NobelProcera® Abutment Titanium is a patient-matched CAD/CAM prosthetic component directly connected to endosseous dental implants and is indicated for use as an aid in prosthetic rehabilitation.

Omnigrip Clinical Screw Titanium:

Clinical and Abutment Screws are indicated for use to secure a dental abutment or framework to a dental implant in the maxilla or mandible for supporting tooth replacements and are indicated as an aid in prosthetic rehabilitation.

Device Description

The Subject Device NobelProcera® Titanium ASC Abutment is composed of two device lines: NobelProcera® Titanium ASC Abutment and the Clinical Screw Omnigrip Titanium.

NobelProcera® Titanium ASC Abutment is a patient matched CAD/CAM dental prosthesis which is connected to the Nobel Biocare implants featuring an internal conical and/or internal tri-channel connection, is available in the platform sizes NP, RP WP and 6.0 (for internal tri-channel connection only) and is intended for use as an aid in prosthetic rehabilitation to restore chewing function and esthetic appearance.

NobelProcera® Titanium ASC Abutments undergo patient matched customization at a Nobel Biocare production facility for the final, finished abutment device manufacturing.

NobelProcera® Titanium ASC Abutment is connected to the implant with a clinical screw and features an angulated screw channel which can be defined by the customer in an angulation (to the implant's axis) between 0° and 25°, in addition the abutment can be angulated to a maximum of 30°. The clinical screw features the Omnigrip Interface which allows tightening up to 25°.

NobelProcera® Titanium ASC Abutment and Omnigrip Clinical Screw Titanium are composed of titanium vanadium alloy Ti6Al4V ELI (ISO 5832-3, ASTM F136) and the surface of the abutments are provided with and without anodization and the Omnigrip Clinical Screw Titanium are provided with and without DLC coating.

The finished NobelProcera® Titanium ASC Abutment supports the placement of a cement-retained dental prosthesis.

Omnigrip Clinical Screw Titanium is available for the NP, RP, WP and 6.0 (for internal tri-channel connection only) platform, the devices connect the NobelProcera Titanium ASC Abutments to the dental implants. The devices feature an Omnigrip interface.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and device performance.

Important Note: The provided document is an FDA 510(k) Premarket Notification letter. This type of document is a submission seeking regulatory clearance, not a standalone study report. As such, it outlines the basis for demonstrating substantial equivalence to a predicate device, which includes non-clinical testing. It does not typically contain detailed acceptance criteria and performance data for a study proving a device meets those criteria in the way a clinical trial report or a comprehensive validation study would.

The document primarily focuses on demonstrating that the new device is substantially equivalent to legally marketed predicate devices, meaning it is as safe and effective. It refers to non-clinical tests that were performed, but does not present the specific acceptance criteria or the numerical results of those tests in a "performance table" format.

Therefore, many of the requested points below cannot be fully extracted from this document, as it's not the type of report that contains that level of detail for acceptance criteria and specific study outcomes. I will highlight what can be inferred or directly stated from the provided text, and what cannot.

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of "acceptance criteria" alongside "reported device performance" in a quantitative manner as one might find in a detailed engineering validation report or a clinical study. Instead, it states that "non-clinical tests demonstrate that the device is substantial equivalent."

The document mentions several tests and standards the device was subjected to:

Packaging system performance testing: per ASTM D4169. (Specific acceptance criteria and reported performance not detailed.)
Dynamic loading testing: conducted according to ISO 14801 and FDA Guidance Document ("Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" (May 12, 2004)). (Specific acceptance criteria and reported performance not detailed.)
Magnetic Resonance compatibility testing: according to ASTM F2052, ASTM F2213, ASTM F2119, and ASTM F2182. Status: "MR Conditional." (This is a performance outcome, but the specific metrics and acceptance thresholds for each ASTM standard are not detailed.)
Verification of biocompatibility: in accordance with ISO 10993-1. (The conclusion is that "no new issues regarding biocompatibility were raised," implying acceptance, but specific criteria and test results not detailed.)
End user cleaning and sterilization validation: in accordance with ISO 17665-1. (Implied acceptance, but specific criteria and results not detailed.)

The "acceptance criteria" here are generally referred to as meeting the requirements of the standards and demonstrating substantial equivalence to the predicate device. The "reported device performance" is summarized as favorable results sufficient for substantial equivalence determination.

