Who is the manufacturer of On1 Universal Abutment?

Nobel Biocare AB filed the 510(k) submission for On1 Universal Abutment (K181869).

What is the FDA product code for On1 Universal Abutment?

NHA. It is classified under 21 CFR 872.3630 as a Class 2 device in the Dental panel.

What is the regulatory pathway for On1 Universal Abutment?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like On1 Universal Abutment?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

On1 Universal Abutment

K181869 · Nobel Biocare AB · NHA · Dec 12, 2018 · Dental

Device Facts

Record ID	K181869
Device Name	On1 Universal Abutment
Applicant	Nobel Biocare AB
Product Code	NHA · Dental
Decision Date	Dec 12, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3630
Device Class	Class 2
Attributes	Therapeutic

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. The On1 Universal Abutments consist of three major parts. Specifically, the On1 Base, the On1 Universal Abutment, and the mesostructure components make up a multi-piece abutment. The system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories.

Device Story

On1 Universal Abutment is a multi-piece dental abutment system; attaches to On1 Base on Nobel Biocare implants. Input: digital scan data from intra-oral scanners (e.g., 3Shape TRIOS). Process: CAD/CAM workflow using 3Shape Abutment Designer software to design mesostructures; milling via CORiTEC imes-icore unit. Output: custom-designed mesostructure or abutment crown bonded to the abutment. Used in dental clinics by clinicians; facilitates prosthetic rehabilitation by providing a standardized platform for CAD/CAM design. Benefits: simplifies design process; enables patient-specific restorative solutions. Output affects clinical decision-making by providing a stable, predictable interface for final dental restorations.

Clinical Evidence

Bench testing only. Included dynamic fatigue testing per ISO 14801, biocompatibility testing per ISO 10993-5 (cytotoxicity), and GC-MS analysis for organic leachables/extractables per ISO 10993-12/18. Software verification and validation performed for the design library and workflow integration.

Technological Characteristics

Materials: Titanium vanadium alloy (ASTM F136). Design: Multi-piece abutment with fixed upper shape and indexing feature for CAD/CAM. Connectivity: Integrates with 3Shape digital workflow. Sterilization: Non-sterile, steam sterilized by end-user (ISO 17665-1/2). Mechanical: Dynamic fatigue testing per ISO 14801. Max angulation: 20°.

Indications for Use

Indicated for prosthetic rehabilitation in patients requiring endosseous dental implant-supported restorations. Used in conjunction with Nobel Biocare dental implants (internal conical connection).

Regulatory Classification

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.

Special Controls

*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.)

Predicate Devices

On1 Concept (K161655)

