(99 days)
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 is a dental implant abutment system composed of dental abutments, screws, as well as other dental abutment accessories, 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:
- Titanium base (Interface) abutments (INC3D);
- Multi-Unit abutments (MUA);
- Overdenture Abutments (PSD);
- Temporary Abutments (PP);
- Healing Abutments (TC).
The system also includes the use of the corresponding screws intended to attach the prosthesis to the dental implant. Specifically:
- Ti Screw (TT): Used during restoration fabrication.
- TiN Screw (TTN): Used in finished restorations, with TiN coating.
- TPA Screw (TPA): 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 "Implant 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 offerings with:
• New IPD's compatible dental implant systems,
• New angulations available abutment-category specific.
• New in-house TiN coating.
IPD dental implant abutments and screws are compatible with the following commercially available dental implant systems:
(Table 2. Summary of IPD abutments categories with compatibilized OEM Implant/Abutment Systems with specific reference to maximum angulation specifically included in this submission. provided in original text)
Ti Base (Interface) abutments are attached (screw-retained) to the implant/abutment 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)
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.
The provided FDA 510(k) clearance letter pertains to IPD Dental Implant Abutments, a medical device, not an AI/ML-driven software product. Therefore, the information requested regarding acceptance criteria and study data for an AI/ML device (e.g., sample size for test/training sets, expert ground truthing, MRMC studies, standalone performance) is not applicable to this document.
The document describes the device, its intended use, comparison to predicate devices, and the non-clinical performance testing conducted to demonstrate substantial equivalence. These tests are physical and chemical in nature, not related to the performance of an AI/ML algorithm.
Here's a breakdown of why an AI/ML-focused response is not possible, based on the provided text:
- Device Type: The device is "IPD Dental Implant Abutments," which are physical components used in dentistry (titanium alloy abutments, screws, designed for zirconia superstructures). It is not software, a diagnostic imaging tool, or an AI/ML algorithm.
- Purpose of Submission: The submission aims to expand compatibility with new dental implant systems and include new angulations and in-house TiN coating. This is a modification of a physical medical device, not a new AI/ML development.
- Performance Data (Section VII): This section explicitly lists non-clinical performance testing such as:
- Sterilization validation (ISO 17665-1)
- Biocompatibility testing (Cytotoxicity, Sensitization, Irritation per ISO 10993)
- Reverse engineering and dimensional analysis for compatibility
- Validation of the digital workflow and software system (but this refers to the CAD/CAM software used to design the physical abutments, not an AI/ML diagnostic tool)
- Static and dynamic fatigue testing (ISO 14801)
- Modified Surfaces Information
- MRI safety review
Conclusion:
The provided document describes a 510(k) clearance for a physical dental implant component. It does not contain any information about the acceptance criteria or study design for an AI/ML driven medical device. Therefore, a table of acceptance criteria and reported device performance related to AI/ML, sample sizes for test/training sets, details on expert ground truthing, MRMC studies, or standalone performance of an algorithm cannot be extracted from this text.
FDA 510(k) Clearance Letter - IPD Dental Implant Abutments
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.00
IMPLANT PROTESIS DENTAL 2004, S.L.
Francesc Fumanal
Regulatory Affairs Manager
Carrer Rosa dels Vents, 9-15.
Premià de Dalt (Barcelona), 08338
SPAIN
Re: K251471
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: July 22, 2025
Received: July 22, 2025
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.
August 20, 2025
Page 2
K251471 - Francesc Fumanal Page 2
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 (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-reporting-combination-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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
Page 3
K251471 - Francesc Fumanal Page 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/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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
Page 4
Indications for Use
Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions.
Please provide the device trade name(s).
IPD Dental Implant Abutments
Please provide your Indications for Use below.
