(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 and screws intended to be placed into dental implants to provide support for dental prosthetic restorations. Abutments provide basis for single or multiple tooth prosthetic restorations. They are available in a variety of connection types to enable compatibility with commercially available dental implants systems. IPD Dental Implant Abutments includes the following categories of dental abutment designs: Healing abutments; Temporary abutments; Cementing titanium abutments; Titanium base (interface) abutments; The system also includes the corresponding Titanium Screws intended to attach the prosthesis to the dental implant.
This is a Premarket Notification (510(k)) summary for the IPD Dental Implant Abutments. This document does not describe a study proving the device meets acceptance criteria as would be found in a clinical trial for a novel AI device with specific performance metrics. Instead, it demonstrates substantial equivalence to predicate devices based on bench testing and engineering analysis.
Here's an breakdown of the information provided, tailored to your request, but emphasizing that this is not a typical AI/ML performance study:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) for dental abutments, the "acceptance criteria" are not reported as specific performance metrics (like sensitivity/specificity for an AI model), but rather as compliance with recognized standards and demonstration of substantial equivalence to predicate devices. The "reported device performance" refers to successful completion of various non-clinical tests.
| Acceptance Criteria (Demonstrated Equivalence/Compliance) | Reported Device Performance (Test Results) |
|---|---|
| Same intended use as predicate device | Intended use is identical |
| Same operating principle as predicate device | Operating principle is identical |
| Similar design and same device categories | Very similar design, same categories |
| Same materials and surface coatings | Identical materials and surface coatings |
| Same sterilization processes | Identical sterilization processes |
| Sterilization validation (SAL of 1 x 10^-6) | Met ISO 17665-1 requirements |
| Biocompatibility: Cytotoxicity | Non-cytotoxic (ISO 10993-5 met) |
| Biocompatibility: Sensitization (TiN coated) | Met ISO 10993-10 requirements |
| Biocompatibility: Irritation (TiN coated) | Met ISO 10993-23 requirements |
| Mechanical compatibility (with OEM implants) | Confirmed by reverse engineering/dimensional analysis |
| Validation of digital workflow and software system | Ensured design/manufacturing within parameters |
| Static and dynamic fatigue testing | Met ISO 14801 requirements (worst-case configurations) |
| MRI safety (magnetically induced displacement force/torque) | Reviewed using scientific rationale and published literature, parameters addressed per FDA Guidance |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable in the context of human data or AI model test sets. The "test set" here refers to the physical samples of the IPD Dental Implant Abutments (and their components, potentially in various configurations) that were subjected to the specified bench and biocompatibility tests. The exact number of physical abutments, screws, or zirconia superstructures tested for each specific criterion is not detailed in this summary but would be found in the full test reports.
- Data Provenance: Not applicable in the context of country of origin for patient data. The tests were performed on the manufactured device components. The materials are specified (e.g., Titanium alloy conforming to ISO 5832-3).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. "Ground truth" in this context would generally refer to expert-derived labels for clinical data, which is not part of this 510(k) submission. The "truth" for the performance tests is established by adherence to recognized international standards (e.g., ISO, FDA Guidance) and objective measurements from engineering or biological tests.
4. Adjudication method for the test set
Not applicable. Adjudication methods (like 2+1 or 3+1) are used for resolving disagreements among human readers or expert labelers of clinical data, which is not relevant here. The evaluation criteria for the bench tests are objective and defined by established standards.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. This device is a dental implant abutment, not an AI software. Therefore, MRMC studies and AI assistance effect sizes are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is a physical medical device (dental abutments), not a standalone algorithm.
7. The type of ground truth used
The "ground truth" for this device's performance is established by:
- Compliance with international standards (e.g., ISO 14801 for fatigue testing, ISO 10993 series for biocompatibility, ISO 17665-1 for sterilization).
- Engineering specifications and dimensional analysis to ensure compatibility with other specified dental implant systems.
- Validated digital dentistry workflow parameters (e.g., minimum gingival height, wall thickness, post height, angulation for zirconia superstructures), which are based on established dental prosthetic principles.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. No training set is used for this physical device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Implant Protesis Dental 2004, S.L Francesc Fumanal Regulatory Affairs Manager Carrer Rosa dels Vents, 9-15 Premià de Dalt, Barcelona, 08338 SPAIN
June 7, 2024
Re: K240570
Trade/Device Name: IPD Dental Implant Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA. PNP Dated: May 10, 2024 Received: May 10, 2024
Dear Francesc Fumanal:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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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.
