Who is the manufacturer of CreoDent Solidex Customized Abutment?

Creodent Prosthetics, Ltd. filed the 510(k) submission for CreoDent Solidex Customized Abutment (K162734).

What is the FDA product code for CreoDent Solidex Customized Abutment?

NHA. It is classified under 21 CFR 872.3630 as a Class 2 device in the Dental panel.

What is the regulatory pathway for CreoDent Solidex Customized Abutment?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like CreoDent Solidex Customized Abutment?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

CreoDent Solidex Customized Abutment

Q: What are the predicate devices for CreoDent Solidex Customized Abutment?

Creodent Solidex® Customized Abutments (K150012).

K162734 · Creodent Prosthetics, Ltd. · NHA · May 8, 2017 · Dental

Device Facts

Record ID	K162734
Device Name	CreoDent Solidex Customized Abutment
Applicant	Creodent Prosthetics, Ltd.
Product Code	NHA · Dental
Decision Date	May 8, 2017
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3630
Device Class	Class 2
Attributes	Therapeutic

Indications for Use

The CreoDent Solidex® Customized Abutment and Screw is intended for use with an endosseous implant to support a prosthetic device in patients who are partially or completely edentulous. The device can be used for single or multiple restorations. The prosthesis can be cemented or screw retained to the abutment. An abutment screw is used to secure the abutment to the endosseous implant.

Device Story

Device consists of customized titanium abutment and screw; used to support prosthetic restorations (crowns, bridges) on endosseous dental implants. Input: patient-specific digital design files; processed via CAD/CAM manufacturing at validated facility. Output: patient-specific titanium abutment. Used in dental clinics; operated by dentists. Abutment secured to implant via screw; prosthesis cemented or screw-retained to abutment. Benefits: provides customized prosthetic support for edentulous patients. Material: Ti-6Al-4V ELI titanium alloy.

Clinical Evidence

Bench testing only. Static and fatigue testing conducted per ISO 14801:2007E using worst-case connection platforms. Reverse engineering dimensional analysis performed to verify compatibility with OEM implant bodies. Sterilization validated per ISO 17665-1.

Technological Characteristics

Material: Ti-6Al-4V ELI titanium alloy (ASTM F-136). Design: Customized abutment for screw-retained or cement-retained restorations. Connectivity: CAD/CAM digital workflow. Sterilization: ISO 17665-1 compliant. Dimensions: Patient-specific, angulation up to 20 degrees.

Indications for Use

Indicated for partially or completely edentulous patients requiring single or multiple-unit prosthetic restorations supported by endosseous dental implants.

Regulatory Classification

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.

Special Controls

*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.)

Predicate Devices

Creodent Solidex® Customized Abutments (K150012)