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 System | Implant/Abutment Diameter (mm) | Platform Diameter |
|---|---|---|
| OsseoSpeed™ Plus | 3.0 | 3.0 |
| 3.6 | 3.6 | |
| 4.2 | 4.2 | |
| 4.8 | 4.8 | |
| Bio Horizons Tapered Internal Implant System | 3.0 | 3.0 |
| 3.4 | 3.0 | |
| 3.8 | 3.5 | |
| 4.6 | 4.5 | |
| 5.8 | 5.7 | |
| Straumann® BLX Implant System | 3.5 - 4.5 | RB |
| 5.0 - 6.5 | WB | |
| Straumann BLX Ø3.5 mm Implants | 3.5 | RB |
| Straumann® Screw-Retained Abutments | 3.5 | NC |
| 4.6 | RC | |
| Xpeed AnyRidge Internal Implant System | 3.5 - 8.0 | RP |
| 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 |
Page 11 of 59
Page 5
| Compatible System | Implant/Abutment Diameter (mm) | Platform Diameter |
|---|---|---|
| 3.5 | Mini | |
| 4.0 - 7.0 | Regular | |
| Straumann® Tissue Level | 3.3/4.1/4.8 | RN (4.8 mm) |
| 4.8 | WN (6.5 mm) | |
| 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 | 3.5mm |
| 4.7 | 4.5mm | |
| 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.
Please select the types of uses (select one or both, as applicable).
IPD Dental Implant Abutments
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
Page 12 of 59
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IPD Dental Implant Abutments
Administrative Information – 510(k) Summary
1 of 16
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@ipd2004.com
Date prepared: July 31, 2025.
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: K242819, IPD Dental Implant Abutments
Reference Devices: K240570, IPD Dental Implant Abutments,
The list of all the proposed third-party compatible dental implant systems, as additional Reference Devices, has been provided in Table 1.
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IPD Dental Implant Abutments
Administrative Information – 510(k) Summary
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Table 1. Reference Devices - Compatible Dental Implant Systems:
| 510(k) Holder | Compatible Implant/Abutment System | 510(k) Number | 510(k) Device Name |
|---|---|---|---|
| Astra Tech AB | OsseoSpeed™ Plus | K120414 | OsseoSpeed™ Plus |
| Biohorizons Implant Systems, Inc. | BioHorizons Tapered Internal Implant System | K071638 | BioHorizons Tapered Internal Implant System |
| 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 |
| Institut Straumann AG | Straumann® Screw-Retained Abutments | K192401 | Straumann® Screw-Retained Abutments |
| MegaGen Implant Co., Ltd | Xpeed AnyRidge Internal Implant System | K140091 | Xpeed AnyRidge Internal Implant System |
| 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 |
| Zimmer Biomet Dental | Tapered Screw-Vent® | K112160 | Tapered Screw-Vent® X Implant |
Note: K140878 (Straumann® Bone Level) has been referenced just for informative purposes since Straumann® Screw-Retained Abutments (K192401) are mounted on the Straumann® Bone Level dental implant system.
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IPD Dental Implant Abutments
Administrative Information – 510(k) Summary
3 of 16
IV. DEVICE DESCRIPTION
IPD Dental Implant Abutments is a dental implant abutment system composed of dental abutments, screws, as well as other dental abutment accessories, 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:
- Titanium base (Interface) abutments (INC3D);
- Multi-Unit abutments (MUA);
- Overdenture Abutments (PSD);
- Temporary Abutments (PP);
- Healing Abutments (TC).
The system also includes the use of the corresponding screws intended to attach the prosthesis to the dental implant. Specifically:
- Ti Screw (TT): Used during restoration fabrication.
- TiN Screw (TTN): Used in finished restorations, with TiN coating.
- TPA Screw (TPA): 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 offerings with:
• New IPD's compatible dental implant systems,
• New angulations available abutment-category specific.
• New in-house TiN coating.