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3
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Andrew I. Steen -S
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
K240570
Device Name
IPD Dental Implant Abutments
Indications for Use (Describe)
IPD Dental Implant Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single or multiple dental prosthetic restorations.
| Compatible Implant Systems | ||
|---|---|---|
| Compatible Implant System | Implant Diameter (mm) | Platform Diameter |
| Astra Tech Implant System(Osseospeed®) | 3.0 // 3.5/4.0 // 4.5/5.0 | 3.0 // 3.5/4.0 // 4.5/5.0 |
| OsseoSpeed™ Plus | 3.6 // 4.2 | 3.6 // 4.2 |
| BioHorizons Tapered InternalImplant System | 3.0 // 3.4 // 3.8 // 4.6 // 5.8 | 3.0 // 3.0 // 3.5 // 4.5 // 5.7 |
| 3i Osseotite® Certain®Dental Implants | 3.25 // 4.0 // 5.0 | 3.4 // 4.1 // 5.0 |
| 3i® Osseotite® Dental Implants | 3.25 // 4.0 // 5.0 | 3.4 // 4.1 // 5.0 |
| Straumann® BLX Implant System | 3.5 - 4.5 // 5.0 - 6.5 | RB // WB |
| Straumann BLX Ø3.5 mm Implants | 3.5 | RB |
| Anyone™ Internal Implant System | 3.5-8.0 | RP |
| Xpeed AnyRidge InternalImplant System | 3.5-8.0 | RP |
| Conical Connection Implants(MIS® C1) | 3.75 // 4.2 | SP // SP |
| MIS Internal Hex DentalImplant System (MIS® Seven®) | 3.30 // 3.75 // 4.20 // 5.0 // 6.0 | Narrow // Standard //Standard // Wide // Wide |
| Osstem Implant System | 3.0 // 3.5 // 4.0-7.0 | Mini // Mini // Regular |
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The zirconia superstructures for use with the Ti Base (Interface) are only intended to be designed and manufactured according to digital dentistry workflow system integrates multiple components of the digital dentistry workflow: scan files from intra-oral scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
I. SUBMITTER
IMPLANT PROTESIS DENTAL 2004, S.L
Carrer Rosa dels Vents, 9-15 08338 Premià de Dalt (Barcelona), Spain.
Contact Person:
Francesc Fumanal +34 93 278 84 91 ffumanal@jpd2004.com
Date prepared: June 7, 2024.
II. DEVICE
| Device name: | IPD DENTAL IMPLANT ABUTMENTS |
|---|---|
| Common Name: | ENDOSSEOUS DENTAL IMPLANT ABUTMENT |
| Classification Name: | Endosseous Dental Implant Abutment (21 CFR 872.3630) |
| Regulatory Class: | Class II |
| Product Code(s): | Primary: NHA; Secondary: PNP. |
III. PREDICATE DEVICE(S):
| Primary Predicate: | K231413, IPD Dental Implant Abutments |
|---|---|
| Reference Devices: | K222288, DESS Dental Smart Solutions |
| The list of all the proposed third-party compatible dental implant systems, as additional Reference Devices, has been provided in Table 1 . |
Table 1. Reference Devices - Compatible Dental Implant Systems:
| 510(k) Holder | Compatible Implant System | 510(k) Number | 510(k) Device Name |
|---|---|---|---|
| Astra Tech AB | Astra Tech Implant System(Osseospeed®) | K101732 | Astra Tech Implant System(Osseospeed®) |
| Astra Tech AB | OsseoSpeed™ Plus | K120414 | OsseoSpeed™ Plus |
| Biohorizons ImplantSystems, Inc. | BioHorizons Tapered Internal ImplantSystem | K071638 | BioHorizons Tapered InternalImplant System |
| Implant Innovations,Inc. | 3i Osseotite® Certain® DentalImplants | K063341 | 3i Osseotite® Certain®Dental Implants |
| Implant Innovations,Inc. | 3i® Osseotite® Dental Implants | K063286 | 3i OSSEOTITE® DentalImplants |
| Institut Straumann AG | Straumann® BLX Implant System | K173961 | Straumann® BLX ImplantSystem |
| Institut Straumann AG | Straumann BLX Ø3.5 mm Implants | K191256 | Straumann BLX Ø3.5 mmImplants |
| MegaGen ImplantCo., Ltd | Anyone™ Internal Implant System | K123988 | Anyone™ Internal ImplantSystem |
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Administrative Information - 510(k) Summary
| 510(k) Holder | Compatible Implant System | 510(k) Number | 510(k) Device Name |
|---|---|---|---|
| MegaGen ImplantCo., Ltd | Xpeed AnyRidge Internal ImplantSystem | K140091 | Xpeed AnyRidge InternalImplant System |
| MIS ImplantsTechnologies Ltd. | Conical Connection Implants(MIS® C1) | K112162 | Conical Connection Implants |
| MIS ImplantsTechnologies Ltd. | MIS Internal Hex Dental ImplantSystem (MIS® Seven®) | K180282 | MIS Internal Hex DentalImplant System |
| OSSTEM ImplantCo., Ltd. | Osstem Implant System | K161604 | Osstem Implant System |
IV. DEVICE DESCRIPTION
IPD Dental Implant Abutments is a dental implant abutment system composed of dental abutments and screws intended to be placed into dental implants to provide support for dental prosthetic restorations.
