(206 days)
Not Found
No
The document describes dental implant abutments and their compatibility with a CAD/CAM system for design and milling. There is no mention of AI or ML in the intended use, device description, or performance studies. The digital design process mentioned is standard CAD/CAM technology, not indicative of AI/ML.
No.
The device description states it is an abutment designed to support prosthetic restorations, acting as a connecting component in a dental implant system, not directly providing therapeutic treatment.
No
The device is described as an endosseous dental implant abutment used to support prosthetic rehabilitation, not to diagnose a condition.
No
The device description clearly states it is a physical dental implant abutment made of materials like titanium and CoCr, not software. While it mentions compatibility with a CAD/CAM system for design, the device itself is a physical component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "prosthetic rehabilitation" by connecting to dental implants. This is a clinical application within the body, not a diagnostic test performed on samples outside the body.
- Device Description: The description details physical components (abutments, screws) used to support dental restorations. It doesn't mention any reagents, test strips, or procedures for analyzing biological samples.
- Lack of IVD Indicators: The text does not contain any keywords or phrases typically associated with IVD devices, such as "diagnostic," "assay," "test," "sample," "analyte," "in vitro," etc.
- Performance Studies: The performance studies focus on mechanical properties (compression-bending testing, dimensional analysis) and compatibility with a CAD/CAM system, which are relevant to a dental prosthetic device, not an IVD.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device is a physical component used in a dental procedure.
N/A
Intended Use / Indications for Use
Neoss TiBase: Neoss Abutments are designed to be connected to the Neoss Implants and intended for use as an aid in prosthetic rehabilitation. The Neoss TiBase is compatible with the Sirona Dental System inCoris ZI Meso L. All digitally designed copings and/or crowns for use with the Neoss TiBase Abutments are to be designed and milled using the Sirona Dental CAD/CAM System. Neoss CoCr Abutments: Neoss abutments are designed to be connected to the Neoss Implants and intended for use as an aid in prosthetic rehabilitation.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
Neoss TiBase and CoCr Abutments are endosseous dental implant abutments used to support single tooth or multi-unit prosthetic restorations. All subject abutments have a platform interface that is compatible with Neoss implant diameters Ø3.5-5.5 mm. All Neoss implant sizes have a 4.1 mm implant platform regardless of endosseous implant diameter. Neoss TiBase abutments are provided in two prosthetic platform sizes, N (narrow) and W (wide), to accommodate different emergence profiles. The Neoss TiBase Abutment are patient specific abutments intended for the coping/crown to be designed using the Sirona CAD/CAM System. The Neoss TiBase Abutment can be screw retained. Neoss CoCr abutments are available in two designs (Mono and Multi), one prosthetic platform size and one height (15 mm). The indexed Mono abutment can be used for single tooth screw-retained or cement-retained restorations. The non-indexed Multi abutment is used for multi-unit screw-retained restorations. Neoss Crystaloc screw in TiN/Au coated titanium is used with the Neoss TiBase and CoCr Abutments.
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 submitted, referenced, or relied upon to demonstrate substantial equivalence included: engineering analysis, dimensional analysis, and static and dynamic compression-bending testing according to ISO 14801 Dentistry-Implants-Dynamic fatigue test for endosseous dental implants. Compatibility with Sirona inCoris blocks is secured by Neoss conducting reverse engineering of the Sirona TiBase design mating the inCoris blocks. The compatability is further secured through the fact that the interface between the TiBase and the Sirona inCoris blocks is not a metal-to-ceramic interface, but includes an intervening laver of cement corresponding to a diameter difference of 0.2 mm between the TiBase and the internal geometry of the as-sintered inCoris block which is substantial compared to the small measuring and machining tolerance of TiBase which are ±0.02 mm.
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.
K043195, K071838, K113376, K081851, K111421, K100152, K083496, K121843
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.
