Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the physical components and materials of dental implant abutments and screws, with no mention of AI or ML capabilities. The performance studies are bench tests related to material properties and mechanical performance.

Therapeutic

No
The device is an abutment system for dental implants, providing support for prosthetic restorations, not directly treating a disease or condition.

Diagnostic

No

The device is a dental implant abutment system, which is a physical component used in dental restorations, not a tool for diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "dental implant abutment system composed of dental abutments and screws" made of titanium alloy. This indicates a physical hardware device, not software only. While it mentions validation of a "digital workflow and software system," the core device is hardware.

IVD (In Vitro Diagnostic)

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 mouth, which is a direct clinical application within the body.
Device Description: The device is a physical implant abutment system made of titanium alloy, designed to be placed into dental implants.
Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a disease or condition, or to collect and analyze samples from the body for diagnostic purposes.
Performance Studies: The performance studies focus on the mechanical and biological compatibility of the device itself (sterilization, cytotoxicity, fatigue testing), not on its ability to perform a diagnostic test.

IVD devices are typically used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening. This device is a medical device used for treatment and restoration within the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

IPD Dental Implant Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single or multiple dental prosthetic restorations.

Compatible Implant Systems

The zirconia superstructures for use with the Ti Base (Interface) are only intended to be designed and manufactured according to digital dentistry workflow. 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

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".

The purpose of this submission is to expand IPD Dental Implant Abutments cleared under K222215 to:

. Include new OEM dental implant platform compatibilities (previously not cleared) for previously cleared IPD's abutment designs,
. include previously-cleared OEM platform compatibilities for previously-cleared IPD's abutment designs for which the specific combinations of compatibility and design were not cleared previously, and,
Add angulation to previously Ti Base (Interface) abutments (design parameters for the ● zirconia superstructure).

IPD dental implant abutments and screws are compatible with the following commercially available dental implant systems:
Nobel Active®, Straumann® Bone Level, Neodent Implant System – GM Line, Tapered Screw-Vent®

Ti Base (Interface) abutments are used as an interface between the dental implant and the zirconia superstructure. They are attached (screw-retained) to the implant and cemented to the zirconia superstructure.

The Ti Base (Interface) is a two-piece abutment composed of the Ti Base (Interface) as the bottomhalf and the zirconia superstructure as the top-half. It consists of a pre-manufactured prosthetic component in Titanium alloy per ISO 5832-3, as well as the supporting digital library file for FDAcleared design software (e.g., 3Shape Abutment Designer™ Software cleared under K151455) which enables the design of a patient-specific superstructure by the laboratory/clinician and which will be manufactured in FDA-cleared Zirconia (e.g., DD Bio Z, K142987) according to digital dentistry workflow at the point of care or at a dental laboratory.

The design and fabrication of the zirconia superstructure for Ti Bases (Interfaces) will be conducted using a digital dentistry workflow requiring the use of the following equipment:
Scanner: 3D Scanner D850 Design Software: 3Shape Abutment Designer Software, K151455. Zirconia Material: DD Bio Z, K142987 Milling machine: Brand: Dental Concept System Model: DC1 Milling System Cement: Multilink® Automix, K123397

Ti Base (Interface) abutments design parameters for the zirconia superstructure are defined as follows:
Minimum wall thickness: 0.43 mm
Minimum post height for single-unit restorations: 4.75 mm
Maximum gingival height: 6.0 mm
Minimum gingival height: 1.5 mm
Maximum angulation of the final abutment: 30°

The laboratory designed superstructure is attached to Ti Base (Interface) by the use of an FDA-cleared cement (e.g., Multilink® Automix, K123397). The resulting final prosthetic restoration is screwed to the dental implant. All subject abutments are single-use and provided non-sterile. Final restoration (which includes the corresponding screw) is intended to be sterilized at the dental clinic before it is placed in the patient.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

scan files from intra-oral scanners

Anatomical Site

maxillary or mandibular arch

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Dental clinic, dental laboratory

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The proposed devices have been subject to bench testing to determine fulfilment of design and performance requirements. Bench testing followed the recommendations provided in FDA Guidance Document - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments.

