(161 days)
Straumann® Anatomic Healing Abutments are indicated to be placed in partially edentulous patients after implant placement. The healing components protect the inner configuration of the implant and form, maintain and stabilize the soft tissue during the healing process. Healing components have a maximum duration of usage of 180 days.
The Straumann Anatomic Healing Abutments XC (referred to as the AHAs) are intended for use with the Straumann Dental Implant System (SDIS). The healing components protect the inner configuration of the implant and form, maintain, and stabilize the soft tissue during the osseointegration phase of Straumann endosseous dental implants to be rehabilitated using the delayed loading technique. The AHA are to be used during the implant placement surgery or in the reopening surgery (second surgical phase) and are for temporary use up to 180 days. The AHAs are to be placed out of occlusion. The healing abutments do not support a prosthetic restoration.
The AHAs are composed of two united parts: a body that allows for customization and includes a through hole for fixation screw access, and a basal screw that cannot be altered. The Anatomic Healing Abutments are intended to be customized using only hand milling instruments manually controlled by dental professionals. To protect the consistent emergence profile for final abutment, a maximum 3mm height can be modified down to the occlusal surface. To preserve the scanning function of AHA, a 4.7mm circular area around the central axis of the screw channel cannot be modified. The body is milled from polyetheretherketone (PEEK Classix). The basal screws are existing basal screws manufactured from Titanium-Aluminum-Niobium (TAN) alloy previously cleared as part of the Straumann BLX system in K173961.
The AHA are designed for connection to BLC and BLX implants of the Straumann Dental Implant System (K173961, K181703, K191256, K210855, K212533, K230108, and K234049). The AHA are available in diameters of Ø3.8 mm, 4.5mm, 5.5mm, and 6.5mm. They are available in 4 shapes designed according to specific areas of the dentition including S, S1, M, and XL, however, they are not limited to use exclusively in these positions. The AHA are offered in regular base (RB) and wide base (WB) configurations consistent with the Straumann BLX and BLC prosthetic platform offerings.
The AHAs may also be used in intraoral scanning procedures of single-unit restorations to represent the position, axis, and orientation of the dental implant placed in the patient's jaw relative to the surrounding dentition. A scanbody feature extends from the occlusal surface of the AHA.
The provided text is a 510(k) summary for the Straumann Anatomic Healing Abutments XC (AHA). It describes the device, its intended use, and compares it to predicate devices. However, this document does not contain the detailed acceptance criteria or a study designed to prove the device meets specific performance criteria in the format typically used for AI/software-based medical devices.
Instead, this 510(k) summary focuses on demonstrating substantial equivalence to existing legally marketed devices through comparisons of technological characteristics, intended use, and various performance tests (sterilization, shelf life, biocompatibility, torque, and basic software verification) that confirm the new device functions as expected for a medical device of its class, rather than proving specific numerical performance metrics against defined acceptance criteria in a clinical setting.
Therefore, I cannot populate the requested table and answer many of the questions as the information is not present in the provided text.
Here is what can be extracted and inferred from the document:
1. Table of Acceptance Criteria and Reported Device Performance
As mentioned, explicit, quantifiable acceptance criteria with corresponding performance results are not provided in the document for the device itself (Straumann® Anatomic Healing Abutments XC). The document focuses on demonstrating substantial equivalence to predicate devices through various tests rather than meeting numerical performance thresholds for image analysis or diagnostic accuracy.
The performance tests mentioned are:
- Sterilization Validation and Shelf Life:
- Acceptance Criteria (inferred): Sterility Assurance Level (SAL) of 10^-6 for gamma irradiation and successful steam sterilization validation. Packaging stability for a 5-year shelf life.
- Reported Performance: Met SAL of 10^-6 using VDmax25 in accordance with ISO 11137-1:2006. Steam sterilization validation met all test method acceptance criteria. Packaging stability for the 5-year shelf life of predicate devices was adopted.
