(90 days)
Not Found
No
The 510(k) summary describes a physical dental implant and its intended use for stabilizing dentures. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The submission focuses on labeling changes and references bench and clinical performance studies related to the physical implant's function.
Yes
The device is an implant intended for the stabilization of removable dentures in the upper and/or lower jaw, which qualifies it as a therapeutic device designed to treat a medical condition (edentulism) and improve patient function/quality of life.
No
The device is an implant designed for oral endosteal implantation and stabilization of dentures, not for diagnosing medical conditions.
No
The device description clearly states it is a physical implant made of Roxolid (TiZr) with a finished SLA surface and a Titanium Nitride (TiN) coating. It also mentions bench testing related to physical properties like insertion torque, wear, and dynamic fatigue.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "oral endosteal implantation in the upper and/or lower jaw of fully edentulous patients" for the "stabilization of removable dentures." This describes a surgical implant procedure, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a physical implant made of Roxolid (TiZr) with specific dimensions and coatings. This is a medical device intended for implantation, not a reagent, instrument, or system used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting specific analytes (proteins, genes, pathogens, etc.)
- Providing diagnostic information
- Using reagents or calibrators
The device is a dental implant, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Straumann® RidgeFit Implants Ø2.4 mm are for oral endosteal implantation in the upper and/or lower jaw of fully edentulous patients. The implants can be placed with immediate function when primary stability is achieved for all implants or with conventional loading if primary stability is not achieved for all implants. Straumann® RidgeFit Implants are intended for the stabilization of removable dentures.
- For mandibular restorations, at least 4 Straumann® RidgeFit Implants Ø2.4 mm should be placed.
- For maxillary restorations, at least 6 Straumann® RidgeFit Implants Ø2.4 mm should be placed.
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
The Straumann® RidgeFit Implants are tapered implants manufactured from Roxolid (TiZr) with a finished SLA surface. The implant neck is machined with an Optiloc® attachment portion resulting in a one-piece implant system acting as a retention feature for dentures, this feature is coated in a Titanium Nitride (TiN) coating. The Straumann® RidgeFit Implants have an external diameter of 2.4 mm and are available in implant lengths 10 mm, 12 mm and 14 mm with a gingival height of 2.8 mm and implant lengths 10 mm and 12 mm for gingival heights 3.8 mm and 4.8 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper and/or lower jaw
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following performance data support the substantial equivalence determination.
Sterilization Validation and Shelf Life:
The Straumann® RidgeFit Implants are single patient devices, are provided sterile via gamma irradiation at a dose of 25 kilogray (2.5 Mrad) Minimum and will be sterilized after final packaging. A sterility assurance level (SAL) of 10° has been 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. The validation method used was the VDmax 25method in accordance with ISO 11137-2:2013, Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose. The sterilization validation and shelf life data have been submitted under K191895. The shelf life of the subject RidgeFit Implants is 5 years. Sterilization method and shelf life are identical to the primary predicate devices cleared under K191895.
Biocompatibility Testing:
There are no changes to the materials, surface treatments, or manufacturing methods from the currently marketed predicate devices. Therefore, no new issues of biocompatibility are raised for the subject devices and no additional biocompatibility testing was required.
Electromagnetic Compatibility:
There are no changes to the materials, surface treatments, or manufacturing methods from the currently marketed predicate devices. Therefore, no new issues of electromagnetic compatibility are raised for the subject devices and they can be considered MR Conditional.
Performance Testing - Bench:
The RidgeFit (Mini) Implants with 2.8 mm of gingival height have been cleared under K191895. The gingival heights of 3.8 and 4.8 mm for the lengths 10 and 12mm have been introduced via Memo to File. A fatigue test on the new 4.8 mm gingival height has demonstrated a performance equivalent to the primary predicate device of the K191895. Relevant bench testing, including insertion torque, wear, and dynamic fatigue testing, was performed and provided in K191895 in accordance with 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, Document issued on: May 12, 2004. This submission only intends to propose changes in the labeling of the devices. The subject devices are identical to the previously cleared devices (primary predicate and Memo to File), therefore, no additional performance testing is required.