Not Found
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 shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 8, 2015
Neoss Ltd. c/o Ms. Cherita James Regulatory Consultant M Squared Associates, Inc. 575 8th Avenue, Suite 1212 New York, New York 10018
Re: K150669
Trade/Device Name: Neoss TiBase and CoCr Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: September 8, 2015 Received: September 9, 2015
Dear Ms. James:
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 (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.
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
Indications for Use
510(k) Number (if known) K150669
Device Name Neoss TiBase and CoCr Abutments
Indications for Use (Describe)
Neoss TiBase:
Neoss Abutments are designed to be connected to the Neoss Implants and intended for use as an aid in prosthetic rehabilitation.
The Neoss TiBase is compatible with the Sirona Dental System inCoris ZI Meso L. All digitally designed copings and/or crowns for use with the Neoss TiBase Abutments are to be designed and milled using the Sirona Dental CAD/CAM System.
Neoss CoCr Abutments:
Neoss abutments are designed to be connected to the Neoss Implants and intended for use as an aid in prosthetic rehabilitation.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
[조] Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary Neoss Ltd. Neoss TiBase and CoCr Abutments
October 5, 2015
| ADMINISTRATIVE INFORMATION | |
|---|---|
| Manufacturer Name: | Neoss Ltd. |
| Windsor House, Cornwall Rd. | |
| Harrogate, HG1 2PW, UK | |
| Telephone +46 (0) 1423 817 733 | |
| Fax +44 (0) 1423 817 744 | |
| Official Contact Karin Darle Olsson | |
| Regulatory Assurance Director | |
| Representative/Consultant: | Cherita James |
| M Squared Associates, Inc. | |
| Telephone: +1 703-562-9800 ext 257 | |
| Fax: +1 703-562-9797 | |
| Email: Cjames@MSquaredAssociates.com |
DEVICE NAME AND CLASSIFICATION
Trade/Proprietary Name: Neoss TiBase and CoCr Abutments Common Name: Dental Implant Abutment Classification Name: Endosseous dental implant abutment Classification Regulations: 21 CFR 872.3630, Class II Product Code: NHA Classification Panel: Dental Products Panel Reviewing Branch: Dental Devices Branch
INTENDED USE
Neoss TiBase:
Neoss Abutments are designed to be connected to the Neoss Implants and intended for use as an aid in prosthetic rehabilitation.
The Neoss TiBase is compatible with the Sirona Dental System inCoris ZI Meso L. All digitally designed copings and/or crowns for use with the Neoss TiBase Abutments are to be designed and milled using the Sirona Dental CAD/CAM System.
Neoss CoCr Abutments:
Neoss abutments are designed to be connected to the Neoss Implants and intended for use as an aid in prosthetic rehabilitation.
DEVICE DESCRIPTION
Neoss TiBase and CoCr Abutments are endosseous dental implant abutments used to support single tooth or multi-unit prosthetic restorations. All subject abutments have a platform interface that is compatible with Neoss implant diameters Ø3.5-5.5 mm. All
4
Neoss implant sizes have a 4.1 mm implant platform regardless of endosseous implant diameter. Neoss TiBase abutments are provided in two prosthetic platform sizes, N (narrow) and W (wide), to accommodate different emergence profiles. The Neoss TiBase Abutment are patient specific abutments intended for the coping/crown to be designed using the Sirona CAD/CAM System. The Neoss TiBase Abutment can be screw retained.
Neoss CoCr abutments are available in two designs (Mono and Multi), one prosthetic platform size and one height (15 mm). The indexed Mono abutment can be used for single tooth screw-retained or cement-retained restorations. The non-indexed Multi abutment is used for multi-unit screw-retained restorations.
Neoss Crystaloc screw in TiN/Au coated titanium is used with the Neoss TiBase and CoCr Abutments.
Materials
Neoss TiBase abutment and Crystaloc abutment screws are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). Crystaloc Abutment Screw has a TiN surface and is coated with a layer of pure gold. Neoss CoCr Abutments (Mono and Multi) are made of cobalt chromium alloy (CoCr) conforming to ASTM F1537 Standard specification for wrought cobalt-28chromium-6- molybdenum alloys for surgical implants (UNS R31537, UNS R31538, AND UNS R31539).
