(88 days)
No
The device description and performance studies focus on the mechanical properties, biocompatibility, and compatibility of dental implant abutments and screws. There is no mention of AI or ML in the intended use, device description, or performance testing. While the input mentions "scan files from intra-oral scanners" and "validation of the digital workflow and software system," this refers to the design and manufacturing process, not an AI/ML function within the final device itself.
No.
The device is a dental implant abutment system designed to provide support for dental prosthetic restorations, not to treat a disease or condition. While it aids in the restoration of dental function, its primary role is structural support rather than direct therapeutic intervention.
No
The device is an implant abutment system, which is a component used in dental prosthetic restorations. It does not perform any diagnostic function.
No
The device description clearly states it is a system of physical dental abutments and screws made of titanium alloy, which are hardware components. While there is mention of a "digital workflow and software system" validation, the core device is hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide support for dental prosthetic restorations in the maxillary or mandibular arch. This is a mechanical function within the body.
- Device Description: The device is a system of dental abutments and screws made of titanium alloy. These are physical components used in a surgical and restorative procedure.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a disease or condition, or to examine specimens derived from the human body.
- Performance Studies: The performance studies focus on mechanical properties (fatigue, static strength), biocompatibility (cytotoxicity, sensitization, irritation), sterilization, and dimensional compatibility. These are typical tests for implantable medical devices, not IVDs.
- Input Imaging Modality: While it mentions "scan files from intra-oral scanners," this is likely for designing and fabricating the prosthetic restoration that attaches to the abutment, not for diagnostic purposes related to the abutment itself.
IVD devices are used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
# Intended Use / Indications for Use
IPD Dental Implant Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single or multiple dental prosthetic restorations.
Compatible Implant Systems:
Brånemark
Implant Diameter (mm): 3.5, Platform Diameter: NP (3.5 mm)
Implant Diameter (mm): 3.75 / 4.0, Platform Diameter: RP (4.1 mm)
Implant Diameter (mm): 5.0, Platform Diameter: WP (5.1 mm)
Straumann® Tissue Level
Implant Diameter (mm): 3.3 / 4.1 / 4.8, Platform Diameter: RN (4.8 mm)
Implant Diameter (mm): 4.8, Platform Diameter: WN (6.5 mm)
Tapered Screw-Vent®
Implant Diameter (mm): 3.7 / 4.1, Platform Diameter: 3.5 mm
Implant Diameter (mm): 4.7, Platform Diameter: 4.5 mm
Implant Diameter (mm): 6.0, Platform Diameter: 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.
# Product codes (comma separated list FDA assigned to the subject device)
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 submission 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.
All 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".
IPD dental implant abutments and screws are compatible with the following commercially available dental implant systems listed in the Indications for Use.
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](https://510k.innolitics.com/search/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](https://510k.innolitics.com/search/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](https://510k.innolitics.com/search/K151455).
Zirconia Material: DD Bio Z, [K142987](https://510k.innolitics.com/search/K142987)
Milling machine: Brand: Dental Concept System Model: DC1 Milling System
Cement: Multilink® Automix, [K123397](https://510k.innolitics.com/search/K123397)
Ti Base (Interface) abutments design parameters for the zirconia superstructure are defined as follows:
Minimum wall thickness: 0.43 mm
Minimum post height for single-unit restorations: 4.75 mm
Maximum gingival height: 6.0 mm
Maximum angulation (Occlusal channel): 20°
All CAD/CAM superstructures are for straight abutments only.
The laboratory designed superstructure is attached to Ti Base (Interface) by the use of an FDA-cleared cement (i.e. Multilink® Automix, [K123397](https://510k.innolitics.com/search/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
Not Found
# Description of the training set, sample size, data source, and annotation protocol
Not Found
# Description of the test set, sample size, data source, and annotation protocol
Not Found
# Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The proposed devices have been subject to bench testing to determine fulfilment of design and performance requirements. Bench testing followed the recommendations provided in FDA Guidance Document – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments.
Non-clinical performance testing on the IPD dental abutments and screws 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 Skin sensitization and Irritation Testing according to ISO 10993-10 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 Implant Abutments.
