or both, as applicable) 区Prescription Use (Part 21 CFR 801 Subpart D)
□Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED
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FORM FDA 3881 (7/17)
3
K193046 – Traditional 510(k)
Straumann Retentive System – Novaloc TiN Abutments
510(k) Summary
510(k) Summary 5
5.1 Submitter's Contact Information
| Submitter: | Straumann USA, LLC
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
Director of Regulatory Affairs and Quality
Phone Number: +1-978-747-2509
Fax Number: +1-978-747-0023 |
| Prepared By &
Alternate Contact: | Ana Carolina Martins Vianna
Regulatory Affairs and Compliance Manager
Institut Straumann AG
Phone Number: +41 61 965 1259 |
| Date of Submission: | August 11, 2020 |
5.2 Name of the Device
| Trade Names: | Straumann® Retentive System – Novaloc TiN Abutments |
|---|---|
| Common Name: | Endosseous Dental Implant Abutment |
| Classification Name: | Endosseous Dental Implant Abutment |
| Regulation Number: | 21 CFR 872.3630 |
| Device Classification: | Class II |
| Product Code(s): | NHA |
| Classification Panel: | Dental Devices |
4
K193046 - Traditional 510(k)
Straumann Retentive System - Novaloc TiN Abutments
510(k) Summary
5.3 Predicate Device(s)
Primary Predicate:
-
K190040 Straumann BLX Line Extension New Abutments .
Reference Devices: -
K033699 Locator Bar Female .
-
K151157 – Straumann Variobase Abutments For Bridges/Bars
-
. K171649 – Straumann CARES M-Series CAD/CAM System
-
K190662 MRI Compatibility for Existing Straumann Dental Implant Systems .
Device Description 5.4
The subject Novaloc TiN Abutments are intended to be placed onto Straumann dental implants to provide support for full or partial arch detachable restorations (over-denture). The coronal portion of the subject abutments are similar to the primary predicate devices, whereas the apical portion of the abutments has the appropriate implant-to-abutment interface geometry for each of the platforms of the Straumann Dental Implant System. The Novaloc abutments are manufactured from TAV (Ti-6AI-4V, Titanium-Aluminum-Vanadium). The restoration is connected to the Novaloc abutment through a snap-on fixture provided by a negative shape of Novaloc snap-on fixture embedded into the final restoration. The snap-on feature is TiN coated. The subject Novaloc TiN Abutments are provided in straight and anqulated models, in different heights. The subject Novaloc TiN Abutment is also provided in a bar attachment. The Novaloc TiN abutments are provided non-sterile with instructions for end user sterilization.
Intended Use 5.5
Prosthetic components connected to the implant or abutment, are intended for use as an aid in prosthetic rehabilitation.
Indications for Use 5.6
The Straumann® Retentive System is indicated for the attachment of full or partial dentures on Straumann dental implants and bar constructs.
5
K193046 – Traditional 510(k)
Straumann Retentive System – Novaloc TiN Abutments
510(k) Summary
Technological Characteristics 5.7 -
The primary predicate devices and subject devices have many of the same technological characteristics. The abutment material, surface coating, angulation and snap-on feature are identical to the primary predicate device. The main technological difference is the implant-toabutment connections. Nevertheless, all subject connections are well established and compatible with FDA cleared Straumann implant connections (NC, RC, RN, and WN). A complete comparison of the primary and reference predicate devices with the subject abutments is provided in Table 1.
| FEATURE | PROPOSED DEVICE | PRIMARY PREDICATE
DEVICE | REFERENCE
DEVICES | |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K Number | K193046 | K190040 | K171649 | K151157 |
| Indications
for Use | The Straumann
Retentive System is
indicated for the
attachment of full or
partial dentures on
Straumann dental
implants and bar
constructs. | Straumann BLX Novaloc
Abutments:
The Straumann
Retentive System is
indicated for the
attachment of full or
partial dentures on
Straumann dental
implants.
(Indications for Use related
to other types of abutments
are not considered in this
table) | The Straumann CARES
M-Series CAD/CAM
System is indicated for
the design and fabrication
of single or multiple- unit
implant-borne prosthetics
for the restoration of
partially or fully
edentulous mandibles
and maxillae. The system
integrates multiple
components of the digital
dentistry workflow: scan
files from Intra-Oral
Scanners or Extra-Oral
Scanners, CAD software,
CAM software, restoration
material blanks, milling
machines and associated
tooling and accessories.
