(166 days)
Straumann® Screw Retained Abutments are indicated to be placed into the implants of the Straumann® Dental Implant System to provide support for prosthetic reconstructions such as crowns, bridges and bars. The final processed devices have the purpose of restoring chewing function. Straumann® Screw Retained Abutments are indicated for screw-retained restorations.
Straumann® Screw Retained Abutments include one-piece straight and angled (17° and 30°) abutments, basal screws and abutment carrier pin. The subject device is identical to the primary predicate, K133421, and subsequent premarket notification submissions K141871, K150814 and K151247 with the exception that the subject device will be delivered to the user sterile as opposed to non-sterile and a change in packaging to ensure sterility of the devices.
This document is a 510(k) premarket notification for the Straumann® Screw Retained Abutments. It aims to demonstrate substantial equivalence to previously cleared predicate devices. Since this is not a diagnostic device and doesn't involve an AI algorithm, the information requested in your prompt (acceptance criteria, study details, expert input, MRMC study, standalone performance, training set) typically applies to AI/ML-based medical devices or diagnostic tools.
This submission focuses on engineering, material, and sterilization equivalence for a dental implant component. Therefore, the detailed AI/ML-specific questions in your prompt are not applicable to this document.
However, I can extract information related to the device's technical characteristics and the claim of substantial equivalence.
Here's a breakdown of what is applicable from your prompt, based on the provided text:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly state "acceptance criteria" in the format typically used for performance metrics of diagnostic algorithms. Instead, it relies on demonstrating substantial equivalence to predicate devices. This means that the device's characteristics must be similar enough to the predicate to ensure equivalent safety and effectiveness.
The table provided (pages 5-6) serves as the primary evidence for this. It compares the Subject Device (Straumann® Screw Retained Abutments) to several Predicate Devices across various technical characteristics. The "performance" in this context is demonstrating that these characteristics are either identical or sufficiently similar to the legally marketed predicates.
| Feature | Subject Device Performance | Predicate Device Performance (K133421, K141871, K150814, K151247) |
|---|---|---|
| Indications for Use | Straumann® Screw Retained Abutments are indicated to be placed into the implants of the Straumann® Dental Implant System to provide support for prosthetic reconstructions such as crowns, bridges and bars. The final processed devices have the purpose of restoring chewing function. Straumann® Screw Retained Abutments are indicated for screw-retained restorations. (Identical to predicates) | Straumann® Magellan™ Screw Retained Abutments are indicated to be placed into the implants of the Straumann® Dental Implant System to provide support for prosthetic reconstructions such as crowns, bridges and bars. The final processed devices have the purpose of restoring chewing function. Straumann® Screw Retained Abutments are indicated for screw-retained restorations. (For K133421, K141871, K150814, K151247) |
| Implant-to-Abutment Connection | Narrow CrossFit (NC), Regular CrossFit (RC) (Identical to K133421, K151247; broader than K141871, K150814 which only list NC) | Narrow CrossFit (NC), Regular CrossFit (RC) (K133421, K151247)Narrow CrossFit (NC) (K141871, K150814) |
| Interface Type | Engaging (Identical to all predicates) | Engaging (All predicates) |
| Platform Diameter(s) | NC Straight and Angled: Ø3.5 mm, Ø4.6 mmRC Straight and Angled: Ø4.6 mm (Comparable ranges; Subject device appears to cover the full range of predicates) | NC Straight: Ø3.5 mm, Ø4.6 mmRC Straight and Angled: Ø4.6 mm (K133421)NC Angled: Ø3.5 mm, Ø4.6 mm (K141871)NC Straight: Ø3.5 mm, Ø4.6 mm (K150814)NC Angled: Ø3.5 mm, Ø4.6 mmRC Angled: Ø4.6 mm (K151247) |
| Abutment Angulation(s) | 0°, 17°, 30° (Identical to K133421, K151247; broader than K141871 (17°, 30°) and K150814 (0°)) | 0°, 17°, 30° (K133421)17°, 30° (K141871, K151247) 0° (K150814) |
| Gingival Height(s) | NC and RC Straight: 1.0, 2.5 and 4.0 mmNC and RC Angled: 2.5, 4.0 and 5.5 mm (Comparable and comprehensive ranges) | NC and RC Straight: 1.0, 2.5 and 4.0 mmRC Angled: 2.5 and 4.0 mm (K133421)NC Angled: 2.5 and 4.0 mm (K141871)NC Straight: 1.0 mm (K150814)NC and RC Angled: 5.5 mm (K151247) |