Abutments provide basis for single or multiple tooth prosthetic restorations. They are available in a variety of connection types to enable compatibility with commercially available dental implants systems.
IPD Dental Implant Abutments includes the following categories of dental abutment designs:
- -Healing abutments;
- Temporary abutments; -
- -Cementing titanium abutments;
- -Titanium base (interface) abutments;
The system also includes the corresponding Titanium Screws intended to attach the prosthesis to the dental implant. Specifically:
- Ti Screw: Used during restoration fabrication.
- TiN Screw: Used in finished restorations, with TiN coating.
- TPA Screw: Used in finished angulated restorations, with TiN coating.
The metallic components of the subject abutments and screws are made of titanium alloy conforming to ISO 5832-3 "Implants for surgery – Metallic materials – Part 3: Wrought titanium 6-aluminium 4-vanadium allov".
The purpose of this submission is to expand IPD Dental Implant Abutments cleared under K231413 to:
- Include new OEM dental implant platform compatibilities (previously not cleared) for . previously cleared IPD's abutment designs.
IPD dental implant abutments and screws are compatible with the following commercially available dental implant systems:
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| Compatible Implant System | Type ofconnection | ImplantDiameter (mm) | PlatformDiameter | Device categoryMaterialIPD AbutmentSystems | HealingAbutmentTitanium alloy,ISO 5832-3 | Cementing /TemporaryAbutmentsTitanium alloy, ISO5832-3Temp. Anodized | Ti Base (Interface)AbutmentTitanium alloy, ISO5832-3TiN coated | |
|---|---|---|---|---|---|---|---|---|
| Osstem Implant System | Internal | 3.03.54.0 - 7.0 | MiniMiniRegular | OB | MiniMiniRegular | MiniMiniRegular | Mini (0°)Mini (0°)Regular (30°) | |
| Anyone™ Internal Implant System | Internal | 3.5 -8.0 | RP | WA | RP | RP | RP (30°) | |
| Xpeed AnyRidge Internal ImplantSystem | Internal | 3.5 -8.0 | RP | WB | RP | RP | RP (0°) | |
| 3i® Osseotite® Dental Implants | External | 3.254.05.0 | 3.44.15.0 | BA | 3.44.15.0 | 3.44.15.0 | 3.4 (0°)4.1 (0°)5.0 (0°) | |
| 3i Osseotite® Certain® DentalImplants | Internal | 3.254.05.0 | 3.44.15.0 | BB | 3.44.15.0 | 3.44.15.0 | 3.4 (0°)4.1 (0°)5.0 (0°) | |
| Astra Tech Implant System(Osseospeed®) | Internal | 3.03.5/4.04.5/5.0 | 3.03.5/4.04.5/5.0 | EA | 3.03.5/4.04.5/5.0 | 3.03.5/4.04.5/5.0 | 3.0 (0°)3.5/4.0 (30°)4.5/5.0 (30°) | |
| OsseoSpeed™ Plus | Internal | 3.64.2 | 3.64.2 | EB | 3.64.2 | 3.64.2 | 3.6 (0°)4.2 (0°) | |
| BioHorizons Tapered InternalImplant System | Internal | 3.03.43.84.65.8 | 3.03.03.54.55.7 | LB | 3.03.03.54.55.7 | 3.03.03.54.55.7 | 3.0 (0°)3.0 (0°)3.5 (30°)4.5 (30°)5.7 (30°) | |
| MIS Internal Hex Dental ImplantSystem (MIS® Seven®) | Internal | 3.303.754.205.06.0 | NarrowStandardStandardWideWide | TA | NarrowStandardStandardWideWide | NarrowStandardStandardWideWide | Narrow (0°)Standard (30°)Standard (30°)Wide (30°)Wide (30°) | |
| Conical Connection Implants | Internal | 3.75 | SP | TB | SP | SP | SP (30°) | |
| Compatible Implant System | Type ofconnection | ImplantDiameter (mm) | PlatformDiameter | Device category | HealingAbutment | Cementing /TemporaryAbutments | Ti Base (Interface)Abutment | |
| Material | IPD AbutmentSystems | Titanium alloy,ISO 5832-3 | Titanium alloy, ISO5832-3Temp. Anodized | Titanium alloy, ISO5832-3TiN coated | ||||
| (MIS® C1) | 4.2 | SP | SP | SP | SP (30°) | |||
| Straumann BLX Ø3.5 mm Implants | 3.5 | RB | RB | RB | RB (0°) | |||
| Straumann® BLX Implant System | Internal | 3.5 - 4.5 | RB | DC | RB | RB | RB (0°) | |
| Straumann® BLX Implant System | 5.0 - 6.5 | WB | WB | WB | WB (0°) |
Table 2. Summary of IPD abutments categories with compatibilized OEM Implant Systems to maximum angulation:
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Ti Base (Interface) abutments are used as an interface between the dental implant and the zirconia superstructure. They are attached (screw-retained) to the implant and cemented to the zirconia superstructure.