2. Sample sizes used for the test set and the data provenance

Sample sizes: Not specified in the provided text for any of the non-clinical tests mentioned (packaging, dynamic loading, MR compatibility, biocompatibility, sterilization validation).
Data provenance: Not explicitly stated (e.g., country of origin). The testing is non-clinical/bench testing, not patient data. It is implied to be internal testing by the manufacturer, Nobel Biocare AB (Sweden).
Retrospective or prospective: N/A, as these are non-clinical/bench tests, not clinical studies involving patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Applicability: This question is not directly applicable to the type of non-clinical, bench testing described for the NobelProcera® Titanium ASC Abutment and Omnigrip Clinical Screw Titanium. "Ground truth" established by experts (e.g., radiologists for image interpretation) is relevant for AI/ML device evaluations, particularly in diagnostics. This document refers to physical device testing (mechanical, biocompatibility, etc.).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Applicability: Not applicable. Adjudication methods are typically used in clinical studies or expert reviews to resolve disagreements in interpretations or diagnoses for establishing "ground truth," which is not the nature of the non-clinical tests described here.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Applicability: Not applicable. This device is a dental abutment and screw, not an AI/ML-enabled diagnostic device for image interpretation. Therefore, no MRMC study or AI assistance evaluation would have been performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Applicability: Not applicable. See point 5. This is a physical medical device, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Applicability: The concept of "ground truth" as typically applied in AI/ML validation (e.g., for diagnostic accuracy) does not directly apply to the non-clinical device testing described. For these tests, the "ground truth" is typically defined by the specified parameters and performance requirements of the relevant international standards (e.g., ISO 14801 for dynamic loading, ISO 10993-1 for biocompatibility). The devices are expected to meet the performance criteria defined by these standards.

8. The sample size for the training set

Applicability: Not applicable. This refers to the training of an AI/ML algorithm. The document describes a physical medical device.

9. How the ground truth for the training set was established

Applicability: Not applicable. See point 8.

Summary

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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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 24, 2024

Nobel Biocare AB Bernice Jim Head of RA Product Development and Marketed Products Vastra Hamngatan 1 Goteborg 411 17 SWEDEN

Re: K233208

Trade/Device Name: NobelProcera® Titanium ASC Abutment, Omnigrip Clinical Screw Titanium Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: September 28, 2023 Received: December 20, 2023

Dear Bernice Jim:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Andrew I. Steen -S

Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K233208

Device Name

NobelProcera Titanium® ASC Abutments; Omnigrip Clinical Screw Titanium

Indications for Use (Describe)

NobelProcera® Titanium ASC Abutments:

NobelProcera® Abutment Titanium is a patient-matched CAD/CAM prosthetic component directly connected to endosseous dental implants and is indicated for use as an aid in prosthetic rehabilitation.

Omnigrip Clinical Screw Titanium:

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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Image /page/4/Picture/0 description: The image contains the logo for Nobel Biocare. The logo consists of a stylized red letter "N" enclosed in a square, followed by the words "Nobel Biocare" in black text. The word "Nobel" is placed above the word "Biocare", and there is a trademark symbol after the word "Biocare".

1 – 510(k) Summary – K233208

1.1 Submitter Information

Nobel Biocare AB Submitter: Vastra Hamngatan 1 Goteborg 411 17 Sweden
Submitted By: Nobel Biocare Services AG Balz-Zimmerman-Strasse 7 8302 Kloten Switzerland

Contact Person:	Bernice Jim, Ph.D
E-Mail:	regulatory.affairs.nb@envistaco.com
Telephone Number:	+41 43 211 42 00
Prepared By:	Nicole Fuchs, MLaw
Date Prepared:	January 24th, 2024

1.2 Device Name No. 1

Proprietary name:	NobelProcera® Titanium ASC Abutment
Manufacturer:	Nobel Biocare AB
Common Name:	Dental Abutment
Classification Name:	Endosseous Dental Implant Abutment
Regulation Number:	21 CFR 872.3630
Device Class:	II
Product Code:	NHA

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Image /page/5/Picture/0 description: The image shows the logo for Nobel Biocare. The logo consists of a red square with a stylized white "N" inside of it. To the right of the square is the text "Nobel Biocare" in black font, with the "TM" symbol in superscript.

1.3 Device Name No. 2

Proprietary name:	Omnigrip Clinical Screw Titanium
Manufacturer:	Nobel Biocare AB
Common Name:	Dental Abutment Screw
Classification Name:	Endosseous Dental Implant Abutment
Regulation Number:	21 CFR 872.3630
Device Class:	II
Product Code:	NHA

1.4 Predicate Device

Primary Predicate Device No 1

Proprietary name:	NobelProcera® Abutment Titanium (K091756)
Manufacturer:	Nobel Biocare AB
Common Name:	Dental Abutment
Classification Name:	Endosseous Dental Implant Abutment
Regulation Number:	21 CFR 872.3630
Device Class:	II
Product Code:	NHA

Reference 1 for No. 1 Device

Proprietary name:	NobelProcera Angulated Screw Channel Abutment ConicaConnection (K132746)
Manufacturer:	Nobel Biocare AB
Common Name:	Dental Abutment
Classification Name:	Endosseous Dental Implant Abutment
Regulation Number:	21 CFR 872.3630
Device Class:	II
Product Code:	NHA

Reference 2 for No. 1 Device

Proprietary name:	DESS® Dental Smart Solutions (K221301)
Manufacturer:	Terrats Medical SL
Common Name:	Dental Abutment
Classification Name:	Endosseous Dental Implant Abutment
Regulation Number:	21 CFR 872.3630
Device Class:	II

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Image /page/6/Picture/0 description: The image contains the logo for Nobel Biocare. On the left is a red symbol that looks like a stylized letter N. To the right of the symbol is the text "Nobel Biocare" in black font. The word "Nobel" is on the top line, and "Biocare" is on the bottom line with a trademark symbol.

