(90 days)
No
The summary describes a mechanical dental implant system and does not mention any AI or ML components or functionalities.
No.
The device is an attachment system for dentures on dental implants, which serves a restorative rather than a therapeutic function.
No
The device is described as a system for the attachment and retention of full or partial dentures on implants, which is a restorative and prosthetic function, not a diagnostic one.
No
The device description explicitly details physical components made of zirconia ceramic and titanium, which are hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "attachment of full or partial dentures on Straumann implants." This is a mechanical function within the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details abutments and screws used to connect dentures to implants. This is a physical component for a prosthetic device.
- No mention of in vitro testing: There is no mention of analyzing samples like blood, urine, tissue, etc., which is the hallmark of an IVD.
- Bench testing: The performance studies described are bench tests (dynamic fatigue, snapping force, dynamic force) on the physical components, not clinical trials or studies involving biological samples for diagnostic purposes.
The Straumann® Retentive System is a dental prosthetic device component, specifically designed for retaining dentures on dental implants.
N/A
Intended Use / Indications for Use
The Straumann® Retentive System is indicated for the attachment of full or partial dentures on Straumann implants.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The Straumann® Retentive System (to which PUREloc belongs) is designed for the use with overdentures or partial dentures, retained in whole or in part, by endosseous implants in the mandible or maxilla. The Straumann® Retentive System consists of abutments which are used for the restoration of Straumann dental implants of different types, endosteal diameters, lengths and platforms. They are available in different sizes and angles to fit individual patient needs. Straumann® PUREloc abutments are used exclusively on the Straumann PURE Ceramic Implants, are available in 6 heights (1 mm, 2 mm, 3 mm, 4 mm, 5 mm, and 6 mm) and made of Yttrium-stabilized zirconia ceramic (ISO 13356 - Implants for surgery -- Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP)). The Straumann® PUREloc abutments are non-engaging and the implant-to-abutment connection is provided for by the basal screw. The basal screw is manufactured from Titanium Grade 4 and is identical to the basal screw cleared under K180477.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandible or maxilla
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)
5.8 Performance Testing
5.8.1 Sterilization
The sterilization process for the PUREloc abutments as recommended in the labeling was validated according to applicable recommendations in the FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued on March 17, 2015".
5.8.2 Biocompatibility
The subject device materials were evaluated for biocompatibility according to ISO 10993-1:2009 "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" and the biocompatibility evaluation flow chart according 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".
Although the subject devices materials are identical to the primary predicate and reference devices, cytotoxicity and chemical characterization tests were performed due to differences in geometry, manufacturing processes, and sterilization processes to confirm biocompatibility. These tests were conducted according to ISO 10993-5, 10993-12, and 10993-18 and confirmed the subject devices are biocompatible.
Bench testing 5.8.3
Dynamic fatigue 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", furthermore snapping force, and dynamic force tests were performed and demonstrated that the PUREloc abutments are identical to primary predicate (K190040) in terms of performance.
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.
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 logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the symbol of the Department of Health & Human Services on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out next to it. The full name reads "U.S. Food & Drug Administration".
October 28, 2019
Institut Straumann AG % Jennifer Jackson Director Regulatory Affairs Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01810
Re: K192029
Trade/Device Name: Straumann® PUREloc abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: July 29, 2019 Received: July 30, 2019
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.
for
Srinivas Nandkumar, Ph.D. Acting 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® PUREloc abutments
Indications for Use (Describe)
The Straumann® Retentive System is indicated for the attachment of full or partial dentures on Straumann implants.
