The Straumann Custom Abutments are indicated for single tooth replacement and multiple tooth restorations. The prosthetic restoration can be cemented.

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 inner geometry. The basal screws also contain the connection geometry to mate with the AS screwdrivers for installation into the implant.

AI/ML Overview

The provided text is a 510(k) Summary for "Custom Abutments" and details the substantial equivalence of the device to legally marketed predicate devices. It does not contain information on an AI/ML-driven device or study results proving a device meets acceptance criteria related to AI/ML performance metrics (e.g., sensitivity, specificity, FROC, etc.).

The document describes a dental implant abutment designed for customized patient use, with a key modification being the addition of an angled screw channel. The non-clinical testing sections focus on mechanical fatigue testing, digital workflow validation, sterilization, MRI compatibility, and biocompatibility, as is typical for a medical device of this type.

Therefore, I cannot fulfill your request for information on acceptance criteria and study proving device meets acceptance criteria for an AI/ML device, as the provided text pertains to a traditional medical device (dental abutments) and does not mention any AI/ML component.

Summary

{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)

< | Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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, LLC60 Minuteman RoadAndover, MA 01810Registration No.: 1222315 Owner/Operator No.: 9005052
	On the behalf of:Institut Straumann AGPeter Merian-Weg 124002 Basel, Switzerland
Contact Person:	Jennifer M. Jackson, MSDirector of Regulatory AffairsPhone Number: +1-978-747-2509Fax Number: +1-978-747-0023
Prepared By:	Gordon Dodds, PhDManager, Design Control Quality ManagementPhone 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

{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	K200586Straumann TLX CARESAbutments TAN	K190040Straumann BLX CARES TitaniumAlloy (TAN) Abutments	K052272StraumannCARES Titanium Abutment(RN)	K150203Medentika T and K Series Preface(CAD/CAM) Abutments	K173379Straumann Variobase for Crown AS	Equivalence
Indications for Use	The Straumann CustomAbutments are indicatedfor single toothreplacement and multipletooth restorations. Theprosthetic restoration canbe cemented.	The Straumann CARESAbutments TAN are indicatedfor single tooth replacementandmultiple tooth restorations. Theprosthetic restoration can becemented.	The Straumann CARES Abutmentsare indicated for single toothreplacement and multiple toothrestorations. The prostheticrestoration can be cemented ondirectly veneered/screw-retained.	Abutments are intended to beplaced into dental implants toprovide support for prostheticreconstructions such as crownsor bridges. The StraumannCARES Titanium Abutment isindicated for cementedrestorations. The abutment canbe used in single toothreplacements and multiple toothrestorations.	Medentika Preface CAD/CAM Abutmentsare intended for use with dental implantsas a support for single or multiple toothprostheses in the maxilla or mandible of apartially or fully edentulous patient.Implant System CompatibilityDentsplv Friadent® Frialit/XiVE®Series TImplant Diameter (mm)3.4, 3.8, 4.5, 5.5Platform Diameter (mm)3.4, 3.8, 4.5, 5.5Nobel Biocare Brånemark SystemK SeriesImplant Diameter (mm)3.3, 3.75, 4.0, 5.0Platform Diameter (mm)3.5, 4.1, 5.1Medentika PreFace is intended for usewith the Straumann® CARES® System.All digitally designed abutments for usewith Medentika CAD/CAM Abutments areintended to be manufactured at aStraumann® CARES® validated millingcenter.	The Straumann® Variobase® for Crown AS is atitanium base placed onto Straumann dentalimplants to provide support for customizedprosthetic restorations. Straumann® Variobase®for Crown AS are indicated for screw retainedsingle tooth or cement-retained single tooth andbridge restorations. A temporary restoration canbe used prior to the insertion of the finalcomponents to maintain, stabilize and form thesoft tissue during the healing phase. Temporaryrestorations are indicated to be placed out ofocclusion. All digitally designed copings and/orcrowns for use with the Straumann Variobase®for Crown AS are intended to be sent toStraumann for manufacture at a validated millingcenter.	Equivalent; The indicationsstatements all specify use insingle tooth replacement andmultiple tooth restorations. TheThe statement is only revised toreplace CARES with Custom.The Medentika indications foruse statement directly includesadditional technical details thatare consistent with theStraumann Custom Abutmentsabeling.

Table 2. Comparative summary of technological characteristics.

