(276 days)
No
The summary describes a CAD/CAM system for designing and fabricating dental restorations based on optical impressions. It mentions computer-aided design and fabrication but does not include any terms or descriptions indicative of AI or ML technology being used for image processing, design automation, or any other function. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is described as a system for designing and fabricating dental restorative prosthetic devices, specifically mesostructures and two-piece abutments for dental implants. It is used to restore function and aesthetics, but it does not directly treat or cure a disease or condition; rather, it creates components for a restorative procedure.
No
Explanation: The device is described as a CAD/CAM system intended for designing and fabricating dental restorative prosthetic devices (mesostructures and abutments), not for diagnosing medical conditions. It takes optical impressions and records topographical characteristics but does not perform diagnostic analysis of these impressions.
No
The device description explicitly states the system consists of three major parts: TiBase, InCoris mesostructure, and CAD/CAM software. It also lists several hardware components like CEREC3, CEREC AC, inEos, inEos Blue, CEREC MCXL, and inLab MCXL as part of the system. This indicates it is a system with both hardware and software components, not a software-only device.
Based on the provided information, the Sirona Dental CAD/CAM System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to design and fabricate dental restorative prosthetic devices (two-piece abutments) for use in the oral cavity to restore function and aesthetics. This is a therapeutic and restorative purpose, not a diagnostic one.
- Device Description: The system takes optical impressions of anatomical structures (teeth, impressions, models) and uses CAD/CAM technology to manufacture physical devices. It does not analyze biological samples (blood, tissue, etc.) to provide diagnostic information about a patient's health or condition.
- Lack of Diagnostic Function: The system's function is focused on the creation of a physical medical device for implantation, not on providing information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic purposes. The Sirona Dental CAD/CAM System does not fit this definition.
N/A
Intended Use / Indications for Use
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 two-piece 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)
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The Sirona Dental CAD/CAM-System takes optical impressions and records the topographical characteristics of teeth, dental impressions, or stone models. Dental restorative prosthetic devices are manufactured using computer aided design and fabrication. The system also features the processing of mesostructures, a dental restorative prosthetic device used in conjunction with endosseous dental implant abutments.
The system that features the processing of mesostructures comprises
Titanium bases TiBase and Camlog .
inCoris ZI meso blocks .
Sirona Dental CAD/CAM Design and fabricating devices
Titanium bases are used as an implant prosthetic titanium base for adhesion to mesostructures to restore function and aesthetics in the oral cavity.
inCoris ZI meso blocks are used in manufacturing individually designed mesostructures, which are glued to a fitting titanium base after milling and sintering.
Sirona Dental CAD/CAM design and fabricating devices feature the processing of mesostructures, a dental restorative prosthetic device used in conjunction with endosseous dental implant abutments, i.e. it is an accessory to it. This component consists of the devices CEREC3, CEREC AC, inEos, inEos Blue, CEREC MCXL and inLab MCXL.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
optical impressions
Anatomical Site
partially or fully edentulous mandibles and maxillae, oral cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dentist or dental technician
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)
Nonclinical Testing: According to FDA Guidance "Class II Special Controls Guidance Document: Rootform Endosseous Dental Implants and Endosseous Dental Implant Abutments", May 12, 2004, for no angled abutments fatigue testing is not required for straight abutments and has not been performed. A reverse-engineering analysis has demonstrated that the devices are identical with their predicates and compatible with their mating implants.
Clinical Testing: Clinical testing is not required and has not been performed.
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.
K091756, K081005, K081666, K032158, K072642, K060880, K032448, K062493
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.
K083496, K020646, K022562, K013867, K980549, K091239, K061410, K061176
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
510(k) Summary_
OCT 2 2 2010
for
Sirona Dental Systems
Sirona Dental CAD/CAM System
Sponsor 1
1100152
Sirona Dental Systems GmbH
Fabrikstrasse 31
D-64625 Bensheim Germany
Contact Person: Fritz Kolle 49 6251 16 32 94 Telephone:
Date Prepared: O October 20, 2010
2 Device Name
Sirona Dental CAD/CAM-System Proprietary Name: Abutment, implant, dental, endosseous Common/Usual Name: Endosseous dental implant abutment Classification Names:
Predicate Devices 3
Replace® NP, K091756, Brånemark®, K091756, Tissue level NN, K081005, OsseoSpeed™, K081666, Frialit® / Xive®, K032158, Osseotite K072642, Tapered Screw-Vent®, K060880.
Zirconium oxide sleeve for Camlog titanium bases (K032448).
Lava Software (K062493).
