CreoDent Solidex Customized Abutment
Device Facts
| Record ID | K150012 |
|---|---|
| Device Name | CreoDent Solidex Customized Abutment |
| Applicant | Creodent Prosthetics, Ltd. |
| Product Code | NHA · Dental |
| Decision Date | Jun 4, 2015 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3630 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended 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.
Device Story
Customized dental abutment; interfaces with endosseous implants to support prosthetic restorations (crowns/bridges). Input: patient-specific anatomical requirements specified by dentist. Operation: abutment secured to implant via screw; prosthesis cemented or screw-retained to abutment. Used in dental clinics by dentists. Benefits: provides customized support for prosthetic restorations in edentulous patients. Material: Ti-6Al-4V ELI titanium alloy abutment; CP Ti Gr4 screw.
Clinical Evidence
Bench testing only. Static and fatigue testing performed per ISO 14801:2007E to evaluate mechanical strength under worst-case connection scenarios. Reverse engineering dimensional analysis confirmed compatibility with specified Biomet 3i and Straumann implant systems. Sterilization validation performed per ISO 17665-1.
Technological Characteristics
Abutment: Ti-6Al-4V ELI titanium alloy (ASTM F-136). Screw: CP Ti Gr4 (ASTM F-67). Custom-manufactured based on patient requirements. Max angulation 20 degrees from implant axis. Compatible with specific Biomet 3i and Straumann implant platforms. Sterilization: ISO 17665-1 compliant.
Indications for Use
Indicated for partially or completely edentulous patients requiring single or multiple-unit prosthetic restorations supported by endosseous dental implants.
Regulatory Classification
Identification
An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.
Special Controls
*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)
Predicate Devices
- Creodent Solidex Customized Abutments (K113738)
Reference Devices
- Biomet 3i Encode Patient Specific Dental Abutments (K101608)
- Straumann Cares Titanium Abutments (K082764)
- 3i Osseotite Certain Dental Implants (K063341)
- Modified Dental Implant (K083550)
- Straumann Bone Level Ø4.1mm and Ø 4.8mm Regular Connection (RC) Roxolid Dental Implants (K121131)
Related Devices
- K162734 — CreoDent Solidex Customized Abutment · Creodent Prosthetics, Ltd. · May 8, 2017
- K183106 — TruAbutment DS · Truabutment, Inc. · Jan 29, 2020
- K202095 — CreoDent Solidex Customized Abutment and Screw · Creodent Prosthetics, Ltd. · Dec 16, 2020
- K223634 — Customized Abutment · Arum Dentistry Co., Ltd. · Apr 28, 2023
- K234112 — Customized Abutment · Arum Dentistry Co., Ltd. · May 9, 2024
Submission Summary (Full Text)
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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.
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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
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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)
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K150012
## 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
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# 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
- Biomet 3i Encode Patient Specific Dental Abutments (K101608) o
- o Straumann Cares Titanium Abutments (K082764)
- 3i Osseotite Certain Dental Implants K063341 O
- Modified Dental Implant K083550 O
- Straumann Bone Level Ø4.1mm and Ø 4.8mm Regular Connection (RC) Roxolid Dental O Implants K121131
### Conclusion:
The Creodent Solidex® Customized Abutments are substantially equivalent to the identified predicate products noted in this 510K Summary.