The Ti Base (Interface) is a two-piece abutment composed of the Ti Base (Interface) as the bottomhalf and the zirconia superstructure as the top-half. It consists of a pre-manufactured prosthetic component in Titanium alloy per ISO 5832-3, as well as the supporting digital library file for FDAcleared design software (e.g., 3Shape Abutment Designer™ Software, cleared under K151455) which enables the design of a patient-specific superstructure by the laboratory/clinician and which will be manufactured in FDA-cleared Zirconia (e.g., DD Bio Z, K142987) according to digital dentistry workflow at the point of care, or at a dental laboratory.
The design and fabrication of the zirconia superstructure for Ti Bases (Interfaces) will be conducted using a digital dentistry workflow requiring the use of the following equipment:
Scanner: 3D Scanner D850. Design Software: 3Shape Abutment Designer Software, K151455. Zirconia Material: DD Bio Z, K142987. Milling machine: Brand: Dental Concept System Model: DC1 Milling System. Cement: Multilink® Automix, K123397.
Ti Base (Interface) abutments design parameters for the zirconia superstructure are defined as follows:
| Minimum gingival height: | 1.5 mm |
|---|---|
| Minimum wall thickness: | 0.43 mm |
| Minimum post height for single-unit restorations: | 4.75 mm (1) |
| Maximum gingival height: | 6.0 mm |
| Maximum angulation of the final abutment | 30° (2) |
Note 1: Post height is the length above the abutment collar.
Note 2: in Table 2 it has been specifically referred the angulation depending on the dental implant system and platform.
The laboratory designed superstructure is attached to Ti Base (Interface) by the use of an FDA-cleared cement (e.g., Multilink® Automix, K123397). The resulting final prosthetic restoration is screwed to the dental implant. All subject abutments are single-use and provided non-sterile. Final restoration (which includes the corresponding screw) is intended to be sterilized at the dental clinic before it is placed in the patient.
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V. INDICATIONS FOR USE
IPD Dental Implant Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single or multiple dental prosthetic restorations.
| Compatible Implant System | Implant Diameter (mm) | Platform Diameter |
|---|---|---|
| Astra Tech Implant System(Osseospeed®) | 3.0 | 3.0 |
| 3.5/4.0 | 3.5/4.0 | |
| 4.5/5.0 | 4.5/5.0 | |
| OsseoSpeed™ Plus | 3.6 | 3.6 |
| 4.2 | 4.2 | |
| BioHorizons Tapered Internal ImplantSystem | 3.0 | 3.0 |
| 3.4 | 3.0 | |
| 3.8 | 3.5 | |
| 4.6 | 4.5 | |
| 5.8 | 5.7 | |
| 3i Osseotite® Certain® Dental Implants | 3.25 | 3.4 |
| 4.0 | 4.1 | |
| 5.0 | 5.0 | |
| 3i® Osseotite® Dental Implants | 3.25 | 3.4 |
| 4.0 | 4.1 | |
| 5.0 | 5.0 | |
| Straumann® BLX Implant System | 3.5 - 4.5 | RB |
| 5.0 - 6.5 | WB | |
| Straumann BLX Ø3.5 mm Implants | 3.5 | RB |
| Anyone™ Internal Implant System | 3.5 -8.0 | RP |
| Xpeed AnyRidge Internal Implant System | 3.5 -8.0 | RP |
| Conical Connection Implants(MIS® C1) | 3.75 | SP |
| 4.2 | SP | |
| MIS Internal Hex Dental Implant System(MIS® Seven®) | 3.30 | Narrow |
| 3.75 | Standard | |
| 4.20 | Standard | |
| 5.0 | Wide | |
| 6.0 | Wide | |
| Osstem Implant System | 3.0 | Mini |
| 3.5 | Mini | |
| 4.0 - 7.0 | Regular |
Compatible Implant Systems
The zirconia superstructures for use with the Ti Base (Interface) are only intended to be designed and manufactured according to digital dentistry workflow system integrates multiple components of the digital dentistry workflow: scan files from intra-oral scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories.
