(99 days)
No
The summary describes a system of physical dental implant abutments and screws, with no mention of AI or ML capabilities. The "Validation of the digital workflow and software system" mentioned in the performance studies likely refers to design or manufacturing software, not AI/ML for diagnosis or treatment planning.
Yes
The device, IPD Dental Implant Abutments, is intended to provide support for dental prosthetic restorations in the maxillary or mandibular arch, fitting the definition of a therapeutic device as it treats or alleviates a condition (missing teeth) by facilitating a restoration.
No
Explanation: The device is a dental implant abutment system designed to provide support for dental prosthetic restorations, not to diagnose a condition or disease.
No
The device description clearly states it is a "dental implant abutment system composed of dental abutments and screws," which are physical hardware components. While it mentions a "digital workflow and software system" in the performance studies, the core device is hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The IPD Dental Implant Abutments are physical components (abutments and screws) that are surgically placed into dental implants to support prosthetic restorations. They are used in vivo (within the body), not in vitro (in a lab setting with specimens).
- Intended Use: The intended use clearly states they are used "in conjunction with endosseous dental implants... to provide support for single or multiple dental prosthetic restorations." This is a structural and mechanical function within the patient's mouth.
- Device Description: The description details the physical components and their purpose in supporting dental prosthetics.
- Lack of Specimen Analysis: There is no mention of analyzing any biological specimens from the patient. The input is "scan files from intra-oral scanners," which are digital representations of the anatomical structure, not biological samples.
Therefore, based on the provided information, the IPD Dental Implant Abutments are a medical device used in vivo for structural support in dental restorations, not an In Vitro Diagnostic device.
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.
Compatible Implant Systems
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.
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 systems.
IPD Dental Implant Abutments includes the following categories of dental abutment designs:
- Healing abutments;
- Temporary abutments;
- Cementing titanium abutments;
- Titanium base (interface) abutments;
The system also includes the corresponding Titanium Screws 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 allov".
The purpose of this submission is to expand IPD Dental Implant Abutments cleared under K231413 to:
- Include new OEM dental implant platform compatibilities (previously not cleared) for previously cleared IPD's abutment designs.
IPD dental implant abutments and screws are compatible with the following commercially available dental implant systems:
- Osstem Implant System
- Anyone™ Internal Implant System
- Xpeed AnyRidge Internal Implant System
- 3i® Osseotite® Dental Implants
- 3i Osseotite® Certain® Dental Implants
- Astra Tech Implant System (Osseospeed®)
- OsseoSpeed™ Plus
- BioHorizons Tapered Internal Implant System
- MIS Internal Hex Dental Implant System (MIS® Seven®)
- Conical Connection Implants (MIS® C1)
- Straumann BLX Ø3.5 mm Implants
- Straumann® BLX Implant System
Ti Base (Interface) abutments are used as an interface between the dental implant and the zirconia superstructure. They are attached (screw-retained) to the implant and cemented to the zirconia superstructure.
The Ti Base (Interface) is a two-piece abutment composed of the Ti Base (Interface) 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 (e.g., 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 Bases (Interfaces) will be conducted using a digital dentistry workflow requiring the use of the following equipment:
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) abutments 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)
The laboratory designed superstructure is attached to Ti Base (Interface) by the use of an FDA-cleared cement (e.g., Multilink® Automix, K123397). 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
Dental clinic, dental laboratory
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)
Bench testing including:
- 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.
Results: Non-clinical performance testing leveraged from K231413, previously cleared, 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)
K222288, K101732, K120414, K071638, K063341, K063286, K173961, K191256, K123988, K140091, K112162, K180282, K161604
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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Implant Protesis Dental 2004, S.L Francesc Fumanal Regulatory Affairs Manager Carrer Rosa dels Vents, 9-15 Premià de Dalt, Barcelona, 08338 SPAIN
June 7, 2024
Re: K240570
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: May 10, 2024 Received: May 10, 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.
