(128 days)
K190040 Straumann BLX CARES Titanium Alloy (TAN) Abutments (RB, WB) ., K052272 Straumann CARES Titanium Abutment (RN) ●, K173379 Straumann Variobase for Crown AS ●, K150203 – Medentika CAD/CAM Abutments, K190662 MRI Compatibility for Existing Straumann Dental Implant Systems ●, K203355 Straumann TLX Novaloc and Cementable Abutments .
No
The description focuses on the mechanical design and manufacturing process of dental abutments, with no mention of AI or ML for design, analysis, or any other function. The software mentioned (Straumann CARES Visual) is described as a CAD/CAM software for design, which is a standard digital design tool, not necessarily incorporating AI/ML.
Yes
The device is described as a component for dental implants intended for single tooth replacement and multiple tooth restorations, which falls under therapeutic uses to restore function and aesthetics.
No
The device is a custom abutment used for dental implant restoration, which is a therapeutic and restorative function, not a diagnostic one.
No
The device description explicitly states that the device is a physical abutment fabricated at a milling center, not a software product. While software is used in the design process, the device itself is a hardware component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Description: The description clearly states that the Straumann Custom Abutments are used for the restoration of dental implants. They are physical components designed to connect to implants and support prosthetic restorations.
- Intended Use: The intended use is for single tooth replacement and multiple tooth restorations, which is a surgical/restorative procedure, not a diagnostic test performed on a sample.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, detection of biomarkers, or diagnostic purposes.
The device is a medical device used in dentistry for prosthetic restoration, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Straumann Custom Abutments are indicated for single tooth replacement and multiple tooth restorations. The prosthetic restoration can be cemented.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The Straumann Custom Abutments (previously named Straumann CARES Abutments) are used for the restoration of Straumann dental implants of different types, endosteal diameters, lengths and platforms. The Custom Abutments are patient-matched abutments; the customer scans the intraoral situation and designs the shape using a Straumann-approved CAD/CAM software (such as Straumann CARES Visual). The design data is then transferred to Straumann where the fabrication of the custom abutment is carried out at a Straumann validated milling center (FEI: 3024185724 or FEI: 3011221537). The existing Custom Abutments feature a straight screw channel for the basal screw which fixes the abutment to the respective implant. The purpose of this submission is to add Custom Abutments with an angled screw channel to the Straumann Custom Abutment Portfolio. The subject Custom Abutments can be designed and manufactured with an angled screw channel (as opposed to straight), so that the screw-exit is located in a favorable position (away from the incisal/occlusal edge and tooth cusps) for esthetic and functional results. The screw channel can be angled, the screwdriver maximum angle is 20°.
The Custom Abutments are designed for connection to implants of the Straumann Dental Implant System. The Custom Abutments have an implant-specific connection interface for the respective compatible implant. The Custom Abutments with the SynOcta geometry (RN or WN) are designed for connection to the Straumann Tissue Level (TL) implants. Those with the CrossFit geometry (NC or RC) are designed for connection to the Bone Level (BL) and Bone Level Tapered (BLT) implants. The Custom Abutments with the TorcFit geometry, are designed for connection to the Straumann Bone Level BLX and BLC (RB/WB or WB) or Tissue Level TLX and TLC (NT, RT, WT) implants. The basal screws feature threads to secure the abutment with the implant inner geometry. The basal screws also contain the connection geometry to mate with the AS screwdrivers for installation into the implant.
