IPD Dental Implant Abutments

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration". IMPLANT PROTESIS DENTAL 2004, S.1. Francesc Fumanal Regulatory Affairs Manager Carrer Rosa dels Vents. 9-15. Premià de Dalt (Barcelona), 08338 SPAIN December 19, 2024 Re: K242819 Trade/Device Name: IPD Dental Implant Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA. PNP Dated: September 4, 2024 Received: November 22, 2024 Dear Francesc Fumanal: 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 (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. 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 Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. Submission Number (if known) K242819 Device Name # IPD Dental Implant Abutments Indications for Use (Describe) IPD Dental Implant Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single or multiple dental prosthetic restorations. | Compatible Implant Systems | | | |---------------------------------------------------------|------------------------------------|---------------------------------------------------| | Dental Implant System | Implant Diameter (mm) | Platform Diameter | | Astra Tech Implant System<br>(Osseospeed®) | 3.0 // 3.5/4.0 // 4.5/5.0 | 3.0 // 3.5/4.0 // 4.5/5.0 | | OsseoSpeed™ Plus | 3.6 // 4.2 | 3.6 // 4.2 | | BioHorizons Tapered Internal<br>Implant System | 3.0 // 3.4 // 3.8 // 4.6 // 5.8 | 3.0 // 3.0 // 3.5 // 4.5 // 5.7 | | 3i Osseotite® Certain®<br>Dental Implants | 3.25 // 4.0 // 5.0 | 3.4 // 4.1 // 5.0 | | 3i® Osseotite® Dental Implants | 3.25 // 4.0 // 5.0 | 3.4 // 4.1 // 5.0 | | Straumann® BLX Implant System | 3.5 - 4.5 // 5.0 - 6.5 | RB // WB | | Straumann BLX Ø3.5 mm Implants | 3.5 | RB | | Anyone™ Internal Implant System | 3.5-8.0 | RP | | Xpeed AnyRidge Internal<br>Implant System | 3.5-8.0 | RP | | Conical Connection Implants<br>(MIS® C1) | 3.75 // 4.2 | SP // SP | | MIS Internal Hex Dental<br>Implant System (MIS® Seven®) | 3.30 // 3.75 // 4.20 // 5.0 // 6.0 | Narrow // Standard //<br>Standard // Wide // Wide | | Osstem Implant System | 3.0 // 3.5 // 4.0-7.0 | Mini // Mini // Regular | | Neodent Implant System - GM Line | 3.5 - 7.0 | GM (Grand Morse) | | Nobel Biocare® Brånemark System | 3.5 // 3.75/4.0 // 5.0 | NP (3.5) // RP(4.1) // WP (5.1) | | Nobel Biocare® Nobel Active® | 3.0 // 3.5 // 4.3/5.0 | 3.0 // NP(3.5) // RP(4.3) | | Straumann® Tissue Level | 3.3/4.1/4.8 // 4.8 | RN(4.8) // WN(6.5) | | Straumann® Bone Level | 3.3 // 4.1/4.8 | NC(3.3) // RC(4.1) | | Zimmer Tapered Screw-Vent® | 3.7/4.1 // 4.7 // 6.0 | 3.5 // 4.5 // 5.7 | {4}------------------------------------------------ The zirconia superstructures for use with the Ti Base (Interface) are only intended to be designed and manufactured according to digital dentistry workflow 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) # 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." {5}------------------------------------------------ # 510(k) SUMMARY K242819 #### I. SUBMITTER #### IMPLANT PROTESIS DENTAL 2004, S.L Carrer Rosa dels Vents, 9-15 08338 Premià de Dalt (Barcelona), Spain. # Contact Person: Francesc Fumanal +34 93 278 84 91 ffumanal@ipd2004.com Date prepared: December 19, 2024. #### II. DEVICE | Device name: | IPD DENTAL IMPLANT ABUTMENTS | |----------------------|------------------------------------------------------| | Common Name: | ENDOSSEOUS DENTAL IMPLANT ABUTMENT | | Classification Name: | Endosseous Dental Implant Abutment (21 CFR 872.3630) | | Regulatory