Product Code:

Reference 3 for No. 1 Device

Proprietary name:	Universal Abutment NB N1 TCC (K211109)
Manufacturer:	Nobel Biocare AB
Common Name:	Dental Abutment
Classification Name:	Endosseous Dental Implant Abutment
Regulation Number:	21 CFR 872.3630
Device Class:	II
Product Code:	NHA. PNP

NHA, PNP

Reference 4 for No. 1 Device

Proprietary name:	NOBELACTIVE WIDE PLATFORM (WP) (K133731)
Manufacturer:	Nobel Biocare AB
Common Name:	Dental Abutment
Classification Name:	Endosseous Dental Implant Abutment
Regulation Number:	21 CFR 872.3630
Device Class:	II
Product Code:	NHA

Reference 5 for No. 1 Device

Proprietary name:	Titanium Abutment Blank Nobel Biocare N1 TM TCC(K223677)
Manufacturer:	Nobel Biocare AB
Common Name:	Dental Abutment
Classification Name:	Endosseous Dental Implant Abutment
Regulation Number:	21 CFR§872.3630
Device Class:	II
Product Code:	NHA, PNP

Predicate No. 2 Device

Proprietary name:	Omnigrip Clinical Screw CC (K132746)
Manufacturer:	Nobel Biocare AB
Common Name:	Dental Abutment
Classification Name:	Endosseous Dental Implant Abutment
Regulation Number:	21 CFR 872.3630
Device Class:	II
Product Code:	NHA

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Image /page/7/Picture/0 description: The image contains the logo for Nobel Biocare. The logo consists of a stylized red letter "N" on the left, followed by the words "Nobel Biocare" in black text on the right. The word "Nobel" is on the top line, and the word "Biocare" is on the bottom line with a trademark symbol.

Reference 1 for No. 2 Device

Proprietary name:	NOBELACTIVE MULTI UNIT ABUTMENT (K072570)
Manufacturer:	Nobel Biocare AB
Common Name:	Dental Abutment
Classification Name:	Endosseous Dental Implant Abutment
Regulation Number:	21 CFR 872.3630
Device Class:	II
Product Code:	NHA

Reference 2 for No. 2 Device

Proprietary name:	Trefoil System (K170135)
Manufacturer:	Nobel Biocare AB
Common Name:	Dental Abutment
Classification Name:	Endosseous Dental Implant Abutment
Regulation Number:	21 CFR 872.3630
Device Class:	II
Product Code:	NHA

Reference for No. 1 Device & No. 2 Device

Proprietary name:	Nobel Biocare Dental Implant Systems Portfolio – MRConditional (K212125)
Manufacturer:	Nobel Biocare AB
Common Name:	Dental Implants
Classification Name:	Endosseous Dental Implant and Abutment
Regulation Number:	21 CFR 872.3640, 21 CFR 872.3630, 21 CFR 872.4120
Device Class:	II
Product Code:	DZE, NHA, PNP, DZI

1.5 Device Description Summary

The Subject Device NobelProcera® Titanium ASC Abutment is composed of two device lines: NobelProcera® Titanium ASC Abutment and the Clinical Screw Omnigrip Titanium.

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Image /page/8/Picture/0 description: The image contains the logo for Nobel Biocare. On the left is a red symbol that looks like a stylized letter N. To the right of the symbol is the text "Nobel Biocare" in black. The word "Nobel" is on the top line, and the word "Biocare" is on the bottom line with a trademark symbol.

6.0 (for internal tri-channel connection only) and is intended for use as an aid in prosthetic rehabilitation to restore chewing function and esthetic appearance.

NobelProcera® Titanium ASC Abutments undergo patient matched customization at a Nobel Biocare production facility for the final, finished abutment device manufacturing.

The finished NobelProcera® Titanium ASC Abutment supports the placement of a cement-retained dental prosthesis.

Table 1-1 outlines the restorative design specifications for the NobelProcera Titanium ASC Abutments:

Subject Device	NobelProcera®Titanium ASCAbutment
Maximum abutment anqulation	30°
Minimum screw channel thickness (min. wall thickness)	0.42 mm
Maximum abutment height from implant level	15 mm
Minimum diameter	4.4 mm
Maximum diameter	16 mm
Minimum post height (length above the abutment collar / gingival height)	4 mm
Maximum post height (length above the abutment collar / gingival height)	14.7 mm
Minimum gingival margin height	0.3 mm

Table 1-1: Design Constraints

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Image /page/9/Picture/0 description: The image shows the logo for Nobel Biocare. The logo consists of a red stylized letter N on the left and the words "Nobel Biocare" on the right. The word "Nobel" is above the word "Biocare", and there is a trademark symbol after the word "Biocare".

