(246 days)
K22288
No
The summary describes a physical dental abutment device and its manufacturing process using CAD/CAM technology. There is no mention of AI or ML being used in the design, manufacturing, or function of the device itself. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device, Zfx Abutments, is intended to "provide support for prosthetic restorations" in conjunction with dental implants. Its function is structural support for a prosthesis, not to treat or cure a disease or condition.
No
Explanation: The device, Zfx Abutments, is described as a prosthetic restoration component used with dental implants, not for identifying or investigating a disease, injury, or other condition.
No
The device description clearly states that the device consists of physical components: TiBase and Pre-milled Abutment Blanks made of titanium alloy, and corresponding retaining screws. The submission also includes non-clinical testing data for these physical components (sterilization, biocompatibility, mechanical testing, MR Safety). While the process involves digital design (CAD/CAM), the final device is a physical implant component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for providing support for prosthetic restorations in the mouth, in conjunction with dental implants. This is a mechanical function within the body.
- Device Description: The description details physical components like abutments, screws, and materials used for dental prosthetics.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment. The device itself is a physical component for dental restoration.
Therefore, the Zfx Abutments are a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Zfx Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandbular arch to provide support for prosthetic restorations.
All digitally designed custom abutments or superstructures and/or hybrid abutment crowns for use with Zfx TiBase or Pre-Milled Blank Abutments are intended to be sent to a Zfx validated milling center for manufacture.
The Zfx TiBase abutments for the 03.25 mm Certain implant bodies, and 03.1 mm Eztetic implant bodies are indicated for maxillary lateral and mandibular central/lateral incisors only.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The subject device, Zfx Abutments, consists of two abutment types, a TiBase and a Pre-milled Abutment Blank, with corresponding retaining screws. Zfx Abutments are offered in a variety of connections compatible with ZimVie dental implants. All abutments and screws are provided non-sterile.
TiBase Abutments: Subject device TiBases are two-piece abutments. The pre-manufactured titanium base component is the apical part. The coronal part of the two-piece abutment is a CAD/CAM designed and manufactured superstructure. The subject device TiBase abutments are available in hexed/engaging and non-hexed/nonengaging configurations. The engaging TiBase abutments are intended for single and multi-unit restorations and the non-engaging TiBases are intended for multi-unit restorations. The superstructure is intended to be manufactured at a Zfx validated milling center. Zfx recommends the use of Ivoclar Vivadent Multilink Hybrid Abutment Cement.
Pre-milled Abutment Blanks: The Pre-milled Abutment Blank is a cylindrical titanium alloy abutment designed for patient-specific abutment fabrication with CAD/CAM technology. The patient-specific abutment milled from a Pre-milled Abutment Blank is secured directly to the implant using a retaining screw. Pre-milled Abutment Blanks are available in an engaging/hexed design only for single-unit and multi-unit restorations.
Retaining Screws: Corresponding retaining screws are packaged with the abutment and replacement screws are available individually. All screws are compatible with the corresponding ZimVie dental implants.
Material Composition: All subject device abutments are made of titanium alloy Ti-6Al-4V ELI conforming to ASTM F136. Screws are made of either titanium alloy Ti-6A1-4V ELI conforming to ASTM F136, or Gold-Tite® screws with stainless steel conforming to ASTM F138. Gold-Tite screws have a gold-plating conforming to ASTM B488 and ASTM B571. Zirconia superstructures for use with the TiBase Abutments are made of zirconia conforming to ISO 13356.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillary or mandibular arch, maxillary lateral and mandibular central/lateral incisors
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)
Non-clinical testing data submitted to demonstrate substantial equivalence includes: sterilization validation according to ISO 17665-1; biocompatibility testing according to ISO 10993-1 Table A-1, ISO 10993-5, and ISO 10993-10; reverse engineering analysis to confirm compatibility with the Sirona inCoris Meso Blocks; reprocessing validation according to ISO 17665-2, and mechanical testing according to ISO 14801 to determine that the subject device has sufficient strength for its intended use. MR Safety testing was conducted according to ASTM F2052, ASTM F2213, ASTM F2182, and ASTM F2119 for a determination of MR Conditional.
