(92 days)
No
The summary describes a system of dental implant abutments and screws used in a digital dentistry workflow. While it mentions design software and digital libraries, there is no indication of AI or ML being used for analysis, decision-making, or automated design within the device itself or the described workflow. The software mentioned is for design, not for AI/ML-driven tasks.
No.
The device is an abutment system used to provide support for dental prosthetic restorations, not to directly treat a disease or condition.
No
Explanation: The device, IPD Dental Implant Abutments, is an abutment system used to provide support for dental prosthetic restorations. Its function is to attach a prosthesis to a dental implant, which is a structural and restorative purpose, not a diagnostic one.
No
The device description clearly states that the device is a dental implant abutment system composed of physical components (dental abutments and screws) made of titanium alloy. While it mentions compatibility with digital dentistry workflows and software for designing a component, the core device itself is hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide support for dental prosthetic restorations in conjunction with dental implants. This is a mechanical function within the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a system of dental abutments and screws. These are physical components used in a surgical and restorative procedure.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose a disease, condition, or state of health. It does not analyze biological samples (blood, urine, tissue, etc.) to provide diagnostic information.
- Workflow: The workflow described involves scanning, design, milling, and placement of a physical restoration. This is a manufacturing and surgical process, not a diagnostic one.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, treatment, or prevention of disease. This device does not fit that description.
N/A
Intended Use / 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.
Product codes
NHA, PNP
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:
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillary or mandibular arch
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The proposed devices have been subject to bench testing to determine fulfilment of design and performance requirements. Bench testing followed the recommendations provided in FDA Guidance Document - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments.
Specifically, non-clinical performance testing on the IPD Dental Implant Abutments include:
- Sterilization validation to achieve a SAL of 1 x 10e6 according to ISO 17665-1 to ensure ● sterilization of the final finished device.
- Cytotoxicity testing according to ISO 10993-5 to demonstrate that all patient-contacting surfaces are non-cytotoxic. In addition to Sensitization (ISO 10993-10) and Irritation (ISO 10993-23) testing for TiN coated devices.
- Reverse engineering and dimensional analysis of original manufacturer's components (implants, abutments and screws) to confirm compatibility.
- Validation of the digital workflow and software system to ensure that design and ● manufacturing of the top half was within the specified design parameters.
- Static and dynamic fatigue testing of worst-case implant / abutment configurations and ● combinations in accordance with ISO 14801.
- Modified Surfaces Information per FDA's Class II Special Controls Guidance Document: ● Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments.
- Non-clinical worst-case MRI review was performed to evaluate IPD Dental Implant . Abutments in the MRI environment using scientific rationale and published literature (i.e., Woods, Terry O., Jana G. Delfino, and Sunder Rajan. "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795), for the entire system (including all variations of compatible implant bodies, dental abutments, and fixation screws) and material composition. The rationale addressed parameters per the FDA Guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment", including magnetically induced displacement force and torque.
Non-clinical performance testing leveraged from K240570, K231413 and K222215, together with that provided in current submission, showed that IPD Dental Implant Abutments met the applicable specifications and requirements.
No clinical testing was performed, the determination of substantial equivalence is supported by nonclinical testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.)
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)
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 | ||
| (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 | ||
| 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® | ||
| 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 | ||
| Implant System | 3.5-8.0 | RP |
| Conical Connection Implants | ||
| (MIS® C1) | 3.75 // 4.2 | SP // SP |
| MIS Internal Hex Dental | ||
| Implant System (MIS® Seven®) | 3.30 // 3.75 // 4.20 // 5.0 // 6.0 | Narrow // Standard // |
| 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)
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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, |
| K222215, IPD Dental Implant Abutments, | |
| 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: | |||
|---|---|---|---|
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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
connection | Implant
Diameter
(mm) | Platform
Diameter | Device category | Overdenture
Abutment (PSD) | Multi-Unit
Abutment | Ti Base (Interface)
Abutment |
|--------------------------------------------|-----------------------|-----------------------------|--------------------------------------|------------------------------------|----------------------------------------------|----------------------------------------------|----------------------------------------------|
| | | | | Material | Titanium alloy,
ISO 5832-3.