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| Technological<br>Characteristics | CreoDent Solidex® Customized<br>Abutment and Abutment Screw | Primary Predicate Device for<br>claimed equivalence: Creodent<br>Solidex Customized Abutment<br>(K113738) |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Material | Abutment is Ti-6A1-4V Eli titanium alloy<br>meets ASTM F-136 Standard. It is a higher<br>grade material with more tensile strength.<br>The Screw is CP TI Gr4 meets ASTM F67<br>Standard. | -Abutment and Screw: are CP Ti Gr4<br>and meets ASTM F67 standard.<br>The Screw is exactly the same<br>titanium alloy but the abutment is a<br>lower grade(less tensile strength)<br>titanium alloy compared to Ti-6A1-4V<br>ASTM F-136 standard. |
| Performance<br>Characteristics | Allows the prosthesis to be cemented or<br>screw retained to the abutment. The<br>abutment screw is designed to secure the<br>abutment to the endosseous implant. | Allows the prosthesis to be cemented<br>or screw retained to the abutment. The<br>abutment screw is designed to secure<br>the abutment to the endosseous<br>implant. |
| Indications for<br>Use | The CreoDent Solidex® Customized<br>Abutment is intended for use with an<br>endosseous implant to support a prosthetic<br>device in patients who are partially or<br>completely edentulous. The device can be<br>used for single or multiple-unit restorations.<br>The prosthesis can be cemented or screw<br>retained to the abutment. An abutment screw<br>is used to secure the abutment to the<br>endosseous implant.<br>The CreoDent Solidex® Customized<br>Abutment is compatible with the following:<br>Biomet 3i Osseotite Certain Dental<br>Implants 3.25mm, 4mm, 5mm, 6mm Straumann Bone Level implants<br>3.3mm, 4.1mm, 4.8mm | The CreoDent Solidex® Customized<br>Abutment is intended for use with an<br>endosseous implant to support a<br>prosthetic device in patients who are<br>partially or completely endentulous. The<br>device can be used for single or multiple-<br>unit restorations. The prosthesis can be<br>cemented or screw retained to the<br>abutment. An abutment screw is used to<br>secure the abutment to the endosseous<br>implant.<br>The CreoDent Solidex® Customized<br>Abutment is compatible with the following:<br>Nobel Replace™ TiUnite Endosseous<br>3.5mm (NP), 4.3mm (RP), and 5.0mm<br>(WP) diameter implants.<br>Nobel Active™ Internal Connection<br>3.5mm (NP) and 4.3mm (RP) diameter<br>implants. Zimmer Screw-Vent 3.7mm,<br>4.7mm; Zimmer Tapered Screw-Vent<br>3.7mm (NP), 4.7mm (RP) and 6.0mm<br>diameter implants. |
| Dimensions<br>and<br>Angulations | Creodent Solidex Customized Abutment sizes<br>for Biomet 3i Osseotite Certain 3.25mm,<br>4.0mm, 5.0mm and 6.0mm diameter implants.<br>Straumann Bone Level implants 3.3mm,<br>4.1mm, 4.8mm<br>Angles not to exceed up to 20 degrees from | Abutment sizes for Nobel Replace™<br>TiUnite Endosseous 3.5mm (NP), 4.3mm<br>(RP), and 5.0mm (WP) diameter implants.<br>Nobel Active™ Internal Connection<br>3.5mm (NP) and 4.3mm (RP) diameter<br>implants. Zimmer Screw-Vent 3.7mm,<br>4.7mm; Zimmer Tapered Screw-Vent<br>3.7mm (NP), 4.7mm (RP) and 6.0mm |
| the implant axis. | diameter implants. | |
| | Angles not to exceed up to 20 degrees<br>from the implant axis. | |
Table #1 Legally marketed predicate device (Abutment) to which equivalence is claimed:
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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<br>Characteristics | CreoDent Solidex® Customized<br>Abutment and Abutment Screw | Reference Predicate Device for<br>claimed equivalence: Biomet 3i<br>Encode Patient Specific Dental<br>Abutment (K101608) |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Material | Abutment is Ti-6A1-4V Eli titanium alloy<br>meets ASTM F-136 Standard and Screw is<br>CP TI Gr4 meets ASTM F67 Standard | -Abutment and Screw: Comparable<br>Titanium Alloy |
| Performance<br>Characteristics | Allows the prosthesis to be cemented or<br>screw retained to the abutment. The<br>abutment screw is designed to secure the<br>abutment to the endosseous implant. | Allows the prosthesis to be cemented<br>or screw retained to the abutment. The<br>abutment screw is designed to secure<br>the abutment to the endosseous<br>implant. |
