(150 days)
No
The document describes a customized dental abutment based on patient requirements specified by a dentist, with no mention of AI or ML in the design or manufacturing process.
No.
The device is an abutment for a dental implant, which supports a prosthetic device. It is not intended to treat or cure a disease or condition itself, but rather to aid in the restoration of dental function.
No
The device is an abutment for dental implants, used to support prosthetic devices, not to diagnose conditions.
No
The device description explicitly states the device is made of Ti-6A1-4V Eli titanium alloy and CP TI Gr4, which are physical materials, not software. The performance studies also involve static/fatigue testing of a physical device.
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 the mouth of patients who are partially or completely edentulous. This is a direct clinical application within the body.
- Device Description: The description details a physical implant component made of titanium alloy, designed to be surgically placed and support a dental prosthesis.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Clinical Application: The entire context describes a device used in a surgical and restorative dental procedure, not a laboratory or diagnostic test.
IVD devices are used in vitro (outside the body) to analyze samples (like blood, urine, tissue) to diagnose or monitor medical conditions. This device is used in vivo (within the body) as a structural component of a dental restoration.
N/A
Intended Use / 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 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 is compatible with the following:
- Biomet 3i Osseotite Certain Dental Implants 3.25mm, 4.0mm, 5.0mm, 6.0mm
- Straumann Bone Level Implants 3.3mm, 4.1mm, 4.8mm
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The Solidex® Customized Abutment is Ti-6A1-4V Eli titanium alloy meets ASTM F-136 Standard and Screw is CP TI Gr4 meets ASTM F67 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 compatibe with:
- Biomet 3i Osseotite Certain 3.25mm, 4.0mm, 6.0mm diameter implants K063341.
- Straumann Bone Level implants 3.3mm, 4.1mm, 4.8mm K083550 K121131.
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, 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 compatible implant fixtures and sterilization validation 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 Biomet 3i Osseotite Certain and Straumann Bone level Dental implant system for which they are intended.
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 compatible implant fixtures and sterilization validation 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 Biomet 31 Osseotite Certain Dental implant system for which they are intended.
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 compatible implant fixtures and sterilization 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 Straumann Bone Level implant system for which they are intended.
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.
K101608, K082764, K063341, K083550, K121131
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 black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three abstract human profiles facing right, with flowing lines extending from the bottom profile.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 4, 2015
CreoDent Prosthetics, Ltd. Mr. Calvin Shim Managing Director 29 West 30th Street, 11th Floor New York, New York 10001
Re: K150012
Trade/Device Name: CreoDent Solidex® Customized Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: May 4, 2015 Received: May 5, 2015
Dear Mr. 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.
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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" (21 CFR 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 yours,
Tina
Kiang-S
for Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Premarket Notification Section 4: Page - 10
Indications for Use
510(k) Number (if known)___K150012
Device Name: CreoDent Solidex® Customized Abutment
Indication 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 endentulous. The device can be used for sinqle 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, 4.0mm, 5.0mm, 6.0mm
- o Straumann Bone Level Implants 3.3mm. 4.1mm. 4.8mm
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
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, 11th Floor New York, New York 10001 (212) 302-3860 (212) 302-3865 Calvin Shim (212) 302-3860 June 4, 2015
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 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 is compatible with the following:
- . Biomet 3i Osseotite Certain Dental Implants 3.25mm, 4.0mm, 5.0mm, 6.0mm..
- . Straumann Bone Level implants 3.3mm, 4.1mm, 4.8mm
4
DEVICE DESCRIPTION
The Solidex® Customized Abutment is Ti-6A1-4V Eli titanium alloy meets ASTM F-136 Standard and Screw is CP TI Gr4 meets ASTM F67 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 compatibe with:
- Biomet 3i Osseotite Certain 3.25mm, 4.0mm, 6.0mm diameter implants K063341 .
- Straumann Bone Level implants 3.3mm, 4.1mm, 4.8mm K083550 K121131 .