Sirona Dental 510(k) Summary
October 20, 2010
Sirona Dental CAD/CAM System
APPENDIX N • Page 1 of 27
1
Intended Use ব
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 two-piece 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) ●
5 Device Description
The Sirona Dental CAD/CAM-System takes optical impressions and records the topographical characteristics of teeth, dental impressions, or stone models. Dental restorative prosthetic devices are manufactured using computer aided design and fabrication. The system also features the processing of mesostructures, a dental restorative prosthetic device used in conjunction with endosseous dental implant abutments.
The system that features the processing of mesostructures comprises
- Titanium bases TiBase and Camlog .
- inCoris ZI meso blocks .
- Sirona Dental CAD/CAM Design and fabricating devices . ·
Titanium bases are used as an implant prosthetic titanium base for adhesion to mesostructures to restore function and aesthetics in the oral cavity.
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October 20, 2010
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APPENDIX N • Page 2 of 27
2
blocks are used in manufacturing individually designed inCoris ZI meso mesostructures, which are glued to a fitting titanium base after milling and sintering.
Sirona Dental CAD/CAM design and fabricating devices feature the processing of mesostructures, a dental restorative prosthetic device used in conjunction with endosseous dental implant abutments, i.e. it is an accessory to it. This component consists of the devices CEREC3, CEREC AC, inEos, inEos Blue, CEREC MCXL and inLab MCXL.
5.1 TiBase
Device Function 5.1.1
The Sirona TiBase is a premanufactured prosthetic component directly connected to dedicated endosseous dental implants and is intended for use as an aid in prosthetic rehabilitation.
The Sirona offering consists of the titanium base TiBase, the abutment screw and the scanbody. The parts are marketed non-steril and for single use only.
The Sirona TiBase is bonded to an individually designed mesostructure, a ceramic prosthetic/restoration, that supports the final restoration .. The mesostructure is milled from an inCoris ZI meso block with Sirona CAD/CAM milling machines CEREC or inLab, and sintered afterwards.
The two piece abutment is mounted onto the implant and fixed with a screw.
The scope of delivery contains a scanbody (ABS plastic) which is mounted on a TiBase in order to acquire the topographical surface of the area where the endosseous dental implant abutment is located with Sirona Dental CAD/CAM fabricating devices. From the acquired data the position of the implant can be calculated. After an optical impression has been taken the scanbody is removed.
Sirona TiBase devices are compatible with following systems (Table 1):
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October 20, 2010
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APPENDIX N . Page 3 of 27
3
Sirona TiBase | Compatible System | ||
---|---|---|---|
Manufacturer | System | Diameter | |
NBRS 3.5 | Nobel Biocare | Replace® NP | 3,5 mm |
NBRS 4.3 | Nobel Biocare | Replace® RP | 4.3 mm |
NBRS 5.0 | Nobel Biocare | Replace® WP | 5.0 mm |
NBRS 6.0 | Nobel Biocare | Replace® 6.0 | 6.0 mm |
NBB 3.4 | Nobel Biocare | Brånemark® | 3.4 mm |
NBB 4.1 | Nobel Biocare | Brånemark® | 4.1 mm |
SSO 3.5 | Straumann | Tissue level NN | 3.5 mm |
SSO 4.8 | Straumann | Tissue level RN | 4.8 mm |
SSO 6.5 | Straumann | Tissue level WN | 6.5 mm |
ATOS 3.5/4.0 | Astra Tech | OsseoSpeed™ | 3.5 S / 4.0 S mm |
ATOS 4.5/5.0 | Astra Tech | OsseoSpeed™ | 4.5 / 5.0 mm |
FX 3.4 | Friadent | Frialit® / Xive® | 3.4 mm |
FX 3.8 | Friadent | Frialit® / Xive® | 3.8 mm |
FX 4.5 | Friadent | Frialit® / Xive® | 4.5 mm |
FX 5.5 | Friadent | Frialit® / Xive® | 5.5 mm |
BO 3.4 | Biomet 3i | Osseotite | |
(Connec-tion type: | |||
Ex. Hex) | 3.4 mm | ||
BO 4.1 | Biomet 3i | Osseotite | |
(Connec-tion type: | |||
Ex. Hex) | 4.1 mm | ||
BO 5.0 | Biomet 3i | Osseotite | |
(Connec-tion type: | 5.0 mm | ||
Sirona TiBase | Compatible System | ||
Manufacturer | System | Diameter | |
Ex. Hex) | |||
ZTSV 3.5 | Tapered Screw- | ||
Vent® | 3.5 mm | ||
ZTSV 4.5 | Zimmer | Tapered Screw- | |
Vent® | 4.5 mm | ||
ZTSV 5.7 | Tapered Screw- | ||
Vent® | 5.7 mm |
Table 1: Sirona TiBase Devices Compatibility
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. ·
October 20, 2010
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APPENDIX N • Page 4 of 27
4
Scientific Concept 5.1.2
The underlying scientific concept is the use of an already introduced technology of a titanium base abutment combined with individually CAD/CAM fabricated ceramic prosthetics.