Non-clinical performance testing showed that IPD abutments and screws 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
[K201860](https://510k.innolitics.com/search/K201860) Elos Accurate® Hybrid Base™
# Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
[K170588](https://510k.innolitics.com/search/K170588) DESS Dental Smart Solutions, [K153521](https://510k.innolitics.com/search/K153521) IH Implant System, [K173908](https://510k.innolitics.com/search/K173908) DESS Dental Smart Solutions
# Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there 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.
10/21/2022
Implant Protesis Dental 2004 S.L Francesc Fumanal Regulatory Affairs Manager Cami del Mig. 71. Mataro, Barcelona 08302 SPAIN
Re: K222215
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 19, 2022 Received: July 25, 2022
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 (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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.
for Andrew 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
2
Indications for Use
510(k) Number (if known) K222215
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.
| Implant System Compatibility | Implant Diameter (mm) | Platform Diameter |
|---|---|---|
| Brånemark | 3.5 | NP (3.5 mm) |
| 3.75 / 4.0 | RP (4.1 mm) | |
| 5.0 | WP (5.1 mm) | |
| Straumann® Tissue Level | 3.3 / 4.1 / 4.8 | RN (4.8 mm) |
| 4.8 | WN (6.5 mm) | |
| Tapered Screw-Vent® | 3.7 / 4.1 | 3.5 mm |
| 4.7 | 4.5 mm | |
| 6.0 | 5.7 mm |
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. The workflow system integrates multiple components of the digital dentistry workflow: scan files from intra-oral scanners, CAD software, ceramic material, milling machine and associated tooling and accessories.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) SUMMARY
I. SUBMITTER
IMPLANT PROTESIS DENTAL 2004, S.L
Camí del Mig, 71. 1º 2ª 08302 Mataró (Barcelona), Spain.
Contact Person:
Francesc Fumanal +34 93 672 110 748 ffumanal@ipd2004.com
Date prepared: October 21, 2022.
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: | K201860 Elos Accurate® Hybrid Base™ |
|---|---|
| Reference Devices: | K170588 DESS Dental Smart Solutions |
| K153521 IH Implant System | |
| K173908 DESS Dental Smart Solutions |
| Compatible Implant Systems | ||
|---|---|---|
| Clearance | Device | Manufacturer |
| K022562 | Brånemark | Nobel Biocare AB |
| K130222 | Straumann® Tissue Level | Institut Straumann AG |
| K112160 | Tapered Screw-Vent® | Zimmer Biomet Dental |
4
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 submission 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.
All 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".
IPD dental implant abutments and screws are compatible with the following commercially available dental implant systems:
5
Traditional 510(k) - K222215
| 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 |
| Brånemark | External | 3.5
3.75 / 4.0
5.0 | NP (3.5 mm)
RP (4.1 mm)
WP (5.1 mm) | AA | 3.5
4.1
5.1 | 3.5
4.1
5.1 | 3.5
4.1
5.1 |
| Straumann®
Tissue
Level | Internal | 3.3/4.1/4.8
4.8 | RN (4.8 mm)
WN (6.5 mm) | DA | 4.8 | 4.8
6.5 | 4.8
6.5 |
| Tapered
Screw-
Vent® | Internal | 3.7 / 4.1
4.7
6.0 | 3.5 mm
4.5 mm
5.7 mm | FA | 3.5
4.5 | 3.5
4.5
5.7 | 3.5
4.5
5.7 |
Table 5.1. Summary of IPD abutments categories with compatibilized OEM Implant Systems.
The abovementioned Compatible Implant Systems received FDA-clearance with the following 510(k) concurrence numbers: Brânemark K022562 (aka Various Brånemark System Dental Implant Products); Straumann® Tissue Level K130222 (aka ITI Synocta Meso Abutments), and Tapered Screw-Vent K113756 (aka Tapered Screw-Vent® X Implant).
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
6
Ti Base (Interface) abutments design parameters for the zirconia superstructure are defined as follows:
| Minimum wall thickness: | 0.43 mm |
|---|---|
| Minimum post height for single-unit restorations: | 4.75 mm |
| Maximum gingival height: | 6.0 mm |
| Maximum angulation (Occlusal channel) | 20° |
All CAD/CAM superstructures are for straight abutments only.
The laboratory designed superstructure is attached to Ti Base (Interface) by the use of an FDA-cleared cement (i.e. 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.