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
Straumann® PUREloc Abutments
5 510(k) Summary
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 |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jennifer M. Jackson, MS
Director of Regulatory Affairs and Quality
Phone Number: +1-978-747-2509
Fax Number: +1-978-747-0023
email: jennifer.jackson@straumann.com |
| Prepared By &
Alternate Contact: | Giulia Oran
Regulatory Affairs and Compliance Manager
Institut Straumann AG
Phone number : +41 61 965 16 17 |
| Date of Submission: | October 28, 2019 |
5.2 Name of the Device
| Trade Names: | Straumann® PUREloc abutments |
|---|---|
| Common Name: | Endosseous dental implant abutment |
| Classification Name: | Endosseous dental implant abutment |
| Regulation Number: | 21 CFR 872.3630 |
| Device Classification : | II |
| Product Code(s): | NHA |
| Classification Panel: | Dental |
| Proprietary Name: | Straumann® PUREloc Abutments |
Predicate Device(s) 5.3
Primary Predicate:
- . K190040 – Straumann BLX Line Extension – New Abutments
4
Straumann® PUREloc Abutments
Reference Devices:
- . K180477 – Straumann PURE Ceramic Implant
- . K190662 – MRI compatibility for existing Straumann dental implant systems
5.4 Device Description
The Straumann® Retentive System (to which PUREloc belongs) is designed for the use with overdentures or partial dentures, retained in whole or in part, by endosseous implants in the mandible or maxilla. The Straumann® Retentive System consists of abutments which are used for the restoration of Straumann dental implants of different types, endosteal diameters, lengths and platforms. They are available in different sizes and angles to fit individual patient needs. Straumann® PUREloc abutments are used exclusively on the Straumann PURE Ceramic Implants, are available in 6 heights (1 mm, 2 mm, 3 mm, 4 mm, 5 mm, and 6 mm) and made of Yttrium-stabilized zirconia ceramic (ISO 13356 - Implants for surgery -- Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP)). The Straumann® PUREloc abutments are non-engaging and the implant-to-abutment connection is provided for by the basal screw. The basal screw is manufactured from Titanium Grade 4 and is identical to the basal screw cleared under K180477.
5.5 Intended Use
Prosthetic components connected to the implant or abutment, are intended for use as an aid in prosthetic rehabilitation.
5.6 Indications for Use
The Straumann® Retentive System is indicated for the attachment of full or partial dentures on Straumann implants.
5.7 Technological Characteristics
The technological characteristics of the subject devices are compared to the primary predicate and reference device in the following table:
5
Straumann® PUREloc Abutments
| FEATURE | PROPOSED DEVICE | PRIMARY PREDICATE
DEVICE | REFERENCE PREDICATE
DEVICE | REFERENCE PREDICATE
DEVICE |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|
| K Number | K192029 | K190040 | K180477 | K190662 |
| Indications for
Use | The Straumann® Retentive
System is indicated for the
attachment of full or partial
dentures on Straumann dental
implants. | Straumann BLX Healing
Abutments for Bars and Bridges
Straumann Healing abutments are
indicated to be placed in the
patient's mouth at the end of the
implant placement to protect the
inner configuration of the implant
and to form, maintain and stabilize
the soft tissue during the healing
process.
Healing abutments should be used
only with suitable implant
connections.
Healing components have a
maximum duration of usage of 6
months.
Straumann BLX Temporary
Abutments for Bar and Bridges
Prosthetic components directly or
indirectly connected to the
endosseous dental implant are
intended for use as an aid in
prosthetic rehabilitations.
Temporary components can be used
prior to the insertion of the final
components to maintain, stabilize
and shape the soft tissue during the
healing phase; they may not be
placed into occlusion. Final
abutments may be placed into
occlusion when the implant is fully
osseointegrated.
BLX Temporary Abutments have a
maximum duration of usage of 180
days.
Straumann BLX Variobase
Abutments for Bar and Bridges
Straumann® Variobase™ prosthetic
components directly or indirectly
connected to the endosseous dental | Straumann PURE Ceramic
Implant:
The Straumann PURE Ceramic
Implant is indicated for the
restoration of single-tooth
gaps and in edentulous or partially
edentulous jaws. The prosthetic
restorations used are single crowns,
fixed partial or full dentures, which
are connected to the implants
through the corresponding
components.
Closure and healing caps:
Closure and Healing caps are
intended for use with the Straumann
Dental Implant
System (SDIS) to protect the inner
configuration of the implant and
maintain, stabilize and form the soft
tissue during the healing process.
Closure and Healing caps should be
used only with suitable implant
connections. Do not use healing
components for longer than 6
months.
Temporary Abutments:
The provisional components are
intended to serve as a base for
temporary crown or bridge
restoration out of occlusion for the
Straumann® PURE Ceramic Implant
System. The Straumann® Temporary
Abutment VITA CAD-Temp® for the
Straumann® PURE Ceramic Implant
is indicated for temporary usage of
up to 180 days.
ci RD Straumann PUREbase
Abutments:
ci RD Straumann PUREbase
abutment is a titanium base placed | n/a |
| FEATURE | PROPOSED DEVICE | PRIMARY PREDICATE
DEVICE | REFERENCE PREDICATE
DEVICE | REFERENCE PREDICATE
DEVICE |
| K Number | K192029 | K190040 | K180477 | K190662 |
| | | implant are intended for use as an
aid in prosthetic rehabilitations. The
prosthetic restoration (bridge or
overdenture) can be cemented on
the Straumann® VariobaseTM
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.