IPD dental implant abutments and screws are compatible with the following commercially available dental implant systems:
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IPD Dental Implant Abutments
Administrative Information – 510(k) Summary
4 of 16
Table 2. Summary of IPD abutments categories with compatibilized OEM Implant/Abutment Systems with specific reference to maximum angulation specifically included in this submission.
| Compatible Implant/Abutment System | Type of connection | Implant Diameter (mm) | Platform Diameter | Device category | Overdenture Abutment | Multi-Unit Abutment | Ti Base | Healing Abutment | Temporary Abutment |
|---|---|---|---|---|---|---|---|---|---|
| Material | Titanium alloy, ISO 5832-3. TiN coated | Titanium alloy, ISO 5832-3. TiN coated | Titanium alloy, ISO 5832-3. TiN coated | Titanium alloy, ISO 5832-3. Uncoated | Titanium alloy, ISO 5832-3. Anodized | ||||
| IPD Abutment Systems | |||||||||
| Straumann® Tissue Level | Internal | 3.3/4.1/4.8 | RN (4.8 mm) | DA | RN (20º) | - | - | - | - |
| 4.8 | WN (6.5 mm) | WN (20º) | |||||||
| Straumann BLX Ø3.5 mm Implants | Internal | 3.5 | RB | DC | RB (20º) | - | - | - | - |
| Straumann® BLX Implant System | 3.5 - 4.5 | RB | - | - | - | - | |||
| 5.0 - 6.5 | WB | WB (20º) | |||||||
| Straumann® Screw-Retained Abutments | External | 3.5 | NC | DD | - | - | NC (30º) | NC | NC |
| 4.6 | RC | RC (30º) | RC | RC | |||||
| OsseoSpeed™ Plus | Internal | 3.0 | 3.0 | EB | - | 3.0 (0º) | 3.0 (0º) | 3.0 | 3.0 |
| 3.6 | 3.6 | 3.6 (30º) | - | - | - | ||||
| 4.2 | 4.2 | 4.2 (30º) | |||||||
| 4.8 | 4.8 | 4.8 (30º) | 4.8 (28º) | 4.8 | 4.8 | ||||
| Zimmer Tapered Screw-Vent® | Internal | 3.7 / 4.1 | 3.5 mm | FA | - | 3.5 (30º) | |||
| 4.7 | 4.5 mm | 4.5 (30º) | - | - | - | ||||
| 6.0 | 5.7 mm | 5.7 (30º) | |||||||
| BioHorizons Tapered Internal Implant System | Internal | 3.0 | 3.0 | LB | - | 3.0 (0º) | - | - | - |
| 3.4 | |||||||||
| 3.8 | 3.5 | - | |||||||
| 4.6 | 4.5 | ||||||||
| 5.8 | 5.7 | ||||||||
| Osstem Implant System | Internal | 3.0 | Mini | OB | Mini (20º) | 3.5 | - | - | - |
| 4.0 - 7.0 | Regular | Regular (20º) | |||||||
| MIS Internal Hex Dental Implant System (MIS® Seven®) | Internal | 3.30 | Narrow | TA | - | Narrow (0º) | - | - | - |
| 3.75 | Standard | Standard (30º) | |||||||
| 4.20 | |||||||||
| 5.0 | Wide | Wide (30º) | |||||||
| 6.0 | |||||||||
| Xpeed AnyRidge Internal Implant System | Internal | 3.5 - 8.0 | RP | WB | - | RP (30º) | - | - | - |
Please note that IPD Serie DD refers to Ti bases compatible with SRA system prosthetics mounted on Straumann Bone Level dental implants.
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IPD Dental Implant Abutments
Administrative Information – 510(k) Summary
5 of 16
Ti Base (Interface) abutments are attached (screw-retained) to the implant/abutment 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.
