(153 days)
Not Found
No
The document describes a ceramic dental implant and its mechanical and biological properties. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML.
No
The device is an implant used for restoration in single tooth gaps and in an edentulous or partially edentulous jaw, which is a restorative rather than therapeutic function.
No.
The device is an implant used for restoration, not for diagnosis. Its purpose is to replace missing teeth or support prosthetics, as indicated in the "Intended Use / Indications for Use" section.
No
The device description clearly states the device is a ceramic implant made of yttrium-stabilized zirconia, which is a physical hardware component.
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 restoration of single tooth gaps and edentulous or partially edentulous jaws using implants and prosthetic restorations. This is a surgical and restorative procedure performed directly on the patient's body.
- Device Description: The device is a ceramic implant designed to be surgically placed into bone.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a medical implant.
N/A
Intended Use / Indications for Use
The Straumann® PURE Ceramic Implant (Monotype) is indicated for restoration in single tooth gaps and in an edentulous or partially edentulous jaw. The prosthetic restorations used are single crowns, fixed partial or full dentures, which are connected to the implants through the corresponding components.
The ø3.3 mm reduced diameter implants are recommended for central and lateral incisors only.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
The Straumann® PURE Ceramic Implants are made of 100% yttrium-stabilized zirconia. The endosteal region presents macro- and micro-roughness, a ZLA surface. The implant has a 1.8 mm high machined neck. The implant features a monotype design where the ceramic abutment for final restoration is already built in. Straumann® PURE Ceramic Implant prosthetic components are identified with RD (Regular Diameter) corresponding to the neck diameter of 4.8 mm, and ND (Narrow Diameter) corresponding to the neck diameter of 3.5 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
single tooth gaps, edentulous or partially edentulous jaw, central and lateral incisors
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 and Shelf-Life: A sterilization validation was performed per ISO 11135, Sterilization of healthcare products – Ethylene Oxide – Requirements for development, validation and routine control of a sterilization process for medical devices, using the Half Cycle Overkill Approach. The validation demonstrates that the sterilization process and equipment is capable of reliably and consistently sterilizing the subject device to a minimum Sterility Assurance Level (SAL) of 10-6. A transportation study has been performed per ISTA 2A to demonstrate the integrity of the sterile barrier system considering the new sterilization process. The subject devices continue to meet product release requirements after being subjected to worst-case environmental and handling changes. A packaging stability study was performed to demonstrate the integrity of the packaging system and the sterile barrier system after sterilization process via Ethylene Oxide, handling, distribution, transport and storage up to the defined product shelf life. The subject devices continue to meet product release requirements after being subjected to worst-case environmental and handling changes. Shelf-Life studies have been conducted in accordance with ASTM F1980.
Biocompatibility Testing: The biological safety of the Straumann® PURE Ceramic Implants sterilized via Ethylene Oxide was re-evaluated and further biocompatibility testing was required according to ISO and FDA standard (FDA, 2016; ISO 10993-1, 2009). EO and ECH residues were not detected in the chemical analysis and no cytotoxicity was observed. Based on the test results the change in sterilization method did not affect the biological safety profile of the devices.
Bench Testing: Mechanical testing (static, dynamic fatigue and torque) and surface chemistry analysis was performed to demonstrate the new sterilization method does not affect product performance. Static and dynamic fatigue strength testing was performed per ISO 14801:2007 and the FDA-Guidance to "Root-form endosseous dental implants and endosseous dental implant abutments." All mechanical testing performed demonstrated the new sterilization method does not affect the product performance after being subjected to hydrothermal aging. Cleanliness analysis demonstrated no significant difference in surface chemistry between H2O2 plasma (sterility method per predicate device) and EO sterilization.
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
0
Image /page/0/Picture/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 text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
Straumann USA, LLC (on behalf of Institut Straumann AG) % Jennifer Jackson Director, Regulatory Affairs & Quality Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01810
Re: K171769
Trade/Device Name: Straumann® PURE Ceramic Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: August 15, 2017 Received: August 16, 2017
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. 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.