- Pyrogen Testing (LAL test):
- Acceptance Criteria (inferred): Pyrogen limit specification of 20 endotoxin units (EU)/device.
- Reported Performance: Met the specified limit.
- Biocompatibility Testing:
- Acceptance Criteria (inferred): No cytotoxic reaction, no extractable substances above Analytical Evaluation Threshold (AET).
- Reported Performance: No cytotoxic reaction detected. No extractable substances detected above AET.
- Performance Testing - Bench (Torque Testing):
- Acceptance Criteria (inferred): Withstands repeated insertion and removal torques without damage.
- Reported Performance: Performed, demonstrating the AHA withstands repeated insertion and removal torques without damage. (Specific numerical thresholds not provided).
- Software Testing (Scan Verification and Integration):
- Acceptance Criteria (inferred): Can be scanned with an intraoral scanner and is suitable to work with CARES Visual software.
- Reported Performance: Performed, demonstrating the subject AHAs can be scanned with an intraoral scanner and are suitable to work with CARES Visual software. (No specific metrics provided).
2. Sample size used for the test set and the data provenance
- The document describes engineering tests (sterilization validation, mechanical torque testing, biocompatibility, software verification) rather than a clinical study with a "test set" of patient data. Therefore, this information is not applicable in the context of this 510(k) for a physical device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable as this is not a study involving expert-derived ground truth on a clinical dataset for AI/software performance.
4. Adjudication method for the test set
- Not applicable.
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
- Not applicable. This is a physical medical device (healing abutment), not an AI/software for diagnostic assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the engineering tests:
- Sterilization/Pyrogenicity: Laboratory test results against validated standards and specified limits.
- Biocompatibility: Laboratory test results against ISO standards and AET.
- Torque Testing: Mechanical testing results against functional requirements (withstanding torque without damage).
- Software Testing: Functional verification (can be scanned, works with software).
8. The sample size for the training set
- Not applicable, as this is a physical device and not an AI/ML model that requires a "training set."
9. How the ground truth for the training set was established
- Not applicable.
Summary of what the document implies about meeting criteria:
The document asserts that the Straumann® Anatomic Healing Abutments XC (AHA) meet the necessary performance criteria through a series of benchtop engineering tests and validations designed to demonstrate:
- Effective sterilization (gamma irradiation and steam sterilization).
- Pyrogenicity within acceptable limits.
- Biocompatibility of the materials.
- Mechanical integrity (torque resistance).
- Compatibility with intraoral scanning and associated software.
The primary "study" presented is a comparison to predicate devices to establish substantial equivalence based on similar technological characteristics and performance testing. The "acceptance criteria" are implicitly met by successful completion of these validation tests against established industry standards (e.g., ISO) and functional requirements, rather than through a clinical study with statistical performance metrics against a defined ground truth.
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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.
November 11, 2024
Straumann USA, LLC Jennifer Jackson Sr. Director, Regulatory Affairs and Quality 60 Minuteman Road Andover, Massachusetts 01810
Re: K241575
Trade/Device Name: Straumann® Anatomic Healing Abutments XC (AHA) Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: October 24, 2024 Received: October 25, 2024
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 (the 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 available 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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
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For comprehensive regulatory information about mediation-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,
Andrew I. Steen -S
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Submission Number (if known)
Device Name
Straumann® Anatomic Healing Abutments XC (AHA)
Indications for Use (Describe)
Straumann® Anatomic Healing Abutments are indicated to be placed in partially edentulous patients after implant placement. The healing components protect the inner configuration of the implant and form, maintain and stabilize the soft tissue during the healing components have a maximum duration of usage of 180 days.