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
3
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Andrew I. Steen -S
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
K240570
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 | ||
|---|---|---|
| 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 // 3.5 // 4.0-7.0 | Mini // Mini // Regular |
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)
X 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
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@jpd2004.com
Date prepared: June 7, 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: | K231413, IPD Dental Implant Abutments |
|---|---|
| Reference Devices: | 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 . |
Table 1. Reference Devices - Compatible Dental Implant Systems:
| 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 | |||
| MegaGen Implant | |||
| Co., Ltd | Anyone™ Internal Implant System | K123988 | Anyone™ Internal Implant |
| System |
6
Administrative Information - 510(k) Summary
| 510(k) Holder | Compatible Implant System | 510(k) Number | 510(k) Device Name |
|---|---|---|---|
| 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 | |||
| OSSTEM Implant | |||
| Co., Ltd. | Osstem Implant System | K161604 | Osstem Implant System |
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 systems.
IPD Dental Implant Abutments includes the following categories of dental abutment designs:
- -Healing abutments;
- Temporary abutments; -
- -Cementing titanium abutments;
- -Titanium base (interface) abutments;
The system also includes the corresponding Titanium Screws 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 allov".
The purpose of this submission is to expand IPD Dental Implant Abutments cleared under K231413 to:
- Include new OEM dental implant platform compatibilities (previously not cleared) for . previously cleared IPD's abutment designs.
IPD dental implant abutments and screws are compatible with the following commercially available dental implant systems:
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| Compatible Implant System | Type of
connection | Implant
Diameter (mm) | Platform
Diameter | Device category
Material
IPD Abutment
Systems | Healing
Abutment
Titanium alloy,
ISO 5832-3 | Cementing /
Temporary
Abutments
Titanium alloy, ISO
5832-3
Temp. Anodized | Ti Base (Interface)
Abutment
Titanium alloy, ISO
5832-3
TiN coated | |
|---------------------------------------------------------|-----------------------|------------------------------------|------------------------------------------------|--------------------------------------------------------|------------------------------------------------------|------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|---------------------------------------------|
| Osstem Implant System | Internal | 3.0
3.5
4.0 - 7.0 | Mini
Mini
Regular | OB | Mini
Mini
Regular | Mini
Mini
Regular | Mini (0°)
Mini (0°)
Regular (30°) | |
| Anyone™ Internal Implant System | Internal | 3.5 -8.0 | RP | WA | RP | RP | RP (30°) | |
| Xpeed AnyRidge Internal Implant
System | Internal | 3.5 -8.0 | RP | WB | RP | RP | RP (0°) | |
| 3i® Osseotite® Dental Implants | External | 3.25
4.0
5.0 | 3.4
4.1
5.0 | BA | 3.4
4.1
5.0 | 3.4
4.1
5.0 | 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
4.1
5.0 | 3.4
4.1
5.0 | 3.4 (0°)
4.1 (0°)
5.0 (0°) | |
| 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 | 3.0
3.5/4.0
4.5/5.0 | 3.0
3.5/4.0
4.5/5.0 | 3.0 (0°)
3.5/4.0 (30°)
4.5/5.0 (30°) | |
| OsseoSpeed™ Plus | Internal | 3.6
4.2 | 3.6
4.2 | EB | 3.6
4.2 | 3.6
4.2 | 3.6 (0°)