| Indications for<br>Use | The CreoDent Solidex® Customized<br>Abutment is intended for use with an<br>endosseous implant to support a prosthetic<br>device in patients who are partially or<br>completely edentulous. The device can be<br>used for single or multiple-unit restorations.<br>The prosthesis can be cemented or screw<br>retained to the abutment. An abutment screw<br>is used to secure the abutment to the<br>endosseous implant.<br>The CreoDent Solidex® Customized<br>Abutment is compatible with the following:<br>• Biomet 3i Osseotite Certain Dental<br>Implants 3.25mm, 4mm, 5mm, 6mm | Encode Patient Specific Dental<br>abutments made from Oral scans<br>provided from Lava Chair Scanner<br>and the 3M lava COS (2.0) software<br>are intended for use as an accessory to<br>endosseous dental implants to support<br>a prosthetic device in a partially or<br>edentulous patient. Encode Patient<br>specific dental abutments are intended<br>for use to support single and multiple<br>tooth prostheses, in the mandible or<br>maxilla. The prostheses can be screw<br>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:
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| and<br>Angulations | for Biomet 3i Osseotite Certain 3.25mm,<br>4.0mm, 5.0mm and 6.0mm diameter implants.<br><br>Angles not to exceed up to 20 degrees from<br>the implant axis. | Biomet 3i Osseotite Certain 3.25mm,<br>4.0mm, 5.0mm, 6.0mm diameter<br>implants.<br><br>Angles not to exceed up to 30 degrees<br>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<br>Characteristics | CreoDent Solidex® Customized<br>Abutment and Abutment Screw | Reference Predicate Device for<br>claimed equivalence: Straumann<br>Cares Titanium Abutment<br>(K082764) |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Material | Abutment is Ti-6A1-4V Eli titanium alloy<br>meets ASTM F-136 Standard and Screw is<br>CP TI Gr4 meets ASTM F67 Standard | -Abutment and Screw: Comparable<br>Titanium |
| Performance<br>Characteristics | Allows the prosthesis to be cemented or<br>screw retained to the abutment. The<br>abutment screw is designed to secure the<br>abutment to the endosseous implant. | Allows the prosthesis to be cemented<br>or screw retained to the abutment. The<br>abutment screw is designed to secure<br>the abutment to the endosseous<br>implant. |
| Indications for<br>Use | The CreoDent Solidex® Customized<br>Abutment is intended for use with an<br>endosseous implant to support a prosthetic<br>device in patients who are partially or<br>completely edentulous. The device can be<br>used for single or multiple-unit restorations.<br>The prosthesis can be cemented or screw<br>retained to the abutment. An abutment screw<br>is used to secure the abutment to the<br>endosseous implant.<br><br>The CreoDent Solidex® Customized<br>Abutment is compatible with the following:<br>Straumann Bone Level implants<br>3.3mm, 4.1mm, 4.8mm | Abutments are placed into the dental<br>implants to provide support for<br>prosthetic restoration such as crowns<br>or bridges. The Straumann WN Cares<br>Titanium Abutment is indicated for<br>single tooth replacement and multiple<br>tooth restorations. The prosthetic<br>restoration is cement retained. |
| Dimensions<br>and | Solidex Abutment sizes for Straumann Bone<br>Level implants 3.3mm, 4.1mm, 4.8mm | Straumann Cares Abutment sizes for<br>Straumann Bone Level implants 3.3mm,<br>4.1mm, 4.8mm |
Table #3 Legally marketed predicate device (Abutment) to which equivalence is claimed:
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| 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<br>implants. (K063341) | 3.25mm | 8.5mm |
| | 3.25mm | 10.0mm |
| | 3.25mm | 11.5mm |
| | 3.25mm | 13mm |
| | 3.25mm | 15mm |
| Biomet 3i Osseotite Certain<br>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<br>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<br>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 |
|-------------------|-------------------|-----------------|
|-------------------|-------------------|-----------------|
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# Premarket Notification Section 5: Page 11
| Straumann Bone Level implants<br>(K083550) | 3.3mm<br>3.3mm<br>3.3mm<br>3.3mm | 8.0mm<br>10.0mm<br>12mm<br>14mm |
|--------------------------------------------|----------------------------------|---------------------------------|
| Straumann Bone Level implants<br>(K121131) | 4.1mm<br>4.1mm<br>4.1mm<br>4.1mm | 8.0mm<br>10.0mm<br>12mm<br>14mm |
| Straumann Bone Level implants<br>(K121131) | 4.8mm<br>4.8mm<br>4.8mm<br>4.8mm | 8.0mm<br>10.0mm<br>12mm<br>14mm |
