(147 days)
No
The summary describes a physical dental implant and its mechanical properties, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
The device is intended for oral endosteal implantation to stabilize removable dentures, which is a therapeutic purpose to aid patients with edentulism.
No.
The device is an implantable medical device intended for the stabilization of removable dentures, not for diagnostic purposes.
No
The device description clearly states it is a physical implant made of Roxolid material with an SLA surface and a TiN coating, intended for oral endosteal implantation. It undergoes manufacturing processes like machining, surface treatment, cleaning, packaging, and sterilization, and performance studies involve physical testing like insertion torque and wear testing.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description and Intended Use: The description clearly states that the Straumann Mini Implants are for "oral endosteal implantation in the upper and lower jaw" and are intended for "stabilization of removable dentures." This involves surgical implantation into the body (in vivo).
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, diagnostic testing, or providing information about a patient's health based on laboratory results.
This device is a medical device used for surgical implantation and stabilization of dentures, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Straumann® Mini Implants ø2.4 mm are suitable for oral endosteal implantation in the upper and lower jaw of fully or partially edentulous patients. The implants can be placed with immediate function when good primary stability is achieved. Strauman® Mini Implants are intended for the stabilization of removable dentures.
Product codes
DZE
Device Description
The Straumann Mini Implants are tapered implants with an external diameter of 2.4 mm and lengths of 10, 12, and 14 mm.
Standard manufacturing processes such machining, surface treatment, cleaning, packaging and sterilization were applied for the subject devices. There are no significant changes related to the implant material, surface treatment, fundamental operating principles, sterilization processes or procedures between the subject devices and the reference devices cleared under K083550. The main difference is the Optiloc® attachment element incorporated on the top of the implant.
The implants are manufactured utilizing the Roxolid material and are finished with SLA® surface. The implant neck is machined and the Optiloc® attachment element of the implants is acting as a retention feature for dentures and it is coated using a Titanium Nitride (TiN) coating.
Straumann® Mini Implants Ø2.4 mm are suitable for oral endosteal implantation in the upper and lower jaw of fully or partially edentulous patients.
The implants can be placed with immediate function when good primary stability is achieved. The Straumann Mini Implants are intended for the stabilization of removable dentures. The removable dentures are connected to the Mini Implants through the incorporated Optiloc® attachment element.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper and lower jaw
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Insertion torque testing and wear testing were conducted according to the FDA quidance document "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" and demonstrated the Straumann Mini Implants are equivalent to the predicate and reference devices.
The purpose of the insertion torque test is to check that the Straumann Mini Implants and the related cutting instruments make it possible to reach a suitable implant insertion torque. The average value of insertion torque measurements for each bone plate density and each implant length are within the define acceptance criteria. Wear testing is performed to evaluate the performance of the Optiloc® attachment with regard to its retention properties. The retention force loss of the Optiloc® blue ring on Straumann Mini Implants passed the acceptance criteria.
Dynamic fatigue testing was conducted according to ISO 14801, Dentistry – Implants – Dynamic fatigue test for endosseous dental implants and 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". The tests were conducted in ambient air at room temperature and demonstrated the Straumann Mini Implants are equivalent to the primary predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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 logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 9, 2019
Institut Straumann AG % Jennifer Jackson Director, Regulatory Affairs Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01801
Re: K191895
Trade/Device Name: Straumann® Mini Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: September 9, 2019 Received: September 10, 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 (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
510(k) Number (if known)
Device Name :
Straumann® Mini Implants
Indications for Use (Describe)
Straumann® Mini Implants ø2.4 mm are suitable for oral endosteal implantation in the upper and lower jaw of fully or partially edentulous patients. The implants can be placed with immediate function when good primary stability is achieved. Strauman® Mini Implants are intended for the stabilization of removable dentures.