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)
Nonclinical testing data submitted or referenced to demonstrate substantial equivalence in this 510(k) includes:
- Dynamic fatigue testing was performed on worst-case constructs, that were determined . for each connection type and implant body design, according to Root-form endosseous dental implants and endosseous dental abutments- class II special controls guidance document for industry and FDA staff and Guidance for industry and ISO 14801: 2016 Dentistry - implants - dynamic loading test for endosseous dental implant,
- . Testing was performed to confirm that the Custom Abutments components are implemented correctly in within the digital workflow and the centralized workflow performs according to the requirements,
- K203355 (Institut Straumann AG) referenced for steam sterilization validation according . to ISO 17665-1: Sterilization of health care products- Most heat- Part 1: Development, validation and routine control of a sterilization process for medical devices and ISO/TS 17665-2: Sterilization of health care products- Moist heat- Part 2: Guidance on the application of ISO 17665-1,
- K190622 (Institut Straumann AG) referenced for MRI testing in accordance with ASTM . F2052-15, ASTM F2213-06 (2011), ASTM F2182-11a and ASTM F2119-13,
- K190040 and K052272 (Institut Straumann AG) referenced for biocompatibility in . accordance with ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K200586 Straumann TLX CARES Abutments TAN (NT, RT, WT) ., K190040 Straumann BLX CARES Titanium Alloy (TAN) Abutments (RB, WB) ., K052272 Straumann CARES Titanium Abutment (RN) ●, K150203 – Medentika CAD/CAM Abutments
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K190040 Straumann BLX CARES Titanium Alloy (TAN) Abutments (RB, WB) ., K052272 Straumann CARES Titanium Abutment (RN) ●, K173379 Straumann Variobase for Crown AS ●, K150203 – Medentika CAD/CAM Abutments, K190662 MRI Compatibility for Existing Straumann Dental Implant Systems ●, K203355 Straumann TLX Novaloc and Cementable Abutments .
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3630 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 shows 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 21, 2025
Institut Straumann AG % Jennifer Jackson Sr Dir, Regulatory & Quality NAM Straumann USA. LLC 60 Minuteman Road Andover, Massachusetts 01810
Re: K243278
Trade/Device Name: Custom Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: November 6, 2024 Received: February 3, 2025
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 (OS) 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)
K243278
Device Name
Custom Abutments
Indications for Use (Describe)
The Straumann Custom Abutments are indicated for single tooth replacement and multiple tooth restorations. The prosthetic restoration can be cemented.
Type of Use (Select one or both, as applicable)
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Custom Abutments
K243278 510(k) Summary
510(k) Summary
Submitter's Contact Information
| Submitter: | Straumann USA, LLC
60 Minuteman Road
Andover, MA 01810
Registration No.: 1222315 Owner/Operator No.: 9005052 |
|---------------------|---------------------------------------------------------------------------------------------------------------------------|
| | On the behalf of:
Institut Straumann AG
Peter Merian-Weg 12
4002 Basel, Switzerland |
| Contact Person: | Jennifer M. Jackson, MS
Director of Regulatory Affairs
Phone Number: +1-978-747-2509
Fax Number: +1-978-747-0023 |
| Prepared By: | Gordon Dodds, PhD
Manager, Design Control Quality Management
Phone number: +49 89 309075 291 |
| Date of Submission: | February 20, 2025 |
Name of the Device
| Trade Names: | Custom Abutments |
|---|---|
| Common Name: | Endosseous dental implant abutment |
| Classification Name: | Endosseous dental implant abutment |
| Regulation Number: | §872.3630 |
| Device Classification: | II |
| Product Code(s): | Primary product code - NHA |
Predicate Device(s)
Primary Predicates:
-
K200586 Straumann TLX CARES Abutments TAN (NT, RT, WT) .
Reference Devices: -
K190040 Straumann BLX CARES Titanium Alloy (TAN) Abutments (RB, WB) .
5
Custom Abutments
K243278 510(k) Summary
- K052272 Straumann CARES Titanium Abutment (RN) ●
- K173379 Straumann Variobase for Crown AS ●
- . K150203 – Medentika CAD/CAM Abutments
- K190662 MRI Compatibility for Existing Straumann Dental Implant Systems ●
- K203355 Straumann TLX Novaloc and Cementable Abutments .
Device Description
The Straumann Custom Abutments (previously named Straumann CARES Abutments) are used for the restoration of Straumann dental implants of different types, endosteal diameters, lengths and platforms. The Custom Abutments are patient-matched abutments; the customer scans the intraoral situation and designs the shape using a Straumann-approved CAD/CAM software (such as Straumann CARES Visual). The design data is then transferred to Straumann where the fabrication of the custom abutment is carried out at a Straumann validated milling center (FEI: 3024185724 or FEI: 3011221537). The existing Custom Abutments feature a straight screw channel for the basal screw which fixes the abutment to the respective implant. The purpose of this submission is to add Custom Abutments with an angled screw channel to the Straumann Custom Abutment Portfolio. The subject Custom Abutments can be designed and manufactured with an angled screw channel (as opposed to straight), so that the screwexit is located in a favorable position (away from the incisal/occlusal edge and tooth cusps) for esthetic and functional results. The screw channel can be angled, the screwdriver maximum angle is 20°.
