(161 days)
No
The device description and performance studies focus on the physical properties, biocompatibility, and mechanical performance of the healing abutments, with no mention of AI or ML for analysis, decision support, or image processing. The scanning function mentioned is for representing the implant position, not for AI/ML analysis.
No.
The device's intended use is to protect the implant, promote soft tissue healing, and act as a temporary component during the osseointegration phase of dental implants. It does not exert a therapeutic effect on a medical condition or disease.
No
The device is a healing abutment used to protect dental implants and shape soft tissue during the healing process, and it can also be used in intraoral scanning procedures. It is not used to diagnose a medical condition or disease.
No
The device is a physical healing abutment made of PEEK and TAN, intended for surgical placement and temporary use. While it has a scanbody feature and is compatible with intraoral scanning software, its primary function is mechanical and biological, not purely software-based.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Straumann Anatomic Healing Abutments are physical components placed in the patient's mouth to aid in the healing process after dental implant placement. They are not used to analyze biological samples.
- Intended Use: The intended use clearly describes a physical function within the patient's body (protecting the implant, forming and stabilizing soft tissue).
- Device Description: The description details the materials and physical design of the abutments, not a diagnostic test or analysis method.
Therefore, the Straumann Anatomic Healing Abutments fall under the category of a medical device, specifically a dental device, rather than an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
NHA
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
- Performance Testing Sterilization Validation and Shelf Life: The subject devices are 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.
- Biocompatibility Testing: Biological assessment has been performed according to ISO 10993-1 and FDA Guidance document Use of International Standard ISO 10993-1. 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). 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-aluminum-niobium 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 guidance testing and labeling medical devices for safety in the magnetic resonance (MR) environment and cleared under K190662.
- Performance Testing - Bench: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Straumann Healing Abutments (K130808)
Reference Device(s)
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)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.)
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
1
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.
2
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
3
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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4
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 Bleyendaal |
| Sr. RA Specialist | |
| Straumann USA, LLC | |
| Phone 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 |
| Device | |
| Classification: | II |
5
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
6
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
7
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.
8
Straumann Anatomic Healing Abutments XC (AHA)
K241575
Table 1 Comparison of the subject, primary predicate, and reference devices' indications for use
| | Subject Device
Straumann
Anatomic Healing
Abutments (AHA) | Primary Predicate
Straumann
Healing
Abutments
Institute
Straumann AG
K130808 | Reference Device
BellaTek Encode
Emergence Healing
Abutment
Biomet 3i LLC
K212730 | Reference Device
Straumann BLX
Basal Screws
Institute
Straumann AG
K173961 | Reference Device
Protective caps of
Straumann
Magellan Abutment
System
Institute Straumann
AG
K133421 |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use Statement | 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 | Closure screws,
healing caps, and
healing abutments,
are intended for use
with 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.
Customizable
healing abutments
made of PEEK are
for use up to six
months. | The BellaTek Encode
Emergence Healing
Abutments are
intended for use as
an accessory to
endosseous dental
implants during
endosseous and
gingival healing to
prepare gingival
tissue for acceptance
of a final abutment
and restoration.1 | Straumann BLX
Basal Screws and
Temporary
Abutments
Prosthetic
components
directly or indirectly
connected to the
endosseous dental
implant are
intended for use as
an aid in prosthetic
rehabilitations.
Temporary
components can be
used prior to the
insertion of the final
components to
maintain, stabilize
and shape the soft
tissue during the
healing phase; they | The Straumann
Magellan abutments
are indicated to be
placed into
Straumann dental
implants to provide
support for prosthetic
reconstructions such
as crowns, bridges
and bars.
The final processed
devices have the
purpose of restoring
chewing function.
Magellan abutments
are indicated for
screw-retained
restorations.
The protective caps
are placed on
abutments to protect |
| | | K241575 | | | |
| | Subject Device
Straumann
Anatomic Healing
Abutments (AHA) | Primary Predicate
Straumann
Healing
Abutments
Institute
Straumann AG
K130808 | Reference Device
BellaTek Encode
Emergence Healing
Abutment
Biomet 3i LLC
K212730 | Reference Device
Straumann BLX
Basal Screws
Institute
Straumann AG
K173961 | Reference Device
Protective caps of
Straumann
Magellan Abutment
System
Institute Straumann
AG
K133421 |
| | 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. | | | may not be placed
into occlusion. Final
abutments may be
placed into
occlusion when the
implant is fully
osseointegrated.
BLX Temporary
Abutments have a
maximum duration
of usage of 180
days. | the outer
configuration of the
abutment and
maintain, stabilize
and contour the soft
tissue during the
healing process. |
| FDA Product
Code | NHA | NHA | NHA | NHA | NHA |
9
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.