Table 1-2: Omnigrip Clinical Screw Titanium Design Specifications

Connection	Largest nominal diameter	Nominal total length:
Conical	NP: 2.3RP/WP: 2.525	NP: 7.325RP/WP: 7.3
Tri-Channel	NP: 2.465RP/WP/6.0: 2.465	NP: 8.315RP/WP/6.0: 10.03

NobelProcera® Titanium ASC Abutment and Omnigrip Clinical Screw Titanium are compatible with Nobel Biocare implants featuring an internal conical connection (K142260, K073142, K173418 and K202344) and internal tri-channel connection (K023113).

Intended Use/Indication for Use 1.6

NobelProcera® Titanium ASC Abutments:

NobelProcera® Abutment Titanium is a patient-matched CAD/CAM prosthetic component directly connected to endosseous dental implants and is indicated for use as an aid in prosthetic rehabilitation.

Omnigrip Clinical Screw Titanium:

1.7 Indications for Use Comparison

The Intended Use statement and Indications for Use statement are the same, expressed through a similar choice of words.

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Image /page/10/Picture/0 description: The image shows the logo for Nobel Biocare. The logo consists of a red stylized letter N on the left and the words "Nobel Biocare" on the right. The word "Nobel" is on the top line and the word "Biocare" is on the bottom line with a trademark symbol.

1.8 Technological Comparison

1.8.1 NobelProcera® Titanium ASC Abutments

Table 1-3: NobelProcera Titanium ASC Abutment Predicate and Reference Device Summary