The Custom Abutments are designed for connection to implants of the Straumann Dental Implant System. The Custom Abutments have an implant-specific connection interface for the respective compatible implant. The Custom Abutments with the SynOcta geometry (RN or WN) are designed for connection to the Straumann Tissue Level (TL) implants. Those with the CrossFit geometry (NC or RC) are designed for connection to the Bone Level (BL) and Bone Level Tapered (BLT) implants. The Custom Abutments with the TorcFit geometry, are designed for connection to the Straumann Bone Level BLX and BLC (RB/WB or WB) or Tissue Level TLX and TLC (NT, RT, WT) implants. The basal screws feature threads to secure the abutment with the implant
6
Custom Abutments
K243278 510(k) Summary
inner geometry. The basal screws also contain the connection geometry to mate with the AS screwdrivers for installation into the implant.
Indications for Use
Custom Abutments
The Straumann Custom Abutments are indicated for single tooth replacement and multiple tooth restorations. The prosthetic restoration can be cemented.
Technological Characteristics
The indications for use and technological characteristics of the subject devices are consistent with those of the primary predicate and reference devices as detailed in the following tables.
7
Custom Abutments
510(k) Summary
| Comparison | Custom Abutments | K200586
Straumann TLX CARES
Abutments TAN | K190040
Straumann BLX CARES Titanium
Alloy (TAN) Abutments | K052272
Straumann
CARES Titanium Abutment
(RN) | K150203
Medentika T and K Series Preface
(CAD/CAM) Abutments | K173379
Straumann Variobase for Crown AS | Equivalence |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Straumann Custom
Abutments are indicated
for single tooth
replacement and multiple
tooth restorations. The
prosthetic restoration can
be cemented. | The Straumann CARES
Abutments TAN are indicated
for single tooth replacement
and
multiple tooth restorations. The
prosthetic restoration can be
cemented. | The Straumann CARES Abutments
are indicated for single tooth
replacement and multiple tooth
restorations. The prosthetic
restoration can be cemented on
directly veneered/screw-retained. | Abutments are intended to be
placed into dental implants to
provide support for prosthetic
reconstructions such as crowns
or bridges. The Straumann
CARES Titanium Abutment is
indicated for cemented
restorations. The abutment can
be used in single tooth
replacements and multiple tooth
restorations. | Medentika Preface CAD/CAM Abutments
are intended for use with dental implants
as a support for single or multiple tooth
prostheses in the maxilla or mandible of a
partially or fully edentulous patient.
Implant System Compatibility
Dentsplv Friadent® Frialit/XiVE®
Series T
Implant Diameter (mm)
3.4, 3.8, 4.5, 5.5
Platform Diameter (mm)
3.4, 3.8, 4.5, 5.5
Nobel Biocare Brånemark System
K Series
Implant Diameter (mm)
3.3, 3.75, 4.0, 5.0
Platform Diameter (mm)
3.5, 4.1, 5.1
Medentika PreFace is intended for use
with the Straumann® CARES® System.
All digitally designed abutments for use
with Medentika CAD/CAM Abutments are
intended to be manufactured at a
Straumann® CARES® validated milling
center. | The Straumann® Variobase® for Crown AS is a
titanium base placed onto Straumann dental
implants to provide support for customized
prosthetic restorations. Straumann® Variobase®
for Crown AS are indicated for screw retained
single tooth or cement-retained single tooth and
bridge restorations. A temporary restoration can
be used prior to the insertion of the final
components to maintain, stabilize and form the
soft tissue during the healing phase. Temporary
restorations are indicated to be placed out of
occlusion. All digitally designed copings and/or
crowns for use with the Straumann Variobase®
for Crown AS are intended to be sent to
Straumann for manufacture at a validated milling
center. | Equivalent; The indications
statements all specify use in
single tooth replacement and
multiple tooth restorations. The
The statement is only revised to
replace CARES with Custom.
