(140 days)
No
The summary describes a customized dental abutment and screw, focusing on material, compatibility, and mechanical testing. There is no mention of AI or ML in the intended use, device description, or performance studies. The customization is described as being based on dentist specifications and limited by physical dimensions, not algorithmic processing.
No
The device, a customized abutment and screw, is used to support a prosthetic device on dental implants, rather than directly treating a disease or condition. It serves as a component of a restorative dentistry procedure.
No
The device is an abutment and screw used to support a prosthetic dental device, not to diagnose a condition.
No
The device description explicitly states the device is made of Ti-6A1-4V Eli titanium alloy and describes physical characteristics and testing related to mechanical strength and dimensions, 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, used with an endosseous implant. This is a direct clinical application within the body, not a test performed on samples taken from the body.
- Device Description: The description details a physical implant component made of titanium alloy, designed to be surgically placed and support a dental restoration. This is consistent with a medical device, not an IVD.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
- Reagents, calibrators, or controls
The device is a medical device used in dental surgery and prosthetics.
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 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 and Screw are compatible with the following: - Straumann Tissue Level Standard Plus RN 3.3 and WN 6.5 ●
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 Abutment and Screw are compatible with: - . Straumann Tissue Level Standard Plus RN 3.3 and WN 6.5 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 and maximum dimensions for wall thickness, diameter, height, collar height and angulation. The Solidex® Customized Abutment and Screw is CAD/CAM Patient Specific machine manufactured per prescription received from a dentist. The dentist will specify the implant type and size. Upon receiving the prescription from the dentist. CreoDent will only manufacture Solidex® Customized Abutment and Screw for which they have received FDA 510K clearance. Safe guards and limitation in the design software will be imposed according to specified design limitations built into abutment designer. Abutment blanks for each implant platform are produced to CreoDent Prosthetics, Ltd. specifications in Ti-6A1-4V Eli titanium alloy and Screw is CP TI Gr4 supplied by T.Strong INC, a Korean company located at 403, 433-8, Jangan-dong, Dongdeamun-gu, Seoul 130-100, Republic of Korea. T.Strong.INC obtains the abutment blank and screw materials from suppliers in the USA. All abutment blanks have prefabricated interfaces. CreoDent custom mills the non-interface portion of the abutment. T.Strong INC obtains titanium alloy and c.p. titanium from US suppliers and mills the abutment-to-implant connection platform according to the design specifications provided by CreoDent Prosthetics, Ltd. CreoDent Prosthetics finalizes the abutment device, according to a prescription provided by a dentist at the registered and listed CreoDent manufacturing facility in New York.
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 Dentistry-Implants-Dynamic fatigue test for endosseous dental implants with the worst case scenario for the Solidex® Customized Abutment and Screw connection platform. Reverse engineering dimensional analysis was conducted using OEM implant bodies, OEM abutments and OEM abutment screws. Sterilization was conducted according to ISO 17665-1 was performed. These results demonstrated that the Solidex® Customized Abutment and Screw have sufficient mechanical strength for their intended clinical application and are compatible with Straumann Tissue Level Standard Plus RN 3.3 and WN 6.5 for which they are intended. Biocompatibility information is leveraged from our previous 510k (K150012).
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.
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.)
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
CreoDent Prosthetics, Ltd. Calvin Shim Managing Director 29 West 30th Street, 11th Floor New York, New York 10001
Re: K202095
Trade/Device Name: CreoDent Solidex® Customized Abutment and Screw Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: November 11, 2020 Received: November 16, 2020
Dear 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Andrew Steen Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number K202095
Device Name: CreoDent Solidex® Customized Abutment and Screw
Indication 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-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 and Screw are compatible with the following:
- Straumann Tissue Level Standard Plus RN 3.3 and WN 6.5 ●
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)
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510(k) Summary K202095 CreoDent Prosthetics, Ltd. Solidex® Customized Abutment and Screw
Submitter Information
Company Name: Company Address:
Company Telephone: Company Fax: Contact Person:
Date Summary Prepared:
CreoDent Prosthetics, Ltd. 29 West 30th Street, 11th Floor New York, New York 10001 (212) 302-3860 (212) 302-3865 Calvin Shim (212) 302-3860 December 3, 2020
DEVICE NAME AND CLASSIFICATION
Trade/Proprietary Name:
Common Name:
Product Code: Classification Panel: Reviewing Branch:
INDICATIONS FOR USE
CreoDent Solidex® Customized Abutment and Screw Endosseous Dental Implant Abutment, 21 CFR 872.3630 NHA Dental Products Panel Dental Devices Branch
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-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 and Screw are compatible with the following:
- Straumann Tissue Level Standard Plus RN 3.3 and WN 6.5 ●
4
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 Abutment and Screw are compatible with:
- . Straumann Tissue Level Standard Plus RN 3.3 and WN 6.5
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 and maximum dimensions for wall thickness, diameter, height, collar height and angulation.
| Straumann Tissue Level
| Standard Plus | RN 3.3mm | WN 6.5mm | ||
|---|---|---|---|---|
| Max Diameter | 5mm from Implant Axis | 5mm from Implant Axis | ||
| Min Wall thickness | .68mm | .68mm | ||
| Max | Min | Max | Min | |
| Height | 10mm | 5mm | 10mm | 5mm |
| Collar Height | 5mm | 1mm | 5mm | 1mm |
| Post Height | 9mm | 4mm | 9mm | 4mm |
| Degree of Angulation | 20 | 0 | 20 | 0 |
CAD/CAM Work Flow
The Solidex® Customized Abutment and Screw is CAD/CAM Patient Specific machine manufactured per prescription received from a dentist. The dentist will specify the implant type and size. Upon receiving the prescription from the dentist. CreoDent will only manufacture Solidex® Customized Abutment and Screw for which they have received FDA 510K clearance. Safe guards and limitation in the design software will be imposed according to specified design limitations built into abutment designer. Abutment blanks for each implant platform are produced to CreoDent Prosthetics, Ltd. specifications in Ti-6A1-4V Eli titanium alloy and Screw is CP TI Gr4 supplied by T.Strong INC, a Korean company located at 403, 433-8, Jangan-dong, Dongdeamun-gu, Seoul 130-100, Republic of Korea. T.Strong.INC obtains the abutment blank and screw materials from suppliers in the USA. All abutment blanks have prefabricated interfaces. CreoDent custom mills the non-interface portion of the abutment.