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OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. COMPARISON PREDICATE DEVICE
The subject device is substantially equivalent in indications and design principles to the primary predicate device. Comparative tables of indications for use and relevant technological characteristics have been provided as follows.
Table 3. Indications for Use Statements.
| Indications for Use Statements | ||
|---|---|---|
| Subject device | ||
| IPD DentalImplantAbutments | IPD Dental Implant Abutments are intended to be used in conjunction with endosseousdental implants in the maxillary or mandibular arch to provide support for single or multiple | |
| (ImplantProtesis | dental prosthetic restorations. | |
| Dental 2004,SL) | Compatible Implant Systems | |
| Dental Implant System | Implant Diameter(mm) Platform Diameter | |
| Astra Tech Implant System(Osseospeed®) | 3.0 3.0 | |
| 3.5/4.0 3.5/4.0 | ||
| 4.5/5.0 4.5/5.0 | ||
| OsseoSpeed™ Plus | 3.6 3.6 | |
| 4.2 4.2 | ||
| BioHorizons Tapered InternalImplant System | 3.0 3.0 | |
| 3.4 3.0 | ||
| 3.8 3.5 | ||
| 4.6 4.5 | ||
| 5.8 5.7 | ||
| 3i Osseotite® Certain® DentalImplants | 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 ImplantSystem | 3.5 - 4.5 RB | |
| 5.0 - 6.5 WB | ||
| Straumann BLX Ø3.5 mmImplants | 3.5 RB | |
| Anyone™ Internal ImplantSystem | 3.5 -8.0 RP | |
| Xpeed AnyRidge InternalImplant System | 3.5 -8.0 RP | |
| Conical Connection Implants(MIS® C1) | 3.75 SP | |
| 4.2 SP | ||
| MIS Internal Hex Dental ImplantSystem (MIS® Seven®) | 3.30 Narrow | |
| 3.75 Standard |
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| 4.20 | Standard | |||||
|---|---|---|---|---|---|---|
| 5.0 | Wide | |||||
| 6.0 | Wide | |||||
| 3.0 | Mini | |||||
| Osstem Implant System | 3.5 | Mini | ||||
| 4.0 - 7.0 | Regular | |||||
| The zirconia superstructures for use with the Ti Base (Interface) are only intended to bedesigned and manufactured according to digital dentistry workflow. The workflow systemintegrates multiple components of the digital dentistry workflow: scan files from intra-oral scanners, CAD software, CAM software, ceramic material, milling machine andassociated tooling and accessories. | ||||||
| Predicate Devices | ||||||
| Primary Predicate Device | ||||||
| K231413 | IPD Dental Implant Abutments are intended to be used in conjunction with endosseousdental implants in the maxillary or mandibular arch to provide support for single or | |||||
| IPD DentalImplant | multiple dental prosthetic restorations. | |||||
| Abutments | Compatible Implant Systems | |||||
| (Implant | ||||||
| ProtesisDental 2004, | Implant SystemCompatibility | Implant Diameter (mm) | Platform Diameter | |||
| SL) | 3.0 | 3.0 mm | ||||
| NobelActive® | 3.5 | NP (3.5 mm) | ||||
| 4.3/5.0 | RP (4.3 mm) | |||||
| 3.3 | NC (3.3 mm) | |||||
| Straumann® Bone Level | 4.1/4.8 | RC (4.1 mm) | ||||
| Neodent Implant System– GM Line | 3.5 - 7.0 | GM (Grand Morse) | ||||
| 3.7 / 4.1 | 3.5 mm | |||||
| Tapered Screw-Vent® | 4.7 | 4.5 mm | ||||
| 6.0 | 5.7 mm | |||||
| The zirconia superstructures for use with the Ti Base (Interface) are only intended to bedesigned and manufactured according to digital dentistry workflow. The workflow systemintegrates multiple components of the digital dentistry workflow: scan files from intra-oral scanners, CAD software, CAM software, ceramic material, milling machine andassociated tooling and accessories. | ||||||
| Reference Device | ||||||
| K222288DESS DentalSmartSolutions | DESS Dental Smart Solutions abutments are intended to be used in conjunction withendosseous dental implants in the maxillary or mandibular arch to provide support forprosthetic restorations. | |||||
| (TerratsMedical, SL) | All digitally designed custom abutments for use with Ti Base abutments or Pre-milledBlank abutments are to be sent to a Terrats Medical validated milling center formanufacture. | |||||
| Compatible Implant System | Implant Body Diameter, mm | Implant Platform Name | ||||
