(220 days)
No
The summary describes a customized dental abutment and screw made of titanium alloy. The customization is based on patient requirements specified by a dentist, not through automated AI/ML processes. There are no mentions of AI, ML, image processing, or data sets typically associated with AI/ML device descriptions.
No.
The device is an abutment and screw used to support a prosthetic device in patients with dental implants, which is a restorative rather than therapeutic function.
No
This device is a dental abutment intended to support a prosthetic device. Its function is mechanical support, not to diagnose a medical condition or disease.
No
The device description explicitly states the device is made of Ti-6A1-4V Eli titanium alloy and describes physical characteristics and testing, indicating it is a physical medical device, not software-only.
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 supporting a prosthetic device in patients who are partially or completely edentulous. This is a therapeutic and restorative purpose, not a diagnostic one.
- Device Description: The description details a physical implant component (abutment and screw) made of titanium alloy. This is a medical device used in a surgical procedure, not a reagent or instrument used to examine specimens from the human body.
- Lack of IVD Indicators: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status, disease, or condition
- Using reagents or assays
- Performing tests in a laboratory setting
The device described is a dental implant component used in a surgical and restorative procedure.
N/A
Intended Use / Indications 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.
Product codes (comma separated list FDA assigned to the subject device)
NHA
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 |
| 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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: 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.
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.
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.
K121391, K103020, K141457, K151984
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/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.