T.Strong INC obtains titanium alloy and c.p. titanium from US suppliers and mills the abutment-to-implant connection platform according to the design specifications provided by CreoDent Prosthetics, Ltd. CreoDent Prosthetics finalizes the abutment device, according to a prescription provided by a dentist at the registered and listed CreoDent manufacturing facility in New York.
5
EQUIVALENCE TO MARKETED DEVICE
The CreoDent Solidex® Customized Abutments are substantially equivalent in intended use, material, design and performance to:
- CreoDent Solidex Customized Abutments (K150012) Primary Predicate
- . Straumann Tissue Level Standard Plus RN 3.3 and WN 6.5 (K171784)
Conclusion:
The CreoDent Solidex® Customized Abutment and Screw are substantially equivalent to the identified predicate products noted in this 510K Summary.
| 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 and Screw is intended for use
with an endosseous implant to support a
prosthetic device in patients who are
partially or completely endentulous. 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 and Screw are compatible with
the following: | 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: |
| | Straumann Tissue Level Standard
Plus RN 3.3 and WN 6.5 | Biomet 3i Osseotite Certain Dental
Implants 3.25mm, 4mm, 5mm,
6mm |
Table #1 Legally marketed predicate device (Abutment) to which equivalence is claimed:
6
| Straumann Bone Level implants 3.3mm, 4.1mm, 4.8mm | ||
|---|---|---|
| Dimensions and Angulations | CreoDent Solidex Customized Abutment and Screw sizes for Straumann Tissue Level Standard Plus RN 3.3 and WN 6.5 Angles not to exceed up to 20 degrees from the implant axis. | CreoDent Solidex Customized Abutment sizes for Biomet 3i Osseotite Certain 3.25mm, 4.0mm, 5.0mm and 6.0mm diameter implants. |
| Straumann Bone Level implants 3.3mm, 4.1mm, 4.8mm | ||
| Angles not to exceed up to 20 degrees from the implant axis. |
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
Characteristics | CreoDent Solidex® Customized
Abutment and Abutment Screw | Reference Predicate Device for
claimed equivalence: Straumann
Tissue Level Standard Plus RN 3.3
and WN 6.5 (K171784) |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Material | Abutment and Screw are Ti-6A1-4V Eli
titanium alloy meets ASTM F-136
Standard. | Abutment and Screw are Ti-6Al-7Nb
titanium alloy(TAN) |
| 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 and Screw is intended for use
with an endosseous implant to support a
prosthetic device in patients who are
partially or completely endentulous. 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. | Abutments are placed into the dental
implants to provide support for prosthetic
restoration such as crowns, bridges and
overdentures.
Titanium Abutment is indicated for
cemented restoration. The abutment can be
used in single tooth replacements and
multiple tooth restorations |
| | The CreoDent Solidex® Customized
Abutment and Screw are compatible with
the following:
Straumann Tissue Level Standard
Plus RN 3.3 and WN 6.5 | |
Table #2 Legally marketed predicate device (Abutment) to which equivalence is claimed:
7
| Dimensions
and
Angulations | CreoDent Solidex Customized Abutment
and Screw sizes for
Straumann Tissue Level Standard Plus RN 3.3 and WN 6.5 Angles not to exceed up to 20 degrees from the implant axis. | Straumann Abutment sizes for Straumann Tissue Level Implants RN 3.3mm and WN 6.5mm
Angles not to exceed up to 30 degrees from the implant axis. |
| ---------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
Substantial Equivalence discussion differences: The only difference between the subject device and the reference predicate is the maximum angulation. Solidex Customized abutments have a less extreme maximum angulation. The difference is also mitigated by fatigue testing and reverse engineering dimensional analysis.
| Compatible Device | Implant Diameters | Implant Lengths |
|---|---|---|
| Straumann Tissue Level | ||
| Standard Plus | RN 3.3mm | 6 mm |
| 8 mm | ||
| 10 mm | ||
| 12 mm | ||
| 14 mm | ||
| WN 6.5mm | 6 mm | |
| 8 mm | ||
| 10 mm | ||
| 12 mm |
The CreoDent Solidex® Customized Abutment is compatible with the following:
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 and Screw connection platform. Reverse engineering dimensional analysis was conducted using OEM implant bodies, OEM abutments and OEM abutment screws. Sterilization was conducted according to ISO 17665-1 was performed. These results demonstrated that the Solidex® Customized Abutment and Screw have sufficient mechanical strength for their intended clinical application and are compatible with Straumann Tissue Level Standard Plus RN 3.3 and WN 6.5 for which they are intended. Biocompatibility information is leveraged from our previous 510k (K150012).
CONCLUSION:
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 (K150012). Both the subject and predicate device share intended use. The only significant difference between the devices is the implant platform compatibility which has been mitigated through dynamic fatigue testing and 3rd party compatibility testing. The Solidex Customized abutments are substantially equivalent to the predicate (K150012).