| Ankylos C/X | 3.5, 4.5, 5.5 | 2.52 | ||||
| Astra Tech EV | 3.0 | 3.0 | ||||
| 3.6 | 3.6 |
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| 4.2 | 4.2 | ||
|---|---|---|---|
| 4.8 | 4.8 | ||
| 5.4 | 5.4 | ||
| 3.0 | 3.0 | ||
| Astra Tech OsseoSpeed™ | 3.5/4.0 | 3.5/4.0 | |
| 4.5/5.0 | 4.5/5.0 | ||
| 3.0, 3.4, 3.8 | 3.0 | ||
| 3.8, 4.6 | 3.5 | ||
| BioHorizons | 4.6, 5.8 | 4.5 | |
| 5.8 | 5.7 | ||
| 3.25 | 3.4 | ||
| Biomet 3i Certain® | 4.0 | 4.1 | |
| 5.0 | 5.0 | ||
| 3.25 | 3.4 | ||
| Biomet 3i OSSEOTITE® | 3.75, 4.0 | 4.1 | |
| 5.0 | 5.0 | ||
| 3.8 | 3.8 | ||
| Camlog | 4.3 | 4.3 | |
| 5.0 | 5.0 | ||
| Dentium SuperLine | 3.6, 4.0, 4.5, 5.0, 6.0, 7.0 | 3.3 | |
| 3.4 | 3.4 | ||
| 3.8 | 3.8 | ||
| FRIADENT XIVE® | 4.5 | 4.5 | |
| 5.5 | 5.5 | ||
| MegaGen AnyRidge | 3.5, 4.0, 4.5, 5.0, 5.5 | 3.5 | |
| Neodent Grand Morse | 3.5, 3.75, 4.0, 4.3, 5.0, 6.0, 7.0 | Grand Morse (GM) | |
| NobelActive®, NobelParallel | 3.0 | 3.0 | |
| 3.5 | NP | ||
| Conical | 4.3, 5.0 | RP | |
| 3.5 | NP | ||
| 4.3 | RP | ||
| NobelReplace® Trilobe | 5.0 | WP | |
| 6.0 | 6.0 | ||
| 3.3 | NP | ||
| Nobel Brånemark System® | 3.75, 4.0 | RP | |
| 5.0 | WP | ||
| Osstem TS | 3.5 | Mini | |
| 4.0, 4.5, 5.0, 6.0, 7.0 | Regular | ||
| Straumann BLX | 3.5, 3.75, 4.0, 4.5 | RB | |
| 5.0, 5.5, 6.5 | WB | ||
| Straumann® Bone Level | 3.3 | NC | |
| 4.1/4.8 | RC | ||
| 3.3 | NNC, RN | ||
| Straumann® Tissue Level | 4.1 | RN | |
| 4.8 | RN, WN | ||
| Zimmer Eztetic | 3.1 | 2.9 | |
| 3.3, 3.7, 4.1 | 3.5 | ||
| Zimmer Screw Vent®/ | 4.7 | 4.5 | |
| Tapered Screw- Vent® | 6.0 | 5.7 | |
| 3.25 | 3.25 | ||
| Zimmer Spline | 3.75, 4.0 | 3.75/4.0 | |
| 5.0 | 5.0 | ||
| Zimmer SwissPlus | . Children Children Children Children Children Children Children Children Children Children Children Children Children Suite Station Schward Schward Station | رات ل | |
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Administrative Information - 510(k) Summary
Discussion on Indications for Use:
The indications for use of subject device in comparison with primary predicate device are verbatim, with the exception of the new implant systems which IPD is claiming compatibility for this submission. Further than this, no change in the intended use or indications for use of the IPD Dental Implant Abutments has been carried out. The devices are specifically indicated for patients undergoing oral implant surgery to provide support for dental prosthetic restorations.
Similarly, for the subject device and primary predicate device, the design and fabrication of the superstructure is conducted using the same digital dentistry workflow, requiring the use of the following equipment:
| Scanner: | 3Shape scanner |
|---|---|
| Design Software: | 3Shape Abutment Designer Software (K151455) |
| Zirconia Material: | DD Bio Z (K142987) |
| Milling machine: | Dental Concept System DC1 Milling System |
| Cement: | Multilink® Automix (K123397) |
and using the supporting IPD digital library file for K151455.
The adequacy of the digital dentistry workflow for the subject device is substantiated by software validation and mechanical fatigue testing provided with the submission.
As previously referred, differences may be found in the list of compatible implant systems for subject and predicate devices. Compatibility of the subject abutments with the specific OEM implants is based on engineering and dimensional analysis, as well as mechanical fatigue testing. In that sense, reference device, K222288, has been selected for the range of compatibility implant systems which encompasses (not exhaustive list) and which IPD is also citing compatibility. Similarly, the whole set of compatible dental implant systems and their respective 510(k) have been also included in this submission as reference devices.
Despite this, no further differences are found in the device categories included for subject and predicate devices, and same approach is followed for finalizing the zirconia superstructures.