| Orientation of Angulation to Engagement Features | Type A (45°), Type B (0°) (Identical to K133421, K141871, K151247; not applicable for K150814 as it's 0°) | Type A (45°), Type B (0°) (K133421, K141871, K151247)N/A (K150814) |
| Device Material | Ti-6Al-7Nb titanium alloy (Identical to all predicates) | Ti-6Al-7Nb titanium alloy (All predicates) |
| Sterilization Status | End user receives product sterilized per Gamma Irradiation, 25 kGy minimum, Validated per ISO 11137-1 and ISO 11137-2 to an SAL of 10 x 10-6 (Key difference: Subject device is sterile upon delivery) | End user to sterilize product per IFU Method: Autoclave moist heat fractionated vacuum or gravity displacement Conditions: 134°C (273°F) for 5 minutes (All predicates are non-sterile; user is responsible for sterilization) |
| Packaging | Changed to ensure sterility. Equivalent to reference predicate device, Straumann® Healing Abutments, Healing Caps, Closure Screws (K130808) (Difference from non-sterile predicates, similarity to sterile reference predicate) | Not explicitly detailed for non-sterile predicates, but implied to be non-sterile packaging. K130808 (sterile reference predicate) has equivalent packaging. |
The study proving the device meets its "acceptance criteria" (i.e., substantial equivalence) is the comparison to predicate devices and the verification/validation activities for the changes (primarily sterilization and packaging). The document explicitly states: "The subject device is identical to the primary predicate, K133421, and subsequent premarket notification submissions K141871, K150814 and K151247 with the exception that the subject device will be delivered to the user sterile as opposed to non-sterile and a change in packaging to ensure sterility of the devices." And "Packaging materials and configuration is equivalent to reference predicate device, Straumann® Healing Abutments, Healing Caps, Closure Screws, K130808."
The substantial equivalence is primarily based on:
- Identical Indications for Use.
- Identical fundamental operating principles.
- Identical materials (Ti-6Al-7Nb titanium alloy).
- Comparable design features (Implant-to-Abutment Connection, Interface Type, Platform Diameter(s), Abutment Angulation(s), Gingival Height(s), Orientation of Angulation to Engagement Features).
- Validation of the sterilization process according to recognized standards (ISO 11137-1 and ISO 11137-2) and equivalence of packaging to a previously cleared sterile device (K130808).
The following points are not applicable to this 510(k) submission for a non-AI/ML dental abutment:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
5. 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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
8. The sample size for the training set
9. How the ground truth for the training set was established
These points would be relevant for devices that involve algorithms, image interpretation, or diagnostics where a "ground truth" needs to be established and performance metrics (e.g., sensitivity, specificity, AUC) are calculated based on a test set. This submission is for a physical medical device (dental abutment) where the primary evaluation is based on engineering design, material properties, and manufacturing processes, demonstrated through comparison to legally marketed predicate devices and validation of changes like sterilization.
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Straumann USA, LLC (on behalf of Institut Straumann AG) % Jennifer M. Jackson, MS Director, Regulatory Affairs & Quality Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01810
November 27, 2017
Re: K171757
Trade/Device Name: Straumann® Screw Retained Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: October 25, 2017 Received: October 26, 2017
Dear Jennifer M. 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.
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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); 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 medical devices and radiation-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
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Indications for Use
510(k) Number (if known)
Device Name Straumann® Screw Retained Abutments
Indications for Use (Describe)
Straumann® Screw Retained Abutments are indicated to be placed into the implants of the Straumann® Dental Implant System to provide support for prosthetions such as crowns, bridges and bass. The final processed devices have the purpose of restoring chewing function. Straumann® Screw Retained Abutments are indicated for screw-retained restorations.