Class: | Class II | | Product Code(s): | Primary: NHA; Secondary: PNP. | #### III. PREDICATE DEVICE(S): | Primary Predicate: | K240570, IPD Dental Implant Abutments | |--------------------|---------------------------------------------------------------------------------------------------------------------------| | Reference Devices: | K231413, IPD Dental Implant Abutments,<br>K222215, IPD Dental Implant Abutments,<br>K222288, DESS Dental Smart Solutions, | The list of all the proposed third-party compatible dental implant systems, as additional Reference Devices, has been provided in Table 1. {6}------------------------------------------------ Administrative Information – 510(k) Summary | 510(k) Holder | Compatible Implant System | 510(k) Number | 510(k) Device Name | |-----------------------------------------------------|------------------------------------------------------|---------------|---------------------------------------------| | Astra Tech AB | Astra Tech Implant System (Osseospeed®) | K101732 | Astra Tech Implant System (Osseospeed®) | | Astra Tech AB | OsseoSpeed™ Plus | K120414 | OsseoSpeed™ Plus | | Biohorizons Implant Systems, Inc. | BioHorizons Tapered Internal Implant System | K071638 | BioHorizons Tapered Internal Implant System | | Implant Innovations, Inc. | 3i Osseotite® Certain® Dental Implants | K063341 | 3i Osseotite® Certain® Dental Implants | | Implant Innovations, Inc. | 3i® Osseotite® Dental Implants | K063286 | 3i OSSEOTITE® Dental Implants | | Institut Straumann AG | Straumann® BLX Implant System | K173961 | Straumann® BLX Implant System | | Institut Straumann AG | Straumann BLX Ø3.5 mm Implants | K191256 | Straumann BLX Ø3.5 mm Implants | | Institut Straumann AG | Straumann® Bone Level | K140878 | Straumann® Bone Level Tapered Implants | | Institut Straumann AG | Straumann® Dental Implant System | K130222 | Straumann® Tissue Level | | JJGC Indústria e Comércio de Materiais Dentários SA | Neodent Implant System - GM Line | K163194 | Neodent Implant System - GM Line | | MegaGen Implant Co., Ltd | Anyone™ Internal Implant System | K123988 | Anyone™ Internal Implant System | | MegaGen Implant Co., Ltd | Xpeed AnyRidge Internal Implant System | K140091 | Xpeed AnyRidge Internal Implant System | | MIS Implants Technologies Ltd. | Conical Connection Implants (MIS® C1) | K112162 | Conical Connection Implants | | MIS Implants Technologies Ltd. | MIS Internal Hex Dental Implant System (MIS® Seven®) | K180282 | MIS Internal Hex Dental Implant System | | Nobel Biocare AB | Nobel Active® | K142260 | Nobel Active® | | Nobel Biocare AB | Brånemark | K022562 | Brånemark | | OSSTEM Implant Co., Ltd. | Osstem Implant System | K161604 | Osstem Implant System | | Zimmer Biomet Dental | Tapered Screw-Vent® | K112160 | Tapered Screw-Vent® X Implant | | | Table 1. Reference Devices - Compatible Dental Implant Systems: | | | |--|-----------------------------------------------------------------|--|--| | | | | | {7}------------------------------------------------ ### IV. DEVICE DESCRIPTION IPD Dental Implant Abutments is a dental implant abutment system composed of dental abutments and screws intended to be placed into dental implants to provide support for dental prosthetic restorations. Abutments provide basis for single or multiple tooth prosthetic restorations. They are available in a variety of connection types to enable compatibility with commercially available dental implants svstems. IPD