Specifically, non-clinical performance testing on the IPD Dental Implant Abutments include:

Sterilization validation to achieve a SAL of 1 x 10e6 according to ISO 17665-1 to ensure sterilization of the final finished device.
Cytotoxicity testing according to ISO 10993-5 to demonstrate that all patient-contacting surfaces are non-cytotoxic. In addition to 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 Implants and Endosseous Dental Implant Abutments.
Non-clinical worst-case MRI review was performed to evaluate IPD Dental Implant Abutments in the MRI environment using scientific rationale and published literature (i.e., Woods, Terry O., Jana G. Delfino, and Sunder Rajan. "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795), for the entire system (including all variations of compatible implant bodies, dental abutments, and fixation screws) and material composition. The rationale addressed parameters per the FDA Guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment', including magnetically induced displacement force and torque.

Non-clinical performance testing leveraged from K222215, previously cleared, showed that IPD Dental Implant Abutments met the applicable specifications and requirements.

No clinical testing was performed, the determination of substantial equivalence is supported by nonclinical testing.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K222215, IPD Dental Implant Abutments

Reference Device(s)

K222288, DESS Dental Smart Solutions

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.)

Summary

0

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.

Implant Protesis Dental 2004, S.L. Francesc Fumanal Regulatory Affairs Manager Cami del Mig. 71. 1º 2º Mataro, Barcelona 08302 SPAIN

Re: K231413

Trade/Device Name: IPD Dental Implant Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous dental implant abutment Regulatory Class: Class II Product Code: NHA, PNP Dated: September 6, 2023 Received: September 6, 2023

Dear Francesc Fumanal:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

1

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

2

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Andrew I. Steen -S

Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

3

Indications for Use

510(k) Number (if known)

K231413

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
NobelActive®	3.0	3.0 mm
NobelActive®	3.5	NP (3.5 mm)
NobelActive®	4.3/5.0	RP (4.3 mm)
Straumann® Bone Level	3.3	NC (3.3 mm)
Straumann® Bone Level	4.1/4.8	RC (4.1 mm)
Neodent Implant System – GM Line	3.5 - 7.0	GM (Grand Morse)
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. 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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4

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 93 672 110 748 ffumanal@ipd2004.com

Date prepared: October 10th, 2023.

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:	K222215, IPD Dental Implant Abutments
Reference Device:	K222288, DESS Dental Smart Solutions

Clearance	Device	Manufacturer
K142260	Nobel Active®	Nobel Biocare AB
K140878	Straumann® Bone Level	Institut Straumann AG
K163194	Neodent Implant System – GM Line	JJGC Indústria e Comércio de
Materiais Dentários SA
K112160	Tapered Screw-Vent®	Zimmer Biomet Dental

5

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".

The purpose of this submission is to expand IPD Dental Implant Abutments cleared under K222215 to:

. Include new OEM dental implant platform compatibilities (previously not cleared) for previously cleared IPD's abutment designs,
. include previously-cleared OEM platform compatibilities for previously-cleared IPD's abutment designs for which the specific combinations of compatibility and design were not cleared previously, and,
Add angulation to previously Ti Base (Interface) abutments (design parameters for the ● zirconia superstructure).

IPD dental implant abutments and screws are compatible with the following commercially available dental implant systems:

6

| Compatible
Implant
System | Type of
connection | Implant
Diameter
(mm) | Platform
Diameter | Device
category | Healing
Abutment | Cementing
/
Temporary
Abutments | Ti Base
(Interface)
Abutment |
|-------------------------------------------|-----------------------|-----------------------------|--------------------------------------|----------------------------|----------------------------------|------------------------------------------|----------------------------------------------|
| | | | | Material | | Titanium
alloy, ISO 5832-3 | Titanium
alloy, ISO 5832-3,
TiN coated |
| | | | | IPD
Abutment
Systems | Titanium
alloy, ISO
5832-3 | 3,
Temp.
Anodized | |
| Nobel
Active® | Internal | 3.0
3.5
4.3/5.0 | 3.0 mm
NP (3.5 mm)
RP (4.3 mm) | AD | 3.0
3.5
4.3 | 3.0
3.5
4.3 | 3.0
3.5
4.3 |
| Straumann®
Bone Level | Internal | 3.3
4.1/4.8 | NC (3.3 mm)
RC (4.1 mm) | DB | 3.3
4.1 | 3.3
4.1 | 3.3
4.1 |
| Neodent
Implant
System – GM
Line | Internal | 3.5 – 7.0 | GM
(Grand
Morse) | RB | GM | GM | GM |
| Tapered
Screw-Vent® | Internal | 3.7 / 4.1
4.7
6.0 | 3.5 mm
4.5 mm
5.7 mm | FA | *
*
5.7 | *

```
                              | *
```
```
                                  |
```

Table 5.1. Summary of IPD abutments categories with compatibilized OEM Implant Systems.

(*) Previously cleared under K222215.

The abovementioned Compatible Implant Systems received FDA-clearance with the following 510(k) concurrence numbers: Nobel Active® K142260; Straumann® Bone Level Tapered Implants K140878, Neodent Implant System - GM Line K163194, 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.

7

The design and fabrication of the zirconia superstructure for Ti Bases (Interfaces) will be conducted using a digital dentistry workflow requiring the use of the following equipment:

Scanner: 3D Scanner D850 Design Software: 3Shape Abutment Designer Software, K151455. Zirconia Material: DD Bio Z, K142987 Milling machine: Brand: Dental Concept System Model: DC1 Milling System Cement: Multilink® Automix, K123397

Ti Base (Interface) abutments design parameters for the zirconia superstructure are defined as follows:

Minimum wall thickness:	0.43 mm
Minimum post height for single-unit restorations:	4.75 mm
Maximum gingival height:	6.0 mm
Minimum gingival height:	1.5 mm
Maximum angulation of the final abutment1	30°

The laboratory designed superstructure is attached to Ti Base (Interface) by the use of an FDA-cleared cement (e.g., Multilink® Automix, K123397). The resulting final prosthetic restoration is screwed to the dental implant. All subject abutments are single-use and provided non-sterile. Final restoration (which includes the corresponding screw) is intended to be sterilized at the dental clinic before it is placed in the patient.

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
NobelActive®	3.0	3.0 mm
NobelActive®	3.5	NP (3.5 mm)
	4.3/5.0	RP (4.3 mm)
Straumann® Bone Level	3.3	NC (3.3 mm)
Straumann® Bone Level	4.1/4.8	RC (4.1 mm)
	Neodent Implant System – GM Line	3.5 – 7.0
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 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.

1 With the exception of Nobel Active® 3.0 and 3.5 mm-platforms which final abutment is straight (0°).

8

TECHNOLOGICAL CHARACTERISTICS WITH THE VI. COMPARISON OF 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 in the following pages.

