The On1™ device is a premanufactured prosthetic component directly connected to an endosseous implant and it is intended for use in prosthetic rehabilitation.

Device Description

The On1 Concept is a 2-piece dental implant abutment system. It is intended to be used with the Nobel Biocare dental implants that have the internal conical connection. The On1 Concept features the On1 Base that once placed on the dental implant is not intended to be removed. The top portion of the On1 Clinical Screw incorporates threads to accommodate the On1 Healing Cap and On1 Prosthetic Screw allowing the On1 Clinical Screw to remain in position after placement and securing of the On1 Base. The On1 Concept system includes a healing cap, temporary abutment and esthetic abutments which all fit onto the On1 Base. The esthetic abutments are available in both titanium alloy and zirconium oxide.

AI/ML Overview

This document is a 510(k) premarket notification from the FDA for a dental implant abutment system, the "On1 Concept." It primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving the device meets them in the way one might expect for a diagnostic AI device.

Therefore, much of the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, expert involvement, and ground truth establishment is not available in this document. This document describes a medical device (dental implant abutment), not a software or AI device that would have performance metrics like sensitivity, specificity, or AUC.

However, I can extract the relevant information that is present and indicate where information is absent based on the nature of this document.

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

Based on the document, the primary "acceptance criterion" is demonstrating substantial equivalence to predicate devices, particularly regarding fatigue limit. The reported performance focuses on this.

Acceptance Criteria (Implied)	Reported Device Performance
Fatigue Limit (per ISO 14801)	The fatigue limit of the On1 Concept was determined using the methods described in ISO 14801. (The actual numerical result is not explicitly stated in this summary, but it was presumably deemed sufficient to demonstrate substantial equivalence).
Sterility	Sterilization method (Gamma radiation, pre-vacuum & gravity moist heat) validated in accordance with ANSI/AAMI/ISO 11137 and ANSI/AAMI/ISO 17665-1.
Packaging Integrity	Packaging is the same as the predicate (thermoform tray with peel top lid). No additional testing required.
Shelf Life	Packaging is the same as the predicate and labeled with a 3-year expiration after real-time aging. No additional testing required.
Biocompatibility	Device manufactured from the same material with the same process, intended use, patient contact type and duration as the predicate. No additional testing required.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified in this document. The fatigue testing refers to "methods described in ISO 14801," which would define the number of test pieces, but the specific count is not reported here.
Data Provenance: Not specified. The document outlines regulatory submission information, not the detailed origin of testing data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. This document describes a physical medical device (dental abutment), not a diagnostic device requiring expert interpretation for ground truth establishment. The "ground truth" for a mechanical device is often determined by physical measurements and standardized testing procedures (e.g., force applied until fracture, stress cycles).

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

Not Applicable. As per point 3, this is not a diagnostic study with human readers and adjudication. The "adjudication" for mechanical tests would typically refer to the pass/fail criteria defined by the ISO standard.

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

Not Applicable. This is a physical medical device, not an AI or software device. No MRMC study was conducted.

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

Not Applicable. This is a physical medical device, not an algorithm.

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

The "ground truth" for the non-clinical performance data (specifically fatigue testing) would be established by the physical and mechanical properties of the device measured against engineering standards (e.g., ISO 14801) and internal specifications. For other criteria like sterility, biocompatibility, packaging, and shelf life, the ground truth is established by validated testing methods against relevant international or national standards (e.g., ANSI/AAMI/ISO standards).

8. The sample size for the training set

Not Applicable. This is a physical medical device, not an AI or machine learning model that would have a "training set."

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

Not Applicable. As per point 8, there is no "training set" for this type of device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which consists of a stylized caduceus-like symbol with three intertwined figures. The emblem is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged in a circular fashion around the emblem.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W 066-G609 Silver Spring, MD 20993-0002

February 28, 2017

Nobel Biocare AB % Charlemagne Chua Senior Regulatory Affairs Manager Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda, California 92887

Re: K161655

Trade/Device Name: On1 Concept Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: February 1, 2017 Received: February 2, 2017

Dear Charlemagne Chua:

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 (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. The general controls provisions of the Actinclude 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.