Dental Implant Abutments includes the following categories of dental abutment designs: - -Titanium base (Interface) abutments; - -Multi-unit abutments; - -Overdenture abutments (PSD). The system also includes the corresponding Titanium Screws, which were included in previous premarket notifications. The devices are intended to attach the prosthesis to the dental implant. Specifically: - Ti Screw: Used during restoration fabrication. - TiN Screw: Used in finished restorations, with TiN coating. - TPA Screw: Used in finished angulated restorations, with TiN coating. The metallic components of the subject abutments and screws are made of titanium alloy conforming to ISO 5832-3 "Implants for surgery – Metallic materials – Part 3: Wrought titanium 6-aluminium 4-vanadium alloy". The purpose of this submission is to expand IPD Dental Implant Abutments cleared under K240570: - . To expand IPD's abutment designs (Multi-unit and Overdenture abutments), as well as to expand the range of angulations available for certain compatible Ti Bases (Interfaces). IPD dental implant abutments and screws are compatible with the following commercially available dental implant systems: {8}------------------------------------------------ Table 2. Summary of IPD abutments categories with compatibilized OEM Implant Systems with specific reference to maximum angulation specifically included in this submission. | Compatible Implant System | Type of<br>connection | Implant<br>Diameter<br>(mm) | Platform<br>Diameter | Device category | Overdenture<br>Abutment (PSD) | Multi-Unit<br>Abutment | Ti Base (Interface)<br>Abutment | |--------------------------------------------|-----------------------|-----------------------------|--------------------------------------|------------------------------------|----------------------------------------------|----------------------------------------------|----------------------------------------------| | | | | | Material | Titanium alloy,<br>ISO 5832-3.<br>TiN coated | Titanium alloy,<br>ISO 5832-3.<br>TiN coated | Titanium alloy,<br>ISO 5832-3.<br>TiN coated | | | | | | IPD Abutment<br>Systems | | | | | | | | | Nobel Biocare®<br>Brånemark System | External | 3.5<br>3.75 / 4.0<br>5.0 | NP (3.5 mm)<br>RP (4.1 mm)<br>WP (5.1 mm) | | Nobel Biocare®<br>Nobel Active® | Internal | 3.0<br>3.5<br>4.3/5.0 | 3.0 mm<br>NP (3.5 mm)<br>RP (4.3 mm) | AD | NP (20°)<br>RP (20°) | 3.0 (0°)<br>NP (30°)<br>RP (30°) | NP (30°) | | 3i® Osseotite® Dental Implants | External | 3.25<br>4.0<br>5.0 | 3.4<br>4.1<br>5.0 | BA | - | 3.4 (0°)<br>4.1 (0°)<br>5.0 (0°) | - | | 3i Osseotite® Certain® Dental<br>Implants | Internal | 3.25<br>4.0<br>5.0 | 3.4<br>4.1<br>5.0 | BB | - | 3.4 (0°)<br>4.1 (0°)<br>5.0 (0°) | - | | Straumann®<br>Tissue Level | Internal | 3.3/4.1/4.8<br>4.8 | RN (4.8 mm)<br>WN (6.5 mm) | DA | - | RN (0°) | - | | Straumann®<br>Bone Level | Internal | 3.3<br>4.1/4.8 | NC (3.3 mm)<br>RC (4.1 mm) | DB | NC (20°)<br>RC (20°) | NC (30°)<br>RC (30°) | - | | Straumann<br>BLX Ø3.5 mm Implants | Internal | 3.5 | RB | - | - | RB (30°) | - | | Straumann®<br>BLX Implant System | Internal | 3.5 - 4.5<br>5.0 - 6.5 | RB<br>WB | DC | - | RB (30°)<br>WB (30°) | - | | Astra Tech Implant System<br>(Osseospeed®) | Internal | 3.0<br>3.5/4.0<br>4.5/5.0 | 3.0<br>3.5/4.0<br>4.5/5.0 | EA | - | 3.5/4.0 (0°)<br>4.5/5.0 (0°) | - | | OsseoSpeed™ Plus | Internal | 3.6<br>4.2 | 3.6<br>4.2 | EB | - | 3.6 (0°)<br>4.2 (0°) | 4.2 (30°) | | Zimmer Tapered