(112 days)
Healing abutments, healing caps and closure screws are intended for use with the implants of the Straumann Dental Implant System to protect the inner configuration of the implant and maintain, stabilize and form the soft tissue during the healing process. Fixation caps are used to stabilize bone grafts in cases where bone augmentation is being performed in conjunction with implant placement.
The Straumann Healing Abutments, Healing Caps, and Closure Screws are intended for use with the implants of the Straumann Dental Implant System (SDIS) to protect the inner features of the implant and to maintain, stabilize and form the soft tissue during the healing process. The devices are available in various diameters and heights. They are also not intended for use in immediate loading protocols; none of the devices of the Straumann Sterile Healing Solution are indicated for use in immediate loading protocols as they are intended to protect the internal features of the implant during the healing phase. When the implant has sufficient primary stability, the closure caps and fixation caps are used as a means to retain a bone graft used to augment the bone in the vicinity of the implant. These devices are not intended to be used with granular bone substitute materials or dental membranes.
The document provided is a 510(k) premarket notification for a medical device called "Straumann Sterile Healing Solution." This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving a device meets specific acceptance criteria based on studies involving AI or complex performance metrics typically associated with diagnostic algorithms.
Therefore, the provided document does not contain the information requested regarding acceptance criteria and a study that proves a device meets these criteria in the context of AI/ML or a complex diagnostic system. The document focuses on material, design, and intended use comparison to an existing predicate device for dental implants and associated healing components.
Specifically, the following points from your request cannot be addressed from the given text:
- A table of acceptance criteria and the reported device performance: This document doesn't provide such data. The performance data section refers to sterilization, biocompatibility, and shelf-life validation, not performance metrics for an AI-enabled device.
- Sample sized used for the test set and the data provenance: Not applicable. No test set for an AI model is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There's no AI model or ground truth establishment process described.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: The document explicitly states "No animal or human clinical studies were conducted."
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The document is primarily a regulatory submission demonstrating substantial equivalence based on material, construction, and intended use, rather than performance validation data of an AI-driven or complex diagnostic device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 7, 2016
Institut Straumann AG % Jennifer Jackson Director Of Regulatory Affairs And Quality Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01810
Re: K161677
Trade/Device Name: Straumann Sterile Healing Solution Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: September 5, 2016 Received: September 9, 2016
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 and Part 809); medical device reporting (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); and if applicable, the
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electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and Part 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Michael J. Ryan -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
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Indications for Use
510(k) Number (if known) K161677
Device Name
Straumann® Sterile Healing Solution
Indications for Use (Describe)
Healing abutments, healing caps and closure screws are intended for use with the implants of the Straumann Dental Implant System to protect the inner configuration of the implant and maintain, stabilize and form the soft tissue during the healing process. Fixation caps are used to stabilize bone grafts in cases where bone augmentation is being performed in conjunction with implant placement.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
|X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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| 5. | 510(k) Summary | K161677 |
|---|---|---|
| Submitter: | Straumann USA, LLC (on behalf of Institut Straumann AG)60 Minuteman RoadAndover, MA 01810 | |
| Contact Person: | Jennifer M. Jackson, MSDirector of Regulatory Affairs and Quality+1 (978) 747-2509 | |
| Prepared By: | Christopher KlaczykHead of North American Regulatory AffairsInstitut Straumann AG+41 61 965 1260 | |
| Date Prepared: | October 7, 2016 | |
| Product Code(s): | NHA (21 CFR 872.3630) | |
| Device Class: | II (21 CFR 872.3630) | |
| Classification Panel: | Dental | |
| Classification Name: | Endosseous dental implant abutment (21 CFR 872.3630) | |
| Proprietary Name: | Straumann® Sterile Healing Solution | |
| Predicate Device:: | K130808, Straumann® Sterile Healing Solution (InstitutStraumann) | |
| Reference Device(s): | K062129, Bone Level Implants (Institut Straumann)K120951, SMARTbuilder System (Osstem Implant Co.) | |
| Device Description: | The Straumann Healing Abutments, Healing Caps, and ClosureScrews are intended for use with the implants of the StraumannDental Implant System (SDIS) to protect the inner features ofthe implant and to maintain, stabilize and form the soft tissueduring the healing process. The devices are available in variousdiameters and heights. They are also not intended for use inimmediate loading protocols; none of the devices of theStraumann Sterile Healing Solution are indicated for use inimmediate loading protocols as they are intended to protect theinternal features of the implant during the healing phase.When the implant has sufficient primary stability, the closure | |
| caps and fixation caps are used as a means to retain a bone graft |
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used to augment the bone in the vicinity of the implant. These devices are not intended to be used with granular bone substitute materials or dental membranes.