Reference Devices

Vita Enamic® Implant Solutions (IS) (K153645)
Sirona Dental CAD/CAM System (K111421)
Interactive Smartbase Abutments (K181359)
3Shape Abutment Designer Software (K151455)
Multilink Hybrid Abutment Cement (K130436)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "U.S. Food & Drug Administration" in blue letters. December 12, 2018 Nobel Biocare AB % Charlemagne Chua Senior Regulatory Affairs Manager Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda. California 92887 Re: K181869 Trade/Device Name: On1™ Universal Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA, PNP Dated: November 8, 2018 Received: November 9, 2018 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. 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 located 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}------------------------------------------------ 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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 Tina Kiang, Ph.D. for 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}------------------------------------------------ #### Indications for Use 510(k) Number (if known) K181869 Device Name On1™ Univeral Abutment #### Indications for Use (Describe) The Onl™ device is a premanufactured prosthetic component directly connected to an endosseous implant and it is intended for use in prosthetic rehabilitation. The Onl Universal Abutments consist of three major parts. Specifically, the On1 Base, the On1 Universal Abutment, and the mesostructure components make up a multi-piece abutment.. The system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories. #### 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) #### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 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." {3}------------------------------------------------ A.4. 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 Regulatory Affairs Manager Phone: (714) 282-4800 x 7830 Fax: (714) 998-9348 Date Prepared: December 11, 2018 II. DEVICE Name of Device: On1TM Universal Abutment Common or Usual Name: Endosseous Dental Implant Abutment Classification Name: Endosseous Dental Implant (21 CFR 872.3630) Regulatory Class: II Primary Product Code: NHA Secondary Product Code: PNP III.PREDICATE DEVICE Primary Predicate K161655, Nobel Biocare AB - On1 Concept Reference Devices K153645, Vita Zahnfabrik H. Rauter GmbH Co - Vita Enamic® Implant Solutions (IS) K111421. Sirona Dental Systems GmbH - Sirona Dental CAD/CAM System K181359, Implant Direct Sybron Manufacturing Llc - Interactive Smartbase Abutments K151455, 3Shape A/S - 3Shape Abutment Designer Software K130436, Ivoclar Vivadent, Inc. - Multilink Hybrid Abutment Cement IV. DEVICE DESCRIPTION {4}------------------------------------------------ The On1 Universal Abutment is a dental implant abutment which attaches to the On1 Base of the On1 Concept (K161655) and is intended to be used with the current Nobel Biocare dental implants that have the existing internal conical connection. The On1 Universal Abutment features a fixed upper shape with indexing feature that is intended to serve as the platform for either an in-laboratory CAD/CAM system made mesostructure or abutment crown. The fixed upper shape and indexing feature facilitates the use of CAD/CAM systems by providing a known shape that can be imported into the design software, thereby, simplifying the CAD/CAM design process. The On1 Universal Abutment is available for the Nobel Biocare Narrow Platform (NP), Regular Platform (RP) and Wide Platform (WP) for the internal conical connection. The On1 Universal Abutment is made of titanium vanadium alloy. The digital workflow requires the use of the following equipment: - Scanner: 3Shape intra oral scanner Trios (3Shape A/S) । - -Design Software: 3Shape Abutment Designer Software (3Shape A/S) -K151455 where the Implant Libraries are obtained via the 3Shape server in the software - -Restorative Material: Enamic (Vita Zahnfabrik H. Rauter GmbH Co) -K153645 - Milling Unit: CORiTEC, imes-icore milling unit - | Restorative design specifications for Universal Base | | |------------------------------------------------------|-------------------------------------------------| | Parameter | Specification | | Angle from axis of the implant | 20° Max | | Wall Thickness Circular | 0.8mm min. | | Wall Thickness Margin | 0.275mm min. | | Post Height | 5.2mm min. | | Maximum Length, width and Height | EM-14 blank 12x14x18mm EM-10 blank 8x10x15mm | The following restorative design specifications is required: # 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. The On1 Universal Abutments consists of three major parts. Specifically, the On1 Base, the On1 Universal Abutment, and the mesostructure components make up a {5}------------------------------------------------ multi-piece abutment. The system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories. {6}------------------------------------------------ #### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS VI. | Technological characteristics | Subject Device | Primary Predicate | Reference Device | Reference Device | Reference Device | | |----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | On1 Universal Abutment | On1 Concept (K161655) | VITA ENAMIC IS (K153645) | Sirona Dental