TiN coated | Titanium alloy,
ISO 5832-3.
TiN coated | Titanium alloy,
ISO 5832-3.
TiN coated |
| | | | | IPD Abutment
Systems | | | |
| | | | | Nobel Biocare®
Brånemark System | External | 3.5
3.75 / 4.0
5.0 | NP (3.5 mm)
RP (4.1 mm)
WP (5.1 mm) |
| Nobel Biocare®
Nobel Active® | Internal | 3.0
3.5
4.3/5.0 | 3.0 mm
NP (3.5 mm)
RP (4.3 mm) | AD | NP (20°)
RP (20°) | 3.0 (0°)
NP (30°)
RP (30°) | NP (30°) |
| 3i® Osseotite® Dental Implants | External | 3.25
4.0
5.0 | 3.4
4.1
5.0 | BA | - | 3.4 (0°)
4.1 (0°)
5.0 (0°) | - |
| 3i Osseotite® Certain® Dental
Implants | Internal | 3.25
4.0
5.0 | 3.4
4.1
5.0 | BB | - | 3.4 (0°)
4.1 (0°)
5.0 (0°) | - |
| Straumann®
Tissue Level | Internal | 3.3/4.1/4.8
4.8 | RN (4.8 mm)
WN (6.5 mm) | DA | - | RN (0°) | - |
| Straumann®
Bone Level | Internal | 3.3
4.1/4.8 | NC (3.3 mm)
RC (4.1 mm) | DB | NC (20°)
RC (20°) | NC (30°)
RC (30°) | - |
| Straumann
BLX Ø3.5 mm Implants | Internal | 3.5 | RB | - | - | RB (30°) | - |
| Straumann®
BLX Implant System | Internal | 3.5 - 4.5
5.0 - 6.5 | RB
WB | DC | - | RB (30°)
WB (30°) | - |
| Astra Tech Implant System
(Osseospeed®) | Internal | 3.0
3.5/4.0
4.5/5.0 | 3.0
3.5/4.0
4.5/5.0 | EA | - | 3.5/4.0 (0°)
4.5/5.0 (0°) | - |
| OsseoSpeed™ Plus | Internal | 3.6
4.2 | 3.6
4.2 | EB | - | 3.6 (0°)
4.2 (0°) | 4.2 (30°) |
| Zimmer Tapered Screw-Vent® | Internal | 3.7 / 4.1
4.7 | 3.5 mm
4.5 mm | FA | - | 3.5 (0°)
4.5 (0°) | - |
9
Administrative Information – 510(k) Summary
| Compatible Implant System | Type of
connection | Implant
Diameter
(mm) | Platform
Diameter | Device category | | | Overdenture
Abutment (PSD) | Multi-Unit
Abutment | Ti Base (Interface)
Abutment |
|------------------------------------------------------------|-----------------------|-----------------------------|----------------------|-------------------------------------|----------|----------------------------------------------|----------------------------------------------|----------------------------------------------|---------------------------------|
| | | | | Material
IPD Abutment
Systems | | Titanium alloy,
ISO 5832-3.
TiN coated | Titanium alloy,
ISO 5832-3.
TiN coated | Titanium alloy,
ISO 5832-3.