	Subject Device	Primary PredicateDevice	Reference Device#1	Reference Device#2	Reference Device#3
	NobelProceraTitanium ASCAbutment	NobelProcera®Abutment Titanium	NobelProceraAngulated ScrewChannel AbutmentConicalConnection	DESS® DentalSmart Solutions	UniversalAbutment NB N1TCC	Comparison
		K091756	K132746	K221301	K211109
Manufacturer	Nobel Biocare AB	Nobel Biocare AB	Nobel Biocare AB	Terrats Medical SL	Nobel Biocare AB
Product Classification	Class II	Class II	Class II	Class II	Class II	Same as Primary Predicate
Regulation Number /Name	21 CFR 872.3630Endosseous DentalImplant Abutment	21 CFR 872.3630Endosseous DentalImplant Abutment	21 CFR 872.3630Endosseous DentalImplant Abutment	21 CFR 872.3630Endosseous DentalImplant Abutment	21 CFR 872.3630Endosseous DentalImplant Abutment	Same as Primary Predicate
Product Code, primary	NHA	NHA	NHA	NHA	NHA	Same as Primary Predicate
Product Code,secondary	N/A	N/A	N/A	PNP	PNP	Same as Primary Predicate
Review Panel	Dental	Dental	Dental	Dental	Dental	Same as Primary Predicate
Intended Use	Intended to befinalized into a single-unit dental prosthesis,which is connected toan endosseous dentalimplant to restorechewing function	Nobel Biocare'sNobelProcera®/Procera® AbutmentTitanium/Zirconia is acustomized dentalabutment. Theabutment attachesdirectly to theendosseous dentalimplant with a clinicalscrew and provides a	Nobel Biocare'sNobelProcera®ASC AbutmentZirconia is acustomized dentalabutment. Theabutment is seatedand attacheddirectly to theendosseous dentalimplant andprovides a platform	Support of aprosthesis torestore chewingfunction	Intended to beconnected to anendosseous dentalimplant to supportthe placement of adental prosthesis.	Same Intended Use expressedthrough a similar choice ofwords.
Subject Device	Primary PredicateDevice	Reference Device#1	Reference Device#2	Reference Device#3	Comparison
NobelProceraTitanium ASCAbutment	NobelProcera®Abutment Titanium	NobelProceraAngulated ScrewChannel AbutmentConicalConnection	DESS® DentalSmart Solutions	UniversalAbutment NB N1TCC
	K091756	K132746	K221301	K211109
		platform forrestoration.	for restoration. TheNobelProcera®ASC AbutmentZirconia isindividuallydesigned andmanufactured tofulfill the clinicalneed of eachpatient.The NobelProcera®ASC AbutmentZirconia is made outof Zirconia and isdeliveredwith a titaniumadapter and anOmnigrip™ clinicalscrew.
Indications for Use	NobelProcera®Abutment Titanium isa patient-matchedCAD/CAM prostheticcomponent directlyconnected toendosseous dentalimplants and isindicated for use asan aid in prostheticrehabilitation.	Nobel Biocare'sNobelProcera®/Procera® Abutmenttitanium/Zirconia isindicated for thetreatment of partiallyedentulous patientsrequiring prostheticdevices and/orendosseous implantsto restore chewingfunction.	The NobelProceraAngulated ScrewChannel AbutmentConical Connectionarepremanufacturedprostheticcomponents directlyconnected toendosseous dentalimplants and areintended for use asan aid in prostheticrehabilitation.	DESS DentalSmart Solutionsabutments areintended for dentalprostheticrestorations. DESSDental SmartSolutionsabutments areused as aninterface between adental implant ordental abutmentand a dental	Universalabutments areindicated to supportthe placement ofsingle unit, screw-retained prostheticrestorations in themaxilla or mandible.The UniversalAbutment consistsof two major parts.Specifically, thetitanium base andmesostructure	Same Indications for Useexpressed through a similarchoice of words and adjusted tomatch updated wordingaccording to FDA feedback inprev. submissions (K220048).
Subject Device	Primary PredicateDevice	Reference Device#1	Reference Device#2	Reference Device#3
NobelProceraTitanium ASCAbutment	NobelProcera®Abutment Titanium	NobelProceraAngulated ScrewChannel AbutmentConicalConnection	DESS® DentalSmart Solutions	UniversalAbutment NB N1TCC	Comparison
	K091756	K132746	K221301	K211109
			restoration and willbe attached to theimplant orabutment using aprosthetic screwand attached to thedental restorationby cementing.All digitallydesigned customabutments for usewith Base abutmentor Pre-milled Blankare to be sent to aTerrats Medicalvalidated millingcenter formanufacture, or tobe designed andmanufacturedaccording to thedigital dentistryworkflow. Thedigital dentistryworkflow integratesmultiplecomponents: scanfiles from intra-oraland lab (desktop)scanners, CADsoftware, CAMsoftware, ceramic	components makeup a two-pieceabutment.The systemintegrates multiplecomponents of thedigital dentistryworkflow scan filesfrom Intra-OralScanners, CADsoftware, CAMsoftware, ceramicmaterial, millingmachine andassociated toolingand accessories.
Subject Device	Primary Predicate Device	Reference Device #1	Reference Device #2	Reference Device #3	Comparison
NobelProceraTitanium ASCAbutment	NobelProcera®Abutment Titanium	NobelProceraAngulated ScrewChannel AbutmentConicalConnection	DESS® DentalSmart Solutions	UniversalAbutment NB N1TCC
	K091756	K132746	K221301material, millingmachine, andassociated toolingand accessories.	K211109
TechnologicalCharacteristics
Device Dimensions/Design Specifications
Minimum wallthickness:	0.42 mm	0.3637mm	N/A	0.4 mm	N/A	Similar to Primary Predicate.
Platformcompatibility	ConicalConnection	NP, RP, WP	NP, RP	NP, RP	NP, RP, WP(according to 510ksummary)	N/A	Similar to Primary Predicate.Same as Reference Device #2
	TriChannelConnection	NP, RP, WP, 6.0	NP, RP, WP, 6.0	N/A	NP, RP, WP, 6.0(according to 510ksummary)	N/A	Same as Primary Predicate
	TCC	N/A	N/A	N/A	N/A	NP, RP	Same as Primary Predicate
Minimumplatformdiameter	NP CC	$Ø$ 3.13	$Ø$ 3.06	$Ø$ 3.89	2.52 – 6.0 mm(Implant Platformdependent)	N/A	Similar to Primary Predicate andSame as Reference Device #2
	NP Tri-Chan	$Ø$ 3.53	$Ø$ 3.53	N/A		N/A	Same as Primary Predicate
	RP CC	$Ø$ 3.46	$Ø$ 3.46	$Ø$ 4.29		N/A	Same as Primary Predicate
		Subject Device	Primary PredicateDevice	Reference Device#1	Reference Device#2	Reference Device#3
		NobelProceraTitanium ASCAbutment	NobelProcera®Abutment Titanium	NobelProceraAngulated ScrewChannel AbutmentConicalConnection	DESS® DentalSmart Solutions	UniversalAbutment NB N1TCC	Comparison
			K091756	K132746	K221301	K211109
	RP Tri-Chan	Ø 4.3	Ø 4.3	N/A	N/A	N/A	Same as Primary Predicate
	WP CC	Ø 4.486	N/A	N/A	N/A	N/A	Similar as Primary PredicateSame as Reference Device #2
	WP Tri-Chan	Ø 5	Ø 5	N/A	N/A	N/A	Same as Primary Predicate
	6.0	Ø 6	Ø 6	N/A	N/A	N/A	Same as Primary Predicate
	TCC NP	N/A	N/A	N/A	N/A	Ø4.5mm	Same as Primary Predicate
	TCC RP	N/A	N/A	N/A	N/A	Ø4.5mm	Same as Primary Predicate
Minimum gingivalheight:		0.3 mm	N/A	N/A	0.3 mm	N/A	Same as Reference Device #2
Minimum post height:(length above theabutment collar /gingival height)		4mm	4mm	4mm	4mm	N/A	Same as Primary Predicate
Screw Channel		ASC (0°-25°)	Straight (0°)	ASC (0°-25°)	N/A	Straight (0°)	Similar to predicate.Same as Reference Device #1
Abutment Shape		Patient Specific	Patient Specific	Patient Specific	Patient Specific	Standard (bottom) /Patient specific(top)	Same as Primary Predicate
Attachment method toimplant		Screw retained	Screw retained	Screw retained	Screw retained	Screw retained	Same as Primary Predicate
Prosthesis attachmentmethod		Cement retained	Cement retained	Cement retained	Cement retained	Cement retained	Same as Primary Predicate
Restoration type		Single-unit and multi-unit	Single-unit and multi-unit	Single-unit	Single-unit andmulti-unit	Single-unit	Same as Primary Predicate
Design features		Pre-manufacturedimplant-interfaceconnection,customizable	Pre-manufacturedimplant-interfaceconnection,customizable	Pre-manufacturedimplant-interfaceconnection,customizable	N/A	Two-piecepremanufacturedabutment:customizablerestoration and	Same as Primary Predicate
	Subject Device	Primary PredicateDevice	Reference Device#1	Reference Device#2	Reference Device#3	Comparison
	NobelProceraTitanium ASCAbutment	NobelProcera®Abutment Titanium	NobelProceraAngulated ScrewChannel AbutmentConicalConnection	DESS® DentalSmart Solutions	UniversalAbutment NB N1TCC
		K091756	K132746	K221301	K211109
	cylindrical abutmentbody	cylindrical abutmentbody	cylindrical abutmentbody		standardizedbottom
Principle of operation/Mechanism of action	Mechanical screwconnection	Mechanical screwconnection	Mechanical screwconnection	Mechanical screwconnection	Mechanical screwconnection	Same as Primary Predicate
Maximum abutmentangulation	30°	20°	0°	30 max for Blanks	0°	Same as Reference Device #2
Material	Titanium aluminumvanadium alloy	Titanium aluminumvanadium alloy	Adapter:Titanium/vanadiumalloy	Titanium aluminumvanadium alloy	Titaniumaluminumvanadium alloy	Same as Primary Predicate
	Ti6Al4V ELI (ISO5832-3, ASTM F136)MTA005	Ti6Al4V ELI (ISO5832-3, ASTM F136)MTA005	Abutment Body:Zirconium oxide	Ti6Al4V ELI (ISO5832-3, ASTMF136)	Ti6Al4V ELI (ISO5832-3, ASTMF136)	Same as Primary Predicate
Surface Treatment	Anodization (GoldenAbutment) &N/A (Non-AnodizedAbutment)	N/A	N/A	N/A	Anodization	Same as Reference Device #3
Equipment for digitaldesign workflow
Design Worfkflow	Wax-up or CAD.	Wax-up or CAD.	N/A	3Shape Intraoralscanner Triosseries, 3Shape E-series andD/R2000 LabScanner, 3ShapeAbutment DesignerSoftware (3ShapeA/S) K151455	ScannerKavo LS3.3Shape Trios orother scannerswith equal orhigher accuracythan 6.9 µmDesign softwareDTX StudioDesign (K181932,where the implantlibraries are	Same as Primary Predicate
	Subject Device	Primary PredicateDevice	Reference Device#1	Reference Device#2	Reference Device#3
	NobelProceraTitanium ASCAbutment	NobelProcera®Abutment Titanium	NobelProceraAngulated ScrewChannel AbutmentConicalConnection	DESS® DentalSmart Solutions	UniversalAbutment NB N1TCC	Comparison
		K091756	K132746	K221301	K211109
					automaticallyincluded in thesoftware installer)or 3ShapeAbutmentDesigner Software(K151455, wherethe implantlibraries areobtained via the3Shape server inthe software).
ManufacturingWorkflow	Customization milledat devicemanufacturer.	Customization milledat devicemanufacturer.	N/A	Digital DentistryWorkflow &Validated MillingCenter	Milling unit- Indicated forZirconia milling- Minimum 5 axismilling technology- Minimum 30.000rpm spindle speed	Same as Primary Predicate