No clinical data were included in this submission.
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.
K22288
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.
K052648, K100993, K213672, K130436, K092341, K063341, K061629, K063286, K100724, K111216, K130949, K142082, K133339, K113753, K132258, K122300, K220978, K212730
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 1, 2024
GmbH - a company of ZimVie Ana Leitão Regulatory & Compliance Senior Specialist Kopernikusstraße 15 Dachau. 85221 GERMANY
Re: K231915
Trade/Device Name: Zfx Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: January 31, 2024 Received: February 5, 2024
Dear Ana Leitão:
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) K231915
Device Name Zfx Abutments
Indications for Use (Describe)
The Zfx Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandbular arch to provide support for prosthetic restorations.
All digitally designed custom abutments or superstructures and/or hybrid abutment crowns for use with Zfx TiBase or Pre-Milled Blank Abutments are intended to be sent to a Zfx validated milling center for manufacture.
| Table I Compatible Implant Systems | |
|---|---|
| Compatible Implant | Platform Ø (mm) |
| Certain (Tapered and Parallel Walled), | |
| T3, T3 Pro | 3.4 |
| 4.1 | |
| 5.0 | |
| 6.0 | |
| Tapered Screw-Vent, Trabecular Metal | 3.5 |
| 4.5 | |
| 5.7 | |
| TSX | 2.9 |
| 3.5 | |
| 4.5 | |
| Eztetic | 2.9 |
Table 1 Compatible Implant Systems
The Zfx TiBase abutments for the 03.25 mm Certain implant bodies, and 03.1 mm Eztetic implant bodies are indicated for maxillary lateral and mandibular central/lateral incisors only.
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Zfx Abutments 510(k) Summary March 1st, 2024 [510(k) Number K231915]
Administrative Information
| Manufacturer Name | Zfx GmbH |
|---|---|
| Kopernikusstraße 15, 85221 Dachau, Germany | |
| Telephone | +49 162 3088254 |
| Official Contact | Ana Leitão, Regulatory & Compliance Senior Specialist |
| Email: ana.leitao@zimvie.com |
Device Name and Classification
| Trade/Proprietary Name | Zfx Abutments |
|---|---|
| Common Name | Dental Implant Abutment |
| Regulation Number | 21 CFR 872.3630 |
| Regulation Name | Endosseous Dental Implant Abutment |
| Regulatory Class | Class II |
| Product Code | NHA |
| Classification Panel | Dental Products Panel |
| Reviewing Division | Division of Dental Devices |
Predicate Device Information
Primary Predicate Device K22288, DESS Dental Smart Solutions, Terrats Medical SL
Reference Devices
K052648, Modification 3i Patient-Specific Dental Abutment and Overdenture Bar, 3i Implant Innovations, Inc. K100993, Inclusive Titanium Abutments for Astra OsseoSpeed, Prismatik Dental Craft Inc. K213672, T3 Pro Implants, Biomet 3i LLC K130436, Multilink Hybrid Abutment Cement, Ivoclar Vivadent K092341, Biomet 3i Low Profile Abutments K063341, 3i OSSEOTITE Certain(R) Dental Implants, Implant Innovations, Inc. K061629, CERTAIN PREVAIL DENTAL IMPLANT, Implant Innovations, Inc. K063286, OSSEOTITE; OSSEOTITE NT; XP; TG OSSEOTITE, Implant Innovations, Inc. K100724, OSSEOTITE II MODEL XIFOSSXXX, Biomet 3i LLC K111216, OSSEOTITE 2 DENTAL IMPLANTS, Biomet 3i LLC K130949, CP4 OSSEOTITE CERTAIN DENTAL IMPLANTS, Biomet 3i LLC K142082, Zimmer 3.1mm Dental Implant [Eztetic], Zimmer Dental, Inc. K133339, Tapered Screw Vent T & M Implants, Zimmer Dental, Inc. K113753, Tapered Screw-Vent(R) X Implant, Zimmer Dental, Inc. K132258, Trabecular Metal Implant, Zimmer Dental, Inc. K122300, 3i T3 Dental Implant, Biomet 3i LLC
5
K220978, TSX Implants, Biomet 3i LLC
K212730. BellaTek Encode Emergence Healing Abutments, Biomet 3i LLC
Indications for Use Statement
The Zfx 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 or superstructures and/or hybrid abutment crowns for use with Zfx TiBase or Pre-Milled Blank Abutments are intended to be sent to a Zfx validated milling center for manufacture.