Screw-Vent® | Internal | 3.7 / 4.1<br>4.7 | 3.5 mm<br>4.5 mm | FA | - | 3.5 (0°)<br>4.5 (0°) | - | {9}------------------------------------------------ Administrative Information – 510(k) Summary | Compatible Implant System | Type of<br>connection | Implant<br>Diameter<br>(mm) | Platform<br>Diameter | Device category | | | Overdenture<br>Abutment (PSD) | Multi-Unit<br>Abutment | Ti Base (Interface)<br>Abutment | |------------------------------------------------------------|-----------------------|-----------------------------|----------------------|-------------------------------------|----------|----------------------------------------------|----------------------------------------------|----------------------------------------------|---------------------------------| | | | | | Material<br>IPD Abutment<br>Systems | | Titanium alloy,<br>ISO 5832-3.<br>TiN coated | Titanium alloy,<br>ISO 5832-3.<br>TiN coated | Titanium alloy,<br>ISO 5832-3.<br>TiN coated | | | | | | | | | | | | | | | | 6.0 | 5.7 mm | | | - | - | - | | | BioHorizons Tapered Internal<br>Implant System | Internal | 3.0 | 3.0 | LB | | - | - | - | | | | | 3.4 | | | | | - | - | - | | | | 3.8 | 3.5 | | | - | - | 3.5 (30°) | - | | | | 4.6 | 4.5 | | | - | - | 4.5 (30°) | - | | | | 5.8 | 5.7 | | | - | - | 5.7 (30°) | - | | Osstem Implant System | Internal | 3.0 | Mini | OB | | - | - | - | | | | | 3.5 | | | | - | - | Mini (30°) | - | | | | 4.0 - 7.0 | Regular | | | - | - | Regular (30°) | - | | Neodent Implant System<br>GM Line | Internal | 3.5 – 7.0 | GM<br>(Grand Morse) | RB | GM (20°) | - | GM (30°) | - | | | MIS Internal Hex Dental Implant<br>System<br>(MIS® Seven®) | Internal | 3.30 | Narrow | TA | | - | - | - | | | | | 3.75<br>4.20 | Standard | | | - | - | Standard (0°) | - | | | | 5.0<br>6.0 | Wide | | | - | - | Wide (0°) | - | | Conical Connection Implants<br>(MIS® C1) | Internal | 3.75<br>4.2 | SP | TB | | - | SP (0°) | - | | | Anyone™ Internal Implant System | Internal | 3.5 - 8.0 | RP | WA | | - | RP (0°) | - | | | Xpeed AnyRidge Internal Implant<br>System | Internal | 3.5 - 8.0 | RP | WB | | - | RP (0°) | - | | {10}------------------------------------------------ Administrative Information - 510(k) Summary Ti Base (Interface) abutments are attached (screw-retained) to the implant and cemented to the zirconia superstructure. The Ti Base is a two-piece abutment composed of the titanium component, as the bottom-half, and the zirconia superstructure, as the top-half. It consists of a pre-manufactured prosthetic component in Titanium alloy per ISO 5832-3, as well as the supporting digital library file for FDA-cleared design software (3Shape Abutment Designer™ Software, cleared under K151455) which enables the design of a patient-specific superstructure by the laboratory/clinician and which will be manufactured in FDA-cleared Zirconia (e.g., DD Bio Z, K142987) according to digital dentistry workflow at the point of care, or at a dental laboratory. The design and fabrication of the zirconia superstructure for Ti Base (Interface) will be conducted using a digital dentistry workflow requiring the use of the following equipment, software and materials: | Scanner: | 3D Scanner D850. | |------------------------|-------------------------------------------------| | Design Software: | 3Shape Abutment Designer Software, K151455. | | Zirconia Material: | DD Bio Z, K142987. | | Milling machine/Brand: | Dental Concept System Model: DC1 Milling System | | Cement: | Multilink® Automix, K123397. | Ti Base (Interface) abutment design parameters for the zirconia superstructure are defined as follows: | Minimum gingival height: | 1.5 mm | |---------------------------------------------------|-------------| | Minimum wall thickness: | 0.43 mm | | Minimum post height for single-unit restorations: | 4.75 mm (1) | | Maximum gingival height: | 6.0 mm | | Maximum angulation of the final abutment | 30° (2) | Note 1: Post height is the length above the abutment collar. Note 2: In Table 2 it has been specifically referred to the angulation depending on the dental implant system and platform. The resulting final prosthetic restoration is screwed to the dental implant. All subject abutments are single-use and provided non-sterile. Final restoration (which includes the corresponding screw) is intended to be sterilized at the dental clinic before it is placed in the patient. {11}------------------------------------------------ ### V. INDICATIONS FOR USE IPD Dental Implant Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single or multiple dental prosthetic restorations. | Compatible Implant System | Implant Diameter (mm) | Platform Diameter | | |-----------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|------------------------------------------------| | Astra Tech Implant System<br>(Osseospeed®) | 3.0 | 3.0 | | | | 3.5/4.0 | 3.5/4.0 | | | | 4.5/5.0 | 4.5/5.0 | | | OsseoSpeed™ Plus | 3.6 | 3.6 | | | | 4.2 | 4.2 | | | BioHorizons Tapered Internal Implant System | 3.0 | 3.0 | | | | 3.4 | 3.0 | | | | 3.8 | 3.5 | | | | 4.6 | 4.5 | | | | 5.8 | 5.7 | | | 3i Osseotite® Certain® Dental Implants | 3.25 | 3.4 | | | | 4.0 | 4.1 | | | | 5.0 | 5.0 | | | 3i® Osseotite® Dental Implants | 3.25 | 3.4 | | | | 4.0 | 4.1 | | | | 5.0 | 5.0 | | | Straumann® BLX Implant System | 3.5 - 4.5 | RB | | | | 5.0 - 6.5 | WB | | | Straumann BLX Ø3.5 mm Implants | 3.5 | RB | | | Anyone™ Internal Implant System | 3.5 -8.0 | RP | | | Xpeed AnyRidge Internal Implant System | 3.5 -8.0 | RP | | | Conical Connection Implants<br>(MIS® C1) | 3.75 | SP | | | | 4.2 | SP | | | MIS Internal Hex Dental Implant System<br>(MIS® Seven®) | 3.30 | Narrow | | | | 3.75 | Standard | | | | 4.20 | Standard | | | | 5.0 | Wide | | | | 6.0 | Wide | | | Osstem Implant System | 3.0 | Mini | | | | 3.5 | Mini | | | | 4.0 - 7.0 | Regular | | | Neodent Implant System – GM Line | 3.5 - 7.0 | GM (Grand Morse) | | | Nobel Biocare® Brånemark System | 3.5 | NP (3.5 mm) | | | | 3.75/4.0 | RP (4.1 mm) | | | | 5.0 | WP (5.1 mm) | | | Nobel Biocare® Nobel Active® | 3.0 | 3.0 mm | | | | 3.5 | NP (3.5 mm) | | | | 4.3/5.0 | RP (4.3 mm) | | | Straumann® Tissue Level | 3.3/4.1/4.8 | RN (4.8 mm) | | | | 4.8 | WN (6.5 mm) | | | Compatible Implant System | Implant Diameter (mm) | Platform Diameter | | | Straumann® Bone Level | 3.3 | NC (3.3 mm) | | | | 4.1/4.8 | RC (4.1 mm) | | | | Zimmer Tapered Screw-Vent® | 3.7/4.1 | 3.5 mm | | 4.7 | | 4.5 mm | | | 6.0 | | 5.7 mm | | | Indications for Use Statements | | | | | Subject device | | | | | IPD Dental<br>Implant<br>Abutments<br>(Implant<br>Protesis<br>Dental<br>2004, SL) | IPD Dental Implant Abutments are intended to be used in conjunction with endosseous dental<br>implants in the maxillary or mandibular arch to provide support for single or multiple dental<br>prosthetic restorations. | | | | Compatible Implant Systems | | | | | | Compatible Implant System | Implant Diameter<br>(mm) | Platform Diameter | | | Astra Tech