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
	NobelActive®	3.0
3.5
4.3/5.0	3.0 mm
NP (3.5 mm)
RP (4.3 mm)
	Straumann® Bone Level	3.3
4.1/4.8	NC (3.3 mm)
RC (4.1 mm)
	Neodent Implant System – GM Line	3.5 – 7.0	GM (Grand Morse)
	Tapered Screw-Vent®	3.7 / 4.1
4.7
6.0	3.5 mm
4.5 mm
5.7 mm
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
K222215
IPD Dental
Implant
Abutments
(Implant
Protesis Dental
2004, SL)	IPD Dental Implant Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single or multiple dental prosthetic restorations.
	Compatible Implant Systems
	Implant System Compatibility	Implant Diameter (mm)	Platform Diameter
	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
Reference Device
K222288
DESS Dental Smart Solutions
(Terrats Medical, SL)
Compatible Implant System	Implant Body Diameter, mm	Implant Platform Name
Ankylos C/X	3.5, 4.5, 5.5	2.52
	3.0	3.0
Astra Tech EV	3.6	3.6
	4.2	4.2
	4.8	4.8
	5.4	5.4
Astra Tech OsseoSpeed™	3.0	3.0
	3.5/4.0	3.5/4.0
	4.5/5.0	4.5/5.0
BioHorizons	3.0, 3.4, 3.8	3.0
	3.8, 4.6	3.5
	4.6, 5.8	4.5
	5.8	5.7
Biomet 3i Certain®	3.25	3.4
	4.0	4.1
	5.0	5.0
Biomet 3i OSSEOTITE®	3.25	3.4
	3.75, 4.0	4.1
	5.0	5.0
Camlog	3.8	3.8
	4.3	4.3
	5.0	5.0
Dentium SuperLine	3.6, 4.0, 4.5, 5.0, 6.0, 7.0	3.3
FRIADENT XiVE®	3.4	3.4
	3.8	3.8
	4.5	4.5
	5.5	5.5
MegaGen AnyRidge	3.5, 4.0, 4.5, 5.0, 5.5	3.5
Neodent Grand Morse	3.5, 3.75, 4.0, 4.3, 5.0, 6.0, 7.0	Grand Morse (GM)
NobelActive®, NobelParallel Conical	3.0	3.0
	3.5	NP
	4.3, 5.0	RP
NobelReplace® Trilobe	3.5	NP
	4.3	RP

		6.0	6.0
	Nobel Brånemark System®	3.3	NP
		3.75, 4.0	RP
		5.0	WP
	Osstem TS	3.5	Mini
		4.0, 4.5, 5.0, 6.0, 7.0	Regular
	Straumann BLX	3.5, 3.75, 4.0, 4.5	RB
		5.0, 5.5, 6.5	WB
	Straumann® Bone Level	3.3	NC
		4.1/4.8	RC
	Straumann® Tissue Level	3.3	NNC, RN
		4.1	RN
		4.8	RN, WN
	Zimmer Eztetic	3.1	2.9
	Zimmer Screw Vent®/
Tapered Screw- Vent®	3.3, 3.7, 4.1	3.5
		4.7	4.5
		6.0	5.7
	Zimmer Spline	3.25	3.25
		3.75, 4.0	3.75/4.0
		5.0	5.0
	Zimmer SwissPlus	3.7	3.8
		4.8	4.8

9

10

IPD Dental Implant Abutments

Traditional 510(k)

Discussion on Indications for Use:

The indications for use of subject device in comparison with primary predicate device are verbatim, with the exception of the new implant systems which IPD is claiming compatibility for this submission. Further than this, no change in the intended use or indications for use of the IPD Dental Implant Abutments has been carried out. The devices are specifically indicated for patients undergoing oral implant surgery to provide support for dental prosthetic restorations.

Similarly, for the subject device and primary predicate device, the design and fabrication of the superstructure is conducted using the same digital dentistry workflow, requiring the use of the following equipment:

Scanner:	3Shape scanner
Design Software:	3Shape Abutment Designer Software (K151455)
Zirconia Material:	DD Bio Z (K142987)
Milling machine:	Dental Concept System DC1 Milling System
Cement:	Multilink® Automix (K123397)

and using the supporting IPD digital library file for K151455.

The adequacy of the digital dentistry workflow for the subject device is substantiated by software validation and mechanical fatigue testing provided in this submission.

As previously referred, differences may be found in the list of compatible implant systems for subject and predicate devices. Compatibility of the subject abutments with the specific OEM implants is based on engineering and dimensional analysis, as well as mechanical fatigue testing. In that sense, reference device, K222288, has been selected for the range of compatibility implant systems which encompasses and which IPD is citing compatibility by this submission.