The Medentika indications for
use statement directly includes
additional technical details that
are consistent with the
Straumann Custom Abutments
abeling. |
Table 2. Comparative summary of technological characteristics.
| Comparison | Custom Abutments | K200586
Straumann TLX CARES
Abutments TAN | K190040
Straumann BLX CARES Titanium
Alloy (TAN) Abutments | K052272
Straumann
CARES Titanium Abutment
(RN) | K150203
Medentika T Series and K
Series Preface (CAD/CAM)
Abutments | K173379
Straumann Variobase for Crown AS | Equivalence |
|----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FDA product code | NHA | DZE, NHA | NHA | NHA | NHA | NHA | Identical |
| Implant to abutment
connection | SynOcta
RN, WN
CrossFit
NC, RC
TorcFit
RB/WB, WB, NT, RT, WT | TorcFit
NT, RT, WT | TorcFit
RB/WB, WB | SynOcta
RN | Medentika T Series
Medentika K Series | SynOcta
RN, WN
CrossFit
NNC, NC, RC | Equivalent; The Custom Abutments
consist of previously cleared
Straumann implant to abutment
connections. |
| Abutment Designs | Customized | Customized | Customized | Customized | Customized | N/A; Titanium base | Equivalent |
| Prosthesis Attachment | Cement retained | Cement retained | Cement retained or directly
veneered/screw-retained | Cement retained | Cement retained | N/A: Titanium base | Equivalent |
| Restoration | Single unit
Multiple unit | Single unit
Multiple unit | Single unit
Multiple unit | Single unit
Multiple unit | Single unit
Multiple unit | Single unit
Multiple unit | Identical |
| Compatible Implant Body
Diameter (mm) | SynOcta 3.3-4.8
CrossFit 3.3-4.8
TorcFit 3.3-6.5 | TorcFit 3.75-6.5 | TorcFit 3.75-6.5 | SynOcta 4.8 | Dentsply Friadent®
Frialit/XiVE®
3.4, 3.8, 4.5, 5.5
Nobel Biocare Brånemark
3.3, 3.75, 4.0, 5.0 | SynOcta 3.3-4.8
CrossFit 3.3-4.8 | Equivalent; A new implant body
diameter of 3.3 is added for
connection with the TorcFit
connection. This additional diameter
does not raise different questions of
safety and effectiveness. Substantial
equivalence is demonstrated by
dynamic loading testing per ISO
14801. |
| | | | | | | | |
| Comparison | Custom Abutments | K200586
Straumann TLX CARES
Abutments TAN | K190040
Straumann BLX CARES Titanium
Alloy (TAN) Abutments | K052272
Straumann
CARES Titanium Abutment
(RN) | K150203
Medentika T Series and K
Series Preface (CAD/CAM)
Abutments | K173379
Straumann Variobase for Crown AS | Equivalence |
| Abutment & Abutment Screw
Materials | Ti6Al7Nb (TAN) conforming
to ISO 5832-11 or
commercially pure titanium
conforming to ISO 5832-2
Basal screws are TAN
conforming to ISO 5832-11 | TAN conforming to ISO
5832-11 | TAN conforming to ISO 5832-11
Cobalt-chromium alloy (coron®) | Commercially pure titanium
conforming to ISO 5832-2
Basal screw is TAN
conforming to ISO 5832-11 | Ti6Al4V, medical grade 5,
conforming to ASTM F136 | TAN conforming to ISO 5832-11 | Equivalent; All Custom Abutments are
offered in titanium or a titanium alloy. |
| Sterilization | Supplied non-sterile
Moist heat sterilized by end
user | Supplied non-sterile
Moist heat sterilized by
end user | Supplied non-sterile
Moist heat sterilized by end user | Supplied non-sterile
Moist heat sterilized by end
user | Supplied non-sterile
Moist heat sterilized by end
user | Supplied non-sterile
Moist heat sterilized by end user | Identical |
| Usage- All components | Single-patient, single-use | Single-patient, single-
use | Single-patient, single-use | Single-patient, single-use | Single-patient, single-use | Single-patient
single-use | Identical |
| Minimum wall thickness to
screw channel (mm) | 0.5 | 0.33 | 0.4 | N/A-510(k) covers use with
Sirona Inlab 3D design
software | 0.4 | N/A; Titanium base | Equivalent
The increased minimum wall thickness
to screw channel does not raise
different questions of safety and
effectiveness. Substantial equivalence
is demonstrated by dynamic loading
testing per ISO 14801. |
| Minimum gingival height (mm) | RB/WB 0.9
WB 0.5
NC 0.5
RC 0.5
NT, RT, WT 0.0
RN, WN 0.0 | NT, RT, WT 0.0 | RB/WB 1.0
WB 0.5 | N/A-510(k) covers use with
Sirona Inlab 3D design
software | T-Series 0.1
K Series 0 | N/A; Titanium base | Equivalent; The range of gingival
heights within that of K150203.