Reference Devices

Inclusive Titanium Abutments for Camlog (K121391)
Atlantis Abutment for Keystone Implants (K103020)
Dentium Implantium and Superline Abutments (K141457)
Milling Abutment for CAD/CAM Dental Abutments (K151984)
Camlog Screwline Implant System (K022425)
SPI ELEMENT dental Implants (K030689)
Denitum Co., Ltd Implantium (K041368)
PrimaConnex Internal Connection Implant System (K051614)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized caduceus or a series of interconnected human profiles. The symbol is black and stands out against the white background of the seal. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 8, 2017 CreoDent Prosthetics, Ltd. Mr. Calvin Shim Managing Director, CreoDent Prosthetics, Ltd. 29 West 30th Street, 11th Floor New York, New York 10001 Re: K162734 Trade/Device Name: CreoDent Solidex® Customized Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: February 24, 2017 Received: March 9, 2017 Dear Mr. Calvin Shim: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely, # Michael J. Ryan -S for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use #### 510(k) Number K162734 Device Name: CreoDent Solidex® Customized Abutment Indication for Use: The CreoDent Solidex® Customized Abutment and Screw is intended for use with an endosseous implant to support a prosthetic device in patents who are partially or completely edentulous. The device can be used for single or multiple restorations. The prosthesis can be cemented or screw retained to the abutment. An abutment screw is used to secure the abutment to the endosseous implant. The Solidex Abutment is compatible with the following dental implants: | Manufacturer | Implant Line | Platform Diameter (mm) | Body Diameter (mm) | Lengths (mm) | |------------------------------------------|------------------------------------------|------------------------|--------------------|---------------------| | Altatec Biotechnolgies N.A. incorporated | Camlog Screwline Implant Promote | 3.3 | 3.3 | 11,13,16 | | Altatec Biotechnolgies N.A. incorporated | Camlog Screwline Implant Promote | 3.8 | 3.8 | 9,11,13,16 | | Altatec Biotechnolgies N.A. incorporated | Camlog Screwline Implant Promote | 4.3 | 3.8 | 9,11,13,16 | | Altatec Biotechnolgies N.A. incorporated | Camlog Screwline Implant Promote | 5 | 4.3 | 9,11,13,16 | | Thommen Medical AG | SPI Element Dental Implants RC INCELL PF | 3.5 | 2.8 | 8,9.5,11,12.5,14,17 | | Thommen Medical AG | SPI Element Dental Implants RC INCELL PF | 4 | 3.5 | 8,9.5,11,12.5,14 | | Thommen Medical AG | SPI Element Dental Implants RC INCELL PF | 4.2 | 3.5 | 8,9.5,11,12.5,14,17 | | Thommen Medical AG | SPI Element Dental Implants RC INCELL PF | 5 | 4.3 | 8,9.5,11,12.5,14 | | Thommen Medical AG | SPI Element Dental Implants RC INCELL PF | 6 | 5.3 | 8,9.5,11,12.5 | | Dentium CO., Ltd | Dentium 3.6mm Implantium | 3.6 | 3.4 | 8,10,12,14 | | Lifecore Biomedical, Inc | PrimaConnex Implants Internal (KeyStone) | 3.5 | 2.4 | 10,11.5,13,15 | | Lifecore Biomedical, Inc | PrimaConnex Implants Internal (KeyStone) | 4.1 | 2.7 | 10,11.5,13,15 | | Lifecore Biomedical, Inc | PrimaConnex Implants Internal (KeyStone) | 5.0 | 3.3 | 8,10,11.5,13 | All digitally designed files for Creodent Solidex Customzied Abutments are to be sent back to a Creodent validated manufacturing facility for manufacture. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-the-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) {3}------------------------------------------------ #### 510(k) Summary #### K162734 #### CreoDent Prosthetics, Ltd. Solidex® Customized Abutment #### Submitter Information Company Name: Company Address: Company Telephone: Company Fax: Contact Person: CreoDent Prosthetics, Ltd. 29 West 30th Street, 11tt Floor New York, New York 10001 (212) 302-3860 (212) 302-3865 Calvin Shim (212) 302-3860 May 8, 2017 Date Summary Prepared: ## DEVICE NAME AND CLASSIFICATION Trade/Proprietary Name: Common Name: Product Code: Classification Panel: Reviewing Branch: CreoDent Solidex® Customized Abutment Endosseous Dental Implant Abutment, 21 CFR 872.3630 NHA Dental Products Panel Dental Devices Branch #### INDICATIONS FOR USE The CreoDent Solidex® Customized Abutment and Screw is intended for use with an endosseous implant to support a prosthetic device in patients who are partially or completely edentulous. The device can be used for single or multiple