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IPD Dental Implant Abutments
Administrative Information – 510(k) Summary
6 of 16
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 Systems
| Compatible System | Implant/Abutment Diameter (mm) | Platform Diameter |
|---|---|---|
| OsseoSpeed™ Plus | 3.0 | 3.0 |
| 3.6 | 3.6 | |
| 4.2 | 4.2 | |
| 4.8 | 4.8 | |
| 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 | |
| Straumann® BLX Implant System | 3.5 - 4.5 | RB |
| 5.0 - 6.5 | WB | |
| Straumann BLX Ø3.5 mm Implants | 3.5 | RB |
| Straumann® Screw-Retained Abutments | 3.5 | NC |
| 4.6 | RC | |
| Xpeed AnyRidge Internal Implant System | 3.5 -8.0 | RP |
| 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 | |
| Straumann® Tissue Level | 3.3/4.1/4.8 | RN (4.8 mm) |
| 4.8 | WN (6.5 mm) | |
| 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 |
Note: K140878 (Straumann® Bone Level) has been referenced just for informative purposes since Straumann® Screw-Retained Abutments (K192401) are mounted on the Straumann® Bone Level dental implant system.
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.
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IPD Dental Implant Abutments
Administrative Information – 510(k) Summary
7 of 16
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE 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 (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 System | Implant/Abutment Diameter (mm) | Platform Diameter |
|---|---|---|
| OsseoSpeed™ Plus | 3.0 | 3.0 |
| 3.6 | 3.6 | |
| 4.2 | 4.2 | |
| 4.8 | 4.8 | |
| 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 | |
| Straumann® BLX Implant System | 3.5 - 4.5 | RB |
| 5.0 - 6.5 | WB | |
| Straumann BLX Ø3.5 mm Implants | 3.5 | RB |
| Straumann® Screw-Retained Abutments | 3.5 | NC |
| 4.6 | RC | |
| Xpeed AnyRidge Internal Implant System | 3.5 -8.0 | RP |
| 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 | |
| Straumann® Tissue Level | 3.3/4.1/4.8 | RN (4.8 mm) |
| 4.8 | WN (6.5 mm) | |
| 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 |
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| Compatible System | Implant/Abutment Diameter (mm) | Platform Diameter |
|---|---|---|
| 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.
Predicate Devices
Primary Predicate Device K242819
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 | 3.0 |
| 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 |
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| Compatible System | Implant Diameter (mm) | Platform Diameter |
|---|---|---|
| 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.
Predicate Devices
Primary Predicate Device K242819
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 | 3.0 |
| 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) | |
| 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 |
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 K240570
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 | 3.0 |
| 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 |
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| Compatible System | Implant Diameter (mm) | Platform Diameter |
|---|---|---|
| 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) | |
| 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 |
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 K240570
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 | 3.0 |
| 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 |
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.
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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 most of them 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, K240570, has been selected due to abutment designs which were 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.
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Tables 4. Subject and Predicate devices technological characteristics comparison.
| Characteristics | Subject Device IPD Dental Implant Abutments (IPD) | Primary Predicate Device IPD Dental Implant Abutments (IPD) K242819 | Reference Device IPD Dental Implant Abutments (IPD) K240570 |
|---|---|---|---|
| Materials | |||
| Abutment Metallic Materials | Titanium Alloy Grade 5 (ISO 5832-3) + TiN or Anodized (TiO2) | Titanium Alloy Grade 5 (ISO 5832-3) + TiN | Titanium Alloy Grade 5 (ISO 5832-3) + TiN or Anodized (TiO2) |
| Screw Materials | Titanium Alloy Grade 5 (ISO 5832-3) + TiN | Titanium Alloy Grade 5 (ISO 5832-3) + TiN | Titanium Alloy Grade 5 (ISO 5832-3) + TiN |
| Superstructure | DD Bio Z Zirconia (K142987) | DD Bio Z Zirconia (K142987) | DD Bio Z Zirconia (K142987) |