Performance Testing - Clinical:
The change in the Indications for Use to specifically indicate the RidgeFit (Mini) Implants for a minimum of 4 implants in the mandible and a minimum of 6 implants in the maxilla is supported by a clinical summary article by Lemos et al.1
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
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July 08, 2021
Institut Straumann AG % Jennifer Jackson Director, Regulatory Affairs Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01810
Re: K211052
Trade/Device Name: Straumann RidgeFit Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: April 8, 2021 Received: April 9, 2021
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 Andrew Steen Assistant 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® RidgeFit Implants
Indications for Use (Describe)
Straumann® RidgeFit Implants 02.4 mm are for oral endosteal implantation in the upper and/or lower jaw of fully edentulous patients. The implants can be placed with immediate function when primary stability is achieved for all implants or with conventional loading if primary stability is not achieved for all implants. Straumann® RidgeFit Implants are intended for the stabilization of removable dentures.
- For mandibular restorations, at least 4 Straumann® RidgeFit Implants ø2.4 mm should be placed.
- For maxillary restorations, at least 6 Straumann® RidgeFit Implants Ø2.4 mm should be placed. ●
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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FORM FDA 3881 (6/20)
3
Straumann® RidgeFit Implants
510(k) Summary
510(k) Summary
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 |
| Prepared By &
Alternate Contact: | Chanrasmey White, MS
Regulatory Affairs Specialist
Straumann, USA, LLC |
| Date of Submission: | July 8, 2021 |
Name of the Device
| Trade Names: | Straumann® RidgeFit Implants |
|---|---|
| Common Name: | Endosseous dental implant (21 CFR 872.3640) |
| Classification Name: | Endosseous dental implant (21 CFR 872.3640) |
| Regulation Number: | §872.3640 |
| Device Classification: | II |
| Product Code(s): | DZE |
| Classification Panel: | Dental |
Predicate Device(s)
Primary Predicate:
- K191895 Straumann® Mini Implants .
4
Straumann® RidgeFit Implants
510(k) Summary
Device Description
The Straumann® RidgeFit Implants are tapered implants manufactured from Roxolid (TiZr) with a finished SLA surface. The implant neck is machined with an Optiloc® attachment portion resulting in a one-piece implant system acting as a retention feature for dentures, this feature is coated in a Titanium Nitride (TiN) coating. The Straumann® RidgeFit Implants have an external diameter of 2.4 mm and are available in implant lengths 10 mm, 12 mm and 14 mm with a gingival height of 2.8 mm and implant lengths 10 mm and 12 mm for gingival heights 3.8 mm and 4.8 mm. The Straumann® RidgeFit Implants are identical to the Straumann® Mini Implants cleared under K191895 apart from proposed labeling changes. Note for US Markets, Straumann has identified Straumann® Mini Implants as Straumann® RidgeFit Implants to distinguish it from other markets, this change has been documented through Memo to File. The purpose of this traditional 510(k) is to propose labeling changes to the cleared indications and the addition of contraindications to the existing devices cleared under K191895.
Intended Use
The Straumann® RidgeFit Implants are intended for the stabilization of removable dentures. The removable dentures are connected to the RidgeFit Implants through the incorporated Optiloc® attachment element.
Indications for Use
Straumann® RidgeFit Implants Ø2.4 mm are for oral endosteal implantation in the upper and/or lower jaw of fully edentulous patients. The implants can be placed with immediate function when primary stability is achieved for all implants or with conventional loading if primary stability is not achieved for all implants. Straumann® RidgeFit Implants are intended for the stabilization of removable dentures.
- For mandibular restorations, at least 4 Straumann® RidgeFit Implants Ø2.4 mm should . be placed.
- For maxillary restorations, at least 6 Straumann® RidgeFit Implants ø2.4 mm should be . placed.