| Compatible Implant | Platform Ø (mm) |
|---|---|
| Certain (Tapered and Parallel Walled), T3, T3 Pro | 3.4 |
| Certain (Tapered and Parallel Walled), T3, T3 Pro | 4.1 |
| Certain (Tapered and Parallel Walled), T3, T3 Pro | 5.0 |
| Certain (Tapered and Parallel Walled), T3, T3 Pro | 6.0 |
| Tapered Screw-Vent, Trabecular Metal | 3.5 |
| Tapered Screw-Vent, Trabecular Metal | 4.5 |
| Tapered Screw-Vent, Trabecular Metal | 5.7 |
| TSX | 2.9 |
| TSX | 3.5 |
| TSX | 4.5 |
| Eztetic | 2.9 |
Table 1 Compatible Implant Systems
The Zfx TiBase abutments for the Ø3.25 mm Certain implant bodies, and Ø3.1 mm Eztetic implant bodies are indicated for maxillary lateral and mandibular central/lateral incisors only.
Subject Device Description
The subject device, Zfx Abutments, consists of two abutment types, a TiBase and a Pre-milled Abutment Blank, with corresponding retaining screws. Zfx Abutments are offered in a variety of connections compatible with ZimVie dental implants. All abutments and screws are provided non-sterile.
TiBase Abutments
Subject device TiBases are two-piece abutments. The pre-manufactured titanium base component is the apical part. The coronal part of the two-piece abutment is a CAD/CAM designed and manufactured superstructure. The subject device TiBase abutments are available in hexed/engaging and non-hexed/nonengaging configurations. The engaging TiBase abutments are intended for single and multi-unit restorations and the non-engaging TiBases are intended for multi-unit restorations.
6
The superstructure is intended to be manufactured at a Zfx validated milling center. Zfx recommends the use of Ivoclar Vivadent Multilink Hybrid Abutment Cement
Design parameters for the TiBase CAD/CAM zirconia superstructure are listed in the following tables:
Table 2 Design parameters for manufacturing zirconia superstructure and/or hybrid crowns compatible with Certain (Tapered and Parallel Walled), T3, T3 Pro implant systems
| DESIGN PARAMETERS FOR MANUFACTURING ZIRCONIA SUPERSTRUCTURES COMPATIBLE
| WITH CERTAIN IMPLANT SYSTEMS | |||
|---|---|---|---|
| Superstructure Parameters | Superstructure Parameter Values | ||
| Min. | Max. | ||
| Superstucture Gingival | |||
| Height (A) | 0.3mm TiBase | ||
| Collar Height | 5.75mm | ||
| 1.3mm TiBase | |||
| Collar Height | 0.25mm | 4.7mm | |
| 2.6mm TiBase | |||
| Collar Height | 3.4mm | ||
| Angulation (B) | 0° | 30° | |
| Wall Thickness (C) | 0.3mm | N/A | |
| Implant Platform Diameter | 3.5mm | 5.0mm |
Table 3 Design parameters for manufacturing zirconia superstructure and/or hybrid crowns compatible with Tapered Screw-Vent, Trabecular Metal implant systems
| DESIGN PARAMETERS FOR MANUFACTURING ZIRCONIA SUPERSTRUCTURES COMPATIBLE
| WITH TSV IMPLANT SYSTEMS | |||
|---|---|---|---|
| Superstructure Parameters | Superstructure Parameter Values | ||
| Min. | Max. | ||
| Superstructure | |||
| Gingival Height (A) | 0.3mm TiBase | ||
| Collar Height | 5.75mm | ||
| 1.3mm TiBase | |||
| Collar Height | 0.25mm | 4.3mm | |
| 2.6mm TiBase | |||
| Collar Height | 3.4mm | ||
| Angulation (B) | 0° | 30° | |
| Wall Thickness (C) | 0.3mm | N/A | |