restorations. The prosthesis can be cemented or screw retained to the abutment. An abutment screw is used to secure the abutment to the endosseous implant. The Solidex® Abutment is compatible with the following dental implants: | Manufacturer | Implant Line | Platform Diameter (mm) | Body Diameter (mm) | Lengths (mm) | |---------------------------------------------|-----------------------------------|------------------------------|--------------------------|--------------| | Altatec Biotechnolgies N.A. incorporated | Camlog Screwline Implant Promote | 3.3 | 3.3 | 11,13,16 | | Altatec Biotechnolgies N.A. incorporated | Camlog Screwline Implant Promote | 3.8 | 3.8 | 9,11,13,16 | | Altatec Biotechnolgies N.A. incorporated | Camlog Screwline Implant Promote | 4.3 | 3.8 | 9,11,13,16 | {4}------------------------------------------------ | Altatec Biotechnolgies N.A. incorporated | Camlog Screwline Implant Promote | 5 | 4.3 | 9,11,13,16 | |---------------------------------------------|---------------------------------------------|-----|-----|---------------------| | Thommen Medical AG | SPI Element Dental Implants RC INCELL PF | 3.5 | 2.8 | 8,9.5,11,12.5,14,17 | | Thommen Medical AG | SPI Element Dental Implants RC INCELL PF | 4 | 3.5 | 8,9.5,11,12.5,14 | | Thommen Medical AG | SPI Element Dental Implants RC INCELL PF | 4.2 | 3.5 | 8,9.5,11,12.5,14,17 | | Thommen Medical AG | SPI Element Dental Implants RC INCELL PF | 5 | 4.3 | 8,9.5,11,12.5,14 | | Thommen Medical AG | SPI Element Dental Implants RC INCELL PF | 6 | 5.3 | 8,9.5,11,12.5 | | Dentium CO., Ltd | Dentium 3.6mm Implantium | 3.6 | 3.4 | 8,10,12,14 | | Lifecore Biomedical, Inc | PrimaConnex Implants Internal (KeyStone) | 3.5 | 2.4 | 10,11.5,13,15 | | Lifecore Biomedical, Inc | PrimaConnex Implants Internal (KeyStone) | 4.1 | 2.7 | 10,11.5,13,15 | | Lifecore Biomedical, Inc | PrimaConnex Implants Internal (KeyStone) | 5.0 | 3.3 | 8,10,11.5,13 | # All digitally designed files for Creodent Solidex Customzied Abutments are to be sent back to a Creodent validated manufacturing facility for manufacture. # DEVICE DESCRIPTION The Solidex® Customized Abutment and Screw is Ti-6A1-4V Eli titanium alloy meets ASTM F-136 standard and is designed to be screw retained for use with endosseous dental implants to provide support for a prosthetic restoration. These abutments are indicated for cement or screw retained restorations. Solidex® Customized Abutments are compatible with: | Manufacturer | Implant Line | Platform Diameter (mm) | Body Diameter (mm) | Lengths (mm) | |---------------------------------------------|---------------------------------------------|------------------------------|--------------------------|---------------------| | Altatec Biotechnolgies N.A. incorporated | Camlog Screwline Implant Promote | 3.3 | 3.3 | 11,13,16 | | Altatec Biotechnolgies N.A. incorporated | Camlog Screwline Implant Promote | 3.8 | 3.8 | 9,11,13,16 | | Altatec Biotechnolgies N.A. incorporated | Camlog Screwline Implant Promote | 4.3 | 3.8 | 9,11,13,16 | | Altatec Biotechnolgies N.A. incorporated | Camlog Screwline Implant Promote | 5 | 4.3 | 9,11,13,16 | | Thommen Medical AG | SPI Element Dental Implants RC INCELL PF | 3.5 | 2.8 | 8,9.5,11,12.5,14,17 | | Thommen Medical AG | SPI Element Dental Implants RC INCELL PF | 4 | 3.5 | 8,9.5,11,12.5,14 | | Thommen Medical AG | SPI Element Dental Implants RC INCELL PF | 4.2 | 3.5 | 8,9.5,11,12.5,14,17 | {5}------------------------------------------------ | Thommen Medical AG | SPI Element Dental Implants RC INCELL PF | 5 | 4.3 | 8,9.5,11,12.5,14 | |--------------------------|---------------------------------------------|-----|-----|------------------| | Thommen Medical AG | SPI Element Dental Implants RC INCELL PF | 6 | 5.3 | 8,9.5,11,12.5 | | Dentium CO., Ltd | Dentium 3.6mm Implantium | 3.6 | 3.4 | 8,10,12,14 | | Lifecore Biomedical, Inc | PrimaConnex Implants Internal (KeyStone) | 3.5 | 2.4 | 10,11.5,13,15 | | Lifecore Biomedical, Inc | PrimaConnex Implants Internal (KeyStone) | 4.1 | 2.7 | 10,11.5,13,15 | | Lifecore Biomedical, Inc | PrimaConnex Implants Internal (KeyStone) | 5.0 | 3.3 | 8,10,11.5,13 | The design of subject device is customized to the requirements of each patient as may be specified by the prescribing dentist. Customization is limited by the minimum dimensions for wall thickness, diameter, post height, collar height and angulation. # EQUIVALENCE