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

{1}------------------------------------------------

the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm_for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely. Mary S. Runner - 100 A For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

DE PARTENT OF FEATH AND HUNN SERVICESFood and Drug Administration	Form Approved: OMB No. 0910-0170piration Date: January 31, 2017
ndications for Use	es PRA Statement below.
510(k) Number (if known
166665
Onl ConceptDevice Name
Indications for Use (Describe
it it belies is a premiument pirestly compensed to an endossous in and it it
intended for use in prosthetic rehabilitation.

of Use (Select one or both, as applicable,
A BEAR FERRATE A BO A BEACH A NO JUMITHO - CONTINO TON OG BASSED	I Over The -Counter Use (S) est The ------------------------------------------------------------------------------------

ອນາງອານຸຣິນ (HAQC) ປາໄຣອH ໄຂວ່ເງິດໄທ່ເປັນ ປີ ປະຕິທິນ ປີ ຄ.ສ. 2017 ອົງມາອາການປີFOR FDA USE ONLY
. WOJER SSAREDA JIAMA FRATE AAR BHT OT MRO ACT3J9MCO AUOY GM32 TOM ODThe suites and a personis of the superious of the supplies noires and
of this information collection, including suggestions for reducing this purder, to:ədi birinci ildə məqsədə vəq sinə qalınmış si noğramoni in notibellər sinfi növündə sinfi növündə əsirlər.timer wie on and in and in information ship purposes mortune or any the respectivea more bebeen also and nistriam bus redtep , secures etsb priteixe , suoilounteni weiver of
Paperwork Reduction Act (PRA) StaffDepartment of Health and Human ServicesOffice of Chief Information OfficerPagstaff@fdd.hhs.goovFood and Drug Administration
to noticello a st production is nost of the "instructs to the "losured to resource"information unners it disks a currently vila OMB number.
FORM FDA 3888 (11744Page 1 of 1	PSC Publishing Services (301) 4436740ਜ ਤੋਂ

านออนดว นับ โร อยิน Jo Σε อย่าง

{3}------------------------------------------------

510(k) Summary

I. SUBMITTER

Nobel Biocare AB Vastra Hamngatan 1 Goteborg, SE-411 17 Sweden

Submitted by: Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda, CA 92887

Contact Person: Charlemagne Chua. Senior Requlatory Affairs Manager E-mail: Charlemagne.chua@nobelbiocare.com Phone: (714) 282-4800 x 7830 Fax: (714) 998-9348

Date Prepared: February 27, 2017

II. DEVICE

Name of Device: On1 Concept Common or Usual Name: Endosseous Dental Implant Abutment Classification Name: Endosseous Dental Implant (21 CFR 872.3630) Requlatory Class: II Product Code: NHA

III.PREDICATE DEVICE

Primary Predicate NobelProcera Angulated Screw Channel Abutment Conical Connection (K132746)

Reference Predicate NobelActive Wide Platform (WP) (K133731)

IV. DEVICE DESCRIPTION

{4}------------------------------------------------

Prosthetic Screw allowing the On1 Clinical Screw to remain in position after placement and securing of the On1 Base.

The On1 Concept system includes a healing cap, temporary abutment and esthetic abutments which all fit onto the On1 Base. The esthetic abutments are available in both titanium alloy and zirconium oxide.

V. INDICATIONS FOR USE

The On1™ device is a premanufactured prosthetic component directly connected to an endosseous implant and it is intended for use in prosthetic rehabilitation.

VI. Comparison of Technological Characteristics

Technologicalcharacteristics		Subject Device	Primary Predicate	Reference Predicate
		On1 Concept	NobelProcera Angulated ScrewChannel Abutment Conical(K132746)	NobelActive WidePlatform (WP)(K133731)
Design Features	CompatibleImplantPlatform	Nobel Biocare Internal ConicalConnection- Narrow Platform (NP)- Regular Platform (RP)- Wide Platform (WP)	Nobel Biocare Internal ConicalConnection- Narrow Platform (NP)- Regular Platform (RP)	Nobel Biocare InternalConnection / InternalHex- Wide Platform (WP)
	DeviceMaterial	On1 Base, TemporaryAbutment, On1 Healing Cap,Esthetic Abutment Titanium,Clinical Screws and ProstheticScrews - Titanium vanadiumalloy (ASTM F1472, ASTMF136)On1 Esthetic AbutmentZirconia – Y-TZP zirconiumoxide (ISO 6872, ISO 13356)	Abutment base and clinicalscrew - Titanium vanadiumalloy (ASTM F1472, ASTMF136)Abutment post – Y-TZPzirconium oxide (ISO 6872, ISO13356)	Titanium vanadiumalloy (ASTM F1472,ASTM F136)
	AbutmentDesign	2 piece (base placed either attime of implant placement orwith final abutment)Abutment shape fixed	2 piece (base placed with finalabutment)Abutment shape personalized	Patient Specific Design
	Abutmentheight	Combined base and postheightTemporary Abut – 8.3, 9.0 mmEsthetic Abut Ti – 8.2, 9.0 mmEsthetic Abut Zi - 8.2, 9.0 mm	Not applicable - abutmentshape personalized	Not applicable -abutment shapepersonalized
	Abutmentwidth	At base4.8, 5.3, 6.5 mm	Not applicable - abutmentshape personalized	Not applicable -abutment shapepersonalized
	AbutmentAngulation	No abutment angulation	Variable screw channel andabutment angulation based onpersonalized design.	Not applicable -abutment shapepersonalized