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) |
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Straumann® Screw Retained Abutments
510(k) Summary
5 510(k) Summary
5.1 Submitter
Straumann USA, LLC (on behalf of Institut Straumann AG)
60 Minuteman Road
Andover, MA 01810
| Phone Number: | 1-978-747-2614 |
|---|---|
| --------------- | ---------------- |
Fax Number: 1-978-747-0041
Contact Person: Chanrasmey White
Date of Submission: 10/25/2017
5.2 Device
| Trade Name: | Straumann® Screw Retained Abutments |
|---|---|
| Common Name: | Endosseous Dental Implant Abutments |
| Classification Name: | Endosseous Dental Implant Abutments |
| Regulatory Class: | II (21 CFR §872.3630) |
| Product Code: | NHA (21 CFR §872.3630) |
5.3 Predicate Device
Primary Predicate:
-
(K133421) Straumann® Magellan™ Screw Retained Abutment System ●
Reference Predicate: -
(K141871) Straumann Bone Level NC Angled Screw Retained Abutments ●
-
(K151247) Straumann Screw Retained Abutments ●
-
(K150814) Straumann Screw-Retained Abutment .
-
(K130808) Straumann Healing Abutments, Healing Caps, Closure Screws ●
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Straumann® Screw Retained Abutments
510(k) Summary
Device Description 5.4
Straumann® Screw Retained Abutments include one-piece straight and angled (17° and 30°) abutments, basal screws and abutment carrier pin. The subject device is identical to the primary predicate, K133421, and subsequent premarket notification submissions K141871, K150814 and K151247 with the exception that the subject device will be delivered to the user sterile as opposed to non-sterile and a change in packaging to ensure sterility of the devices.
5.5 Indications for Use
Straumann® Screw Retained Abutments are indicated to be placed into the implants of the Straumann® Dental Implant System to provide support for prosthetic reconstructions such as crowns, bridges and bars. The final processed devices have the purpose of restoring chewing function. Straumann® Screw Retained Abutments are indicated for screw-retained restorations.
Technoloqical Characteristics 5.6
The proposed Straumann® Screw Retained Abutments intended use, material, fundamental operating principles and overall design are identical to the primary predicate device. The subject device is identical to the primary predicate. K133421, and subsequent premarket notification submissions K141871, K150814 and K151247 with the exception that the subject device will be delivered to the user sterile as opposed to non-sterile and a change in packaging to ensure sterility of the devices. Packaging materials and configuration is equivalent to reference predicate device, Straumann® Straumann Healing Abutments, Healing Caps, Closure Screws, K130808. The technological characteristics of the subject devices are compared to the non-sterile predicate devices (K133421, K141871, K150814 and K151247) in the following table.