TO MARKETED DEVICE The CreoDent Solidex® Customized Abutments are substantially equivalent in intended use, material, design and performance to: Primary Predicate: Creodent Solidex® Customized Abutments (K150012) Reference Predicates: - Inclusive Titanium Abutments for Camlog (K121391) - Atlantis Abutment for Keystone Implants (K103020) - Dentium Implantium and Superline Abutments (K141457) - Milling Abutment for CAD/CAM Dental Abutments (K151984) #### Compatible Implant Systems Clearance numbers: - Camlog Screwline Implant System (K022425) - SPI ELEMENT dental Implants (K030689) ● - Denitum Co., Ltd Implantium (K041368) ● - PrimaConnex Internal Connection Implant System (K051614) ## Comparison to the Predicates The subject device is substantially equivalent in indications and design principles to the predicate devices shown above. Below are summary tables comparing the technological characteristics and the Indications for Use of the subject device abutments and the predicate device abutments. {6}------------------------------------------------ | Technological Characteristics | CreoDent Solidex® Customized Abutment and Abutment Screw | PRIMARY Predicate Device for claimed equivalence: Creodent Solidex Customized Abutment (K150012) | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Material | Abutment and Screw are Ti-6Al-4V Eli titanium alloy meets ASTM F-136 Standard. | Abutment is Ti-6Al-4V Eli titanium alloy meets ASTM F-136 Standard. It is a higher grade material with more tensile strength. The Screw is CP TI Gr4 meets ASTM F67 Standard. | | Performance Characteristics | Allows the prosthesis to be cemented or screw retained to the abutment. The abutment screw is designed to secure the abutment to the endosseous implant. | Allows the prosthesis to be cemented or screw retained to the abutment. The abutment screw is designed to secure the abutment to the endosseous implant. | | Indications for Use | The CreoDent Solidex® Customized Abutment is intended for use with an endosseous implant to support a prosthetic device in patients who are partially or completely edentulous. The device can be used for single or multiple-unit restorations. The prosthesis can be cemented or screw retained to the abutment. An abutment screw is used to secure the abutment to the endosseous implant. The CreoDent Solidex® Customized Abutment is compatible with the following: Camlog Screwline Implant Promte: 3.3mm, 3.8mm, 4.3mm, 5.0mm SPI Element Dental Implants RC INCELL(Thommen): 3.5mm, 4.0mm, 4.2mm, 5.0mm, 6.0mm Dentium Co., Ltd Implantium: 3.6mm Life Core Prima Connex Internal Connection Implant System Tapered (KeyStone): 3.5mm, 4.1mm, 5.0mm All digitally designed files for Creodent Solidex Customzied Abutments are to be sent back to a Creodent validated manufacturing facility for manufacture. | The CreoDent Solidex® Customized Abutment is intended for use with an endosseous implant to support a prosthetic device in patients who are partially or completely edentulous. The device can be used for single or multiple- unit restorations. The prosthesis can be cemented or screw retained to the abutment. An abutment screw is used to secure the abutment to the endosseous implant. The CreoDent Solidex® Customized Abutment is compatible with the following: Biomet 3i Osseotite Certain Dental Implants 3.25mm, 4mm, 5mm, 6mm Straumann Bone Level implants 3.3mm, 4.1mm, 4.8mm | | Dimensions and Angulations | Creodent Solidex Customized Abutment sizes for Camlog Screwline Implant Promte: 3.3mm, 3.8mm, 4.3mm, 5.0mm | Creodent Solidex Customized Abutment sizes for Biomet 3i Osseotite Certain 3.25mm, 4.0mm, 5.0mm and 6.0mm diameter implants. | | SPI Element Dental Implants RC INCELL(Thommen): 3.5mm, 4.0mm, 4.2mm, 5.0mm, 6.0mm Dentium Co., Ltd Implantium: 3.6mm Life Core Prima Connex Internal Connection Implant System Tapered (KeyStone): 3.5mm, 4.1mm, 5.0mm Angles not to exceed up to 20 degrees from the implant axis. | Straumann Bone Level implants 3.3mm, 4.1mm, 4.8mm Angles not to exceed up to 20 degrees from the implant axis. | | Table #1 Legally marketed predicate device (Abutment) to which equivalence is claimed: {7}------------------------------------------------ Non-clinical Testing Data: Static/Fatigue testing was conducted in accordance with ISO 14801:2007E Dentisty-Implants-Dynamic fatigue test for endosseous dental implants with the worst