4.2 (0°) | |
| BioHorizons Tapered Internal
Implant System | Internal | 3.0
3.4
3.8
4.6
5.8 | 3.0
3.0
3.5
4.5
5.7 | LB | 3.0
3.0
3.5
4.5
5.7 | 3.0
3.0
3.5
4.5
5.7 | 3.0 (0°)
3.0 (0°)
3.5 (30°)
4.5 (30°)
5.7 (30°) | |
| MIS Internal Hex Dental Implant
System (MIS® Seven®) | Internal | 3.30
3.75
4.20
5.0
6.0 | Narrow
Standard
Standard
Wide
Wide | TA | Narrow
Standard
Standard
Wide
Wide | Narrow
Standard
Standard
Wide
Wide | Narrow (0°)
Standard (30°)
Standard (30°)
Wide (30°)
Wide (30°) | |
| Conical Connection Implants | Internal | 3.75 | SP | TB | SP | SP | SP (30°) | |
| Compatible Implant System | Type of
connection | Implant
Diameter (mm) | Platform
Diameter | Device category | | Healing
Abutment | Cementing /
Temporary
Abutments | Ti Base (Interface)
Abutment |
| | | | | Material | IPD Abutment
Systems | Titanium alloy,
ISO 5832-3 | Titanium alloy, ISO
5832-3
Temp. Anodized | Titanium alloy, ISO
5832-3
TiN coated |
| (MIS® C1) | | 4.2 | SP | | | SP | SP | SP (30°) |
| Straumann BLX Ø3.5 mm Implants | | 3.5 | RB | | | RB | RB | RB (0°) |
| Straumann® BLX Implant System | Internal | 3.5 - 4.5 | RB | DC | | RB | RB | RB (0°) |
| Straumann® BLX Implant System | | 5.0 - 6.5 | WB | | | WB | WB | WB (0°) |
Table 2. Summary of IPD abutments categories with compatibilized OEM Implant Systems to maximum angulation:
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Ti Base (Interface) abutments are used as an interface between the dental implant and the zirconia superstructure. They are attached (screw-retained) to the implant and cemented to the zirconia superstructure.
The Ti Base (Interface) is a two-piece abutment composed of the Ti Base (Interface) as the bottomhalf 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 FDAcleared design software (e.g., 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 Bases (Interfaces) will be conducted using a digital dentistry workflow requiring the use of the following equipment:
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) abutments 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 the angulation depending on the dental implant system and platform.
The laboratory designed superstructure is attached to Ti Base (Interface) by the use of an FDA-cleared cement (e.g., Multilink® Automix, K123397). 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.
10
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 |
Compatible Implant Systems
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.
11
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.
| Indications for Use Statements | ||
|---|---|---|
| Subject device | ||
| IPD Dental | ||
| Implant | ||
| Abutments | 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 | ||
| (Implant | ||
| Protesis | dental prosthetic restorations. | |
| 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 | ||
| 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 |
12
| 4.20 | Standard | |||||
|---|---|---|---|---|---|---|
| 5.0 | Wide | |||||
| 6.0 | Wide | |||||
| 3.0 | Mini | |||||
| Osstem Implant System | 3.5 | Mini | ||||
| 4.0 - 7.0 | Regular | |||||
| 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. | ||||||
| Predicate Devices | ||||||
| Primary Predicate Device | ||||||
| K231413 | 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 | ||||||
| IPD Dental | ||||||
| Implant | multiple dental prosthetic restorations. | |||||
| Abutments | Compatible Implant Systems | |||||
| (Implant | ||||||
| Protesis | ||||||
| Dental 2004, | Implant System | |||||
| Compatibility | Implant Diameter (mm) | Platform Diameter | ||||
| SL) | 3.0 | 3.0 mm | ||||