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
November 14, 2017
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mary S. Runner -S
for
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K171769
Device Name Straumann® PURE Ceramic Implants
Indications for Use (Describe)
The Straumann® PURE Ceramic Implant (Monotype) is indicated for restoration in single tooth gaps and in an edentulous or partially edentulous jaw. The prosthetic restorations used are single crowns, fixed partial or full dentures, which are connected to the implants through the corresponding components.
The g3.3 mm reduced diameter implants are recommended for central and lateral incisors only.
Type of Use (Select one or both, as applicable)
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------ | ----------------------------------------------------------------------------------- |
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
510(k) Summary
5.1 Submitter
Straumann USA, LLC (on behalf of Institut Straumann AG) 60 Minuteman Road Andover, MA 01810 Phone Number: 1-978-747-2509 Fax Number: 1-978-747-0023 E-mail: jennifer.jackson@straumann.com Contact Person: Jennifer M. Jackson, MS Prepared By: Chanrasmey White Date of Submission: November 14, 2017 5.2 Device Trade Name: Straumann® PURE Ceramic Implants Common Name: Endosseous Dental Implant Classification Name: Implant, Endosseous, Root-Form Regulatory Number: 8872.3640 Classification: Class II Product Code: DZE Subsequent Product Code: NHA 5.3 Predicate Device
Primary Predicate: K151328, Straumann® PURE Ceramic Implants
5.4 Device Description
The Straumann® PURE Ceramic Implants are made of 100% yttrium-stabilized zirconia. The endosteal region presents macro- and micro-roughness, a ZLA surface. The implant has a 1.8 mm high machined neck. The implant features a monotype design where the ceramic abutment for final restoration is already built in. Straumann® PURE Ceramic Implant prosthetic components are identified with RD (Regular Diameter) Straumann USA, LLC November 14, 2017 5-1
4
510(k) Summary
corresponding to the neck diameter of 4.8 mm, and ND (Narrow Diameter) corresponding to the neck diameter of 3.5 mm.
5.5 Indications for Use
The Straumann® PURE Ceramic Implant (Monotype) is indicated for restoration in single tooth gaps and in an edentulous or partially edentulous jaw. The prosthetic restorations used are single crowns, fixed partial or full dentures, which are connected to the implants through the corresponding components.
The ø3.3 mm reduced diameter implants are recommended for central and lateral incisors only.
Technological Characteristics 5.6
The proposed Straumann® Pure Ceramic Implants intended use, material, fundamental operating principles and overall design are identical to the primary predicate device, K151328. The subject device is identical to the primary predicate, K151328 with the exception that the subject device will be delivered to the user sterile via Ethylene Oxide as opposed to sterile via H₂O₂plasma.
The additional components mentioned in the predicate device indications for use statement are not subject to this submission as the change only impacts the sterilization of the endosseous dental implants. The technological characteristics of the subject devices are compared to the predicate device in the following table.