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 Anatomic Healing Abutments XC (AHA)
K241575
Submitter's Contact Information
| Submitter: | Straumann USA, LLC (on behalf of Institut Straumann AG) |
|---|---|
| 60 Minuteman Road | |
| Andover, MA 01810 | |
| Registration No.: 1222315Owner/Operator No.: 9005052 | |
| On the behalf of: | |
| Institut Straumann AG | |
| Peter Merian weg 12 | |
| Basel BS CH-4002 Switzerland | |
| Contact Person: | Jennifer M. Jackson, MS, RAC |
| Sr. Director, Regulatory Affairs and Quality | |
| Phone Number: +1 978 747-2509 | |
| Fax Number: +1 978 747-0023 | |
| Prepared By &Alternate Contact: | Laura BleyendaalSr. RA SpecialistStraumann USA, LLCPhone number: +1 978 747-2768 |
| Date of Submission: | November 5, 2024 |
| Name of the Device | |
| Trade Names: | Straumann Anatomic Healing Abutments XC (AHA) |
| Common Name: | Abutment, Implant, Dental, Endosseous |
| Classification Name: | Endosseous dental implant abutment |
| Regulation Number: | §872.3630 |
| DeviceClassification: | II |
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Straumann Anatomic Healing Abutments XC (AHA)
Product Code(s): NHA
Classification Panel: Dental
Predicate Device(s)
Primary Predicate:
-
Straumann Healing Abutments (K130808) .
Reference Devices: -
BellaTek Encode Emergence Healing Abutment (K212730) .
-
Protective caps of the Straumann Magellan Abutment System (K133421) .
-
Straumann BLX Basal Screws (K173961) .
-
. MRI Compatibility for Existing Straumann Dental Implant Systems (K190662)
Device Description
The Straumann Anatomic Healing Abutments XC (referred to as the AHAs) are intended for use with the Straumann Dental Implant System (SDIS). The healing components protect the inner configuration of the implant and form, maintain, and stabilize the soft tissue during the osseointegration phase of Straumann endosseous dental implants to be rehabilitated using the delayed loading technique. The AHA are to be used during the implant placement surgery or in the reopening surgery (second surgical phase) and are for temporary use up to 180 days. The AHAs are to be placed out of occlusion. The healing abutments do not support a prosthetic restoration.
The AHAs are composed of two united parts: a body that allows for customization and includes a through hole for fixation screw access, and a basal screw that cannot be altered. The Anatomic Healing Abutments are intended to be customized using only hand milling instruments manually controlled by dental professionals. To protect the consistent emergence profile for final abutment, a maximum 3mm height can be modified down to the occlusal surface. To preserve the scanning function of AHA, a
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Straumann Anatomic Healing Abutments XC (AHA)
K241575
4.7mm circular area around the central axis of the screw channel cannot be modified. Figure 1 depicts, in green, the customizable areas on an AHA. The body is milled from polyetheretherketone (PEEK Classix). The basal screws are existing basal screws manufactured from Titanium-Aluminum-Niobium (TAN) alloy previously cleared as part of the Straumann BLX system in K173961.
Image /page/6/Picture/4 description: The image shows a dental implant. The implant is made of metal and has a screw-like shape. The implant is inserted into the jawbone to replace a missing tooth. The image also shows the abutment, which is the part of the implant that connects to the crown.
Figure 1. Representative image of an AHA connected to a BLX implant. The green area may be customized whereas the red area is not to be customized.
The AHA are designed for connection to BLC and BLX implants of the Straumann Dental Implant System (K173961, K181703, K191256, K210855, K212533, K230108, and K234049). The AHA are available in diameters of Ø3.8 mm, 4.5mm, 5.5mm, and 6.5mm. They are available in 4 shapes designed according to specific areas of the dentition including S, S1, M, and XL, however, they are not limited to use exclusively in these positions. The AHA are offered in regular base (RB) and wide base (WB) configurations consistent with the Straumann BLX and BLC prosthetic platform offerings.
The AHAs may also be used in intraoral scanning procedures of single-unit restorations to represent the position, axis, and orientation of the dental implant placed in the patient's jaw relative to the surrounding dentition. A scanbody feature extends from the
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Straumann Anatomic Healing Abutments XC (AHA)
occlusal surface of the AHA.