11
Straumann Anatomic Healing Abutments XC (AHA)
K241575
Table 2 Comparison of the design and technological characteristics of the subject, predicate, and reference devices
| | Subject Device
Straumann Anatomic
Healing Abutments
XC (AHA) | Primary Predicate
Straumann Healing
Abutments
Customizable
Institute Straumann
AG
K130808 | Reference
Device
BellaTek
Encode
Emergence
Healing
Abutment
K212730
Biomet 3i LLC | Reference Device
Straumann BLX Basal
Screws
Institute Straumann
AG
K173961 | Reference Device
Protective caps of Straumann
Magellan Abutment System
K133421 | Equivalence Discussion |
|-----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Abutment Design | Screw retained | Screw retained | Screw retained1 | Not applicable | Screw retained | Equivalent |
| Abutment Shape | Various anatomical
shapes intended for
different tooth
locations | Conical | Conical | Not applicable | Cylindrical protective caps | Numerous shapes of healing abutments are
available. The physician chooses the appropriately
sized healing abutment based on his treatment
plan. Many healing abutments can be further
modified chairside by the physician to fit the
patient's interocclusal space. No new questions of
safety or effectiveness are raised with anatomical
shaped healing abutments. |
| Body (Ø in mm) | 3.8, 4.5, 5.5, 6.5 | 5,7 | TSV abutments
3.5, 4.5, 5.7
Eztetic abutments
2.9
Certain
abutments 3.4,
4.1, 5.0 and 6.01 | Not applicable | 3.5, 4.6 | Body Ø is driven by the associated implant and
prosthetic system. Different implant systems have
different prosthetic platforms. No new questions of
safety or effectiveness are raised. |
| Abutment Length* | Ø3.8mm, Ø4.5mm:
6.2mm and 7.2mm
Ø5.5mm, Ø6.5mm:
6.4mm and 7.4mm | Ø5mm: 7.6mm
Ø7mm: 8mm | Not specified
(abutment height
3, 5, 7mm1) | Not applicable | Not applicable as placed on the
Magellan abutment. Lengths 5, 6,
8mm (from abutment) | Equivalent; the lengths of the proposed AHA are
within the range of those of the previously cleared
Straumann Healing Abutments customizable
(K130808). |
| Intraoral scanning
identification | Dots can be visualized
in STL files | No | Encode coding
scheme
(machined
markings) can be
visualized in STL
files1 | No | No | Equivalent; the AHA intraoral scanning
identification dots are equivalent to the encode
coding machined markings on the Bellatek Encode
Emergence healing abutments (K212730). |
| Body Material | Polyetheretherketone
(PEEK) Classix ASTM
F2026 | PEEK ASTM F2026 | Titanium-
aluminum-
vanadium alloy
(TAV) ASTM
F136 anodized1 | Not applicable | PEEK Classix
ASTM F2026 | Equivalent; The AHA is machined from the same
material PEEK Classix, as the protective caps of
the Straumann Magellan Abutment System
(K133421). The two devices fall in the same
contact category. |
| Screw Material | Titanium-aluminum-
niobium alloy (TAN) | TAN ISO 5832-11
anodized | TAV ASTM F1361 | TAN ISO 5832-11
anodized | TAN ISO 5832-11 | Same; the basal screw assembled with the AHA is
the same basal screw previously cleared in |
| Subject Device
Straumann Anatomic
Healing Abutments
XC (AHA) | Primary Predicate
Straumann Healing
Abutments
Customizable
Institute Straumann
AG
K130808 | Reference
Device
BellaTek
Encode
Emergence
Healing
Abutment
K212730
Biomet 3i LLC | Reference Device
Straumann BLX Basal
Screws
Institute Straumann
AG
K173961 | Reference Device
Protective caps of Straumann
Magellan Abutment System
K133421 | Equivalence Discussion | |
| Implant Interface | ISO 5832-11 anodized
Straumann TorcFit
(with conical fitting) | Straumann Regular
Crossfit (RC) and
Narrow Crossfit (NC)
(with conical fitting) | TSV abutments:
Zimmer Dental
TSV
Dental Implant
System
Eztetic
Abutments:
Zimmer Dental
Eztetic Dental
Implant System
Certain
Abutments:
Biomet 3i Certain
(Internal Hex)
Dental Implant
System¹ | Straumann TorcFit (with
conical fitting) | Interfaces with abutment | K173961.
Equivalent; each device is designed to mate with
an interface featured in a previously cleared
implant or abutment. More specifically, the AHA
mates with the Straumann TorcFit connection
which is present on the currently marketed
Straumann dental implants including the BLX
(K17396, K181703, K191256) and BLC (K230108
K234049). |
| Customization | Customizable | Customizable | Not specified | Not applicable | Customizable | Equivalent; the AHA is manufactured from PEEK
and customizable like the Straumann healing
abutments customizable (K130808) and the
protective caps of the Straumann Magellan
Abutment System (K133421). |
| Sterility/Sterilization | Sterile by gamma
radiation
End user steam
sterilized if customized | Sterile by gamma
radiation
End user steam
sterilized if
customized | Sterile by gamma
radiation¹ | Non-sterile, end user
steam sterilized | Non-sterile, end user steam
sterilized | Equivalent; The AHA is supplied sterile and
customizable like the previously cleared
Straumann healing abutments customizable
(K130808). |
| Packaging | Abutment assembled
with basal screw
Polyethylene
terephthalate glycol
(PETG) blister and lid
with a Tyvek lid | Abutment assembled
with basal screw
PETG blister and lid
with a Tyvek lid | Blister tray with
Tyvek Lid¹ | They are provided along
with the abutments but
they are also provided
as standalone screws.
Polyethylene
terephthalate glycol-
modified (PETGAG)
blister tray and an
Ovantex sealing lid | Four protective caps each
assembled with basal screw
PETGAG blister tray and an
Ovantex sealing lid | Equivalent; The AHA is packaged in the same
packaging as the previously cleared Straumann
healing 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 Device
Straumann Anatomic
Healing Abutments
XC (AHA) | Primary Predicate
Straumann Healing
Abutments
Customizable
Institute Straumann
AG
K130808 | Reference
Device
BellaTek
Encode
Emergence
Healing
Abutment
K212730
Biomet 3i LLC | Reference Device
Straumann BLX Basal
Screws
Institute Straumann
AG
K173961 | Reference Device
Protective caps of Straumann
Magellan Abutment System
K133421 | Equivalence Discussion | |
| 180 days | months | | | months | | |
1 BellaTek Encode Emergence Healing Abutments 510(k) Summary K212730 accessed at: K212730.pdf ffda.gov).
12
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.
15
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.
16
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.