{5}------------------------------------------------

Technologicalcharacteristics	Subject Device	Primary Predicate	Reference Predicate
Intended use	The On1™ devices areintended for use in the field ofdentistry. They are intended tobe used in the upper or lowerjaw for supporting toothreplacements to restorechewing function andesthetics.The On1™ esthetic abutmentsin combination with the On1™Base on Nobel BiocareConical Connectionendosseous implants areindicated for single-unitcement retained restorations.	Nobel Biocare's NobelProceraASC Abutment Zirconia is acustomized endosseous dentalabutment. The abutmentattaches directly to the dentalimplants and provides aplatform for restoration. TheNobelProcera ASC AbutmentZirconia is designed and madeindividually to fit the individualrequirements for each patient.The NobelProcera ASCAbutment Zirconia is made outof Zirconia and is delivered witha titanium adapter.	Not Applicable –reference predicate tosupport abutment foruse with Wide platformimplants.
Indication forUse	The On1™ device is apremanufactured prostheticcomponent directly connectedto an endosseous implant andit is intended for use inprosthetic rehabilitation.	The NobelProcera AngulatedScrew Channel AbutmentConical Connection arepremanufactured prostheticcomponents directly connectedto endosseous dental implantsand are intended for use as anaid in prosthetic rehabilitation.	Not Applicable –reference predicate tosupport abutment foruse with Wide platformimplants.

Analysis of Differences Between Subject Device and Predicate

The On1 Concept and predicate NobelProcera Angulated Screw Channel Conical Connection (K132746) are both two piece endosseous dental implant abutments intended to fit the Nobel Biocare internal conical connection dental implants.

The On1 Concept base is designed to be placed either when the dental implant is placed or with the final abutment. Once placed on the dental implant the On1 Base is not intended to be removed. The predicate NobelProcera Angulated Screw Channel Conical Connection (K132746) base is intended to adapt the abutment post to the internal conical connection implant and is placed along with the post when the definitive abutment is placed.

The On1 Concept components are all fixed design components. The abutments do not have any angulation built in. The predicate NobelProcera Angulated Screw Channel Conical Connection (K132746) abutments are individually shaped and can be angulated.

{6}------------------------------------------------

Summarv:

The design differences between the subject and predicate devices were evaluated through comparative performance testing. The documentation submitted in the premarket notification demonstrates that the On1 Concept is substantially equivalent to the predicate devices.

VII. PERFORMANCE DATA

Summary of Non-Clinical Testing:

Since the subject device does not represent a new worst case, data from the predicate device was leveraged in the following aspects of the 510(k).

Sterile Device Information
- o The sterilization method for the subject device provided sterile is the same as the predicate. The sterilization method is Gamma radiation and has been validated in accordance with ANSI/AAMI/ISO 11137. Therefore, no additional testing was required.
- o The sterilization methods for the subject devices provided non-sterile and to be end user sterilized are pre-vacuum and gravity moist heat sterilization and have been validated in accordance with ANSI/AAMI/ISO 17665-1.
Device Packaging
- o The packaging for the subject device is the same as the predicate. This is a thermoform tray with peel top lid. Therefore, no additional testing was required.
Shelf Life -
- The packaging for the subject device is the same as the predicate and o is labeled with a 3-year expiration date. Real time aging was used to determine the expiration dating. Therefore, no additional testing was required.
Biocompatibility -
- The subject device is manufactured from the same material using the o same manufacturing method as the predicate, has the same intended use, and the same patient contact type and duration. Therefore, no additional testing was required.

The fatigue limit of the On1 Concept was determined using the methods described in ISO 14801. The results of the testing were used to address questions related to substantial equivalence based on difference in design between the subject and predicate devices.

VIII. CONCLUSIONS

The On1 Concept was evaluated for substantial equivalence using standard and/or comparative testing. In cases where the On1 Concept could be shown to not represent a worst-case with respect to the predicates, data from these predicate

{7}------------------------------------------------

devices was leveraged to support the subject device. Based on technological characteristics and non-clinical test data included in this submission, the On1 Concept has been shown to be substantially equivalent to the NobelProcera Angulated Screw Channel Conical Connection Abutment (K132746).

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.)