It is IPD opinion that these differences do not affect the intended use of the subject device, and/or do not raise differences in terms of safety or efficacy.
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| Characteristics | Subject DeviceIPD Dental ImplantAbutments | Primary PredicateDeviceIPD Dental ImplantAbutments(IPD) K231413 | Reference DeviceDESS Dental SmartSolutions(Terrats Medical, SL)K222288 |
|---|---|---|---|
| Materials | |||
| Abutment Materials | Titanium Alloy Grade 5(ISO 5832-3) + TiN orAnodized (TiO2) | Titanium Alloy Grade 5(ISO 5832-3) + TiN orAnodized (TiO2) | Ti-6Al-4V ELI + ZrNCoating |
| 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 ISO13356 |
| General Design Features | |||
| Overview ofabutment designs | Healing,Temporary,Cementing,Ti-Base (Interface) | Healing,Temporary,Cementing,Ti-Base (Interface) | Healing, TemporaryAbutment, Ti Base, C-base, CrCo Base,Premilled Blank, MultiUnit Abutment, MultiUnit ZRN Abutment,DESSLoc |
| ProsthesisAttachment | Cement-retainedScrew-retained | Cement-retainedScrew-retained | Cement-retainedScrew-retained |
| Restoration Type | Single-unit (crowns)Multiple-unit (bridges) | Single-unit (crowns)Multiple-unit (bridges) | Single-unit,Multi-unit |
| Abutment / ImplantPlatform Diameter(mm) | 3.0 - 5.7 | 3.0 - 5.7 | 2.52 - 6.5 |
| Abutment Angle | Maximum: 30° | Maximum: 30° | 0°, 17°, 30° |
| General Abutment /Implant Connection | Internal and External | Internal and External | Internal and External |
| Sterilization | |||
| Sterilization statusand type | Non-sterile.End user steamsterilization | Non-sterile.End user steamsterilization | Non-sterile.End user steamsterilization |
| Tables 4. Subject and Predicate devices technological characteristics comparison. | |
|---|---|
| ----------------------------------------------------------------------------------- | -- |
| Healing Abutments | |||
|---|---|---|---|
| Characteristics | IPDSubject device | IPD Dental ImplantAbutments (K231413) | DESS Dental SmartSolutions (K222288) |
| Min – Max diameter | 3.0 - 5.7 | 3.0 - 5.7 | 2.52 - 5.7 |
| Angle | Straight (0°) | Straight (0°) | Straight (0°) |
| Intended restorationtype | Single-unit | Single-unit | Single-unit |
| Method of fixation | Screw-retained | Screw-retained | Screw-retained |
| Surface coating | Uncoated | Uncoated | Uncoated |
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| Cementing and Temporary Abutments | |||
|---|---|---|---|
| Characteristics | IPDSubject device | IPD Dental ImplantAbutments (K231413) | DESS Dental SmartSolutions (K222288) |
| Min – Max diameter | 3.0 – 5.7 | 3.0 - 4.3 | 2.52 - 5.7 |
| Angle | Straight (0°) | Straight (0°) | Straight (0°) |
| Intended restoration type | Single-unit / Multi-unit | Single-unit / Multi-unit | Single-unit / Multi-unit |
| Method of fixation | Cement-retained /Screw-retained | Cement-retained /Screw-retained | Cement-retained /Screw-retained |
| Surface coating | Cementing: UncoatedTemporary: Anodized | Cementing: UncoatedTemporary: Anodized | Uncoated |
| Ti Base / Interface Abutments | |||
|---|---|---|---|
| Characteristics | IPDSubject device | IPD Dental ImplantAbutments (K231413) | DESS Dental SmartSolutions (K222288) |
| Min – Max diameter | 3.0 – 5.7 | 3.0 – 4.3 | 2.52 – 5.7 |
| Intended restorationtype | Single-unit / Multi-unit | Single-unit / Multi-unit | Single-unit / Multi-unit |
| Method of fixation | Cement-retainedScrew-retained | Cement-retainedScrew-retained | Cement-retainedScrew-retained |
| Surface coating | TiN | TiN | Anodized |
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| Superstructure Design | |||
|---|---|---|---|
| Characteristics | IPDSubject device | IPD Dental Implant Abutments(K231413) | DESS Dental Smart Solutions(K222288) |
| Superstructure DesignWorkflow | The superstructures for use with the IPD Ti-Base (Interface) abutments are onlyintended to be designed and manufacturedaccording to digital dentistry workflow. Theworkflow system integrates multiplecomponents of the digital dentistryworkflow: scan files from intra-oralscanners, CAD software, CAM software,ceramic material, milling machine andassociated tooling and accessories. | The superstructures for use with the IPD Ti-Base (Interface) abutments are onlyintended to be designed and manufacturedaccording to digital dentistry workflow. Theworkflow system integrates multiplecomponents of the digital dentistryworkflow: scan files from intra-oralscanners, CAD software, CAM software,ceramic material, milling machine andassociated tooling and accessories. | All digitally designed custom abutments foruse with Ti Base abutments or Pre-milledBlank abutments are to be sent to a TerratsMedical validated milling center formanufacture. |
| Zirconia CAD/CAM DesignParameters –Ti (Base) Interface Abutmentcharacteristics | Minimum Gingival height: 1.5 mmMinimum Wall Thickness: 0.43 mmMinimum Post Height: 4.75 mm (1)Maximum Gingival Height: 6 mmMaximum Angulation: 30° (2) | Minimum Gingival height: 1.5 mmMinimum Wall Thickness: 0.43 mmMinimum Post Height: 4.75 mm (1)Maximum Gingival Height: 6 mmMaximum Angulation: 30° (3) | Minimum gingival height: 0.5 mmMinimum wall thickness: 0.4 mmMinimum post height: 4.2 mmMaximum gingival height: 6.0 mmMaximum Angulation: 20°/30° (4) |
Note 1: Post height is the length above the abutment collar.