Comparison	Custom Abutments	K200586Straumann TLX CARESAbutments TAN	K190040Straumann BLX CARES TitaniumAlloy (TAN) Abutments	K052272StraumannCARES Titanium Abutment(RN)	K150203Medentika T Series and KSeries Preface (CAD/CAM)Abutments	K173379Straumann Variobase for Crown AS	Equivalence
FDA product code	NHA	DZE, NHA	NHA	NHA	NHA	NHA	Identical
Implant to abutmentconnection	SynOctaRN, WNCrossFitNC, RCTorcFitRB/WB, WB, NT, RT, WT	TorcFitNT, RT, WT	TorcFitRB/WB, WB	SynOctaRN	Medentika T SeriesMedentika K Series	SynOctaRN, WNCrossFitNNC, NC, RC	Equivalent; The Custom Abutmentsconsist of previously clearedStraumann implant to abutmentconnections.
Abutment Designs	Customized	Customized	Customized	Customized	Customized	N/A; Titanium base	Equivalent
Prosthesis Attachment	Cement retained	Cement retained	Cement retained or directlyveneered/screw-retained	Cement retained	Cement retained	N/A: Titanium base	Equivalent
Restoration	Single unitMultiple unit	Single unitMultiple unit	Single unitMultiple unit	Single unitMultiple unit	Single unitMultiple unit	Single unitMultiple unit	Identical
Compatible Implant BodyDiameter (mm)	SynOcta 3.3-4.8CrossFit 3.3-4.8TorcFit 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, 5.5Nobel Biocare Brånemark3.3, 3.75, 4.0, 5.0	SynOcta 3.3-4.8CrossFit 3.3-4.8	Equivalent; A new implant bodydiameter of 3.3 is added forconnection with the TorcFitconnection. This additional diameterdoes not raise different questions ofsafety and effectiveness. Substantialequivalence is demonstrated bydynamic loading testing per ISO14801.

Comparison	Custom Abutments	K200586Straumann TLX CARESAbutments TAN	K190040Straumann BLX CARES TitaniumAlloy (TAN) Abutments	K052272StraumannCARES Titanium Abutment(RN)	K150203Medentika T Series and KSeries Preface (CAD/CAM)Abutments	K173379Straumann Variobase for Crown AS	Equivalence
Abutment & Abutment ScrewMaterials	Ti6Al7Nb (TAN) conformingto ISO 5832-11 orcommercially pure titaniumconforming to ISO 5832-2Basal screws are TANconforming to ISO 5832-11	TAN conforming to ISO5832-11	TAN conforming to ISO 5832-11Cobalt-chromium alloy (coron®)	Commercially pure titaniumconforming to ISO 5832-2Basal screw is TANconforming to ISO 5832-11	Ti6Al4V, medical grade 5,conforming to ASTM F136	TAN conforming to ISO 5832-11	Equivalent; All Custom Abutments areoffered in titanium or a titanium alloy.
Sterilization	Supplied non-sterileMoist heat sterilized by enduser	Supplied non-sterileMoist heat sterilized byend user	Supplied non-sterileMoist heat sterilized by end user	Supplied non-sterileMoist heat sterilized by enduser	Supplied non-sterileMoist heat sterilized by enduser	Supplied non-sterileMoist 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-patientsingle-use	Identical
Minimum wall thickness toscrew channel (mm)	0.5	0.33	0.4	N/A-510(k) covers use withSirona Inlab 3D designsoftware	0.4	N/A; Titanium base	EquivalentThe increased minimum wall thicknessto screw channel does not raisedifferent questions of safety andeffectiveness. Substantial equivalenceis demonstrated by dynamic loadingtesting per ISO 14801.
Minimum gingival height (mm)	RB/WB 0.9WB 0.5NC 0.5RC 0.5NT, RT, WT 0.0RN, WN 0.0	NT, RT, WT 0.0	RB/WB 1.0WB 0.5	N/A-510(k) covers use withSirona Inlab 3D designsoftware	T-Series 0.1K Series 0	N/A; Titanium base	Equivalent; The range of gingivalheights within that of K150203.Note: The top of the tissue levelimplants are placed at the height ofthe gingiva, so the smallest gingivalcollar height is 0 mm.
Maximum gingival height (mm)	RB/WB 4.5WB 4.5NC 3.5RC 3.5NT 4.6RT 4.6WT 4.6RN 4.0WN 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 withSirona Inlab 3D designsoftware	30°	N/A; Titanium base	Equivalent
Minimum abutment post height(mm) (length above theabutment collar/gingivalheight)	4	4	Not specified	N/A-510(k) covers use withSirona Inlab 3D designsoftware	4	N/A; Titanium base	Equivalent
Minimum surface area (mm²) -considered after fulfilment ofthe specified minimum designlimits	37, 43, 47 & 56 dependenton tooth position	37, 43, 47 & 56dependent on toothposition	37, 43, 47 & 56 dependent on toothposition	N/A-510(k) covers use withSirona Inlab 3D designsoftware	37, 43, 47 & 56 dependent ontooth position	N/A; Titanium base	Identical
Max screw channel angulation(degrees)	25° from the knee point(screwdriver maximumangulation of 20°)	Straight	Straight	Straight	Straight	The titanium base provides possibilityfor an angled screw channel (up to 25°from the implant axis corresponding toa screwdriver angulation of 20°) in thecoping 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 CARESvalidated milling center	Milled at StraumannCARES validated millingcenter	Milled at Straumann CARESvalidated milling center	Milled at Straumann CARESvalidated milling center	Milled at Straumann CARESvalidated 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.

{10}------------------------------------------------

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.

Regulation Number and Section

§ 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.)