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)
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3
Straumann® Mini Implants
510(k) Summary
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
E-mail: jennifer.jackson@straumann.com |
| Prepared By &
Alternate Contact: | Viviana Horhoiu
Regulatory Affairs and Compliance Manager
Institut Straumann AG
Phone number : +41 61 965 1512 |
| Date of Submission: | December 9, 2019 |
5.2 Name of the Device
| Trade Names: | Straumann Mini Implants |
|---|---|
| Common Name: | Endosseous Dental Implant |
| Classification Name: | Endosseous Dental Implant |
| Regulation Number: | §872.3640 |
| Device Classification : | II |
| Product Code(s): | DZE |
| Proprietary Name: | Straumann Mini Implants |
5.3 Predicate Device(s)
Primary Predicate:
- K031106 IMTEC Sendax MDI and MDI Plus •
4
Straumann® Mini Implants
510(k) Summary
Reference Devices:
- K083550 Straumann Dental Implant System ●
- K190040 Straumann BLX Line Extension New Abutments .
- K190662 MRI Compatibility for Existing Straumann Dental Implant Systems ●
5.4 Device Description
The Straumann Mini Implants are tapered implants with an external diameter of 2.4 mm and lengths of 10, 12, and 14 mm.
Standard manufacturing processes such machining, surface treatment, cleaning, packaging and sterilization were applied for the subject devices. There are no significant changes related to the implant material, surface treatment, fundamental operating principles, sterilization processes or procedures between the subject devices and the reference devices cleared under K083550. The main difference is the Optiloc® attachment element incorporated on the top of the implant.
The implants are manufactured utilizing the Roxolid material and are finished with SLA® surface. The implant neck is machined and the Optiloc® attachment element of the implants is acting as a retention feature for dentures and it is coated using a Titanium Nitride (TiN) coating.
Straumann® Mini Implants Ø2.4 mm are suitable for oral endosteal implantation in the upper and lower jaw of fully or partially edentulous patients.
The implants can be placed with immediate function when good primary stability is achieved. The Straumann Mini Implants are intended for the stabilization of removable dentures. The removable dentures are connected to the Mini Implants through the incorporated Optiloc® attachment element.
5.5 Indications for Use
Straumann® Mini Implants Ø2.4 mm are suitable for oral endosteal implantation in the upper and lower jaw of fully or partially edentulous patients. The implants can be placed with immediate function when good primary stability is achieved. Straumann® Mini Implants are intended for the stabilization of removable dentures.
5
Straumann® Mini Implants
510(k) Summary
Technological Characteristics 5.6
The technological characteristics of the subject devices are compared to the primary predicate and reference devices in Table 1. The Indications for Use for the subject devices differs from the primary predicate (K031106) with respect to the indication for inter-radicular transitional applications. The subject devices are not indicated for interradicular transitional applications, however, the remaining indications are equivalent. The reference predicate K190662 is included for reference to all MRI compatibility. The reference predicate K190040 is included for reference to the TiN coating on the Straumann BLX Novaloc Abutments (for clarity only this portion of the cleared Indications for Use Statement for K190040 is included in Table 1).
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Straumann® Mini Implants
510(k) Summary
| FEATURE | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | REFERENCE DEVICE |
|---|---|---|---|---|
| K Number | K191895 | K031106 | K083550 | K190040 |
| Indications for | ||||
| Use | Straumann® Mini Implants Ø2.4 mm | |||
| are suitable for oral endosteal | ||||
| implantation in the upper and lower | ||||
| jaw of fully or partially edentulous | ||||
| patients. The implants can be placed | ||||
| with immediate function when good | ||||
| primary stability is achieved. | ||||
| Straumann® Mini Implants are | ||||
| intended for the stabilization of | ||||
| removable dentures. | The MDI and MDI PLUS are self- | |||
| tapping titanium threaded screws | ||||
| indicated for long-term intra-bony | ||||
| applications. | ||||
| Additionally, the MDI may also be | ||||
| used for inter-radicular transitional | ||||
| applications. | ||||
| These devices will permit immediate | ||||
| splinting stability and long-term | ||||
| fixation of new or existing crown and | ||||
| bridge installations, for full partial | ||||
| edentulism, and employing minimally | ||||
| invasive surgical intervention. | Straumann® dental implants are | |||
| suitable for the treatment of oral | ||||
| endosteal implantation in the upper | ||||