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.
| Implant System Compatibility | Implant Diameter (mm) | Platform Diameter |
|---|---|---|
| Brånemark | 3.5 | NP (3.5 mm) |
| Brånemark | 3.75 / 4.0 | RP (4.1 mm) |
| Brånemark | 5.0 | WP (5.1 mm) |
| Straumann® Tissue Level | 3.3 / 4.1 / 4.8 | RN (4.8 mm) |
| Straumann® Tissue Level | 4.8 | WN (6.5 mm) |
| Tapered Screw-Vent® | 3.7 / 4.1 | 3.5 mm |
| Tapered Screw-Vent® | 4.7 | 4.5 mm |
| Tapered Screw-Vent® | 6.0 | 5.7 mm |
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.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The subject device is substantially equivalent in indications and design principles to the primary and reference predicate devices. Comparative tables of indications for use and relevant technological characteristics have been provided in the following pages.
7
Table 5.2. Indications for Use Statements.
| Indications for Use Statements | |||
|---|---|---|---|
| Subject device | IPD Dental Implant Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single or multiple dental prosthetic restorations. | ||
| IPD Dental Implant Abutments (Implant Protesis Dental 2004 SL) | Compatible Implant Systems | ||
| Implant System Compatibility | Implant Diameter (mm) | ||
| Platform Diameter | |||
| Brånemark | 3.5 | ||
| 3.75 / 4.0 | |||
| 5.0 | |||
| NP (3.5 mm) | |||
| RP (4.1 mm) | |||
| WP (5.1 mm) | |||
| Straumann® Tissue Level | 3.3 / 4.1 / 4.8 | ||
| 4.8 | |||
| RN (4.8 mm) | |||
| WN (6.5 mm) | |||
| Tapered Screw-Vent® | 3.7 / 4.1 | ||
| 4.7 | |||
| 6.0 | |||
| 3.5 mm | |||
| 4.5 mm | |||
| 5.7 mm | |||
| The zirconia superstructures for use with the Ti Base (Interface) are only intended to be designed and manufactured according to digital dentistry workflow. The workflow system integrates multiple components of the digital dentistry workflow: scan files from intra-oral scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories. | |||
| Primary Predicate Device | |||
| K201860 | |||
| Elos Accurate® Hybrid Base™ | The Elos Accurate® Hybrid Base™ is intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Hyblid Base™ is used as an interface between a dental implant and a zirconia superstructure and will be attached to the implant using a prosthetic screw and attached to the zirconia superstructure by cementing. The Elos Accurate® Hybrid Base™ is compatible with the implant systems listed in table 1: | ||
| Table 1. | |||
| Implant Platform compatibility | Platform diameter [mm] | ||
| Implant Body diameter [mm] | |||
| Nobel Replace NP | 3.5 | ||
| 3.5 | |||
| Nobel Replace RP | 4.3 | ||
| 4.3 | |||
| Nobel Replace WP | 5 | 5 | |
| Nobel Replace 6.0 | 6 | 6 | |
| Nobel CC 3.0 | 3 | 3 | |
| Nobel CC NP | 3.5 | 3.5 & 3.75 | |
| Nobel CC RP | 3.9 | 4.3 & 5 | |
| Nobel CC WP | 5.1 | 5.5 | |
| Straumann Bone Level NC | 3.3 | 3.3 | |
| Straumann Bone Level RC | 4.1 & 4.8 | 4.1 & 4.8 | |
| Astra Tech 3.0 | 3 | 3 | |
| Astra Tech 3.5/4.0 | 3.5 & 4 | 3.5 & 4 | |
| Astra Tech 4.5/5.0 | 4.5 & 5 | 4.5 & 5 | |
| Astra Tech EV 3.0 | 3 | 3 | |
| Astra Tech EV 3.6 | 3.6 | 3.6 | |
| Astra Tech EV 4.2 | 4.2 | 3.6 & 4.2 | |
| Astra Tech EV 4.8 | 4.8 | 4.2 & 4.8 | |
| Astra Tech EV 5.4 | 5.4 | 5.4 | |
| Brånemark NP | 3.5 | 3.3 | |
| Brånemark RP | 4.1 | 3.75, 4 & 5 | |
| Brånemark WP | 5.1 | 5 & 6 | |
| The zirconia superstructures for use with the Elos Accurate® Hybrid Base™ 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 Devices | |||
| K170588 | |||
| DESS Dental Smart Solutions (Terrats Medical) | 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. | ||
| 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 Systems | |||
| Compatible Implant System | Implant Body Diameter (mm) | Implant Platform Diameter (mm) | |