Sterilization
Neoss abutments and screws are provided non-sterile. Standard autoclave sterilization is recommended, using fractionated vacuum procedures with an FDA cleared wrap, with an exposure time of 3 minutes at 135 ℃ / 275 °F with a drying time of 16 minutes. This cycle has been validated by the overkill method to a sterility assurance level (SAL) of 10-6 according to ISO 17665-1.
PERFORMANCE DATA
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included: engineering analysis, dimensional analysis, and static and dynamic compression-bending testing according to ISO 14801 Dentistry-Implants-Dynamic fatigue test for endosseous dental implants. Compatibility with Sirona inCoris blocks is secured by Neoss conducting reverse engineering of the Sirona TiBase design mating the inCoris blocks. The compatability is further secured through the fact that the interface between the TiBase and the Sirona inCoris blocks is not a metal-to-ceramic interface, but includes an intervening laver of cement corresponding to a diameter difference of 0.2 mm between the TiBase and the internal geometry of the as-sintered inCoris block which is substantial compared to the small measuring and machining tolerance of TiBase which are ±0.02 mm.
Biocompatibility of the subject devices is confirmed by conformance to FDA recognized consensus material standards (titanium alloy conforming to ASTM F136, and cobalt chromium alloy conforming to ASTM F1537). The manufacturing processes and materials for the Ti Base are identical to those used for Neoss Implant System
5
components previously cleared in K043195. K071838 and K113376. The pure gold and process used to coat the titanium alloy Crystaloc screw are identical to the titanium and gold screw cleared in K081851. The cobalt chromium alloy (CoCr) material is substantially equivalent to the material used in K121843 NP-Cast Abutment System. No clinical data were included.
EQUIVALENCE TO MARKETED DEVICE
Neoss Ltd. submits the following information in this Premarket Notification to demonstrate, for the purposes of FDA's regulation of medical devices, the subject device is substantially equivalent in indications and design principles to the following legally marketed predicate devices:
Neoss Ltd., Neo Implant System cleared under K043195; (primary predicate) Reference Predicates
Neoss Ltd., Neoss Various Titanium Abutments cleared under K071838;
Neoss Ltd., Neoss Tapered Implant cleared under K113376;
Neoss Ltd., Neoss Access Abutments cleared under K081851;
Sirona Dental Systems GmbH, Sirona Dental CAD/CAM System cleared under K111421;
Sirona Dental Systems GmbH, Sirona Dental CAD/CAM System cleared under K100152;
Altatec GmbH, Camlog Implant System Modified Implants and Abutments cleared under K083496; and
OSSTEM Implant Co., Ltd., NP-Cast Abutment System cleared under K121843.
Performance data showed compatibility with the Sirona inCoris ZI Meso L and sufficient strength of the final finished device for its intended use. Any differences in the technological characteristics between the subject and predicate devices do not raise different questions of safety or effectiveness.
CONCLUSIONS
The subject device and the predicate devices have intended use, have similar technological characteristics, and are made of similar materials. The subject device and predicate devices encompass the same range of physical dimensions, including length, width, height, and angle. The subject and predicate devices are packaged in similar materials and sterilized using similar methods.
The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.
Overall, the subject device has the following similarities to the predicate devices:
- has the same intended use. ●
- uses the same operating principle, ●
- . incorporates the same basic design,
- . incorporates the same or very similar materials, and
- has similar packaging and is sterilized using the same materials and processes. .
6
7
Substantial Equivalence Tables
| Subject Device | Indications for Use Statement | | Subject
Device | Predicate Devices | | | | | | | |
|-------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|-------------------------------------------|-------------------------------------|-----------------------------------------------------|--------------------------------------|---------------------------------------------|----------------------------------------------------------------------------------|----------------------------------------------------------------------------------|------------------------------------------------------------------------|-------------------------------------------|
| Neoss Ltd.