| Implant Platform Diameter | 3.5mm | 5.7mm |
7
Table 4 Design parameters for manufacturing zirconia superstructure and/or hybrid crowns compatible with TSX implant system
| DESIGN PARAMETERS FOR MANUFACTURING ZIRCONIA SUPERSTRUCTURES COMPATIBLE
| WITH TSX IMPLANT SYSTEMS | |||
|---|---|---|---|
| Superstructure Parameter Values | |||
| Superstructure Parameters | Min. | Max. | |
| 0.3mm TiBase | |||
| Collar Height | 5.75mm | ||
| 1.3mm TiBase | |||
| Collar Height | 4.7mm | ||
| Superstructure | |||
| Gingival Height (A) | 2.6mm TiBase | ||
| Collar Height | 0.25mm | 3.4mm | |
| 1.0mm TiBase | |||
| Collar Height | 5.0mm | ||
| 1.7mm TiBase | |||
| Collar Height | 4.3mm | ||
| Angulation (B) | 0° | 30° | |
| Wall Thickness (C) | 0.3mm | N/A | |
| Implant Platform Diameter | 2.9mm | 4.5mm |
Table 5 Design parameters for manufacturing zirconia superstructure and/or hybrid crowns compatible with Eztetic implant systems
| DESIGN PARAMETERS FOR MANUFACTURING ZIRCONIA SUPERSTRUCTURES COMPATIBLE
| WITH EZTETIC IMPLANT SYSTEMS | |||
|---|---|---|---|
| Superstructure Parameters | Superstructure Parameter Values | ||
| Min. | Max. | ||
| Superstructure | |||
| Gingival Height (A) | 1.0 mm TiBase Collar | ||
| Height | 5.0 mm | ||
| 1.7 mm TiBase Collar | |||
| Height | 0.25mm | 4.3 mm | |
| 2.6 mm TiBase Collar | |||
| Height | 3.4 mm | ||
| Angulation (B) | 0° | 30° | |
| Wall Thickness (C) | 0.3mm | N/A | |
| Implant Platform Diameter | 2.9mm | N/A |
The post height of an abutment is the cementable post measured above the gingival margin of the final abutment design including that of the ceramic top-half. The minimum allowable post height for patient-matched Zfx abutments intended for single-unit loading is 4.0 mm.
8
Pre-milled Abutment Blanks
The Pre-milled Abutment Blank is a cylindrical titanium alloy abutment designed for patient-specific abutment fabrication with CAD/CAM technology. The patient-specific abutment milled from a Pre-milled Abutment Blank is secured directly to the implant using a retaining screw. Pre-milled Abutment Blanks are available in an engaging/hexed design only for single-unit and multi-unit restorations.
Design parameters for the CAD/CAM patient-specific abutment using a Pre-milled Abutment Blank are included in the following table:
| Description | Min. | Max. |
|---|---|---|
| Gingival Margin Height (Collar) | 0.25 mm | 6.0 mm |
| Platform Diameter | 2.9mm | 6.0mm |
| Angulation | 0° | 30° |
| Wall Thickness | 0.5mm | N/A |
| Post Height | 4.0 mm | N/A |
Table 6 - Design parameters for manufacturing Pre-milled Blank custom abutments
Retaining Screws
Corresponding retaining screws are packaged with the abutment and replacement screws are available individually. All screws are compatible with the corresponding ZimVie dental implants.
Material Composition
All subject device abutments are made of titanium alloy Ti-6Al-4V ELI conforming to ASTM F136.
Screws are made of either titanium alloy Ti-6A1-4V ELI conforming to ASTM F136, or Gold-Tite® screws with stainless steel conforming to ASTM F138. Gold-Tite screws have a gold-plating conforming to ASTM B488 and ASTM B571.