case scenario for the Solidex® Customized Abutment connection platform. Reverse engineering dimensional analysis using OEM compatible implant bodies, abutments, and abutment fixation screws. Sterilization according to ISO 17665-1 was performed. These results demonstrated that the Solidex® customized Abutment have sufficient mechanical strength for their intended clinical application. Substantial Equivalence discussion difference: The differences between the subject device and the Primary predicate is the compatible implant bodies. This comparison is for similarity of device not for implant compatibility. | Technological | CreoDent Solidex® Customized | Reference Predicate Device for | |------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Characteristics | Abutment and Abutment Screw | claimed equivalence: Atlantis | | | | Abutment for Camlog (K022425) | | Material | Abutment and Screw are Ti-6A1-4V Eli titanium alloy meets ASTM F-136 Standard. | -Abutment and Screw: Same Titanium Alloy | | Performance | Allows the prosthesis to be cemented or | Allows the prosthesis to be cemented | | Characteristics | screw retained to the abutment. The abutment screw is designed to secure the abutment to the endosseous implant. | or screw retained to the abutment. The abutment screw is designed to secure the abutment to the endosseous implant. | | Indications for Use | The CreoDent Solidex® Customized Abutment is intended for use with an endosseous implant to support a prosthetic device in patients who are partially or completely edentulous. The device can be used for single or multiple-unit restorations. The prosthesis can be cemented or screw retained to the abutment. An abutment screw is used to secure the abutment to the endosseous implant. The CreoDent Solidex® Customized Abutment is compatible with the following: Camlog Screwline Implant Promte: 3.3mm, 3.8mm, 4.3mm, 5.0mm | Altatec Biotechnologies implants are indicated for single tooth replacement, as immediate abutments on long span to bridgework, as distal abutments on free-end edentulous areas to be restored with fixed bridgework, to support overdentures in total or partially edentulous arches, and as abutments supporting a full arch fixed prosthesis in the totally endentulous mandible or maxilla. | Table #2 Legally marketed predicate device (Abutment) to which equivalence is claimed: {8}------------------------------------------------ | All digitally designed files for Creodent Solidex Customzied Abutments are to be sent back to a Creodent validated manufacturing facility for manufacture. | | | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|----------------------------------------------------------------------------| | Dimensions and Angulations | • Camlog Screwline Implant Promte: 3.3mm, 3.8mm, 4.3mm, 5.0mm | • Camlog Screwline Implant System: 3.3mm, 3.8mm, 4.3mm, 5.0mm, 6.0mm | | | Angles not to exceed up to 20 degrees from the implant axis. | Angles not to exceed up to 30 degrees from the implant axis. | Non-clinical Testing Data: Static/Fatigue testing was conducted in accordance with ISO 14801:2007E Dentistry-Implants-Dynamic fatigue test for endosseous dental implants with the worst case scenario for the Solidex® Customized Abutment connection platform. Reverse engineering dimensional analysis using OEM compatible implant bodies, abutments, and abutment fixation screws. Sterilization according to ISO 17665-1 was performed. These results demonstrated that the Solidex® customized Abutment have sufficient mechanical strength for their intended clinical application and are compatible with the Camlog Screwline Implant system for which they are intended. Substantial Equivalence discussion differences: The only difference between the subject device and the reference predicate is the angulation. This difference is mitigated by fatigue testing, reverse engineering dimensional analysis. | Technological Characteristics | CreoDent Solidex® Customized Abutment and Abutment Screw | Reference Predicate Device for claimed equivalence: Thommen Milling Abutments for CAD/CAM (K151984) | |----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Material | Abutment and Screw are Ti-6A1-4V Eli titanium alloy meets ASTM F-136 Standard. | -Abutment and Screw: Same Titanium Alloy | | Performance Characteristics | Allows the prosthesis to be cemented or screw retained to the abutment. The