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, 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 Customlized Abutments (K113738) о
- . Reference Predicates
Conclusion:
The Creodent Solidex® Customized Abutments are substantially equivalent to the identified predicate products noted in this 510K Summary.
5
| Technological
Characteristics | CreoDent Solidex® Customized
Abutment and Abutment Screw | Primary Predicate Device for
claimed equivalence: Creodent
Solidex Customized Abutment
(K113738) |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Material | Abutment is Ti-6A1-4V 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. | -Abutment and Screw: are CP Ti Gr4
and meets ASTM F67 standard.
The Screw is exactly the same
titanium alloy but the abutment is a
lower grade(less tensile strength)
titanium alloy compared to Ti-6A1-4V
ASTM F-136 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:
Biomet 3i Osseotite Certain Dental
Implants 3.25mm, 4mm, 5mm, 6mm Straumann Bone Level implants
3.3mm, 4.1mm, 4.8mm | 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 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 is compatible with the following:
Nobel Replace™ TiUnite Endosseous
3.5mm (NP), 4.3mm (RP), and 5.0mm
(WP) diameter implants.
Nobel Active™ Internal Connection
3.5mm (NP) and 4.3mm (RP) diameter
implants. Zimmer Screw-Vent 3.7mm,
4.7mm; Zimmer Tapered Screw-Vent
3.7mm (NP), 4.7mm (RP) and 6.0mm
diameter implants. |
| Dimensions
and
Angulations | 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 | Abutment sizes for Nobel Replace™
TiUnite Endosseous 3.5mm (NP), 4.3mm
(RP), and 5.0mm (WP) diameter implants.
Nobel Active™ Internal Connection
3.5mm (NP) and 4.3mm (RP) diameter
implants. Zimmer Screw-Vent 3.7mm,
4.7mm; Zimmer Tapered Screw-Vent
3.7mm (NP), 4.7mm (RP) and 6.0mm |
| the implant axis. | diameter implants. | |
| | Angles not to exceed up to 20 degrees
from the implant axis. | |
Table #1 Legally marketed predicate device (Abutment) to which equivalence is claimed:
6
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 compatible implant fixtures and sterilization validation 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 Biomet 3i Osseotite Certain and Straumann Bone level Dental implant system for which they are intended.
Substantial Equivalence discussion: The difference between the subject device and the Primary predicate is the compatible implant bodies. This difference is mitigated by fatigue testing, reverse engineering dimensional analysis, and identification of reference predicate for compatible implant bodies. The difference between the subiect device and the primary predicate abutment is the titanium grade. The subject device is a higher grade titanium alloy that exhibits higher tensile strength. The difference is mitigated by fatigue testing. The screw material is exactly the same.
| Technological
Characteristics | CreoDent Solidex® Customized
Abutment and Abutment Screw | Reference Predicate Device for
claimed equivalence: Biomet 3i
Encode Patient Specific Dental
Abutment (K101608) |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Material | Abutment is Ti-6A1-4V Eli titanium alloy
meets ASTM F-136 Standard and Screw is
CP TI Gr4 meets ASTM F67 Standard | -Abutment and Screw: Comparable
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:
• Biomet 3i Osseotite Certain Dental
Implants 3.25mm, 4mm, 5mm, 6mm | Encode Patient Specific Dental
abutments made from Oral scans
provided from Lava Chair Scanner
and the 3M lava COS (2.0) software
are intended for use as an accessory to
endosseous dental implants to support
a prosthetic device in a partially or
edentulous patient. Encode Patient
specific dental abutments are intended
for use to support single and multiple
tooth prostheses, in the mandible or
maxilla. The prostheses can be screw
or cement retained. |
| Dimensions | Creodent Solidex Customized Abutment sizes | Biomet 3i Encode Abutment sizes for |
Table #2 Legally marketed predicate device (Abutment) to which equivalence is claimed:
7
| and
Angulations | for Biomet 3i Osseotite Certain 3.25mm,
4.0mm, 5.0mm and 6.0mm diameter implants.