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Despite this, no differences are found in the device categories included for subject and predicate devices, and same approach is followed for finalizing the zirconia superstructures. Similarly, and thanks to the fatigue testing carried out and provided in this submission, the maximum angulation of the final abutment has been expanded. 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.

| Characteristics | Subject Device
IPD Dental Implant
Abutments | Primary Predicate
Device
IPD Dental Implant
Abutments
(IMPLANT PROTESIS
DENTAL 2004, S.L.)
K222215 | Reference Device
DESS Dental Smart
Solutions
(Terrats Medical, SL)
K222288 |
|----------------------------------------------|-------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Materials | | | |
| Abutment Materials | Titanium Alloy Grade 5
(ISO 5832-3) + TiN or
Anodized | Titanium Alloy Grade 5
(ISO 5832-3) + TiN or
Anodized | Ti-6Al-4V ELI |
| Screw Materials | Titanium Alloy Grade 5
(ISO 5832-3) + TiN | Titanium Alloy Grade 5
(ISO 5832-3) + TiN | Ti-6Al-4V ELI
DLC Coating |
| Superstructure | DD Bio Z Zirconia
(K142987) | DD Bio Z Zirconia
(K142987) | Zirconia conforming
ISO 13356 |
| General Design features | | | |
| Overview of abutment
designs | Healing,
Temporary,
Cementing Titanium,
Titanium interface | Healing,
Temporary,
Cementing Titanium,
Titanium interface | Healing, Temporary
Abutment, Ti Base, C-
base, CrCo Base,
Premilled Blank, Multi
Unit Abutment, Multi
Unit ZRN Abutment,
DESSLoc |
| Prosthesis Attachment | Cement-retained
Screw-retained | Cement-retained
Screw-retained | Cement-retained
Screw-retained |
| Restoration Type | Single-unit (crowns)
Multiple-unit (bridges) | Single-unit (crowns)
Multiple-unit (bridges) | Single-unit,
Multi-unit |
| Abutment / Implant
Platform Diameter (mm) | 3.0 - 5.7 | 3.5 - 6.5 | 2.52 - 6.5 |
| Abutment Angle | Abutment: Straight (0°)
Superstructure:
Maximum Angulation
30° | Abutment: Straight (0°)
Superstructure:
Maximum Angulation
20° | 0°, 17°, 30° |
| General Abutment /
Implant Connection | Internal | Internal and External | Internal and External |
| Sterilization | | | |
| Sterilization status and
type | Non-sterile.
End user steam
sterilization | Non-sterile.
End user steam
sterilization | Non-sterile.
End user steam
sterilization |

Tables 5.3. Subject and Predicate devices technological characteristics comparison.

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Healing Abutments
Characteristics	IPD (Subject device)	IPD Dental Implant
Abutments
(K222215)	DESS Dental Smart
Solutions
(K222288)
Min – Max diameter	3.0 - 5.7	3.5 - 5.1	2.52 - 5.7
Angle	Straight (0°)	Straight (0°)	Straight (0°)
Intended restoration
type	Single-unit	Single-unit	Single-unit
Method of fixation	Screw-retained	Screw-retained	Screw-retained
Surface coating	Uncoated	Uncoated	Uncoated

Cementing and Temporary Abutments
Characteristics	IPD
Subject device	IPD Dental Implant
Abutments
(K222215)	DESS Dental Smart
Solutions
(K222288)
Min – Max diameter	3.0 - 4.3	3.5 - 6.5	2.52 - 5.7
Angle	Straight (0°)	Straight (0°)	Straight (0°)
Intended restoration
type	Single-unit / Multi-unit	Single-unit / Multi-unit	Single-unit / Multi-unit
Method of fixation	Cement-retained /
Screw-retained	Cement-retained /
Screw-retained	Cement-retained /
Screw-retained
Surface coating	Cementing: Uncoated
Temporary: Anodized	Cementing: Uncoated
Temporary: Anodized	Uncoated

Ti Base (Interface) Abutment
Characteristics	IPD
Subject device	IPD Dental Implant
Abutments
(K222215)	DESS Dental Smart
Solutions
(K222288)
Min – Max diameter	3.0 - 4.3	3.5 - 6.5	2.52 – 5.7
Intended restoration
type	Single-unit / Multi-unit	Single-unit / Multi-unit	Single-unit / Multi-unit
Method of fixation	Cement-retained
Screw-retained	Cement-retained
Screw-retained	Cement-retained
Screw-retained
Surface coating	TiN	TiN	Anodized