Intended Use
Straumann sterile healing components are intended for use with implants of the Straumann Dental Implant System (SDIS) to protect the inner configuration of the implant and maintain, stabilize and form the soft tissue during the healing process.
Indications for Use
Straumann Anatomic Healing Abutments are indicated to be placed in partially edentulous patients after implant placement. The healing components protect the inner configuration of the implant and form, maintain and stabilize the soft tissue during the healing process. Healing components have a maximum duration of usage of 180 days.
Summary of Similarities and Differences in Technological Characteristics and Intended Use
The proposed indications for use for the subject AHA are the consistent with the indications for use for the currently marketed Straumann Healing Abutments. Both devices are intended as healing abutments for use with a Straumann dental implant to protect the inner configuration of the implant and maintain, stabilize and form the soft tissue during the healing process. The duration of usage in both statements is identified as a maximum of 180 days stated in another format as up to six months (6 months times approximately 30 days per month results in 180 days). Table 1 includes the exact indications for use statements.
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Straumann Anatomic Healing Abutments XC (AHA)
K241575
Table 1 Comparison of the subject, primary predicate, and reference devices' indications for use
| Subject DeviceStraumannAnatomic HealingAbutments (AHA) | Primary PredicateStraumannHealingAbutmentsInstituteStraumann AGK130808 | Reference DeviceBellaTek EncodeEmergence HealingAbutmentBiomet 3i LLCK212730 | Reference DeviceStraumann BLXBasal ScrewsInstituteStraumann AGK173961 | Reference DeviceProtective caps ofStraumannMagellan AbutmentSystemInstitute StraumannAGK133421 | |
|---|---|---|---|---|---|
| Indications forUse Statement | Intended useStraumann sterilehealing componentsare intended for usewith implants of theStraumann DentalImplant System(SDIS) to protect theinner configuration ofthe implant andmaintain, stabilizeand form the softtissue during thehealing process.Indications for useStraumann AnatomicHealing Abutmentsare indicated to beplaced in partiallyedentulous patientsafter implant | Closure screws,healing caps, andhealing abutments,are intended for usewith the StraumannDental ImplantSystem (SDIS) toprotect the innerconfiguration of theimplant andmaintain, stabilizeand form the softtissue during thehealing process.Customizablehealing abutmentsmade of PEEK arefor use up to sixmonths. | The BellaTek EncodeEmergence HealingAbutments areintended for use asan accessory toendosseous dentalimplants duringendosseous andgingival healing toprepare gingivaltissue for acceptanceof a final abutmentand restoration.1 | Straumann BLXBasal Screws andTemporaryAbutmentsProstheticcomponentsdirectly or indirectlyconnected to theendosseous dentalimplant areintended for use asan aid in prostheticrehabilitations.Temporarycomponents can beused prior to theinsertion of the finalcomponents tomaintain, stabilizeand shape the softtissue during thehealing phase; they | The StraumannMagellan abutmentsare indicated to beplaced intoStraumann dentalimplants to providesupport for prostheticreconstructions suchas crowns, bridgesand bars.The final processeddevices have thepurpose of restoringchewing function.Magellan abutmentsare indicated forscrew-retainedrestorations.The protective capsare placed onabutments to protect |
| K241575 | |||||
| Subject DeviceStraumannAnatomic HealingAbutments (AHA) | Primary PredicateStraumannHealingAbutmentsInstituteStraumann AGK130808 | Reference DeviceBellaTek EncodeEmergence HealingAbutmentBiomet 3i LLCK212730 | Reference DeviceStraumann BLXBasal ScrewsInstituteStraumann AGK173961 | Reference DeviceProtective caps ofStraumannMagellan AbutmentSystemInstitute StraumannAGK133421 | |
| placement. Thehealing componentsprotect the innerconfiguration of theimplant and form,maintain, andstabilize the softtissue during thehealing process.Healing componentshave a maximumduration of usage of180 days. | may not be placedinto occlusion. Finalabutments may beplaced intoocclusion when theimplant is fullyosseointegrated.BLX TemporaryAbutments have amaximum durationof usage of 180days. | the outerconfiguration of theabutment andmaintain, stabilizeand contour the softtissue during thehealing process. | |||
| FDA ProductCode | NHA | NHA | NHA | NHA | NHA |
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Straumann Anatomic Healing Abutments XC (AHA)
The technological characteristics of the subject AHA are consistent with those of the primary predicate and reference devices. Each device features a two-piece screw retained design. Like the previously cleared Straumann healing abutments customizable, the subject AHA may be customized and is composed of a PEEK abutment with a titaniumaluminum niobium (TAN) alloy basal screw that is supplied sterile by gamma radiation for single use. Like the previously
{10}------------------------------------------------
Straumann Anatomic Healing Abutments XC (AHA)
cleared Bellatek Encode Emergence Healing Abutments, the subject AHA can be scanned using an intra oral scanner and features markings that can be visualized in STL files. A detailed comparison of the subject, predicate, and reference devices is included in Table 2.