| General Design Features | |||
| Overview of abutment designs | Healing, Temporary, Ti-Base, Multi-Unit and Overdenture Abutments | Ti-Base, Multi-Unit and Overdenture Abutments | Healing, Temporary, Cementing and Ti-Base Abutments |
| 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 (crowns) Multiple-unit (bridges) |
| Abutment / Implant Platform Diameter (mm) | 3.0 – 6.5 | 3.0 – 5.7 | 3.0 – 5.7 |
| Abutment Angle | Maximum: 30° | Maximum: 30° | Maximum: 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 |
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Specific Design features
Healing Abutments
| Characteristics | IPD Subject device | IPD Dental Implant Abutments (K240570) |
|---|---|---|
| Min – Max diameter | 3.5 – 4.6 | 3.0 – 5.7 |
| Angle | Straight (0°) | Straight (0°) |
| Intended restoration type | Single-unit | Single-unit |
| Method of fixation | Screw-retained | Screw-retained |
| Surface coating | Uncoated | Uncoated |
Temporary Abutments
| Characteristics | IPD Subject device | IPD Dental Implant Abutments (K240570) |
|---|---|---|
| Min – Max diameter | 3.5 – 4.6 | 3.0 – 5.7 |
| Angle | Straight (0°) | Straight (0°) |
| Intended restoration type | Single-unit / Multi-unit | Single-unit / Multi-unit |
| Method of fixation | Cement-retained / Screw-retained | Cement-retained / Screw-retained |
| Surface coating | Anodized | Anodized |
Multi-Unit Abutments
| Characteristics | IPD Subject device | IPD Dental Implant Abutments (K242819) |
|---|---|---|
| Abutment/Implant Platform diameter (mm) | 3.0 – 4.8 | 3.0 – 7.0 |
| Prosthetic Platform diameter (mm) | 4.8 | 4.8 |
| Gingival Height | 1.0 – 4.5 | 0.9 – 5.0 |
| 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 | TiN coated |
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Overdenture Abutments
| Characteristics | IPD Subject device | IPD Dental Implant Abutments (K242819) |
|---|---|---|
| Abutment/Implant Platform diameter (mm) | 3.5 – 6.5 | 3.3 – 7.0 |
| Gingival Height | 1.0 – 5.0 | 1.0 – 5.0 |
| Divergence | ± 20º | ± 20º |
| Intended restoration type | Single-unit | Single-unit |
| Method of fixation | Screw-retained | Screw-retained |
| Surface coating | TiN coated | TiN coated |
Ti Base Abutments
| Characteristics | IPD Subject device | IPD Dental Implant Abutments (K242819) |
|---|---|---|
| Min – Max diameter | 3.0 – 4.8 | 3.0 – 5.7 |
| Angle | Interface: Straight (0º) | Interface: Straight (0º) |
| Intended restoration type | Single-unit / Multi-unit | Single-unit / Multi-unit |
| Method of fixation | Cement-retained Screw-retained | Cement-retained Screw-retained |
| Surface coating | TiN | TiN |
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.
Superstructure Design w/ Ti Base (Interface)
| Characteristics | IPD Subject device | IPD Dental Implant Abutments (K242819) |
|---|---|---|
| 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 mmMinimum Wall Thickness: 0.43 mmMinimum Post Height: 4.75 mm (1)Maximum Gingival Height: 6 mmMaximum Angulation: 30º (2) | Minimum Gingival height: 1.5 mmMinimum Wall Thickness: 0.43 mmMinimum Post Height: 4.75 mm (1)Maximum Gingival Height: 6 mmMaximum Angulation: 30º |
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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 identical operating principle;
- Incorporates similar design and identical device categories;
- Incorporates identical materials and surface coatings;
- It is sterilized using identical processes.
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 identical, with slight design differences adapted to compatible dental implant systems 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 10-6 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
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Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment", including magnetically induced displacement force and torque.
Non-clinical performance testing leveraged from K242819 and K240570, 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 non-clinical testing.
VIII. CONCLUSIONS
The subject device and the primary predicate device have identical intended use, materials, and technological characteristics. The subject device and the primary and reference predicates devices encompass the same range of device categories, similar (OEM implant dependent) diameters, and similar designs. The subject device and primary predicate and reference devices are produced using identical materials and surface coatings, with identical 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.
§ 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.)