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Image /page/11/Picture/0 description: The image contains the logo for Nobel Biocare. On the left is a red square with a stylized white "N" inside. To the right of the square is the text "Nobel Biocare™" in black. The "™" symbol is in superscript.

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Image /page/12/Picture/0 description: The image contains the logo for Nobel Biocare. On the left is a red square with a stylized white "N" inside. To the right of the square is the text "Nobel Biocare™" in black. The "™" symbol is in superscript.

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Image /page/13/Picture/0 description: The image contains the logo for Nobel Biocare. On the left is a red square with a stylized white "N" inside. To the right of the square is the text "Nobel Biocare™" in black. The word "Nobel" is on the top line and "Biocare™" is on the bottom line.

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Image /page/14/Picture/0 description: The image contains the logo for Nobel Biocare. On the left is a red square with a stylized white "N" inside. To the right of the square is the text "Nobel Biocare™" in black. The word "Nobel" is on the top line and "Biocare™" is on the bottom line.

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Image /page/15/Picture/0 description: The image contains the logo for Nobel Biocare. On the left is a red square with a stylized white "N" inside. To the right of the square is the text "Nobel Biocare™" in black. The "™" symbol is in superscript.

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Image /page/16/Picture/0 description: The image shows the logo for Nobel Biocare. The logo consists of a red stylized letter "N" on the left and the words "Nobel Biocare" on the right. The word "Nobel" is above the word "Biocare", and there is a trademark symbol after the word "Biocare".