| NobelActive® | 3.5 | NP (3.5 mm) | ||||
| 4.3/5.0 | RP (4.3 mm) | |||||
| 3.3 | NC (3.3 mm) | |||||
| Straumann® Bone Level | 4.1/4.8 | RC (4.1 mm) | ||||
| Neodent Implant System | ||||||
| – GM Line | 3.5 - 7.0 | GM (Grand Morse) | ||||
| 3.7 / 4.1 | 3.5 mm | |||||
| Tapered Screw-Vent® | 4.7 | 4.5 mm | ||||
| 6.0 | 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. | ||||||
| Reference Device | ||||||
| K222288 | ||||||
| DESS Dental | ||||||
| Smart | ||||||
| Solutions | DESS Dental Smart Solutions abutments are intended to be used in conjunction with | |||||
| endosseous dental implants in the maxillary or mandibular arch to provide support for | ||||||
| prosthetic restorations. | ||||||
| (Terrats | ||||||
| Medical, SL) | All digitally designed custom abutments for use with Ti Base abutments or Pre-milled | |||||
| Blank abutments are to be sent to a Terrats Medical validated milling center for | ||||||
| manufacture. | ||||||
| Compatible Implant System | Implant Body Diameter, mm | Implant Platform Name | ||||
| Ankylos C/X | 3.5, 4.5, 5.5 | 2.52 | ||||
| Astra Tech EV | 3.0 | 3.0 | ||||
| 3.6 | 3.6 |
13
| 4.2 | 4.2 | ||
|---|---|---|---|
| 4.8 | 4.8 | ||
| 5.4 | 5.4 | ||
| 3.0 | 3.0 | ||
| Astra Tech OsseoSpeed™ | 3.5/4.0 | 3.5/4.0 | |
| 4.5/5.0 | 4.5/5.0 | ||
| 3.0, 3.4, 3.8 | 3.0 | ||
| 3.8, 4.6 | 3.5 | ||
| BioHorizons | 4.6, 5.8 | 4.5 | |
| 5.8 | 5.7 | ||
| 3.25 | 3.4 | ||
| Biomet 3i Certain® | 4.0 | 4.1 | |
| 5.0 | 5.0 | ||
| 3.25 | 3.4 | ||
| Biomet 3i OSSEOTITE® | 3.75, 4.0 | 4.1 | |
| 5.0 | 5.0 | ||
| 3.8 | 3.8 | ||
| Camlog | 4.3 | 4.3 | |
| 5.0 | 5.0 | ||
| Dentium SuperLine | 3.6, 4.0, 4.5, 5.0, 6.0, 7.0 | 3.3 | |
| 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) | |
| NobelActive®, NobelParallel | 3.0 | 3.0 | |
| 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 | ||
| Osstem TS | 3.5 | Mini | |
| 4.0, 4.5, 5.0, 6.0, 7.0 | Regular | ||
| Straumann BLX | 3.5, 3.75, 4.0, 4.5 | RB | |
| 5.0, 5.5, 6.5 | WB | ||
| Straumann® Bone Level | 3.3 | NC | |
| 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 | |
| 3.3, 3.7, 4.1 | 3.5 | ||
| Zimmer Screw Vent®/ | 4.7 | 4.5 | |
| Tapered Screw- Vent® | 6.0 | 5.7 | |
| 3.25 | 3.25 | ||
| Zimmer Spline | 3.75, 4.0 | 3.75/4.0 | |
| 5.0 | 5.0 | ||
| Zimmer SwissPlus | . Children Children Children Children Children Children Children Children Children Children Children Children Children Suite Station Schward Schward Station | رات ل | |
14
Administrative Information - 510(k) Summary
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 new implant systems which IPD is claiming compatibility for this submission. 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:
| 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.
As previously referred, differences may be found in the list of compatible implant systems for subject and predicate devices. Compatibility of the subject abutments with the specific OEM implants is based on engineering and dimensional analysis, as well as mechanical fatigue testing. In that sense, reference device, K222288, has been selected for the range of compatibility implant systems which encompasses (not exhaustive list) and which IPD is also citing compatibility. Similarly, the whole set of compatible dental implant systems and their respective 510(k) have been also included in this submission as reference devices.
Despite this, no further differences are found in the device categories included for subject and predicate devices, and same approach is followed for finalizing the zirconia superstructures.
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.