TiN coated | |
| | | | | | | | | | |
| | | 6.0 | 5.7 mm | | | - | - | - | |
| BioHorizons Tapered Internal
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
GM Line | Internal | 3.5 – 7.0 | GM
(Grand Morse) | RB | GM (20°) | - | GM (30°) | - | |
| MIS Internal Hex Dental Implant
System
(MIS® Seven®) | Internal | 3.30 | Narrow | TA | | - | - | - | |
| | | 3.75
4.20 | Standard | | | - | - | Standard (0°) | - |
| | | 5.0
6.0 | Wide | | | - | - | Wide (0°) | - |
| Conical Connection Implants
(MIS® C1) | Internal | 3.75
4.2 | SP | TB | | - | SP (0°) | - | |
| Anyone™ Internal Implant System | Internal | 3.5 - 8.0 | RP | WA | | - | RP (0°) | - | |
| Xpeed AnyRidge Internal Implant
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 | |||
| (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 | |||
| (MIS® C1) | 3.75 | SP | |
| 4.2 | SP | ||
| MIS Internal Hex Dental Implant System | |||
| (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 | |||
| Implant | |||
| Abutments | |||
| (Implant | |||
| Protesis | |||
| Dental | |||
| 2004, SL) | 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 | |||
| Compatible Implant System | Implant Diameter | ||
| (mm) | Platform Diameter | ||
| Astra Tech Implant System | |||
| (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 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® 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 Implant | |||
| System | 3.5 -8.0 | RP | |
| Conical Connection Implants | |||
| (MIS® C1) | 3.75 | ||
| 4.2 | SP | ||
| SP | |||
| MIS Internal Hex Dental Implant | |||
| System (MIS® Seven®) | 3.30 | ||
| 3.75 | |||
| 4.20 | |||
| 5.0 | |||
| 6.0 | Narrow | ||
| Standard | |||
| Standard | |||
| Wide | |||
| 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) |
| Compatible Implant Systems | ||
|---|---|---|
| Dental Implant System | Implant Diameter
(mm) | Platform Diameter | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|-------------------------------------------|
| Astra Tech Implant System
(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 | |
| | Straumann® BLX Implant
System | 5.0 | 5.0 |
| | | 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
(MIS® C1) | 3.75 | SP |
| | | 4.2 | SP |
| | | 3.30 | Narrow |
| | MIS Internal Hex Dental Implant
System (MIS® Seven®) | 3.75 | Standard |
| | | 4.20 | Standard |
| | | 5.0 | Wide |
| | | 6.0 | Wide |
| | | 3.0 | Mini |
| | Osstem Implant System | 3.5 | Mini |
| | | 4.0 - 7.0 | Regular |
| Reference Devices
K231413
IPD Dental
Implant
Abutments
(Implant
Protesis
Dental
2004, SL) | 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 | | |
| | Implant System
Compatibility | Implant Diameter (mm) | Platform Diameter |
| | NobelActive® | 3.0
3.5
4.3/5.0 | 3.0 mm
NP (3.5 mm)
RP (4.3 mm) |
| | Straumann® Bone Level | 3.3
4.1/4.8 | NC (3.3 mm)
RC (4.1 mm) |
| | Neodent Implant System –
GM Line | 3.5 - 7.0 | GM (Grand Morse) |
| | Tapered Screw-Vent® | 3.7 / 4.1
4.7
6.0 | 3.5 mm
4.5 mm
5.7 mm |
| K222215 | IPD Dental Implant Abutments are intended to be used in conjunction with endosseous dental | | |
| IPD Dental
Implant | implants in the maxillary or mandibular arch to provide support for single or multiple dental
prosthetic restorations. | | |
| Abutments | Compatible Implant Systems | | |
| (Implant
Protesis
Dental
2004, SL) | Implant System Compatibility | Implant Diameter (mm) | Platform Diameter |
| | Brånemark | 3.5
3.75 / 4.0
5.0 | NP (3.5 mm)
RP (4.1 mm)