abutment screw is designed to secure the abutment to the endosseous implant. | Allows the prosthesis to be cemented or screw retained to the abutment. The abutment screw is designed to secure the abutment to the endosseous implant. | | Indications for Use | The CreoDent Solidex® Customized Abutment is intended for use with an endosseous implant to support a prosthetic device in patients who are partially or completely edentulous. The device can be used for single or multiple-unit restorations. The prosthesis can be cemented or screw retained to the abutment. An abutment screw is used to secure the abutment to the | Thommen Milling abutments for CAD/CAM are intended to be used in conjunction with Thommen System dental implants in the maxillary and/or mandibular arch to provide support for crowns, bridges, and over dentures. All digitally designed abutments for use with Thommen Milling abutments | Table #3 Legally marketed predicate device (Abutment) to which equivalence is claimed: {9}------------------------------------------------ | | endosseous implant. The CreoDent Solidex® Customized Abutment is compatible with the following: • SPI Element Dental Implants RC INCELL(Thommen): 3.5mm, 4.0mm, 4.2mm, 5.0mm, 6.0mm All digitally designed files for Creodent Solidex Customzied Abutments are to be sent back to a Creodent validated manufacturing facility for manufacture. | for CAD/CAM are intended to be sent to a Thommen validated milling center for manufacture. | |----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------| | Dimensions and Angulations | Solidex Abutment sizes for • SPI Element Dental Implants RC INCELL(Thommen): 3.5mm, 4.0mm, 4.2mm, 5.0mm, 6.0mm Angles not to exceed up to 20 degrees from the implant axis. | Thommen SPI Implants 3.5mm, 4.0mm, 4.5mm, 5.0mm, 6.0mm Angles not to exceed up to 30 degrees from the implant axis. | Non-clinical Testing Data: Static/Fatigue testing was conducted in accordance with ISO 14801:2007E Dentistry-Implants-Dynamic fatigue test for endosseous dental implants with the worst case scenario for the Solidex® Customized Abutment connection platform. Reverse engineering dimensional analysis using OEM compatible implant bodies, abutments, and abutment fixation screws. Sterilization according to ISO 17665-1 was performed. These results demonstrated that the Solidex® customized Abutment have sufficient mechanical strength for their intended clinical application and are compatible with the SPI Element Dental Implant (Thommen) system for which they are intended. Substantial Equivalence discussion differences: The only difference between the subject device and the reference predicate is the angulation. This difference is mitigated by fatigue testing, reverse engineering dimensional analysis. Table #4 Legally marketed predicate device (Abutment) to which equivalence is claimed: | Technological Characteristics | CreoDent Solidex® Customized Abutment and Abutment Screw | Reference Predicate Device for claimed equivalence: Dentium Implantium Dental Abutments (K052823) | |----------------------------------|--------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------| | Material | Abutment and Screw are Ti-6A1-4V Eli titanium alloy meets ASTM F-136 Standard. | -Abutment and Screw: Comparable Titanium | | Performance | Allows the prosthesis to be cemented or | Allows the prosthesis to be cemented | {10}------------------------------------------------ | Characteristics | screw retained to the abutment. The abutment screw is designed to secure the abutment to the endosseous implant. | or screw retained to the abutment. The abutment screw is designed to secure the abutment to the endosseous implant. | |----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | The CreoDent Solidex® Customized Abutment is intended for use with an endosseous implant to support a prosthetic device in patients who are partially or completely edentulous. The device can be used for single or multiple-unit restorations. The prosthesis can be cemented or screw retained to the abutment. An abutment screw is used to secure the abutment to the endosseous implant. The CreoDent Solidex® Customized Abutment is compatible with the following: • Dentium Co., Ltd Implantium: 3.6mm All digitally designed files for Creodent Solidex Customzied Abutments are to be sent back to a Creodent validated manufacturing facility for