15
| Characteristics | Subject Device
IPD Dental Implant
Abutments | Primary Predicate
Device
IPD Dental Implant
Abutments
(IPD) K231413 | Reference Device
DESS Dental Smart
Solutions
(Terrats Medical, SL)
K222288 |
|-------------------------------------------------|--------------------------------------------------------------------|---------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Materials | | | |
| Abutment Materials | Titanium Alloy Grade 5
(ISO 5832-3) + TiN or
Anodized (TiO2) | 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 | Healing,
Temporary,
Cementing,
Ti-Base (Interface) | 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. | |
|---|---|
| ----------------------------------------------------------------------------------- | -- |
| Healing Abutments | |||
|---|---|---|---|
| Characteristics | IPD | ||
| Subject device | IPD Dental Implant | ||
| Abutments (K231413) | DESS Dental Smart | ||
| Solutions (K222288) | |||
| Min – Max diameter | 3.0 - 5.7 | 3.0 - 5.7 | 2.52 - 5.7 |
| Angle | Straight (0°) | Straight (0°) | Straight (0°) |
| Intended restoration | |||
| type | Single-unit | Single-unit | Single-unit |
| Method of fixation | Screw-retained | Screw-retained | Screw-retained |
| Surface coating | Uncoated | Uncoated | Uncoated |
16
| Cementing and Temporary Abutments | |||
|---|---|---|---|
| Characteristics | IPD | ||
| Subject device | IPD Dental Implant | ||
| Abutments (K231413) | DESS Dental Smart | ||
| Solutions (K222288) | |||
| Min – Max diameter | 3.0 – 5.7 | 3.0 - 4.3 | 2.52 - 5.7 |
| Angle | Straight (0°) | Straight (0°) | 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 | Cementing: Uncoated | ||
| Temporary: Anodized | Cementing: Uncoated | ||
| Temporary: Anodized | Uncoated |
| Ti Base / Interface Abutments | |||
|---|---|---|---|
| Characteristics | IPD | ||
| Subject device | IPD Dental Implant | ||
| Abutments (K231413) | DESS Dental Smart | ||
| Solutions (K222288) | |||
| Min – Max diameter | 3.0 – 5.7 | 3.0 – 4.3 | 2.52 – 5.7 |
| 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 |
17
| Superstructure Design | |||
|---|---|---|---|
| Characteristics | IPD | ||
| Subject device | IPD Dental Implant Abutments | ||
| (K231413) | DESS Dental Smart Solutions | ||
| (K222288) | |||
| Superstructure Design | |||
| Workflow | 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. | 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. | All digitally designed custom abutments for | ||
| use with Ti Base abutments or Pre-milled | |||
| Blank abutments are to be sent to a Terrats | |||
| Medical validated milling center for | |||
| manufacture. | |||
| Zirconia CAD/CAM Design | |||
| Parameters – | |||
| Ti (Base) Interface Abutment | |||
| characteristics | 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° (3) | Minimum gingival height: 0.5 mm | ||
| Minimum wall thickness: 0.4 mm | |||
| Minimum post height: 4.2 mm | |||
| Maximum gingival height: 6.0 mm | |||
| Maximum Angulation: 20°/30° (4) |
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.
Note 3: With the exception of Nobel Active® 3.0 and 3.5 mm-platforms which final abutment is straight (0°).
Note 4: Design parameters for Ti Base Interface with Bionet 3: Certain, NobelReplace Trilobe, and Zimner Screw-Vent (except for 3.3 mm implants).
18
Administrative Information - 510(k) Summary
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 the same intended use;
- Uses the same operating principle;
- Incorporates similar design and same device categories;
- Incorporates the same materials and surface coatings;
- It is sterilized using the same processes.
Ti Base (Interface) 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.
Materials and technological characteristics of the subject device are identical to previously cleared IPD Dental Implant Abutments (primary predicate device). Subject device categories are very similar in design, with differences on the proposed compatibilized OEM dental implant systems.
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.
19
Non-clinical performance testing leveraged from K231413, previously cleared, 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.
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 almost identical designs. The subject and 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, we conclude that the data included in the submission demonstrate that the subject device, IPD Dental Implant Abutments, is substantially equivalent to the predicate devices.