| 3i Certain® | 3.25, 4.0, 5.0 | 3.4, 4.1, 5.0 | |
| 3i OSSEOTITE® | 3.25, 3.75, 4.0, 5.0 | 3.4, 4.1, 5.0 | |
| OsseoSpeed™ | 3.5, 4.0, 5.0 | 3.5/4.0, 4.5/5.0 | |
| FRIADENT XIVE | 3.4, 3.8, 4.5 | 3.4, 3.8, 4.5 | |
| NobelActive® | 3.5, 4.3, 5.0 | NP, RP | |
| NobelReplace Conical | 3.5, 4.3, 5.0 | NP, RP | |
| Nobel Replace Trilobe | 3.5, 4.3, 5.0 | NP, RP, WP | |
| Brånemark | 3.5, 3.75/4.0, 5.0 | NP, RP, WP | |
| Straumann® Bone Level | 3.3, 4.1, 4.8 | NC, RC | |
| Straumann® Tissue Level | 3.3, 4.1, 4.8 | RN, WN | |
| Tapered Screw-Vent® | 3.7, 4.1, 4.7, 6.0 | 3.5, 4.5, 5.7 | |
| K153521 | |||
| IH Implant System | |||
| (Sewonmedix) | IH Implant System is device made of titanium and titanium alloy indicated for in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained or screw retained restorations and terminal or interminal abutment support for fixed bridgework. IH Implant System is for single and two stage surgical procedures. It is intended for delayed loading. | ||
| K173908 | |||
| DESS Dental Smart Solutions | |||
| (Terrats Medical) | DESS Dental Smart Solutions are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations. |
All digitally designed custom abutments for use with Aurum™ Abutment or Pre-milled Blank are to be sent to a Terrats Medical validated milling center for manufacture. | | |
| | Compatible Implant Systems | | |
| | Implant System Compatibility | Implant Body | Implant Platform |
| | 3i Certain® | 3.25, 4.0, 5.0 | 3.4, 4.1, 5.0 |
| | 3i OSSEOTITE® | 3.25, 3.75, 4.0, 5.0 | 3.4, 4.1, 5.0 |
| | OsseoSpeed™ | 3.5, 4.0, 5.0 | 3.5/4.0, 4.5/5.0 |
| | FRIADENT XIVE | 3.4, 3.8, 4.5 | 3.4, 3.8, 4.5 |
| | NobelActive® | 3.5, 4.3, 5.0 | NP, RP |
| | NobelReplace® Conical | 3.5, 4.3, 5.0 | NP, RP |
| | NobelReplace® Trilobe | 3.5, 4.3, 5.0 | NP, RP, WP |
| | Branemark | 3.5, 3.75/4.0, 5.0 | NP, RP, WP |
| | Straumann® Bone Level | 3.3, 4.1, 4.8 | NC, RC |
| | Straumann® Tissue Level | 3.3, 4.1, 4.8 | RN, WN |
| | Tapered Screw-Vent® | 3.7, 4.1, 4.7, 6.0 | 3.5, 4.5, 5.7 |
8
9
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Discussion on Indications for Use:
Although there has been some change in the wording the indications for use statement in comparison with predicate devices to adapt to subject device, it is considered that there has been no change in the intended use or indications for use of the IPD Dental Implants. The devices are specifically indicated for patients undergoing oral implant surgery to dental prosthetic restorations.
When comparing the indications for use subject device and primary predicate device (K201860) together with reference predicate (K170588), it is observed that all are dental abutment systems that are intended for use with implants in the maxilla and mandible to provide functional and esthetic support for detic restorations (single or multiple) as relabilitation of edentulous maxilla and mandbles.
Primary predicate K201860 refers to a specific type of abutinent (Hybrid Base) to be used as an interface between the dental implant and a cemented zirconia superstructure, wheres subject device to PD specific abutment. It is interesting to observe that reference predicates (K170588 and K 153521) refer to other types of dental abutments, as IPD do, in that sense, differences may be found on the digital dentisty workflow selected for the reference predicate (K170588 or K173908) by the use of validated milling centers versus the definition of the digital work10w system. Information on the software tools to be user to digitally design custom abutments within appropriate limits and to produce them (either at the point of care or at a dental laboratory selected by the user) has been included in this submission.