| and lower jaw and for the functional | ||||
| and esthetic oral rehabilitation of | ||||
| edentulous and partially dentate | ||||
| patients (unless specific indications | ||||
| and limitations are present, as stated | ||||
| below). 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). When placing | ||||
| implants in the posterior region, we | ||||
| recommend using only large | ||||
| diameter implants. In cases of fully | ||||
| edentulous patients, 4 or more | ||||
| implants must be used in immediately | ||||
| loaded cases. | ||||
| Specific indications for small | ||||
| diameter (Ø3.3 mm) implants: | ||||
| Because of their reduced mechanical | ||||
| stability, small diameter implants are | ||||
| only used in cases with a low | ||||
| mechanical load. Placement in the | ||||
| molar region is not recommended. | Straumann BLX Novaloc Abutments | |||
| The Straumann® Retentive System is | ||||
| indicated for the attachment of full or | ||||
| partial dentures on Straumann dental | ||||
| implants. | ||||
| Implant | ||||
| Diameter | 2.4 mm | 2.4 mm | 3.3 mm | The reference device is not an |
| implant |
7
Straumann® Mini Implants
510(k) Summary
| FEATURE | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | REFERENCE DEVICE |
|---|---|---|---|---|
| K Number | K191895 | K031106 | K083550 | K190040 |
| Implant Length | 10, 12, 14 mm | 10, 13, 15, 18 mm | 8, 10, 12, 14, 16 mm | The reference device is not an |
| implant | ||||
| Material | Roxolid | Ti-6Al-4V | Roxolid | Ti-6Al-4V |
| Coating | TiN coated | No coating | No coating | TiN coated |
| Surface | ||||
| Treatment | SLA | Not available | SLA | Partially anodized |
| Abutment-to- | ||||
| restoration | ||||
| connection | Anchor ball | O-Ball | Screw retained | Snap-on feature |
| Type of | ||||
| recommended | ||||
| restoration | Stabilization of removable dentures | Stabilization of removable dentures | Support for prosthetic devices, | |
| crowns, bridges and overdentures | Attachment of full or partial dentures | |||
| on dental implants | ||||
| Sterilization | ||||
| Method | Gamma irradiation | No information available | Gamma irradiation | Not provided sterile |
Table 1 – Comparison of subject device versus predicate/reference devices
8
Straumann® Mini Implants
510(k) Summary
5.7 Performance Testing
Insertion torque testing and wear testing were conducted according to the FDA quidance document "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" and demonstrated the Straumann Mini Implants are equivalent to the predicate and reference devices.
The purpose of the insertion torque test is to check that the Straumann Mini Implants and the related cutting instruments make it possible to reach a suitable implant insertion torque. The average value of insertion torque measurements for each bone plate density and each implant length are within the define acceptance criteria. Wear testing is performed to evaluate the performance of the Optiloc® attachment with regard to its retention properties. The retention force loss of the Optiloc® blue ring on Straumann Mini Implants passed the acceptance criteria.
No new issues of biocompatibility are raised for the subject devices. The Roxolid material was previously cleared per K083550 and the TiN coating was previously cleared per K190040.
The sterilization process for the Straumann Mini Implants as recommended in the labeling was validated 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 subject devices are sterilized via gamma irradiation at a dose of 25 kilogray (2.5 Mrad) Minimum and will be sterilized after packaging. A sterility assurance level (SAL) of 10-6 had been validated according to the standard cited above. The validation method used was the over kill bioburden method in accordance with ISO 11137-2:2013, Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose.
The subject devices are single use and are provided sterile. The shelf life is five years. Shelf life determination has been conducted in real time and accelerated (according to ASTM F 1980 - Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices) samples. The subject devices will not be marketed as non-pyrogenic. The method used to make the determination that the device meets pyrogen limit specifications is LAL Endotoxin Analysis. The testing limit is 20 EU/device.
9
Straumann® Mini Implants
510(k) Summary
Dynamic fatigue testing was conducted according to ISO 14801, Dentistry – Implants – Dynamic fatigue test for endosseous dental implants and 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". The tests were conducted in ambient air at room temperature and demonstrated the Straumann Mini Implants are equivalent to the primary predicate devices.
5.8 Conclusion
The documentation submitted in this premarket notification demonstrates the Straumann Mini Implants are substantially equivalent to the primary predicate and reference devices.