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Straumann® Screw Retained Abutments
510(k) Summary
| Feature | Subject Device | Primary PREDICATEDevice | Reference DEVICE | Reference DEVICE | Reference DEVICE |
|---|---|---|---|---|---|
| K Number | K133421 | K141871 | K150814 | K151247 | |
| Indication | Straumann® ScrewRetained Abutments areindicated to be placed intothe implants of theStraumann® Dental ImplantSystem to provide supportfor prostheticreconstructions such ascrowns, bridges and bars.The final processed deviceshave the purpose ofrestoring chewing function.Straumann® ScrewRetained Abutments areindicated for screw-retainedrestorations. | Straumann® Magellan ™Screw Retained Abutmentsare indicated to be placedinto the implants of theStraumann® Dental ImplantSystem to provide supportfor prostheticreconstructions such ascrowns, bridges and bars.The final processed deviceshave the purpose ofrestoring chewing function.Straumann® ScrewRetained Abutments areindicated for screw-retainedrestorations. | Straumann® ScrewRetained Abutments areindicated to be placed intothe implants of theStraumann® Dental ImplantSystem to provide supportfor prostheticreconstructions such ascrowns, bridges and bars.The final processed deviceshave the purpose ofrestoring chewing function.Straumann® ScrewRetained Abutments areindicated for screw-retainedrestorations. | Straumann® ScrewRetained Abutments areindicated to be placed intothe implants of theStraumann® Dental ImplantSystem to provide supportfor prostheticreconstructions such ascrowns, bridges and bars.The final processed deviceshave the purpose ofrestoring chewing function.Straumann® ScrewRetained Abutments areindicated for screw-retainedrestorations. | Straumann® ScrewRetained Abutments areindicated to be placed intothe implants of theStraumann® Dental ImplantSystem to provide supportfor prostheticreconstructions such ascrowns, bridges and bars.The final processed deviceshave the purpose ofrestoring chewing function.Straumann® ScrewRetained Abutments areindicated for screw-retainedrestorations. |
| Implant-to-AbutmentConnection | Narrow CrossFit (NC)Regular CrossFit (RC) | Narrow CrossFit (NC)Regular CrossFit (RC) | Narrow CrossFit (NC) | Narrow CrossFit (NC) | Narrow CrossFit (NC)Regular CrossFit (RC) |
| Interface Type | Engaging | Engaging | Engaging | Engaging | Engaging |
| Platform Diameter(s) | NC Straight and Angled: | NC Straight: | NC Angled:Ø3.5 mm, Ø4.6 mm | NC Straight:Ø3.5 mm, Ø4.6 mm | NC Angled:Ø3.5 mm, Ø4.6 mmRC Angled: |
| Feature | Subject Device | Primary PREDICATE Device | Reference DEVICE | Reference DEVICE | Reference DEVICE |
| K Number | K133421 | K141871 | K150814 | K151247 | |
| Ø3.5 mm, Ø4.6 mmRC Straight and Angled:Ø4.6 mm | Ø3.5 mm, Ø4.6 mmRC Straight and Angled:Ø4.6 mm | Ø4.6 mm | |||
| Abutment Angulation(s) | 0°, 17°, 30° | 0°, 17°, 30° | 17°, 30° | 0° | 17°, 30° |
| Gingival Height(s) | NC and RC Straight:1.0, 2.5 and 4.0 mmNC and RC Angled:2.5, 4.0 and 5.5 mm | NC and RC Straight:1.0, 2.5 and 4.0 mmRC Angled:2.5 and 4.0 mm | NC Angled:2.5 and 4.0 mm | NC Straight:1.0 mm | NC and RC Angled:5.5 mm |
| Orientation of Angulationto Engagement Features | Type A (45°), Type B (0°) | Type A (45°), Type B (0°) | Type A (45°), Type B (0°) | N/A | Type A (45°), Type B (0°) |
| Device Material | Ti-6Al-7Nb titanium alloy | Ti-6Al-7Nb titanium alloy | Ti-6Al-7Nb titanium alloy | Ti-6Al-7Nb titanium alloy | Ti-6Al-7Nb titanium alloy |
| Sterilization | End user receives productsterilized per GammaIrradiation, 25 kGy minimumValidated per ISO 11137-1and ISO11137-2 to an SAL of 10 x10-6 | End user to sterilize productper IFU Method: Autoclavemoist heat fractionatedvacuum or gravitydisplacementConditions: 134°C (273°F)for 5 minutes | End user to sterilize productper IFU Method: Autoclavemoist heat fractionatedvacuum or gravitydisplacementConditions: 134°C (273°F)for 5 minutes | End user to sterilize productper IFU Method: Autoclavemoist heat fractionatedvacuum or gravitydisplacementConditions: 134°C (273°F)for 5 minutes | End user to sterilize productper IFU Method: Autoclavemoist heat fractionatedvacuum or gravitydisplacementConditions: 134°C (273°F)for 5 minutes |
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Straumann® Screw Retained Abutments
510(k) Summary
Table 1: Comparison of Subject Devices to non-sterile Predicates
§ 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.)