manufacture. | The Implantium abutments are intended to be used with Implantium root form endosseous dental implant to aid in prosthetic rehabilitation including overdenture retention. After the root for endosseous dental implant is surgically placed, the endosseous dental implant abutment device is attached to it. | | Dimensions and Angulations | Solidex Abutment sizes for • Dentium Co., Ltd Implantium: 3.6mm Angles not to exceed up to 20 degrees from the implant axis. | • Dentium Co., Ltd Implantium: 3.6mm- 4.8mm Angles not to exceed up to 20 degrees from the implant axis. | Non-clinical Testing Data: Static/Fatigue testing was conducted in accordance with ISO 14801:2007E Dentistry-Implants-Dynamic fatigue test for endosseous dental implants with the worst case scenario for the Solidex® Customized Abutment connection platform. Reverse engineering dimensional analysis using OEM compatible implant bodies, abutments, and abutment fixation validation according to ISO 17665-1 was performed. These results demonstrated that the Solidex® customized Abutment have sufficient mechanical strength for their intended clinical and are compatible with the Dentium Co., Ltd Implantium system for which thev are intended. Substantial Equivalence discussion difference: The only differences between the subject device and the reference predicate is that Dentium abutments are stock abutments verse Solidex Customized Abutments. Table #5 Legally marketed predicate device (Abutment) to which equivalence is claimed: | Technological Characteristics | CreoDent Solidex® Customized Abutment and Abutment Screw | Reference Predicate Device for claimed equivalence: Atlantis | |--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | Abutment for Keystone Implant (K103020) | | Material | Abutment and Screw are Ti-6A1-4V Eli titanium alloy meets ASTM F-136 Standard. | -Abutment and Screw: Same Titanium Alloy | | Performance Characteristics | Allows the prosthesis to be cemented or screw retained to the abutment. The abutment screw is designed to secure the abutment to the endosseous implant. | Allows the prosthesis to be cemented or screw retained to the abutment. The abutment screw is designed to secure the abutment to the endosseous implant. | | Indications for Use | The CreoDent Solidex® Customized Abutment is intended for use with an endosseous implant to support a prosthetic device in patients who are partially or completely edentulous. The device can be used for single or multiple-unit restorations. The prosthesis can be cemented or screw retained to the abutment. An abutment screw is used to secure the abutment to the endosseous implant. The CreoDent Solidex® Customized Abutment is compatible with the following: Life Core Prima Connex Internal Connection Implant System Tapered (KeyStone): 3.5mm, 4.1mm, 5.0mm All digitally designed files for Creodent Solidex Customzied Abutments are to be sent back to a Creodent validated manufacturing facility for manufacture. | The Atlantis Abutment is intended for use as an accessory to an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The Prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant. This device is compatible with the following manufacturers' implant systems: The titanium abutments are compatible with the Keystone 3.5mm, 4.0mm, 4.1mm and 5.0mm Keystone Implants. The zirconia abutments are compatible with the Keystone 3.5mm, 4.0mm, 4.1mm and 5.0mm Keystone Implants. Please note: This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional. Highly angled abutments on small diameter implants are intended for the anterior region only. | | Dimensions and Angulations | Life Core Prima Connex Internal Connection Implant System Tapered (KeyStone): 3.5mm, 4.1mm, 5.0mm | Life Core Prima Connex Internal Connection Implant System (KeyStone): 3.5mm, 4.1mm, 5.0mm | | Angles not to exceed up to 20 degrees from | Angles not to exceed up to 30 degrees | | | the implant axis. | from the implant axis. | | {11}------------------------------------------------ {12}------------------------------------------------ Non-clinical Testing Data: Static/Fatigue testing was conducted in accordance with ISO 14801:2007E Dentistry-Implants-Dynamic fatigue test for endosseous dental implants with the worst case scenario for the Solidex® Customized Abutment connection platform. Reverse engineering dimensional analysis using OEM