The system is used to
design and fabricate
CAD/CAM milled coping,
crown and bridge
restorations to be
cemented onto
Straumann® Variobase®
Abutments, as well as
milled abutments to be
affixed to the endosseous
dental implants of the
Straumann® Dental
Implant System using a
basal screw. | Straumann Variobase
prosthetic components
directly connected to
the endosseous dental
implants are indicated
for use as an aid in
prosthetic
rehabilitations. The
prosthetic restoration
(bridge or overdenture)
can be cemented on
the Straumann®
Variobase prosthetic
components. A
temporary restoration
can be used prior to
the insertion of the
final components to
maintain, stabilize and
form the soft tissue
during the healing
phase. They may not
be placed into
occlusion. Final
abutments and
restorations may be
placed into occlusion
when the implant is
fully osseointegrated. |
| Material | TAV
(Ti-6Al-4V) | TAV
(Ti-6Al-4V) | Ti-6Al-7Nb | Ti-6Al-7Nb |
| Surface
Treatment | TiN coating | TiN coating | No coating | No coating |
6
K193046 – Traditional 510(k)
Straumann Retentive System - Novaloc TiN Abutments
| FEATURE | PROPOSED DEVICE | PRIMARY PREDICATE
DEVICE | REFERENCE
DEVICES | |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| K Number | K193046 | K190040 | K171649 | K151157 |
| Implant to
Abutment
Connection | Straumann NC
connection
Straumann RC
connection
Straumann RN
connection
Straumann WN
connection | Straumann BLX
connection | Straumann NC
connection
Straumann RC
connection
Straumann NNC
connection
Straumann RN
connection
Straumann WN
connection | Straumann NC
connection
Straumann RC
connection
Straumann NNC
connection
Straumann RN
connection
Straumann WN
connection |
| Abutment
Height | 1, 2, 3, 4, 5, and 6
mm | up to 6.5 mm | n/a | 3.5 - 5.2 mm |
| Angulation | 0 and 15° | 0 and 15° | 30° of coping
angulation | 30° of coping
angulation |
| Sterilization
Method | Moist heat end user
sterilization | Moist heat end user
sterilization | Moist heat end user
sterilization | Moist heat end user
sterilization |
510(k) Summary
Table 1 – Comparison of subject Novaloc TiN Abutments versus primary predicate and reference device
The primary predicate (K190040) is included for reference to the Straumann BLX Novaloc Abutments. The indications for use for the primary predicate contains reference to many different types of abutments. The intended use and indications for use of the subject device are identical to the Straumann BLX Novaloc Abutments.
The reference device K190662 is included for the MRI compatibility.
The subject Novaloc Abutments for bar attachments are equivalent to the reference device K033699 as described in Table 2.
| FEATURE | PROPOSED DEVICE | REFERENCE DEVICE |
|---|---|---|
| K Number | K193046 | K033699 |
| Indications for Use | The Straumann® Retentive System is | |
| indicated for the attachment of full or partial | ||
| dentures on Straumann dental implants | ||
| and bar constructs. | The Locator Bar Attachment System is | |
| designed for use with overdentures or | ||
| partial dentures retained in whole or in | ||
| part by bar splinted endosseous | ||
| implants in the mandible or maxilla | ||
| Connection | Bar | Bar |
| Abutment to | ||
| restoration connection | Snap on feature | Snap on Feature |
| Type of restoration | Multiunit | Multiunit |
| Compatible Matrix | ||
| System | Zest LOCATOR | |
| Valoc Novaloc | Zest LOCATOR | |
| Angulation | 0° | 0° |
7
K193046 - Traditional 510(k)
Straumann Retentive System - Novaloc TiN Abutments
| Material | Titanium grade 5 alloy
(Ti-6Al-7V or TAV) | Titanium,
Stainless Steel |
|------------------|----------------------------------------------|---------------------------------------|
| Abutment Coating | TiN | TiN |
| Construction | One Piece | One Piece |
| Sterility | Non-sterile
End user sterilization | Non-sterile
End user sterilization |
510(k) Summary
Table 2 – Comparison of subject Novaloc Abutments for bar attachments versus reference device
Performance Testing 5.8
The following performance data support the substantial equivalence determination.
5.8.1 Sterilization Validation
The subject Novaloc TiN Abutments are provided non-sterile and need to be sterilized by moist heat (steam) by the end-user. The recommended sterilization method has been validated according to ISO 17665-1 and ISO 17665-2 applicable recommendations in the FDA quidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued on March 17, 2015".
5.8.2 Biocompatibility Testing
Biological assessment has been performed according to ISO 10993-1:2009 "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 have the same nature of body contact, contact duration, material formulation and sterilization methods compared to the primary predicate devices.
5.8.3 Bench Testing
Dynamic fatigue and static strength tests conducted according to the FDA guidance document "Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Rootform Endosseous Dental Implants and Endosseous Dental Abutments" and ISO 14801, Dentistry - Implants - Dynamic fatigue test for endosseous dental implants, demonstrated that the Straumann Novaloc TiN Abutments are equivalent to the predicate and reference devices.
8
K193046 -- Traditional 510(k)
Straumann Retentive System – Novaloc TiN Abutments
510(k) Summary
5.8.4 Clinical data
No device specific clinical data has been submitted to demonstrate substantial equivalence.
5.9 Conclusion
The documentation submitted in this premarket notification demonstrates the subject Straumann Novaloc TiN Abutments are substantially equivalent to the primary predicate and reference devices.