Note: The top of the tissue level
implants are placed at the height of
the gingiva, so the smallest gingival
collar height is 0 mm. |
| Maximum gingival height (mm) | RB/WB 4.5
WB 4.5
NC 3.5
RC 3.5
NT 4.6
RT 4.6
WT 4.6
RN 4.0
WN 4.0 | Not specified | Not specified | Not specified | Maximum gingival height 6mm | Not specified | Not specified |
| Max angulation (degrees) | 30° | 30° | 30° | N/A-510(k) covers use with
Sirona Inlab 3D design
software | 30° | N/A; Titanium base | Equivalent |
| Minimum abutment post height
(mm) (length above the
abutment collar/gingival
height) | 4 | 4 | Not specified | N/A-510(k) covers use with
Sirona Inlab 3D design
software | 4 | N/A; Titanium base | Equivalent |
| Minimum surface area (mm²) -
considered after fulfilment of
the specified minimum design
limits | 37, 43, 47 & 56 dependent
on tooth position | 37, 43, 47 & 56
dependent on tooth
position | 37, 43, 47 & 56 dependent on tooth
position | N/A-510(k) covers use with
Sirona Inlab 3D design
software | 37, 43, 47 & 56 dependent on
tooth position | N/A; Titanium base | Identical |
| Max screw channel angulation
(degrees) | 25° from the knee point
(screwdriver maximum
angulation of 20°) | Straight | Straight | Straight | Straight | The titanium base provides possibility
for an angled screw channel (up to 25°
from the implant axis corresponding to
a screwdriver angulation of 20°) in the
coping and/or crown. | Equivalent |
| Design workflow | Computer aided design
(CAD) | Computer aided design
(CAD) | Computer aided design (CAD) | Computer aided design (CAD) | Computer aided design (CAD) | N/A; Titanium base | Equivalent |
| Manufacturing workflow | Milled at Straumann CARES
validated milling center | Milled at Straumann
CARES validated milling
center | Milled at Straumann CARES
validated milling center | Milled at Straumann CARES
validated milling center | Milled at Straumann CARES
validated milling center | N/A; Titanium base | Equivalent |
8
Custom Abutments
510(k) Summary
9
Custom Abutments
510(k) Summary
Materials
The abutments are manufactured from titanium alloy conforming to ISO 5832-11:2014 Implants for surgery- Metallic materials Part 11: Wrought titanium 6-aluminium 7-niobium alloy or commercially pure titanium conforming to ISO 5832-2:2018 Implants for surgery- Metallic materials Part 2: Unalloyed titanium. The basal screws are manufactured from titanium alloy conforming to ISO 5832-11:2014.
Summary of Nonclinical Testing
Nonclinical testing data submitted or referenced to demonstrate substantial equivalence in this 510(k) includes:
- Dynamic fatigue testing was performed on worst-case constructs, that were determined . for each connection type and implant body design, according to Root-form endosseous dental implants and endosseous dental abutments- class II special controls guidance document for industry and FDA staff and Guidance for industry and ISO 14801: 2016 Dentistry - implants - dynamic loading test for endosseous dental implant,
- . Testing was performed to confirm that the Custom Abutments components are implemented correctly in within the digital workflow and the centralized workflow performs according to the requirements,
- K203355 (Institut Straumann AG) referenced for steam sterilization validation according . to ISO 17665-1: Sterilization of health care products- Most heat- Part 1: Development, validation and routine control of a sterilization process for medical devices and ISO/TS 17665-2: Sterilization of health care products- Moist heat- Part 2: Guidance on the application of ISO 17665-1,
- K190662 (Institut Straumann AG) referenced for MRI testing in accordance with ASTM . F2052-15, ASTM F2213-06 (2011), ASTM F2182-11a and ASTM F2119-13,
- K190040 and K052272 (Institut Straumann AG) referenced for biocompatibility in . accordance with ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
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Custom Abutments
510(k) Summary
Conclusion
The data included in this submission demonstrate substantial equivalence to the predicate device listed above. Performance testing and comparison to previous clearances show that the subject devices are substantially equivalent.