The similarities between the Subject Device line NobelProcera® Titanium ASC Abutments and the Primary Predicate Device are as follows:

The design methods, manufacturing and packaging, compatible Implant/Abutment connection (CC and Tri-Ch) and platforms । (NP/RP/WP/6.0) and utilized materials are identical for the Subject and Predicate Device.

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Image /page/17/Picture/0 description: The image shows the logo for Nobel Biocare. On the left is a red square with a stylized white "N" inside. To the right of the square is the text "Nobel Biocare" in black. The word "Nobel" is on top of the word "Biocare", and there is a trademark symbol after the word "Biocare".

The Indications for Use of the Subject Device and the Primary Predicate Device is the same and expressed through a similar l choice of words.
Both the Subject Device and the Primary Predicate Device are labelled MR Conditional l

Details of the Differences Between the Subject and Predicate Device:

There are no significant differences between the Subject and Predicate Devices but there are minor differences as follows:

The minimum platform dimensions for the Connection NP platform is different in the Subject and Predicate Device, however, the minimum device dimensions are within the range of the Predicate Device and Reference Device.
The Subject Device has a maximum angulation of 30°, identical to Reference Device #2, whereas the Predicate Device has a maximum angulation of 20°.
The Subject Device features an anqulated screw channel, whereas the Predicate Device features a straight screw channel. This difference does not affect the shared intended use, between the devices as demonstrated by non-clinical testing. The same screw channel angulation (0° - 25°) is used for the Reference Device #1.
The minimal wall thickness and gingival height of the Subject Device are similar and slightly greater than the Predicate Device.
The Subject Device is provided with and without surface anodization, whereas the Predicate is not treated. The surface treated Subject Device features the same anodization already cleared in K211109.

Conclusion:

Based on a comparison of intended use, indications for use, technological characteristics, principle of operation, features, and performance data, NobelProcera® Titanium ASC Abutments is deemed to be substantially equivalent to the Primary Predicate Device as it satisfies all criteria of substantial equivalence and does not raise new concerns regarding substantial equivalence: Indications for Use, Technological Characteristics and Performance Data. The new device does not introduce a fundamentally new scientific technology and the nonclinical tests demonstrate that the device is substantial equivalent.

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Image /page/18/Picture/0 description: The image shows the logo for Nobel Biocare. On the left is a red square with a stylized white "N" inside. To the right of the square is the text "Nobel Biocare" in black. The word "Nobel" is on top of the word "Biocare", and there is a trademark symbol after the word "Biocare".

1.8.2 Omnigrip Clinical Screw Titanium

Table 1-4: Omnigrip Clinical Screw Titanium Predicate and Reference Device Summary

	Subject Device	Predicate Device	Comparison
	Omnigrip Clinical Screw Titanium CC NPOmnigrip Clinical Screw Titanium CC RP/WPOmnigrip Clinical Screw Titanium Tri-Channel NPOmnigrip Clinical Screw Titanium Tri-Channel RP/WP/6.0	Omnigrip Clinical Screw CCNP/RP/WP
		K132746
Manufacturer	Nobel Biocare AB	Nobel Biocare AB	Same as Predicate
Product Classification	Class II	Class II	Same as Predicate
Regulation Number / Name	21 CFR 872.3630	21 CFR 872.3630	Same as Predicate
Name	Endosseous Dental Implant Abutment	Endosseous Dental Implant Abutment	Same as Predicate
Product Code, primary	NHA	NHA	Same as Predicate
Product Code, secondary	N/A	N/A	Same as Predicate
Review Panel	Dental	Dental	Same as Predicate
Intended Use	Intended for use to fasten dental implant system components to a dental implant or to another component.	Intended for use to fasten dental implant system components to a dental implant or to another component.	Same as Predicate
Indications for Use	Clinical and Abutment Screws are indicated for use to secure a dental abutment or framework to a dental implant in the maxilla or mandible for supporting tooth replacements and are indicated as an aid in prosthetic rehabilitation.	Clinical Screws are indicated for use to secure a dental abutment or framework to a dental implant in the maxilla or mandible for supporting tooth replacements and are indicated as an aid in prosthetic rehabilitation.	Same as Predicate
Technological Characteristics
Device Dimensions/ Design Specifications
Screw body dimensions	Largest nominal diameter:CC NP: 2.3CC RP/WP: 2.525	Largest nominal diameter:NP: 2.375 mmRP: 2.525 mm	Similar as Predicate