In regard to reference predicate K153521, due to the combination of dental implants and abutments, the intended use is mainly focused on dental implant indications for use, although dental abutments indications are also referenced.
For the subject device, the design and fabrication of the superstructure is conducted using a digital dentistry workflow 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 substantiated by software validation and mechanical fatigue testing provided in this submission.
11
Likewise, differences may be found in the list of compatibility of the subject abutments with the specific OEM implants listed for the subject device is based on engineering analysis, as well as mechanical fatigue testing, as previously referenced.
Nevertheless, no differences further than device categories included in each of the selected primary or reference predicates, the approach followed for finalizing the zirconia superstructures or claimed CEM implant systems compatibility, have been observed. 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.
Tables 5.3. Subject and Predicate device technological characteristics comparison.
| Subject Device | Primary Predicate | Reference Device | Reference Device | Reference Device | |
|---|---|---|---|---|---|
| Characteristics | IPD Dental Implant | ||||
| Abutments | Device | ||||
| Elos Accurate® Hybrid | |||||
| Base™ (Elos Medtech | |||||
| Pinol) K201860 | DESS Dental Smart | ||||
| Solutions (Terrats) | |||||
| K170588 | IH Implant System | ||||
| (Sewon medix) K153521 | DESS Dental Smart | ||||
| Solutions (Terrats) | |||||
| K173908 | |||||
| Materials | |||||
| Abutment | |||||
| Materials | Titanium Alloy Grade 5 | ||||
| (per ISO 5832-3) + TiN | |||||
| or Anodized | Ti-6Al-4V alloy | ||||
| (Anodized, non- | |||||
| anodized) | Ti-6Al-4V + ZrN | Titanium Alloy | |||
| (ASTM F 136) / Pure | |||||
| Titanium Gr. 4 | |||||
| (ASTMF67-06) + TiN | Titanium Alloy | ||||
| CoCr, | |||||
| Zirconia | |||||
| Screw Materials | Titanium Alloy Grade 5 | ||||
| (per ISO 5832-3) + TiN | Ti-6Al-4V alloy | ||||
| (ASTM F136) | |||||
| (Medicarb/DLC coating) | Ti-6Al-4V alloy |
- DLC | Not available in the
510(k) summary. | Titanium Alloy |
| Superstructure | DD Bio Z Zirconia
(K142987) | 3M Lava Plus Zirconia
(K011394) | Not available in the
510(k) summary. | Not included. | Not available in the
510(k) summary. |
| General Design features | | | | | |
| Overview of
abutment designs | Healing,
Temporary,
Cementing Titanium,
Titanium interface | Hybrid Base
(2 piece - zirconia
bonded to hybrid base
mounted on to the
implant and fixed with a
screw) | Healing,
Temporary,
Straight,
Ti bases,
Pre-milled Blank,
DESSLOC (Locator-
type), | Healing,
Temporary,
Cement,
Solid,
Angled,
Multi-unit,
FreeMilling | CAD/CAM Blank
CAD/CAM TiBase
Castable Abutment
Aurum Abutment |
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IPD Dental Implant Abutments
Traditional 510(k) — K222215
| Multi-Unit | |||||||
|---|---|---|---|---|---|---|---|
| Prosthesis | |||||||
| Attachment | Cement-retained | ||||||
| Screw-retained | Cement-retained | ||||||
| Screw-retained | Cement-retained | ||||||
| Screw-retained | Cement-retained | ||||||
| Screw-retained | Cement-retained | ||||||
| Screw-retained | |||||||
| Restoration Type | Single-unit (crowns) | ||||||
| Multiple-unit (bridges) | Single-unit | ||||||
| Multi-unit | Single-unit | ||||||
| Multi-unit | Single-unit | ||||||
| Multi-unit | Single-unit | ||||||
| Multi-unit | |||||||
| Abutment / | |||||||
| Implant Platform | |||||||
| Diameter (mm) | 3.5 – 6.5 | 3.0 – 6.0 | 3.5 - 6.5 | 4.0 – 7.0 | 3.4 – 6.5 | ||
| Abutment Angle | Abutment: Straight (0°) | ||||||
| Superstructure: | |||||||
| Maximum Angulation | |||||||
| 20° | Maximum: 20° | Straight | Angled: 15°/25° | ||||
| Multi-unit Angled: | |||||||
| 17°/30° | Straight (0°) | ||||||
| General Abutment | |||||||
| / Implant | |||||||
| Connection | Internal and External | Internal and External | Internal and External | 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 | IH Prosthetic System: | ||||||
| Non-sterile. | |||||||
| End user steam | |||||||
| sterilization | Non-sterile. | ||||||
| End user steam | |||||||
| sterilization |
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| Healing Abutments | ||||
|---|---|---|---|---|
| Characteristics | IPD (Subject device) | DESS Dental Smart Solutions (K170588) | ||