Straumann BLX Variobase
Abutments AS
The Straumann Variobase for Crown
AS is a titanium base placed onto
Straumann dental implants to
provide support for customized
prosthetic restorations. Straumann
Variobase for Crown AS are
indicated for screw retained single
tooth or cement-retained single tooth
and bridge restorations. 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. Temporary
restorations are indicated to be
placed out of occlusion. All digitally
designed copings and/or crowns for
use with the Straumann Variobase
for Crown AS are intended to be
sent to Straumann for manufacture
at a validated milling center.
Straumann BLX Novaloc
Abutments | onto Straumann ceramic dental
implants to provide support for
customized prosthetic restorations
and is indicated for screw-retained
single tooth or cement-retained
single tooth and bridge restorations.
All digitally designed copings and/or
crowns for use with the Straumann®
Variobase Abutment system are
intended to be sent to Straumann for
manufacture at a validated milling
center. | |
| FEATURE | PROPOSED DEVICE | PRIMARY PREDICATE
DEVICE | REFERENCE PREDICATE
DEVICE | REFERENCE PREDICATE
DEVICE |
| K Number | K192029 | K190040 | K180477 | K190662 |
| | | The Straumann® Retentive System
is indicated for the attachment of full
or partial dentures on Straumann
dental implants.
Straumann BLX CARES
Abutments
The Straumann CARES Abutments
are indicated for single tooth
replacement and multiple tooth
restorations. The prosthetic
restoration can be cemented or
directly veneered/screw-retained. | | |
| Material | Y-TZP according to ISO 13356 | Ti-6Al-4V | Y-TZP according to ISO 13356 | n/a |
| Surface
Treatment | none | Partially anodized / TiN coated | Sand-blasted, large-grit, acid
etched (ZLA®) | n/a |
| Implant to
Abutment
Connection | Screw-retained (via CI Basal
Screw) | TorcFit connection | Screw-retained (via CI Basal
Screw) | n/a |
| Diameter | 4.8 mm | 4.5 mm | 4.1 mm (endosteal Ø)
4.8 mm (platform Ø) | n/a |
| Gingival height | 1, 2, 3, 4, 5, 6 mm | 1.5 to 6.5 mm | n/a | n/a |
| Abutment-to-
restoration
connection | Snap on feature | Snap on feature | n/a | n/a |
| Type of
recommended
restoration | Multi-unit | Multi-unit | n/a | n/a |
| Abutment
Angulation | straight | 0 and 15° | n/a | n/a |
| Sterilization
Method | Non-sterile/
End user sterilized | Non-sterile/
End user sterilized | Ethylene Oxide | n/a |
| FEATURE | PROPOSED DEVICE | PRIMARY PREDICATE
DEVICE | REFERENCE PREDICATE
DEVICE | REFERENCE PREDICATE
DEVICE |
| K Number | K192029 | K190040 | K180477 | K190662 |
| MRI
Compatibility | MRI conditional | Labeling does not contain MRI
Safety Information | Labeling does not contain MRI
Safety Information | MRI conditional |
6
Straumann® PUREloc Abutments
7
Straumann® PUREloc Abutments
8
Straumann® PUREloc Abutments
Table 1 – Comparison of subject device versus primary predicate device and reference predicate device
9
Straumann® PUREloc Abutments
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. Dimensionally, the platform diameter is slightly smaller for the subject device to accommodate the implant diameter of the compatible implants. The material of the subject device is identical to the implants of the reference device (K180477) and the screw used to secure the abutment to the implant is identical to the basal screw cleared under K180477. The reference device (K190662) is included in support of considerations for MRI compatibility.
5.8 Performance Testing
5.8.1 Sterilization
The sterilization process for the PUREloc abutments as recommended in the labeling was validated according to applicable recommendations in the FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued on March 17, 2015".
5.8.2 Biocompatibility
The subject device materials were evaluated for biocompatibility according to ISO 10993-1:2009 "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" and the biocompatibility evaluation flow chart according 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".
Although the subject devices materials are identical to the primary predicate and reference devices, cytotoxicity and chemical characterization tests were performed due to differences in geometry, manufacturing processes, and sterilization processes to confirm biocompatibility. These tests were conducted according to ISO 10993-5, 10993-12, and 10993-18 and confirmed the subject devices are biocompatible.
10
Straumann® PUREloc Abutments
Bench testing 5.8.3
Dynamic fatigue 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", furthermore snapping force, and dynamic force tests were performed and demonstrated that the PUREloc abutments are identical to primary predicate (K190040) in terms of performance.
5.9 Conclusion
The documentation submitted in this premarket notification demonstrates the PUREloc abutments are substantially equivalent to the primary predicate and reference devices.