5
510(k) Summary
| FEATURE | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE |
|---|---|---|
| K Number | K171769 | K151328 |
| Indications for Use | The Straumann® PURE | |
| Ceramic Implant (Monotype) | ||
| is indicated for restoration in | ||
| single tooth gaps and in an | ||
| edentulous or partially | ||
| edentulous jaw. The prosthetic | ||
| restorations used are single | ||
| crowns, fixed partial or full | ||
| dentures, which are connected | ||
| to the implants through the | ||
| corresponding components. | ||
| The ø3.3 mm reduced | ||
| diameter implants are | ||
| recommended for central | ||
| and lateral incisors only. | The Straumann® PURE Ceramic | |
| lmplant (Monotype) is indicated for | ||
| restoration in single tooth gaps and | ||
| in an edentulous or partially | ||
| edentulous jaw. The prosthetic | ||
| restorations used are single crowns, | ||
| fixed partial or full dentures, which | ||
| are connected to the implants | ||
| through the corresponding | ||
| components. | ||
| The ø3.3 mm reduced diameter | ||
| implants are recommended for | ||
| central and lateral incisors only. | ||
| The Straumann® PURE Ceramic | ||
| Implant Protective Cap is intended | ||
| to protect the Straumann® PURE | ||
| Ceramic Implant (Monotype) | ||
| during the healing phase after | ||
| implant placement for up to 6 | ||
| months. | ||
| Temporary copings are intended to | ||
| serve as a base for temporary | ||
| crown or bridge restoration for the | ||
| Straumann® PURE Ceramic | ||
| Implant (Monotype) for up to 30 | ||
| days. | ||
| Material | Y-TZP | Y-TZP |
| Surface | ||
| Treatment | Sand-blasted, large- | |
| grit, acid etched | Sand-blasted, large-grit, acid | |
| etched (ZLA®) | ||
| Apical Diameter | Ø3.3 and Ø4.1 mm | Ø3.3 and Ø4.1 mm |
| Coronal | ||
| Diameter | Ø3.5 and Ø4.8 mm | Ø3.5 and Ø4.8 mm |
| Length | 8, 10, 12, and 14 mm | 8, 10, 12, and 14 mm |
| Implant | ||
| Design | Cylindrical Monotype | Cylindrical Monotype |
| Implant Neck | 1.8 mm, machined | 1.8 mm, machined |
| Thread Pitch | 0.8 mm | 0.8 mm |
| Implant/Abutment | ||
| Connection | None (Monotype) | None (Monotype) |
| Sterilization | End user receives product | |
| sterilized per Ethylene Oxide | ||
| Validated per ISO 11135 to | ||
| a SAL of 10-6 | End user receives product | |
| sterilized per H2O2 - plasma in | ||
| accordance with DIN EN 556- | ||
| 1:2002 (equivalent to ANSI AAMI | ||
| ST67:2011) to a SAL of 10-6 |
6
510(k) Summary
5.7 Performance Data
The following performance data were provided in support of the substantial equivalence determination.
Sterilization and Shelf-Life
A sterilization validation was performed per ISO 11135, Sterilization of healthcare products – Ethylene Oxide – Requirements for development, validation and routine control of a sterilization process for medical devices, using the Half Cycle Overkill Approach. The validation demonstrates that the sterilization process and equipment is capable of reliably and consistently sterilizing the subject device to a minimum Sterility Assurance Level (SAL) of 10-6.
A transportation study has been performed per ISTA 2A to demonstrate the integrity of the sterile barrier system considering the new sterilization process. The subject devices continue to meet product release requirements after being subjected to worst-case environmental and handling changes.
A packaging stability study was performed to demonstrate the integrity of the packaging system and the sterile barrier system after sterilization process via Ethylene Oxide,
handling, distribution, transport and storage up to the defined product shelf life. The subject devices continue to meet product release requirements after being subjected to worst-case environmental and handling changes.
Shelf-Life studies have been conducted in accordance with ASTM F1980.
Biocompatibility Testing
The biological safety of the Straumann® PURE Ceramic Implants sterilized via Ethylene Oxide was re-evaluated and further biocompatibility testing was required according to ISO and FDA standard (FDA, 2016; ISO 10993-1, 2009). EO and ECH residues were not detected in the chemical analysis and no cytotoxicity was observed. Based on the test results the change in sterilization method did not affect the biological safety profile of the devices.
Bench Testing
Mechanical testing (static, dynamic fatigue and torque) and surface chemistry analysis was performed to demonstrate the new sterilization method does not affect product performance. Static and dynamic fatigue strength testing was performed per ISO 14801:2007 and the FDA-Guidance to "Root-form endosseous dental implants Straumann USA, LLC November 14, 2017
7
510(k) Summary
and endosseous dental implant abutments." All mechanical testing performed demonstrated the new sterilization method does not affect the product performance after being subjected to hydrothermal aging. Cleanliness analysis demonstrated no significant difference in surface chemistry between H2O2 plasma (sterility method per predicate device) and EO sterilization.
5.8 Conclusion
The documentation submitted in this premarket notification demonstrates that the Straumann® PURE Ceramic Implants are substantially equivalent to the predicate device and do not pose new issues of safety and effectiveness.