Angles not to exceed up to 20 degrees from
the implant axis. | Biomet 3i Osseotite Certain 3.25mm,
4.0mm, 5.0mm, 6.0mm diameter
implants.
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 compatible implant fixtures and sterilization validation 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 Biomet 31 Osseotite Certain Dental implant system for which they are intended.
Substantial Equivalence discussion: The 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: Straumann
Cares Titanium Abutment
(K082764) |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Material | Abutment is Ti-6A1-4V Eli titanium alloy
meets ASTM F-136 Standard and Screw is
CP TI Gr4 meets ASTM F67 Standard | -Abutment and Screw: Comparable
Titanium |
| 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:
Straumann Bone Level implants
3.3mm, 4.1mm, 4.8mm | Abutments are placed into the dental
implants to provide support for
prosthetic restoration such as crowns
or bridges. The Straumann WN Cares
Titanium Abutment is indicated for
single tooth replacement and multiple
tooth restorations. The prosthetic
restoration is cement retained. |
| Dimensions
and | Solidex Abutment sizes for Straumann Bone
Level implants 3.3mm, 4.1mm, 4.8mm | Straumann Cares Abutment sizes for
Straumann Bone Level implants 3.3mm,
4.1mm, 4.8mm |
Table #3 Legally marketed predicate device (Abutment) to which equivalence is claimed:
8
| Angulations | 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 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 compatible implant fixtures and sterilization 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 Straumann Bone Level implant system for which they are intended.
Substantial Equivalence discussion: The difference between the subject device and the reference predicate is the angulation. This difference is mitigated by fatigue testing, reverse engineering dimensional analysis.
Table #3 Legally marketed predicate device (Implant) to which compatibility is claimed for the Solidex® Customized Abutment:
| Compatible Device | Implant Diameters | Implant Lengths |
|---|---|---|
| Biomet 3i Osseotite Certain | ||
| implants. (K063341) | 3.25mm | 8.5mm |
| 3.25mm | 10.0mm | |
| 3.25mm | 11.5mm | |
| 3.25mm | 13mm | |
| 3.25mm | 15mm | |
| Biomet 3i Osseotite Certain | ||
| dental implants. (K063341) | 4.0mm | 8.5mm |
| 4.0mm | 10.0mm | |
| 4.0mm | 11.5mm | |
| 4.0mm | 13mm | |
| 4.0mm | 15mm | |
| Biomet 3i Osseotite Certain | ||
| dental implants. (K063341) | 5.0mm | 8.5mm |
| 5.0mm | 10.0mm | |
| 5.0mm | 11.5mm | |
| 5.0mm | 13mm | |
| 5.0mm | 15mm | |
| Biomet 3i Osseotite Certain | ||
| Dental Implants (K063341) | 6.0mm | 8.5mm |
| 10.0mm | ||
| 11.5mm | ||
| 13mm | ||
| 15mm |
Table #4 Legally marketed predicate device (Implant) to which compatibility is claimed for the Solidex® Customized Abutment:
| Compatible Device | Implant Diameters | Implant Lengths |
|---|---|---|
| ------------------- | ------------------- | ----------------- |
9
Premarket Notification Section 5: Page 11
| Straumann Bone Level implants
(K083550) | 3.3mm
3.3mm
3.3mm
3.3mm | 8.0mm
10.0mm
12mm
14mm |
|--------------------------------------------|----------------------------------|---------------------------------|
| Straumann Bone Level implants
(K121131) | 4.1mm
4.1mm
4.1mm
4.1mm | 8.0mm
10.0mm
12mm
14mm |
| Straumann Bone Level implants
(K121131) | 4.8mm
4.8mm
4.8mm
4.8mm | 8.0mm
10.0mm
12mm
14mm |