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Straumann Anatomic Healing Abutments XC (AHA)
K241575
Table 2 Comparison of the design and technological characteristics of the subject, predicate, and reference devices
| Subject DeviceStraumann AnatomicHealing AbutmentsXC (AHA) | Primary PredicateStraumann HealingAbutmentsCustomizableInstitute StraumannAGK130808 | ReferenceDeviceBellaTekEncodeEmergenceHealingAbutmentK212730Biomet 3i LLC | Reference DeviceStraumann BLX BasalScrewsInstitute StraumannAGK173961 | Reference DeviceProtective caps of StraumannMagellan Abutment SystemK133421 | Equivalence Discussion | |
|---|---|---|---|---|---|---|
| Abutment Design | Screw retained | Screw retained | Screw retained1 | Not applicable | Screw retained | Equivalent |
| Abutment Shape | Various anatomicalshapes intended fordifferent toothlocations | Conical | Conical | Not applicable | Cylindrical protective caps | Numerous shapes of healing abutments areavailable. The physician chooses the appropriatelysized healing abutment based on his treatmentplan. Many healing abutments can be furthermodified chairside by the physician to fit thepatient's interocclusal space. No new questions ofsafety or effectiveness are raised with anatomicalshaped healing abutments. |
| Body (Ø in mm) | 3.8, 4.5, 5.5, 6.5 | 5,7 | TSV abutments3.5, 4.5, 5.7Eztetic abutments2.9Certainabutments 3.4,4.1, 5.0 and 6.01 | Not applicable | 3.5, 4.6 | Body Ø is driven by the associated implant andprosthetic system. Different implant systems havedifferent prosthetic platforms. No new questions ofsafety or effectiveness are raised. |
| Abutment Length* | Ø3.8mm, Ø4.5mm:6.2mm and 7.2mmØ5.5mm, Ø6.5mm:6.4mm and 7.4mm | Ø5mm: 7.6mmØ7mm: 8mm | Not specified(abutment height3, 5, 7mm1) | Not applicable | Not applicable as placed on theMagellan abutment. Lengths 5, 6,8mm (from abutment) | Equivalent; the lengths of the proposed AHA arewithin the range of those of the previously clearedStraumann Healing Abutments customizable(K130808). |
| Intraoral scanningidentification | Dots can be visualizedin STL files | No | Encode codingscheme(machinedmarkings) can bevisualized in STLfiles1 | No | No | Equivalent; the AHA intraoral scanningidentification dots are equivalent to the encodecoding machined markings on the Bellatek EncodeEmergence healing abutments (K212730). |
| Body Material | Polyetheretherketone(PEEK) Classix ASTMF2026 | PEEK ASTM F2026 | Titanium-aluminum-vanadium alloy(TAV) ASTMF136 anodized1 | Not applicable | PEEK ClassixASTM F2026 | Equivalent; The AHA is machined from the samematerial PEEK Classix, as the protective caps ofthe Straumann Magellan Abutment System(K133421). The two devices fall in the samecontact category. |
| Screw Material | Titanium-aluminum-niobium alloy (TAN) | TAN ISO 5832-11anodized | TAV ASTM F1361 | TAN ISO 5832-11anodized | TAN ISO 5832-11 | Same; the basal screw assembled with the AHA isthe same basal screw previously cleared in |