Implant System<br>(Osseospeed®) | 3.0<br>3.5/4.0<br>4.5/5.0 | 3.0<br>3.5/4.0<br>4.5/5.0 | | | OsseoSpeed™ Plus | 3.6<br>4.2 | 3.6<br>4.2 | | | BioHorizons Tapered Internal Implant<br>System | 3.0<br>3.4<br>3.8<br>4.6<br>5.8 | 3.0<br>3.0<br>3.5<br>4.5<br>5.7 | | | 3i Osseotite® Certain® Dental<br>Implants | 3.25<br>4.0<br>5.0 | 3.4<br>4.1<br>5.0 | | | 3i® Osseotite® Dental Implants | 3.25<br>4.0<br>5.0 | 3.4<br>4.1<br>5.0 | | | Straumann® BLX Implant System | 3.5 - 4.5<br>5.0 - 6.5 | RB<br>WB | | | Straumann BLX Ø3.5 mm Implants | 3.5 | RB | | | Anyone™ Internal Implant System | 3.5 -8.0 | RP | | | Xpeed AnyRidge Internal Implant<br>System | 3.5 -8.0 | RP | | | Conical Connection Implants<br>(MIS® C1) | 3.75<br>4.2 | SP<br>SP | | | MIS Internal Hex Dental Implant<br>System (MIS® Seven®) | 3.30<br>3.75<br>4.20<br>5.0<br>6.0 | Narrow<br>Standard<br>Standard<br>Wide<br>Wide | | | Osstem Implant System | 3.0 | Mini | | | 3.5 | Mini | | | | 4.0 - 7.0 | Regular | | | Neodent Implant System – GM Line | 3.5 - 7.0 | GM (Grand Mor | | | | 3.5 | NP (3.5 mm) | | | Nobel Biocare® Brånemark System | 3.75/4.0 | RP (4.1 mm) | | | | 5.0 | WP (5.1 mm) | | | | 3.0 | 3.0 mm | | | Nobel Biocare® Nobel Active® | 3.5 | NP (3.5 mm) | | | | 4.3/5.0 | RP (4.3 mm) | | | | 3.3/4.1/4.8 | RN (4.8 mm) | | | Straumann® Tissue Level | 4.8 | WN (6.5 mm) | | | Straumann® Bone Level | 3.3 | NC (3.3 mm) | | | | 4.1/4.8 | RC (4.1 mm) | | | | 3.7 / 4.1 | 3.5 mm | | | Zimmer Tapered Screw-Vent® | 4.7 | 4.5 mm | | | | 6.0 | 5.7 mm | | Compatible Implant Systems {12}------------------------------------------------ Administrative Information - 510(k) Summary The zirconia superstructures for use with the Ti Base (Interface) are only intended to be designed and manufactured according to digital dentistry workflow 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. {13}------------------------------------------------ #### OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. COMPARISON PREDICATE DEVICE The subject device is substantially equivalent in indications and design principles to the primary predicate device. Comparative tables of indications for use and relevant technological characteristics have been provided as follows. Table 3. Indications for Use Statements. {14}------------------------------------------------ #### Administrative Information – 510(k) Summary scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories. ### Predicate Devices Primary Predicate Device IPD Dental Implant Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single or multiple dental prosthetic restorations. | IPD Dental | |------------| | Implant | | Abutments | | (Implant | | Prosthesis | | Dental | | 2004, SL) | K240570 | | | Compatible Implant Systems | |--|--|----------------------------| | | | | | Dental Implant System | Implant Diameter<br>(mm) | Platform Diameter | | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|-------------------------------------------| | Astra Tech Implant System<br>(Osseospeed®) | 3.0 | 3.0 | | | | 3.5/4.0 | 3.5/4.0 | | | | 4.5/5.0 | 4.5/5.0 | | | OsseoSpeed™ Plus | 3.6 | 3.6 | | | | 4.2 | 4.2 | | | BioHorizons Tapered Internal<br>Implant System | 3.0 | 3.0 | | | | 3.4 | 3.0 | | | | 3.8 | 3.5 | | | | 4.6 | 4.5 | | | | 5.8 | 5.7 | | | 3i Osseotite® Certain® Dental<br>Implants | 3.25 | 3.4 | | | | 4.0 | 4.1 | | | | 5.0 | 5.0 | | | 3i® Osseotite® Dental Implants | 3.25 | 3.4 | | | | 4.0 | 4.1 | | | | Straumann® BLX Implant<br>System…