Neoss TiBase and CoCr Abutments | Neoss TiBase: Neoss abutments are designed to be connected to the Neoss Implants and
intended for use as an aid in prosthetic rehabilitation.
The Neoss TiBase is compatible with the Sirona Dental System inCoris ZI Meso L. All digitally
designed copings and/or crowns for use with the Neoss TiBase Abutments are to be designed
and milled using the Sirona Dental CAD/CAM System.
Neoss CoCr Abutments:
Neoss abutments are designed to be connected to the Neoss Implants and intended for use as an
aid in prosthetic
rehabilitation. | | Neoss Ltd. | Neoss Ltd. | Neoss Ltd. | Neoss Ltd. | Neoss Ltd. | Sirona Dental
Systems GmbH | Sirona Dental
Systems GmbH | Altatec
GmbH | Osstem Implant
Co., Ltd |
| Predicate Devices | | | Neoss
TiBase
and CoCr
Abutment | Neo
Implant
System
K043195 | Neoss
Various
Titanium
Abutment
K071838 | Neoss
Taper
Implant
K113376 | Neoss
Access
Abutment
s
K081851 | Sirona Dental
CAD/CAM
System
K111421 | Sirona Dental
CAD/CAM
System
K100152 | Camlog
Implant
System
Modified
Implants
and
Abutment | NP-Cast
Abutmen
t System
K121843 |
| Neoss Ltd.
Neo Implant System
K043195 (Primary Predicate) | The Neo Implants - Neo Implant System are for single-stage and two-stage surgical procedures
and cement or screw retained restorations. The Neo Implants - Neo Implant System are intended
for immediate placement and function on single tooth and /or multiple tooth applications
recognizing sufficient bone stability and appropriate occlusal loading, to restore
chewing function. Multiple tooth applications may be splinted with a bar. | Design | | | | | | | | | |
| Neoss Ltd.
Neoss Various Titanium Abutments
K071838 | The Neoss various Titanium Abutments are designed to be connected to the Neoss implants and
intended for use as an aid in prosthetic rehabilitation. | Implant
Diameter
(mm) | NA | 3.5, 4.0, 4.5,
5.0, 5.5 | NA | 3.5, 4.0,
5.0, 5.5 | NA | NA | NA | 3.3, 3.8, 4.3,
6.0 | NA |
| Neoss Ltd.
Neoss Tapered Implant
K113376 | The Neoss Tapered Implant is for single-stage or two-stage surgical procedure and cement or
screw retained restorations.
The Neoss Tapered Implant is intended for immediate placement and function on single tooth
and for multiple tooth applications recognizing sufficient bone stability and appropriate occlusal
loading, to restore chewing function. Multiple tooth applications may be splinted with a bar. | Abutment
Diameter
(mm) | 4.1 Interface | 4.1 Interface | 4.1 Interface | NA | 4.1 Interface | 3.3, 3.4, 3.5,
3.8, 4.0, 4.1,
4.3, 4.5, 4.8,
5.0, 5.5, 5.7,
6.0, 6.5 | 3.3, 3.4, 3.5,
3.8, 4.0, 4.1,
4.3, 4.5, 4.8,
5.0, 5.5, 5.7,
6.0, 6.5 | 3.3, 3.8, 4.3,
6.0 | 4.0, 4.5, 5.0, 6.3 |
| Neoss Ltd.
Neoss Access Abutments
K081851 | The Neoss Access Abutments are designed to be connected to the Neoss implants and intended
for use as an aid in prosthetic rehabilitation.
Neoss Access Abutments represent a two piece abutment system and are designed to be
connected to the Neoss implants, to receive another abutment or framework and intended for use
as an aid in multiple-unit prosthetic rehabilitation such as dental bridge restorations. | Abutment
Angle | Straight | Straight, 20° | Straight, 15°,
20° | NA | Straight, 10°,
20°, 30° | Straight to 20° | Straight to 20° | Straight, 15°,
20° | Straight to 30° |
| Sirona Dental Systems GmbH
Sirona Dental CAD/CAM System
K111421 | The Sirona Dental CAD/CAM System is intended for use in partially or fully edentulous
mandibles and maxillae in support of single or multiple-unit cement retained restorations. The
system consists of three major parts: TiBase, InCoris mesostructure, and CAD/CAM software.