| Subject DeviceStraumann AnatomicHealing AbutmentsXC (AHA) | Primary PredicateStraumann HealingAbutmentsCustomizableInstitute StraumannAGK130808 | ReferenceDeviceBellaTekEncodeEmergenceHealingAbutmentK212730Biomet 3i LLC | Reference DeviceStraumann BLX BasalScrewsInstitute StraumannAGK173961 | Reference DeviceProtective caps of StraumannMagellan Abutment SystemK133421 | Equivalence Discussion | |
| Implant Interface | ISO 5832-11 anodizedStraumann TorcFit(with conical fitting) | Straumann RegularCrossfit (RC) andNarrow Crossfit (NC)(with conical fitting) | TSV abutments:Zimmer DentalTSVDental ImplantSystemEzteticAbutments:Zimmer DentalEztetic DentalImplant SystemCertainAbutments:Biomet 3i Certain(Internal Hex)Dental ImplantSystem¹ | Straumann TorcFit (withconical fitting) | Interfaces with abutment | K173961.Equivalent; each device is designed to mate withan interface featured in a previously clearedimplant or abutment. More specifically, the AHAmates with the Straumann TorcFit connectionwhich is present on the currently marketedStraumann dental implants including the BLX(K17396, K181703, K191256) and BLC (K230108K234049). |
| Customization | Customizable | Customizable | Not specified | Not applicable | Customizable | Equivalent; the AHA is manufactured from PEEKand customizable like the Straumann healingabutments customizable (K130808) and theprotective caps of the Straumann MagellanAbutment System (K133421). |
| Sterility/Sterilization | Sterile by gammaradiationEnd user steamsterilized if customized | Sterile by gammaradiationEnd user steamsterilized ifcustomized | Sterile by gammaradiation¹ | Non-sterile, end usersteam sterilized | Non-sterile, end user steamsterilized | Equivalent; The AHA is supplied sterile andcustomizable like the previously clearedStraumann healing abutments customizable(K130808). |
| Packaging | Abutment assembledwith basal screwPolyethyleneterephthalate glycol(PETG) blister and lidwith a Tyvek lid | Abutment assembledwith basal screwPETG blister and lidwith a Tyvek lid | Blister tray withTyvek Lid¹ | They are provided alongwith the abutments butthey are also providedas standalone screws.Polyethyleneterephthalate glycol-modified (PETGAG)blister tray and anOvantex sealing lid | Four protective caps eachassembled with basal screwPETGAG blister tray and anOvantex sealing lid | Equivalent; The AHA is packaged in the samepackaging as the previously cleared Straumannhealing abutments (K130808). |
| Usage | Single use, for up to | Single use, for up to 6 | Single use¹ | Single use | Single use, for use up to 6 | Equivalent |
| Subject DeviceStraumann AnatomicHealing AbutmentsXC (AHA) | Primary PredicateStraumann HealingAbutmentsCustomizableInstitute StraumannAGK130808 | ReferenceDeviceBellaTekEncodeEmergenceHealingAbutmentK212730Biomet 3i LLC | Reference DeviceStraumann BLX BasalScrewsInstitute StraumannAGK173961 | Reference DeviceProtective caps of StraumannMagellan Abutment SystemK133421 | Equivalence Discussion | |