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Superstructure Design
Characteristics	IPD
Subject device	IPD Dental Implant Abutments
(K222215)	DESS Dental Smart Solutions
(K222288)
Superstructure Design
Workflow	The superstructures for use with the IPD Ti-Base (Interface) abutments are only intended to be designed and manufactured according to digital dentistry workflow. The workflow system integrates multiple components of the digital dentistry workflow: scan files from intra-oral scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories.	The superstructures for use with the IPD Ti-Base (Interface) abutments are only intended to be designed and manufactured according to digital dentistry workflow. The workflow system integrates multiple components of the digital dentistry workflow: scan files from intra-oral scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories.	All digitally designed custom abutments for use with Ti Base abutments or Pre-milled Blank abutments are to be sent to a Terrats Medical validated milling center for manufacture.
	Zirconia CAD/CAM
Design Parameters –
Ti (Base) Interface
Abutment characteristics	Minimum Gingival height: 1.5 mm
Minimum Wall Thickness: 0.43 mm
Minimum Post Height: 4.75 mm
Maximum Gingival Height: 6 mm
Maximum Angulation: 30° (1)	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°

Note 1: With the exception of Nobel Active® 3.0 and 3.5 mm-platforms which final abutment is straight (0).

Note 2: Design parameters for Ti Base Interface with Biomet 3i Certain, NobelReplace Trilobe, and Zimner Screw-Vent (except for 3.3 mm implants).

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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 the same intended use;
Uses the same operating principle;
Incorporates similar design and same device categories;
Incorporates the same materials and surface coatings;
It is sterilized using the same processes.

Ti Base (Interface) and primary predicate device are both intended to be used in a digital dentistry workflow which includes the scanning of patient's teeth setup, the design of the zirconia superstructure, the manufacturing of the superstructure, and the later cementation.

The adequacy of the digital dentistry workflow for the subject device is substantiated by software validation and mechanical fatigue testing provided in this submission.

Device categories, materials and technological characteristics of the subject device are almost identical with previously cleared IPD Dental Implant Abutments (predicate device). Subject and predicate devices are very similar in design, with differences on the expanded compatibilized OEM dental implant systems for IPD Dental Implant Abutments and the increased maximum angulation of the final abutment (design parameters for the zirconia superstructure) thanks to the verifications performed by fatigue testing included in this submission.

VII. PERFORMANCE DATA

The proposed devices have been subject to bench testing to determine fulfilment of design and performance requirements. Bench testing followed the recommendations provided in FDA Guidance Document - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments.

Specifically, non-clinical performance testing on the IPD Dental Implant Abutments include:

Sterilization validation to achieve a SAL of 1 x 106 according to ISO 17665-1 to ensure . sterilization of the final finished device.
. Cytotoxicity testing according to ISO 10993-5 to demonstrate that all patient-contacting surfaces are non-cytotoxic. In addition to 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 Implants and Endosseous Dental Implant Abutments.
Non-clinical worst-case MRI review was performed to evaluate IPD Dental Implant

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Abutments in the MRI environment using scientific rationale and published literature (i.e., Woods, Terry O., Jana G. Delfino, and Sunder Rajan. "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795), for the entire system (including all variations of compatible implant bodies, dental abutments, and fixation screws) and material composition. The rationale addressed parameters per the FDA Guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment', including magnetically induced displacement force and torque.

Non-clinical performance testing leveraged from K222215, previously cleared, showed that IPD Dental Implant Abutments met the applicable specifications and requirements.

No clinical testing was performed, the determination of substantial equivalence is supported by nonclinical testing.

VIII. CONCLUSIONS

The subject device and the primary predicate device have identical intended use and materials and similar technological characteristics. The subject device and reference devices encompass the same range of device categories, similar (OEM implant dependent) diameters, and almost identical designs. The subject and predicate device are produced using identical materials and surface coatings, as well as fabrication processes, and are to be sterilized by the user using identical methods.

Based on the similarities observed and the results of non-clinical testing performed, we conclude that the data included in the submission demonstrate that the subject device, IPD Dental Implant Abutments, is substantially equivalent to the predicate devices.