5
Straumann® RidgeFit Implants
510(k) Summary
Technological Characteristics
The Straumann® RidgeFit Implants are identical to the Straumann® Mini Implants cleared under K191895 apart from proposed labeling changes under this submission. The purpose of this traditional 510(k) is to propose changes to the cleared indications and to add additional contraindications to the devices cleared under K191895. The technological characteristics of the subject devices are compared to the primary predicate devices in Table 1.
| FEATURE | SUBJECT DEVICES | PRIMARY PREDICATE DEVICES |
|---|---|---|
| K Number | K211052 | K191895 |
| Indications for | ||
| Use | Straumann® RidgeFit Implants Ø2.4 mm are | |
| for oral endosteal implantation in the upper | ||
| and/or lower jaw of fully edentulous patients. | ||
| The implants can be placed with immediate | ||
| function when primary stability is achieved for | ||
| all implants or with conventional loading if | ||
| primary stability is not achieved for all | ||
| implants. Straumann® RidgeFit Implants are | ||
| intended for the stabilization of removable | ||
| dentures. | ||
| · For mandibular restorations, at least 4 | ||
| Straumann® RidgeFit Implants Ø2.4 mm | ||
| should be placed. | ||
| · For maxillary restorations, at least 6 | ||
| Straumann® RidgeFit Implants Ø2.4 mm | ||
| should be placed. | 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. | ||
| Implant | ||
| Diameter | 2.4 mm | 2.4 mm |
| Implant Length | 10, 12, 14 mm | 10, 12, 14 mm |
| Gingival heights | 2.8 mm | 2.8, 3.8 and 4.8 mm |
| Material | Roxolid (TiZr) | Roxolid (TiZr) |
| Coating | TiN coated | TiN coated |
| Surface | ||
| Treatment | SLA | SLA |
| Abutment-to- | ||
| restoration | ||
| connection | Anchor Ball | Anchor Ball |
| Recommended | ||
| restoration | Stabilization of removable dentures | Stabilization of removable dentures |
| Sterilization | ||
| Method | Gamma Irradiation | Gamma Irradiation |
Table 1 - Comparison of the Subject and the Primary Predicate Devices
6
Straumann® RidgeFit Implants
510(k) Summary
Performance Testing
The following performance data support the substantial equivalence determination.
Sterilization Validation and Shelf Life
The Straumann® RidgeFit Implants are single patient devices, are provided sterile via gamma irradiation at a dose of 25 kilogray (2.5 Mrad) Minimum and will be sterilized after final packaging. A sterility assurance level (SAL) of 10° has been 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. The validation method used was the VDmax 25method in accordance with ISO 11137-2:2013, Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose. The sterilization validation and shelf life data have been submitted under K191895. The shelf life of the subject RidgeFit Implants is 5 years. Sterilization method and shelf life are identical to the primary predicate devices cleared under K191895.
Biocompatibility Testing
There are no changes to the materials, surface treatments, or manufacturing methods from the currently marketed predicate devices. Therefore, no new issues of biocompatibility are raised for the subject devices and no additional biocompatibility testing was required.
Electromagnetic Compatibility
There are no changes to the materials, surface treatments, or manufacturing methods from the currently marketed predicate devices. Therefore, no new issues of electromagnetic compatibility are raised for the subject devices and they can be considered MR Conditional.
Performance Testing - Bench
The RidgeFit (Mini) Implants with 2.8 mm of gingival height have been cleared under K191895. The gingival heights of 3.8 and 4.8 mm for the lengths 10 and 12mm have been introduced via Memo to File. A fatigue test on the new 4.8 mm gingival height has demonstrated a performance equivalent to the primary predicate device of the K191895.
Relevant bench testing, including insertion torque, wear, and dynamic fatigue testing, was performed and provided in K191895 in accordance with the FDA guidance document Guidance
7
Straumann® RidgeFit Implants
510(k) Summary
for Industry and FDA Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments, Document issued on: May 12, 2004.
This submission only intends to propose changes in the labeling of the devices. The subject devices are identical to the previously cleared devices (primary predicate and Memo to File), therefore, no additional performance testing is required.
Performance Testing - Clinical
The change in the Indications for Use to specifically indicate the RidgeFit (Mini) Implants for a minimum of 4 implants in the mandible and a minimum of 6 implants in the maxilla is supported by a clinical summary article by Lemos et al.1
Conclusion
The documentation submitted in this premarket notification demonstrates the Straumann® RidgeFit Implants are substantially equivalent to the primary predicate.
1 Lemos CA, Verri FR, Batista VE, Júnior JF, Mello CC, Pellizzer EP. Complete overdentures retained by mini implants: A systematic review. J Dent. 2017 Feb; 57:4-13. Doi: 10.1016/i,ident.2016.11.009. Epub 2016 Nov 22.