| 180 days | months | months |
1 BellaTek Encode Emergence Healing Abutments 510(k) Summary K212730 accessed at: K212730.pdf ffda.gov).
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Straumann Anatomic Healing Abutments XC (AHA)
Institut Straumann AG
{13}------------------------------------------------
Straumann Anatomic Healing Abutments XC (AHA)
{14}------------------------------------------------
Straumann Anatomic Healing Abutments XC (AHA)
Performance Testing Sterilization Validation and Shelf Life
The subject devices will be gamma irradiated. like the predicate devices in K130808. The AHA have been assessed for their relative challenge to the sterilization process by comparison to similar devices previously validated to a sterility assurance level (SAL) of 10-9, utilizing VDmax25 in accordance with ISO 11137-1:2006. The standard dose of radiation used for routine irradiation sterilization is 25 kilogray. This dose has been validated in accordance with ISO 11137-1: 2006, utilizing VDmax25 in accordance with ISO 11137-2: 2013, to achieve a sterility assurance level of 10-6.
If the AHA is customized, the device must be steam sterilized prior to intra-oral use. A validation of the labeled steam sterilization cycle using the half cycle validation approach outlined in ANSI/AAMI/ISO 17665-1: 2006/(R)2013, Annex D was performed with a subject device. All test method acceptance criteria were met.
The subject AHAs are labeled with a 5-year shelf-life like the previously cleared Straumann healing abutments (K130808). The packaging materials, configuration, and sterilization method for the AHA are the same as the Straumann healing abutments. Also, the subject AHA do not represent a new worst case in terms of dimension and weight, therefore, the packaging stability study for the Straumann healing abutments is adopted to support the subject AHA.
The subject devices are implants and will not be marketed as non-pyrogenic. The method used to make the determination that the devices meet pyrogen limit specifications is the Limulus amebocyte lysate (LAL) test. The testing limit is 20 endotoxin units (EU)/device. The testing limit is consistent with the recommendation identified in the FDA Guidance Submission and review of sterility information in premarket notification (510(k)) submissions for devices labeled as sterile.
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Straumann Anatomic Healing Abutments XC (AHA)
Biocompatibility Testing
Biological assessment has been performed according to ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process and to the FDA Guidance document Use of International Standard ISO 10993-1, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process, (June 16, 2016). The subject AHA devices are manufactured from PEEK Classix conforming to ASTM F2026. The AHA share the same nature of body contact, contact duration, device material and manufacturing process as the reference protective caps of the Straumann Magellan Abutment System (K133421). Unlike the reference protective caps, the subject AHAs will be sterile packaged, and gamma irradiated. Cytotoxicity and chemical extraction tests were performed. No cytotoxic reaction was detected. No extractable substances were detected in the chemical analysis above the analytical evaluation threshold (AET). The basal screws of the subject AHA are manufactured from Titanium-aluminumniobium alloy (TAN) conforming to ISO 5832-11. The basal screws of the subject AHA share the same nature of body contact, contact duration, material formulation, and sterilization methods as the basal screws of the primary predicate Straumann healing
abutments customizable (K130808) and therefore, no new testing has been performed on these devices.
Electromagnetic Compatibility
No new materials or worst-case constructs were introduced compared to the Straumann portfolio MR tested in accordance with FDA's quidance testing and labeling medical devices for safety in the magnetic resonance (MR) environment and cleared under K190662.
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Straumann Anatomic Healing Abutments XC (AHA)
Performance Testing - Bench
The physician will insert the AHA during the implant placement surgery or in the reopening surgery (second surgical phase) and remove the AHA upon placement of a final abutment and restoration. Therefore, torque testing was performed to demonstrate the AHA withstands repeated insertion and removal torques without damage.
Software Testing
A scan verification test and software integration were performed to demonstrate the subject AHAs can be scanned with an intraoral scanner and are suitable to work with CARES Visual software.
Conclusion
The documentation submitted in this premarket notification demonstrates the subject devices are substantially equivalent to the primary predicate and reference 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.)