WP (5.1 mm) |
| | Straumann® Tissue Level | 3.3 / 4.1 / 4.8
4.8 | RN (4.8 mm)
WN (6.5 mm) |
| | Tapered Screw-Vent® | 3.7 / 4.1
4.7
6.0 | 3.5 mm
4.5 mm
5.7 mm |
| The zirconia superstructures for use with the Ti Base (Interface) are only intended to be
designed and manufactured according to digital dentistry workflow. The 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. | | | |
| | 3.4 | 3.4 | |
| | 3.8 | 3.8 | |
| FRIADENT XIVE® | 4.5 | 4.5 | |
| | 5.5 | 5.5 | |
| MegaGen AnyRidge | 3.5, 4.0, 4.5, 5.0, 5.5 | 3.5 | |
| Neodent Grand Morse | 3.5, 3.75, 4.0, 4.3, 5.0, 6.0, 7.0 | Grand Morse (GM) | |
| | 3.0 | 3.0 | |
| NobelActive®, NobelParallel | 3.5 | NP | |
| Conical | 4.3, 5.0 | RP | |
| | 3.5 | NP | |
| | 4.3 | RP | |
| NobelReplace® Trilobe | 5.0 | WP | |
| | 6.0 | 6.0 | |
| | 3.3 | NP | |
| Nobel Brånemark System® | 3.75, 4.0 | RP | |
| | 5.0 | WP | |
| | 3.5 | Mini | |
| Osstem TS | 4.0, 4.5, 5.0, 6.0, 7.0 | Regular | |
| | 3.5, 3.75, 4.0, 4.5 | RB | |
| Straumann BLX | 5.0, 5.5, 6.5 | WB | |
| | 3.3 | NC | |
| Straumann® Bone Level | 4.1/4.8 | RC | |
| | 3.3 | NNC, RN | |
| Straumann® Tissue Level | 4.1 | RN | |
| | 4.8 | RN, WN | |
| Zimmer Eztetic | 3.1 | 2.9 | |
| Zimmer Screw Vent®/ | 3.3, 3.7, 4.1 | 3.5 | |
| | 4.7 | 4.5 | |
| Tapered Screw- Vent® | 6.0 | 5.7 | |
| Zimmer Spline | 3.25 | 3.25 | |
| | 3.75, 4.0 | 3.75/4.0 | |
| | 5.0 | 5.0 | |
| Zimmer SwissPlus | 3.7 | 3.8 | |
| | 4.8 | 4.8 | |
15
Administrative Information – 510(k) Summary
designed and manufactured according to digital dentistry workflow. The 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.
16
Administrative Information – 510(k) Summary
17
Administrative Information – 510(k) Summary
18
Discussion on Indications for Use:
The indications for use of subject device in comparison with primary predicate device are verbatim, with the exception of the dental implant compatible systems which IPD is claiming compatibility in this submission, and which were already included in previous premarket notification submissions. Further than this, no change in the intended use or indications for use of the IPD Dental Implant Abutments has been carried out. The devices are specifically indicated for patients undergoing oral implant surgery to provide support for dental prosthetic restorations.
Similarly, for the subject device and primary predicate device, the design and fabrication of the superstructure is conducted using the same digital dentistry workflow, requiring the use of the following equipment, software and materials:
| Scanner: | 3Shape scanner |
|---|---|
| Design Software: | 3Shape Abutment Designer Software (K151455), |
| Zirconia Material: | DD Bio Z (K142987) |
| Milling machine: | Dental Concept System DC1 Milling System |
| Cement: | Multilink® Automix (K123397) |
and using the supporting IPD digital library file for K151455.
The adequacy of the digital dentistry workflow for the subject device is substantiated by software validation and mechanical fatigue testing provided with the submission.
Reference device, K222288, has been selected due to new abutment designs which were not previously included in previous IPD submissions. Despite these, no further differences are found in the device categories and workflows included for subject and predicate devices.
It is IPD opinion that these differences do not affect the intended use of the subject device, and/or do not raise differences in terms of safety or efficacy.