Specifically, the InCoris mesostructure and TiBase components make up a twopiece
abutment which is used in conjunction with endosseous dental implants to restore the function
and aesthetics in the oral cavity. The InCoris mesostructure may also be used in conjunction
with the Camlog Titanium base CAD/CAM (types K2244.xxxx) (K083496) in the Camlog
Implant System. The CAD/CAM software is intended to design and fabricate the
InCoris mesostructure. The InCoris mesostructure and TiBase two-piece abutment is compatible
with the following implant systems: | Prosthesis
Attachment | TiBase: Screw
CoCr: Screw or
Cement | Screw- or
Cement
retain | Screw- or
Cement
retain | NA | Screw-
retained | Cement
retained | Cement
retained | Screw-
retained,
Cement-
retained | Screw-retained,
Cement-
retained |
| Sirona Dental Systems GmbH
Sirona Dental CAD/CAM System
K100152 | • Nobel Biocare Replace (K020646) • Nobel Biocare Branemark (K022562)
• Friadent Xive (K013867) • Biomet 3i Osseotite (K980549) • Astra Tech Osseospeed (K091239) | Restoration | Single, Multi | Single, Multi | Single, Multi | NA | Multi | Single, Multi | Single, Multi | Single, Multi | Single,Multi |
| Sirona Dental Systems GmbH
Sirona CAD/CAM System
K100152 (cont.) | The Sirona Dental CAD/CAM System is intended for use in partially or fully edentulous mandibles and maxillae in support of single or multiple-unit cement retained restorations. The system consists of three major parts: TiBase, InCoris mesostructure, and CAD/CAM software. Specifically, the InCoris mesostructure and TiBase components make up a twopiece abutment which is used in conjunction with endosseous dental implants to restore the function and aesthetics in the oral cavity. The InCoris mesostructure may also be used in conjunction with the Camlog Titanium base CAD/CAM (types K2244.xxxx) (K083496) in the Camlog Implant System. The CAD/CAM software is intended to design and fabricate the InCoris mesostructure. The InCoris mesostructure and TiBase two-piece abutment is compatible with the following implants systems:
• Nobel Biocare Replace (K020646) • Nobel Biocare Branemark (K022562)
• Friadent Xive (K013867) • Biomet 3i Osseotite (K980549)
• Astra Tech Osseospeed (K091239) • Zimmer Tapered Screw-Vent (K061410)
• Straumann SynOcta (K061176) | Material | | | | | | | | | |
| Altatec GmbH
Camlog Implant System
Modified Implants and Abutments
K083496 | Camlog Implant System implants are intended for immediate or delayed placement in the bone of the maxillary or mandibular arch. Camlog Implant System Abutments are intended for use as support for crowns, bridges or overdentures.
When a one-stage surgical approach is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate. | Abutment | Ti6Al4V,
CoCr | CpTi
Gr4,
Ti6Al4V, | CpTi
Gr4,
Ti6Al4V | NA | CpTi Gr4,
Ti6Al4V,
Au | Ti6Al4V,
Y-TZP | Ti6Al4V,
Y-TZP | CpTi Gr4,
Ti6Al4V,
Y-TZP, | Co-Cr-Mo
Alloy |
| OSSTEM Implant Co., Ltd.
NP-Cast Abutment System
K121843 | NP-Cast Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. | Abutment
Screw | Ti6Al4V,
TiN/Au | Ti6Al4V, Au | Ti6Al4V | NA | Ti6Al4V, Au,
TiN/Au | Ti6Al4V | Ti6Al4V | Ti6Al4V | Ti6Al4V |
| Bonding
Material | TiBase:
PANAVIA F
2.0 | NA | PANAVIA F
2.0 | NA | NA | PANAVIA F 2.0 | PANAVIA F 2.0 | NA | NA | | |
8
9