compatible implant bodies, abutments, and abutment fixation screws. Sterilization according to ISO 17665-1 was performed. These results demonstrated that the Solidex® customized Abutment have sufficient mechanical strength for their intended clinical application and are compatible with the Life Core Prima Connex Internal Connection Implant System for which they are intended. Substantial Equivalence discussion: The only difference between the subject device and the reference predicate is the angulation. This difference is mitigated by fatigue testing, reverse engineering dimensional analysis. | Compatible Device | Implant Diameters | Implant Lengths | |--------------------------------------|-------------------|-----------------------------| | Camlog Screwline Implants Promote | 3.3mm | 11mm 13mm 16mm | | Camlog Screwline Implants Promote | 3.8mm | 9mm 11mm 13mm 16mm | | Camlog Screwline Implants Promote | 4.3mm | 9mm 11mm 13mm 16mm | | Camlog Screwline Implants Promote | 5.0mm | 9mm 11mm 13mm 16mm | ## The CreoDent Solidex® Customized Abutment is compatible with the following: | Compatible Device | Implant Diameters | Implant Lengths | |----------------------------------------------------|-------------------|-----------------| | SPI Element Dental Implants RC INCELL (Thommen) | 3.5mm | 8mm | | | | 9.5mm | | | | 11mm | | | | 12.5mm | | | | 14mm | | | | 17mm | | SPI Element Dental Implants RC INCELL (Thommen) | 4.0mm | 8mm | | | | 9.5mm | | | | 11mm | | | | 12.5mm | | | | 14mm | | SPI Element Dental Implants RC | 4.2mm | 8mm | | | | 9.5mm | {13}------------------------------------------------ | INCELL (Thommen) | | 11mm | |----------------------------------------------------|-------|--------| | | | 12.5mm | | | | 14mm | | | | 17mm | | SPI Element Dental Implants RC INCELL (Thommen) | 5.0mm | 8mm | | | | 9.5mm | | | | 11mm | | | | 12.5mm | | | | 14mm | | SPI Element Dental Implants RC INCELL (Thommen) | 6.0mm | 8mm | | | | 9.5mm | | | | 11mm | | | | 12.5mm | | Compatible Device | Implant Diameters | Implant Lengths | |------------------------------|-------------------|-----------------| | Dentium Co., Ltd Implantium: | 3.6mm | 8mm | | | | 10mm | | | | 12mm | | | | 14mm | | Compatible Device | Implant Diameters | Implant Lengths | |------------------------------------------------------------------------------------|-------------------|-----------------| | Life Core Prima Connex Internal Connection Implant System Tapered (KeyStone) | 3.5mm | 10mm | | | | 11.5mm | | | | 13mm | | | | 15mm | | Life Core Prima Connex Internal Connection Implant System Tapered (KeyStone) | 4.1mm | 10mm | | | | 11.5mm | | | | 13mm | | | | 15mm | | Life Core Prima Connex Internal Connection Implant System Tapered (KeyStone) | 5.0mm | 8mm | | | | 10mm | | | | 11.5mm | | | | 13mm | CONCLUSION: {14}------------------------------------------------ Solidex Customized Abutments incorporates the same material, similar indications for use, dimension, design, abutment seat, screw seat, anatomical site, connection, type of retention and technological characteristics as the predicate device. Both the subject and predicate device share intended use, namely to serve as an aid in prosthetic reconstructions, such as crowns and bridges Also both the predicate and subject devices are intended to be milled into patient specific abutments using CAD/CAM technology. The only difference is the implant platform which has been validated through fatigue testing and reverse engineering dimensional analysis. Any differences in technology characteristics are accompanied by information that demonstrated the device is substantially equivalent as the predicate. The Solidex Customized abutments constitute a substantially equivalent medical device, meeting all the declared requirements of its intended use. This system has the same intended use and fundamental scientific technology as its predicate device. Therefore, Solidex Customized abutments and its predicate are substantially equivalent.

CreoDent Solidex Customized Abutment

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Reference Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

CreoDent Solidex Customized Abutment

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Reference Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

Create Alert

Search Filters

Agent Token

Connected apps

Welcome

Check your email

Welcome!