19
| Characteristics | Subject Device
IPD Dental Implant
Abutments | Primary Predicate
Device
IPD Dental Implant
Abutments
(IPD) K240570 | Reference Device
DESS Dental Smart
Solutions
(Terrats Medical, SL)
K222288 |
|-------------------------------------------------|-------------------------------------------------------------|---------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Materials | | | |
| Abutment Metallic
Materials | Titanium Alloy Grade 5
(ISO 5832-3) + TiN | Titanium Alloy Grade 5
(ISO 5832-3) + TiN or
Anodized (TiO2) | Ti-6Al-4V ELI + ZrN
Coating |
| Screw Materials | Titanium Alloy Grade 5
(ISO 5832-3) + TiN | Titanium Alloy Grade 5
(ISO 5832-3) + TiN | Ti-6Al-4V ELI +
DLC Coating |
| Superstructure | DD Bio Z Zirconia
(K142987) | DD Bio Z Zirconia
(K142987) | Zirconia conforming ISO
13356 |
| General Design Features | | | |
| Overview of
abutment designs | Ti-Base
(Interface),
Multi-Unit,
Overdenture (PSD) | Healing,
Temporary,
Cementing,
Ti-Base (Interface) | Healing, Temporary
Abutment, Ti Base, C-
base, CrCo Base,
Premilled Blank, Multi
Unit Abutment, Multi
Unit ZRN Abutment,
DESSLoc |
| Prosthesis
Attachment | Cement-retained
Screw-retained | Cement-retained
Screw-retained | Cement-retained
Screw-retained |
| Restoration Type | Single-unit (crowns)
Multiple-unit (bridges) | Single-unit (crowns)
Multiple-unit (bridges) | Single-unit,
Multi-unit |
| Abutment / Implant
Platform Diameter
(mm) | 3.0 - 5.7 | 3.0 - 5.7 | 2.52 - 6.5 |
| Abutment Angle | Maximum: 30° | Maximum: 30° | 0°, 17°, 30° |
| General Abutment /
Implant Connection | Internal and External | Internal and External | Internal and External |
| Sterilization | | | |
| Sterilization status
and type | Non-sterile.
End user steam
sterilization | Non-sterile.
End user steam
sterilization | Non-sterile.
End user steam
sterilization |
| Tables 4. Subject and Predicate devices technological characteristics comparison. | ||
|---|---|---|
| ----------------------------------------------------------------------------------- | -- | -- |
| Multi-Unit Abutments | ||
|---|---|---|
| Characteristics | IPD | |
| Subject device | DESS Dental Smart Solutions | |
| (K222288) | ||
| Abutment/Implant Platform | ||
| diameter (mm) | 3.0 - 7.0 | 3.0 - 7.0 |
| Prosthetic Platform diameter | ||
| (mm) | 4.8 | 4.8 |
| Gingival Height | 0.9 - 5.0 | 1 - 5 |
| Angle | 0°, 17°, 30° | 0°, 17°, 30° |
| Intended restoration type | Multi-unit | Multi-unit |
| Method of fixation | Screw-retained | Screw-retained |
| Surface coating | TiN coated | ZrN coated / uncoated |
20
Administrative Information - 510(k) Summary
| Overdenture Abutments (PSD) | ||
|---|---|---|
| Characteristics | IPD | |
| Subject device | DESS Dental Smart Solutions | |
| (K222288) | ||
| Abutment/Implant Platform | ||
| diameter (mm) | 3.3 - 7.0 | 2.52 - 6.5 |
| Gingival Height | 1.0 - 5.0 | 1.0 - 5.5 |
| Divergence | $\pm$ 20° | $\pm$ 20° |
| Intended restoration type | Single-unit | Single-unit |
| Method of fixation | Screw-retained | Screw-retained |
| Surface coating | TiN coated | ZrN coated / uncoated |
| Ti Base Abutments | |||
|---|---|---|---|
| Characteristics | IPD | ||
| Subject device | IPD Dental Implant | ||
| Abutments (K240570) | DESS Dental Smart | ||
| Solutions (K222288) | |||
| Min – Max diameter | 3.0 - 5.7 | 3.0 - 5.7 | 2.52 - 5.7 |
| Angle | Interface: Straight (0°) | Interface: Straight (0°) | Ti Base: Straight (0°) |
| Intended restoration | |||
| type | Single-unit / Multi-unit | Single-unit / Multi-unit | Single-unit / Multi-unit |
| Method of fixation | Cement-retained | ||
| Screw-retained | Cement-retained | ||
| Screw-retained | Cement-retained | ||
| Screw-retained | |||
| Surface coating | TiN | TiN | Anodized |
| Superstructure Design w/ Ti Base (Interface) | ||
|---|---|---|
| Characteristics | IPD | IPD Dental Implant Abutments |
| (K240570) | ||
| Subject device | ||
| Superstructure | ||
| Design Workflow | The superstructures for use with the IPD Ti- | |
| Base abutments are only intended to be | ||
| designed and manufactured according to | ||
| digital dentistry workflow. The 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. | The superstructures for use with the IPD Ti- | |
| Base (Interface) abutments are only intended | ||
| to be designed and manufactured according | ||
| to digital dentistry workflow. The 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. | ||
| Zirconia CAD/CAM | ||
| Design Parameters | Minimum Gingival height: 1.5 mm | |
| Minimum Wall Thickness: 0.43 mm | ||
| Minimum Post Height: 4.75 mm (1) | ||
| Maximum Gingival Height: 6 mm | ||
| Maximum Angulation: 30° (2) | Minimum Gingival height: 1.5 mm | |
| Minimum Wall Thickness: 0.43 mm | ||
| Minimum Post Height: 4.75 mm (1) | ||
| Maximum Gingival Height: 6 mm | ||
| Maximum Angulation: 30° |
Note 1: Post height is the length above the abutment collar.