Note 2: Please consult Table 2 for specific angulation as per dental implant system and platform.
Note 3: With the exception of Nobel Active® 3.0 and 3.5 mm-platforms which final abutment is straight (0°).
Note 4: Design parameters for Ti Base Interface with Bionet 3: Certain, NobelReplace Trilobe, and Zimner Screw-Vent (except for 3.3 mm implants).
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Administrative Information - 510(k) Summary
The data included in this submission demonstrate substantial equivalence to the predicate devices. It is considered that the subject device is substantially equivalent based on the following aspects:
- Has the same intended use;
- Uses the same operating principle;
- Incorporates similar design and same device categories;
- Incorporates the same materials and surface coatings;
- It is sterilized using the same processes.
Ti Base (Interface) and primary predicate device are both intended to be used in a digital dentistry workflow which includes the scanning of patient's teeth setup, the design of the zirconia superstructure, the manufacturing of the superstructure, and the later cementation.
The adequacy of the digital dentistry workflow for the subject device is substantiated by software validation and mechanical fatigue testing provided in this submission.
Materials and technological characteristics of the subject device are identical to previously cleared IPD Dental Implant Abutments (primary predicate device). Subject device categories are very similar in design, with differences on the proposed compatibilized OEM dental implant systems.
VII. PERFORMANCE DATA
The proposed devices have been subject to bench testing to determine fulfilment of design and performance requirements. Bench testing followed the recommendations provided in FDA Guidance Document – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments.
Specifically, non-clinical performance testing on the IPD Dental Implant Abutments include:
- . Sterilization validation to achieve a SAL of 1 x 106 according to ISO 17665-1 to ensure sterilization of the final finished device.
- . Cytotoxicity testing according to ISO 10993-5 to demonstrate that all patient-contacting surfaces are non-cytotoxic. In addition to Sensitization (ISO 10993-10) and Irritation (ISO 10993-23) testing for TiN coated devices.
- . Reverse engineering and dimensional analysis of original manufacturer's components (implants, abutments and screws) to confirm compatibility.
- . Validation of the digital workflow and software system to ensure that design and manufacturing of the top half was within the specified design parameters.
- Static and dynamic fatigue testing of worst-case implant / abutment configurations and . combinations in accordance with ISO 14801.
- Modified Surfaces Information per FDA's Class II Special Controls Guidance Document: ● Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments.
- . Non-clinical worst-case MRI review was performed to evaluate IPD Dental Implant Abutments in the MRI environment using scientific rationale and published literature (i.e., Woods, Terry O., Jana G. Delfino, and Sunder Rajan. "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795), for the entire system (including all variations of compatible implant bodies, dental abutments, and fixation screws) and material composition. The rationale addressed parameters per the FDA Guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment", including magnetically induced displacement force and torque.
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Non-clinical performance testing leveraged from K231413, previously cleared, showed that IPD Dental Implant Abutments met the applicable specifications and requirements.
No clinical testing was performed, the determination of substantial equivalence is supported by nonclinical testing.
VIII. CONCLUSIONS
The subject device and the primary predicate device have identical intended use and materials and similar technological characteristics. The subject device and the primary and reference predicate devices encompass the same range of device categories, similar (OEM implant dependent) diameters, and almost identical designs. The subject and predicate device are produced using identical materials and surface coatings, as well as fabrication processes, and are to be sterilized by the user using identical methods.
Based on the similarities observed and the results of non-clinical testing performed, we conclude that the data included in the submission demonstrate that the subject device, IPD Dental Implant Abutments, is substantially equivalent to the predicate devices.
§ 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.)