CAD/CAM- System (K111421) | InterActive SMARTBase Abutments (K181359) | | | | Compatible Implant Platform | Nobel Biocare Internal Conical Connection - Narrow Platform (NP) - Regular Platform (RP) - Wide Platform (WP) | Nobel Biocare Internal Conical Connection - Narrow Platform (NP) - Regular Platform (RP) - Wide Platform (WP) | The InCoris mesostructure and TiBase two-piece abutment is compatible with the following implant systems: Nobel Biocare Replace (K020646), Nobel Biocare Branemark (K022562), Friadent Xive (K013867), Biomet 3i Osseotite (K980549), Astra Tech Osseospeed (K091239), Zimmer Tapered Screw-Vent (K061410), Straumann Synocta (K061176), Straumann Bone Level (K053088), Biomet 3i Certain (K014235), Nobel Biocare Active (K071370). | The InCoris mesostructure and TiBase two-piece abutment is compatible with the following implant systems: Nobel Biocare Replace (K020646), Nobel Biocare Branemark (K022562), Friadent Xive (K013867), Biomet 3i Osseotite (K980549), Astra Tech Osseospeed (K091239), Zimmer Tapered Screw-Vent (K061410), Straumann Synocta (K061176), Straumann Bone Level (K053088), Biomet 3i Certain (K014235), Nobel Biocare Active (K071370). | InterActive SMARTBase abutments are compatible at the implant level with InterActive (3.0mm and 3.4mm Platform) and SwishActive (3.0mm and 3.4mm Platform) system implants. | | | Ti/ Abutment Material | On1 Base (K161655), On1 Universal Abutment - Titanium vanadium alloy (ASTM F136) | On1 Base, On1 Esthetic Abutment Titanium - Titanium vanadium alloy (ASTM F136) On1 Esthetic Abutment Zirconia - Y-TZP zirconium oxide (ISO 6872, ISO 13356) | Titanium vanadium alloy (ISO 5832-3) | Tibase - Titanium 6AL4V | Titanium | | Design Features | Mesostructure / Crown Material | Enamic (K153645) | N/A | VITA ENAMIC IS, identical in composition to Enamic (K153645) | Cercon HT | Zirconia | | | Mesostructure /Crown Fixation | Bonded | N/A | Bonded | Bonded | Bonded | | | Abutment Design | 2 piece abutment on On1 Base - Enamic (K153645) | 1 piece abutment on On1 Base - Esthetic Abutment | 2 piece - VITA ENAMIC IS bonded to Sirona TiBase | The TiBase is a premanufactured prosthetic | Abutment body consisting of a titanium base and | | Technological characteristics | | Subject Device | Primary Predicate | Reference Device | Reference Device | Reference Device | | | | On1 Universal Abutment | On1 Concept (K161655) | VITA ENAMIC IS (K153645) | Sirona Dental CAD/CAM- System (K111421) | InterActive SMARTBase Abutments (K181359) | | | | bonded to the On1 Universal Abutment and mounted on to the On1 Base (K161655). On1 Base is mounted on to the implant and fixed with a screw. | Titanium is mounted on to the On1 Base. On1 Base is mounted on to the implant and fixed with a screw. | (K111421) mounted on to the implant and fixed with a screw | component directly connected to endosseous dental implants with a screw and is intended for use as an aid in prosthetic rehabilitation. | supplied with a fixation screw. The bases are provided with straight, angled, and modified zirconia tops for patient specific devices. The devices are also provided without a zirconia top and a superstructure or hybrid crown or bridge can be milled to fit the bases intended to be manufactured at Implant Direct Manufacturing facility. | | | Abutment Fixation | Screwed | Screwed | Screw or Cement Retained | Screw or Cement Retained | Screw Retained | | | Maximum Angulation | 20° | 0° | 20° | 20° | 30° | | | Design Workflow | 3Shape intra oral scanner Trios (3Shape A/S), 3Shape Abutment Designer Software (3Shape A/S) - K151455 | Traditional workflow | Sirona software - inlab 15.0 and above Sirona software - CEREC 4.4 and above | Sirona software - inlab 15.0 and above Sirona software - CEREC 4.4 and above | 3M Tru-Definition, ITero Scanner 3Shape Abutment Designer Software (3Shape A/S) - K151455 | | | Manufacturing Workflow | CORITEC milling unit (imes-icore) | Traditional workflow | Sirona CEREC milling systems | Sirona CEREC milling systems | Wieland-Zenotec Select & Zenotec CAM | | | Mechanical Testing | Dynamic Fatigue Testing per ISO 14801 | Dynamic Fatigue Testing per ISO 14801 | Dynamic Fatigue Testing per ISO 14801 | - | Dynamic Fatigue Testing per ISO 14801 | | | Subject Device | Primary Predicate | Reference Device | Reference Device | Reference Device | | | Technological characteristics | On1 Universal Abutment | On1 Concept (K161655) | VITA ENAMIC IS (K153645) | Sirona Dental CAD/CAM- System (K111421) | InterActive SMARTBase Abutments (K181359) | | | 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. The On1 Universal Abutments consist of three major parts. Specifically, the On1 Base, the On1 Universal Abutment, and the mesostructure components make up a multi-piece abutment. The system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories | The On1™ device is a premanufactured prosthetic component directly connected t…

On1 Universal Abutment

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Reference Devices

Submission Summary (Full Text)

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On1 Universal Abutment

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Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Reference Devices

Submission Summary (Full Text)

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