	TriCh NP: 2.465TriCh RP/WP/6.0: 2.465
	Nominal total length:CC NP: 7.325CC RP/WP: 7.3TriCh NP: 8.315TriCh RP/WP/6.0: 10.03	Nominal total length:NP: 8.905 mmRP: 8.705 mm
Compatible implantplatform sizes	Narrow Platform (NP)Regular Platform (RP)Wide Platform (WP)6.0	Narrow Platform (NP)Regular Platform (RP)Wide Platform (WP)	Same as Predicate
Screw Interface	OmniGrip	OmniGrip	Same as Predicate
Principle of operation/(Attachment method)	The Omnigrip clinical screws are used forsecuring the abutment to the endosseous implant.	The Omnigrip clinical screws areused for securing the abutment to theendosseous implant.	Same as Predicate
Material	Titanium vanadium alloyMTA 005(Ti6Al4V ELI, ASTM F136-13 / ISO 5832)"	Titanium vanadium alloyMTA 005(Ti6Al4V ELI, ASTM F136-13 / ISO5832)"	Same as Predicate
Surface material	CC & TriCh NP: N/A (machined surface, no PVD(DLC) coating)CC RP/WP &: TriCh RP/WP/6.0: PVD (DLC)surface treatment	NP: N/A (machined surface, no PVD(DLC) coating) ,Blue anodization onscrew headRP/WP: PVD (DLC) surfacetreatmentBlue anodization on screw head"	Similar as Predicate

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Image /page/19/Picture/0 description: The image shows the logo for Nobel Biocare. The logo consists of a red stylized letter N on the left and the words "Nobel Biocare" on the right. The word "Nobel" is above the word "Biocare", and there is a trademark symbol after the word "Biocare".

The similarities between the Omnigrip Clinical Screw Titanium and the Predicate Device Omnigrip Clinical Screw CC NP/RP/WP are as follows:

The Intended Use, Indications for Use, the Principle of operation, device material, compatible implant platform, thread । design and screw interfaces are the same for both, Subject Device and the Predicate Devices are used to

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Image /page/20/Picture/0 description: The image shows the logo for Nobel Biocare. The logo consists of a red square with a stylized "N" inside of it on the left. To the right of the square is the text "Nobel Biocare" in black. The word "Nobel" is on top of the word "Biocare", and there is a trademark symbol after the word "Biocare".

fix a prosthetic component to a dental abutment. Furthermore, both, the Subject and Predicate Device are non-sterile, single-use devices.

Details of the Differences Between the Subject and Predicate Device:

There are no significant differences between the Subject and Predicate Devices but there are minor differences as follows:

Both devices, Subject Device and Predicate Device, are provided with and without DLC (Diamond like carbon) coating, however, the screw head of the Subject Device is not anodized in comparison to the Predicate device.
The Subject Device and Predicate Device have different screw body dimensions. ।
The compatible abutment platforms of the Subject Device features either a conical connection (CC) or a Tri-Channel । Connection (Tri-Ch) whereas the Predicate Device features a conical connection (CC).

Conclusion:

Based on a comparison of intended use, indications for use, technological characteristics, principle of operation, features, and performance data, Omnigrip Clinical Screw Titanium is deemed to the Primary Predicate Device as it satisfies all criteria of substantial equivalence and does not raise new concerns regarding substantial equivalence: Indications for Use, Technological Characteristics and Performance Data. The new device does not introduce a fundamentally new scientific technology and the nonclinical tests demonstrate that the device is substantial equivalent.

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Image /page/21/Picture/0 description: The image contains the logo for Nobel Biocare. The logo consists of a stylized red letter "N" on the left, followed by the words "Nobel" and "Biocare" stacked on top of each other on the right. The word "Nobel" is in a larger, bolder font than "Biocare", and the trademark symbol is next to the word "Biocare".

Non-Clinical and/or Clinical Tests Summary & Conclusions: 1.9

Non-clinical testing was performed on the Subject Device lines NobelProcera® Titanium ASC Abutment and Omnigrip Clinical Screw Titanium:

Packaging system performance testing per ASTM D4169
. Dynamic loading testing performed according to ISO 14801 was conducted according to ISO 14801 and the FDA Guidance Document entitled, "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" (May 12, 2004)
. Magnetic Resonance compatibility testing according to ASTM F2052, ASTM F2213, ASTM F2119 and ASTM F2182. There are no significant changes to the materials and dimensions from the currently marketed Predicate Devices. Therefore, no new issues of electromagnetic compatibility are raised for the Subject Devices and they can be considered MR Conditional. The Subject Devices have obtained the status of MR Conditional per K212125. The MR Conditional tests were conducted according to FDA's Guidance "Testing and Labeling Medical Devices for Safety in Magnetic Resonance (MR) Environment".
Verification of biocompatibility of the final device in accordance with ISO 10993-1. The Subject Devices are equivalent in material, surface, manufacturing processes, sterilization process, body contact and contact duration to the Reference Devices per K072570, K133731, K170135, K223677 therefore, no new issues reqarding biocompatibility were raised.
End user cleaning and sterilization validation in in accordance with ISO 17665-1 ●

Clinical performance data is not required to establish substantial equivalence for the Subject Devices.

Based on a comparison of intended use, indications, material composition, technological characteristics, principle of operation, features and performance data, the two device lines NobelProcera® Titanium ASC Abutment and Omnigrip Clinical Screw Titanium are deemed to be substantially equivalent to the Predicate Devices.

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.)