Zirconia superstructures for use with the TiBase Abutments are made of zirconia conforming to ISO 13356.
Performance Data
Non-clinical testing data submitted to demonstrate substantial equivalence includes: sterilization validation according to ISO 17665-1; biocompatibility testing according to ISO 10993-1 Table A-1, ISO 10993-5, and ISO 10993-10; reverse engineering analysis to confirm compatibility with the Sirona inCoris Meso Blocks; reprocessing validation according to ISO 17665-2, and mechanical testing according to ISO 14801 to determine that the subject device has sufficient strength for its intended use. MR Safety testing was conducted according to ASTM F2052, ASTM F2213, ASTM F2182, and ASTM F2119 for a determination of MR Conditional.
No clinical data were included in this submission.
9
Equivalence to Marketed Devices
Zfx Abutments (subject device) are substantially equivalent in design, function, material, and Indications for Use to the Primary Predicate, DESS Dental Smart Solutions abutments cleared in K222288. All are intended for use with endosseous dental implants in the maxilla and mandible to provide support for single and multi-unit restorations.
All digitally designed subject device abutments and primary predicate abutments are to a validated milling center for manufacture. Subject device abutments are similar in range of sizes, connections, and technological characteristics to the DESS Dental Smart Solutions, K22288. Implant/abutment compatibility for the subject device is substantially equivalent to the primary predicate.
Material for the superstructure of both the subject device and the predicate device is zirconia conforming to ISO 13356. The cement recommended for bonding of superstructures for both the subject device and the predicate device is Multilink Hybrid Abutment Cement.
| Subject Device | Indications for Use Statement | |||||
|---|---|---|---|---|---|---|
| Zfx Abutments | The Zfx Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandbular arch to provide | |||||
| support for prosthetic restorations. | ||||||
| All digitally designed custom abutments or superstructures and/or hybrid abutment crowns for use with Zfx TiBase or Pre-Milled Blank | ||||||
| Abutments are intended to be sent to a Zfx validated milling center for manufacture. | ||||||
| Table 1 Compatible Implant Systems | ||||||
| Compatible Implant System | Platform Ø (mm) | |||||
| 3.4 | ||||||
| Certain (Tapered and Parallel Walled), | 4.1 | |||||
| T3, T3 Pro | ||||||
| 6.0 | ||||||
| Tapered Screw-Vent, | ||||||
| Trabecular Metal | 4.5 | |||||
| 5.7 | ||||||
| TSX | 3.5 | |||||
| 4.5 | ||||||
| Eztetic | 2.9 | |||||
| mandibular central/lateral incisors only. | The Zfx TiBase abutments for the 03.25 mm Certain implant bodies are indicated for maxillary lateral and | |||||
| Primary Predicate | ||||||
| Device | ||||||
| K22288 | DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandbular | |||||
| DESS Dental | ||||||
| Smart Solutions | arch to provide support for prosthetic restorations. | |||||
| validated milling center for manufacture. | All digitally designed custom abutments or Pre-milled Blank abutments or Pre-milled Blank abutments a Terrats Medical | |||||
| Compatible Implant Systems | ||||||
| Compatible Implant System | Implant Body Diameter, mm | Implant Platform Name | ||||
| Ankylos C/X | 3.5, 4.5, 5.5 | 2.52 |
Table 7 - Substantial Equivalence - Indications for Use
10
| Astra Tech EV | 3.0 | 3.0 | |
|---|---|---|---|
| 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 | ||
| Reference Devices | |||
| K100993 | |||
| Inclusive Titanium | |||
| Abutments for | |||
| OsseoSpeed | The Inclusive Titanium Abutments for Astra OsseoSpeed Implants are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. They are compatible with the Astral Tech OsseoSpeed 3.0, 3.5, 4.0,4.5, 5.0 implants. | ||