The subject devices are identified in the table below.
| ArticleNumber | Description |
|---|---|
| 024.0000S | RC Healing Abutment, conical, Ø 4.5, H2 |
| 024.0001S | RC Healing Abutment, conical, Ø 4.5, H4 |
| 024.0002S | RC Healing Abutment, conical, Ø 4.5, H6 |
| 024.0003S | RC Healing Abutment, conical, Ø 6.0, H2 |
| 024.0004S | RC Healing Abutment, conical, Ø 6.0, H4 |
| 024.0005S | RC Healing Abutment, conical, Ø 6.0, H6 |
| 024.2100S | NC Closure Screw, H 0 |
| 024.2100S-04 | NC Closure Screw, H 0 (4-Pack) |
| 024.2105S | NC Closure Screw, H 0.5 |
| 024.2105S-04 | NC Closure Screw, H 0.5 (4-Pack) |
| 024.2220S | NC Closure & Fixation Cap, Ø 5.5mm, Ti |
| 024.4100S | RC Closure Screw, H 0 |
| 024.4100S-04 | RC Closure Screw, H 0 (4-Pack) |
| 024.4105S | RC Closure Screw, H 0.5 |
| 024.4105S-04 | RC Closure Screw, H 0.5 (4-Pack) |
| 024.4220S | RC Closure & Fixation Cap, Ø 5.5mm, Ti |
| 048.324S | NNC Closure Screw, H 0 |
| 048.324SV4 | NNC Closure Screw, H 0 (4-Pack) |
| 048.325S | NNC Closure Screw, H 0.5 |
| 048.325SV4 | NNC Closure Screw, H 0.5 (4-Pack) |
| 048.371SV4 | RN Closure Cap, H 0, Ti (4-Pack) |
| 048.373SV4 | RN Closure Cap, H 1.5 mm, Ti (4-Pack) |
Indications For Use: Healing abutments, healing caps and closure screws are intended for use with the implants of the Straumann Dental Implant System to protect the inner configuration of the implant and maintain, stabilize and form the soft tissue during the healing process. Fixation caps are used to stabilize bone grafts in cases where bone augmentation is being performed in conjunction with implant placement. Materials: The material for all Healing Abutments, Closure Caps and Closure Screws is commercially pure Titanium (grade 4)
conforming to ISO 5832-2.
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Technological Characteristics:
A comparison of the relevant technological characteristics between the subject and primary predicate devices is provided in the table that follows.
| Feature | Primary Predicate DeviceStraumann Sterile Healing Solution | Subject DevicesStraumann Sterile Healing Solution |
|---|---|---|
| Indications For UseK130808 | Closure screws, healing caps, and healingabutments, are intended for use with thestraumann dental implant system (sdis) toprotect the inner configuration of theimplant and maintain, stabilize and formthe soft tissue during the healing process.Customizable healing abutments made ofpeek are for use for up to six months. | Healing abutments, healing caps andclosure screws are intended for use with theimplants of the Straumann Dental ImplantSystem to protect the inner configuration ofthe implant and maintain, stabilize andform the soft tissue during the healingprocess. Fixation caps are used to stabilizebone grafts in cases where boneaugmentation is being performed inconjunction with implant placement. |
| Indications For UseK120951 | SMARTbuilder System is a metal (Non-resorbable membrane) device intended foruse with a dental implant to stabilize andsupport of bone graft in dento-alveolarbony defect sites. | The Indications for Use differ with theremoval of the PEEK abutments. Thesubject devices do not include PEEKabutments and only include Titaniumabutments; therefore the modification ofthe Indications for Use is acceptable as thePEEK abutment limitation for 6 monthsdoes not apply to the subject device |
| Compatible Implants | Straumann Bone Level implants having theNC and RC implant-to-abutment interfacegeometries.Straumann Tissue Level implants havingthe NNC, RN and WN implant-to-abutmentinterface geometries. | Straumann Bone Level implants having theNC and RC implant-to-abutment interfacegeometries.Straumann Tissue Level implants havingthe NNC and RN implant-to-abutmentinterface geometries. |
| Material | Commercially pure grade 4 Titaniumper ISO 5832-2 | Commercially pure grade 4 Titaniumper ISO 5832-2 |
| Construction | One-piece solid device. | One-piece solid devices and two-piecedevice assemblies. Two-piece devices aresupported via comparison with componentsof the Osstem SMARTbuilder System(K120951) |
| Packaging | Primary barrier package consists of aPETG blister tray with a PETG insert and aTyvek 1073B lid stock. The primarypackage is contained within a paperboardshelf box. | Primary barrier package consists of aPETG blister tray with a PETG insert and aTyvek 1073B lid stock. The primarypackage is contained within a paperboardshelf box. |
| Sterility | Provided sterile via gamma irradiation to aSterility Assurance Level of 10-6.Cycle validated per ISO 11137-2. | Provided sterile via gamma irradiation to aSterility Assurance Level of 10-6.Cycle validated per ISO 11137-2. |
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| Performance Data: | Test data to support the evaluation of the subject closure capand fixation cap devices has been included directly or byreference as follows:Sterilization validation in accordance with ISO 11137 series of standards. Biocompatibility assessment per the ISO 10993 series of standards. Shelf Life validation in accordance ASTM F1980 |
|---|---|
| No animal or human clinical studies were conducted. | |
| Conclusions: | Based upon our assessment of the design and applicableperformance data, the subject devices have been determined tobe substantially equivalent to the identified predicate devices. |
§ 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.)