Note 2: Please consult Table 2 for specific angulation as per dental implant system and platform.
The data included in this submission demonstrate substantial equivalence to the predicate devices. It is considered that the subject device is substantially equivalent based on the following aspects:
- Has identical intended use;
- Uses similar operating principle;
- Incorporates similar design and similar device categories;
- Incorporates identical materials and surface coatings;
- It is sterilized using identical processes.
21
Ti Bases from subject device and primary predicate device are both intended to be used in a digital dentistry workflow which includes the scanning of patient's teeth setup, the design of the zirconia superstructure, the manufacturing of the superstructure, and the later cementation.
The adequacy of the digital dentistry workflow for the subject device is substantiated by software validation and mechanical fatigue testing provided in this submission, where applicable, based on IPD's role as abutment library provider, for combined and specific use with Ti Base (Interface).
Materials and technological characteristics of the subject device are identical to previously cleared in IPD Dental Implant Abutments (primary predicate device). Subject device categories are very similar in design, with slight design differences, when compared to designs from device categories included in the predicates.
VII. PERFORMANCE DATA
The proposed devices have been subject to bench testing to determine fulfilment of design and performance requirements. Bench testing followed the recommendations provided in FDA Guidance Document - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments.
Specifically, non-clinical performance testing on the IPD Dental Implant Abutments include:
- Sterilization validation to achieve a SAL of 1 x 106 according to ISO 17665-1 to ensure ● sterilization of the final finished device.
- . Cytotoxicity testing according to ISO 10993-5 to demonstrate that all patient-contacting surfaces are non-cytotoxic. In addition to Sensitization (ISO 10993-10) and Irritation (ISO 10993-23) testing for TiN coated devices.
- . Reverse engineering and dimensional analysis of original manufacturer's components (implants, abutments and screws) to confirm compatibility.
- Validation of the digital workflow and software system to ensure that design and ● manufacturing of the top half was within the specified design parameters.
- Static and dynamic fatigue testing of worst-case implant / abutment configurations and ● combinations in accordance with ISO 14801.
- Modified Surfaces Information per FDA's Class II Special Controls Guidance Document: ● Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments.
- Non-clinical worst-case MRI review was performed to evaluate IPD Dental Implant . Abutments in the MRI environment using scientific rationale and published literature (i.e., Woods, Terry O., Jana G. Delfino, and Sunder Rajan. "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795), for the entire system (including all variations of compatible implant bodies, dental abutments, and fixation screws) and material composition. The rationale addressed parameters per the FDA Guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment", including magnetically induced displacement force and torque.
Non-clinical performance testing leveraged from K240570, K231413 and K222215, together with that provided in current submission, showed that IPD Dental Implant Abutments met the applicable specifications and requirements.
No clinical testing was performed, the determination of substantial equivalence is supported by nonclinical testing.
22
VIII. CONCLUSIONS
The subject device and the primary predicate device have identical intended use and materials, and similar technological characteristics. The subject device and the primary and reference predicate devices encompass the same range of device categories, similar (OEM implant dependent) diameters, and similar designs. The subject and primary predicate device are produced using identical materials and surface coatings, as well as fabrication processes, and are to be sterilized by the user using identical methods.
Based on the similarities observed and the results of non-clinical testing performed, it can be concluded that the data presented in the current submission demonstrate that the subject device, IPD Dental Implant Abutments, is substantially equivalent to the predicate devices.