| K052648 | |||
| Modification 3i | |||
| Patient-Specific | The 3i Patient-Specific Dental Abutments and Overdenture Bars are intended for use as an accessory to an endosseous dental implant to support a prosthetic device in a partially or edentulous patient. It is intended for use to support single and multiple tooth prostheses, in the mandible or maxilla. The prostheses can be screw or cement retained to the abutment. |
11
| and Overdenture
| Bars | |
|---|---|
| K092341 | |
| Biomet 3i Low | |
| Profile Abutments | BIOMET 3i Dental Abutments are intended for use as accessories to endosseous dental implants to support a prosthetic device in a partially or completely edentulous patient. A dental abutment is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be screw retained or cement retained to the abutment. |
| Table 8 - Substantial Equivalence - Technological Characteristics | |||
|---|---|---|---|
| Comparison | Subject Device | Subject Device | Primary
Predicate
(K222288) | Reference Device
(K100993) | Reference Device
(K052648) | Reference Device
(K092341) |
|------------------------------------|------------------------------------------------------------|-----------------------------------------------------------------|--------------------------------------------------|---------------------------------------------------------|------------------------------------------------------------------------------|-------------------------------------------|
| | TiBase Abutment | Pre-milled
Abutment Blank | DESS Dental
Smart Solutions | Inclusive Titanium
Abutments for
Astra OsseoSpeed | Modified 3i Patient-
Specific Dental
Abutments and
Overdenture Bars | Biomet 3i Low
Profile Abutments |
| | Zfx GmbH | Zfx GmbH | Terrats Medical
SL | Prismatik
Dentalcraft | | |
| Design | | | | | | |
| Platform
Diameter
(mm) | 2.9mm, 3.4mm,
3.5mm, 4.1mm,
4.5mm, 5.0mm,
5.7mm | 2.9mm, 3.4mm,
3.5mm, 4.1mm,
4.5mm, 5.0mm,
5.7mm, 6.0mm | 4.5 - 6.5mm | 3.0-5.0mm | 3.4 - 6 mm | 3.4-5.0mm |
| Gingival
Height (mm) | 0.25-5.75mm | 0.25 - 6.0 mm | 0.3 - 6.0 mm | Multiple stock
abutments | 0.25 mm (min) | 1.0-5.0mm |
| Post Height
(mm) | 4.0. 4.5, 4.75, 5.7 | Min = 4.0 mm | 4.0, 4.2, 4.5, 4.7mm | Multiple stock
abutments | 4.5 mm (min) | 6.2mm (max) |
| Abutment
Angle | Straight (0
degrees),
Up to 30 degrees | Straight (0
degrees),
Up to 30 degrees | Straight (0
degrees),
Up to 30 degrees | Straight (0
degrees),
Up to 30 degrees | Straight (0 degrees),
Up to 30 degrees | Straight (0 degrees),
Up to 30 degrees |
| Implant
/Abutment
Connection | Internal;
Engaging; Non-
engaging | Internal ;
Engaging; Non-
engaging | Internal, External
Engaging; Non-
engaging | Internal | External Hex,
Internal | External Hex,
Internal |
| Restoration
Type | Single unit &
Multi-unit | Single unit &
Multi-unit | Single unit &
Multi-unit | Single unit &
Multi-unit | Single unit & Multi-
unit | Single unit & Multi-
unit |
| Prosthesis
Attachment | Screw or Cement
retained | Screw or Cement
retained | Screw or Cement
retained | Cement retained | Screw or Cement
retained | Screw or Cement
retained |
| Material | | | | | | |
| Abutment | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Ti-6Al-4V ELI
Co-Cr-Mo Alloy | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Ti-6Al-4V ELI |
| Retaining
Screw | Ti-6Al-4V ELI
Stainless steel 316L
with gold-plating | Ti-6Al-4V ELI
Stainless steel 316L
with gold-plating | Ti-6Al-4V ELI
DLC coating | Ti-6Al-4V ELI | Titanium Alloy
Gold Alloy | Stainless steel 316L
with gold-plating |
Conclusion
The subject device has demonstrated substantial equivalence to the predicate device in that it has the same intended use, uses the same operating principle, incorporates the same basic design and materials, and uses the same sterilization method.