| Min – Max diameter | 3.5 - 5.1 | 3.5 - 6.5 | ||
| Angle | Straight (0°) | Straight (0°) | ||
| Intended restoration type | Single-unit | Single-unit | ||
| Method of fixation | Screw-retained | Screw-retained |
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| Cementing and Temporary Abutments | ||||
|---|---|---|---|---|
| Characteristics | IPD | |||
| Subject device | DESS Dental Smart Solutions | |||
| (K170588) | IH Implant System (K153521) | |||
| Min – Max diameter | 3.5 – 6.5 | 3.5 – 6.5 | Cement: 4.5 - 6.5 | |
| Temporary: 4.0 - 4.5 | ||||
| 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 | Uncoated | Temporary: Uncoated. | ||
| Cement: TiN |
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| Ti interface Abutment | ||||
|---|---|---|---|---|
| Characteristics | IPD | |||
| Subject device | Elos Accurate Hybrid Base | |||
| (K201860) | DESS Dental Smart | |||
| Solutions (K170588) | IH Implant System | |||
| (K153521) | ||||
| Min – Max diameter | 3.5 – 6.5 | 3.5 - 5.1 | 3.5 – 6.5 | Solid: 4.0 - 7.0 |
| Angle | Straight (0°) | Max. 20° | Straight | Straight |
| Intended restoration type | Single-unit | |||
| Multi-unit | 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 | Cement-retained | |||
| Screw-retained | ||||
| Surface coating | TiN | Anodized | Uncoated | TiN |
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| Superstructure Design 1 | |||
|---|---|---|---|
| Characteristics | IPD | ||
| Subject device | Elos Accurate Hybrid Base (K201860) | DESS Dental Smart Solutions | |
| (K173908) | |||
| 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 zirconia superstructures for use with | ||
| the Elos Accurate® Hybrid Base™ 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 Aurum™ Abutment or Pre-milled | |||
| Blank 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 | |||
| Maximum Gingival Height: 6 mm | |||
| Maximum Angulation: 20° | Gingival height: Not stated. | ||
| Minimal Wall Thickness: 0.5 mm | |||
| Minimum Post Height: 4.0 mm (for single | |||
| unit restorations) | |||
| Maximum Gingival Height: 5.0 mm | |||
| Maximum Angulation: 20° | Gingival height: Not stated | ||
| Minimal Wall Thickness: 0.4 mm | |||
| Minimum Post Height: 4.0 mm | |||
| Maximum Gingival Height: 6.0 mm | |||
| Angulation: 0° (for straight abutments only) |
1 Please note that K153521 has not been included in the comparison as no reference to CAD/CAM technology is included in the 510(k) Summary.
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The data included in this submission demonstrate substantial equivalence to the primary and/or reference predicate devices listed above. 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 basic design and device categories;
- Incorporates the same or similar 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.
Reference devices K170588 and K173908 refer to custom abutments intended to be used in a digital dentistry workflow but to be sent to a validated milling center for design and manufacture. Despite this, they are similar in design, device categories, materials and technological characteristics to those proposed of the subject device and just some differences in terms of surface coatings solutions applied are found, which may be covered by the secondary reference device K153521, like TiN coating. Hence, Reference devices K173908 and K153521 account for the differences in device categories and surface coatings compared to Primary Predicate K201860 to support substantial equivalence.
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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 abutments and screws 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 Skin sensitization and Irritation Testing according to ISO 10993-10 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 Implant Abutments.
Non-clinical performance testing showed that IPD abutments and screws 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 the same intended use and have similar technological characteristics. The subject device and the predicate and reference devices encompass the same range of device categories, diameters, and similar designs. The subject and predicate and reference devices are produced using similar materials and surface coatings, as well as fabrication processes, and are to be sterilized by the user using similar 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 device.