Physical and Performance Characteristics 5.1.3
5.1.3.1 Design
The TiBase devices have various diameters, are compatible with dedicated implant systems, and fit to compatible implants as provided in Table 2.
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5
Table 2: Implant Compatibility
| TiBase | Implant-
Manufacturer | Implant-System | 510(k) Implant |
|--------|--------------------------|--------------------|----------------|
| NBRS | Nobel Biocare | Replace | K020646 |
| NBB | Nobel Biocare | Branemark | K022562 |
| FX | Friadent | Xive | K013867 |
| BO | Biomet 3i | Osseotite | K980549 |
| ATOS | Astra Tech | OsseoSpeed | K091239 |
| ZTSV | Zimmer | Tapered Screw-Vent | K061410 |
| SSO | Straumann | SynOcta | K061176 |
5.1.3.2 Material Used
TiBase and abutment screw are made of Ti6Al4V.
5.1.3.3 Physical Properties
TiBase material composition and mechanical properties comply with ISO 5832-3:1996, Implants for surgery -- Metallic materials -- Part 3: Wrought titanium 6aluminium 4-vanadium alloy
Sirona TiBase devices are compatible with systems listed in Table 1.
5.2 inCoris ZI meso
Device Description 5.2.1
The inCoris ZI meso offerings are blocks of various sizes from which individual dental mesostructures are grinded by milling machines (inLab MCXL, CEREC MCXL). The mesostructure is a part of a 2 part endosseous dental implant abutment which comprises a titanium base and a zirconium oxide mesostructure. The connection geometries are prefabricated.
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October 20, 2010
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APPENDIX N • Page 6 of 27
6
5.2.2 __ Scientific Concept_________________________________________________________________________________________________________________________________________________
The underlying scientific concept is the use of an already introduced technology of a titanium base abutment combined with individually CAD/CAM fabricated ceramic prosthetics.
Physical and Performance Characteristics 5.2.3
5.2.3.1 Design
The inCoris ZI meso are blocks of various sizes. The marketed ceramic is presintered. One side of a block is mounted to a mandrel that will be inserted in the spindle's clamping chuck of the grinding machine. The connection geometry to titanium bases is prefabricated, i.e. already included in the shipped block. Connection geometries fit on Camlog (type K2244.xxxx) and Sirona (Tibase) titanium bases (Table 3 and Table 4).
Titanium Base | Ceramic Block | ||||
---|---|---|---|---|---|
TiBase | |||||
(Sirona) | REF | Diameter | inCoris ZI | ||
meso | |||||
(Sirona) | REF | Color | |||
inCoris ZI | |||||
meso | |||||
(Sirona) | |||||
NBRS 3.5 | 6282474 | 3,5 mm | inCoris ZI | ||
meso L | 62 31 810 | ||||
62 31 836 | F0.5 | ||||
F2 | |||||
NBRS 4.3 | 6282482 | 4.3 mm | inCoris ZI | ||
meso L | 62 31 810 | ||||
62 31 836 | F0.5 | ||||
F2 | |||||
NBRS 5.0 | 6282490 | 5.0 mm | inCoris ZI | ||
meso L | 62 31 810 | ||||
62 31 836 | F0.5 | ||||
F2 | |||||
NBRS 6.0 | 6282508 | 6.0 mm | inCoris ZI | ||
meso L | 62 31 810 | ||||
62 31 836 | F0.5 | ||||
F2 | |||||
NBB 3.4 | 6282516 | 3.4 mm | inCoris ZI | ||
meso L | 62 31 810 | ||||
62 31 836 | F0.5 | ||||
F2 | |||||
NBB 4.1 | 6282524 | 4.1 mm | inCoris ZI | ||
meso L | 62 31 810 | F0.5 | |||
Titanium Base | Ceramic Block | ||||
TiBase | |||||
(Sirona) | REF | Diameter | inCoris ZI | ||
meso | |||||
(Sirona) | REF | Color | |||
inCoris ZI | |||||
meso | |||||
(Sirona) | |||||
meso L | 62 31 836 | F2 | |||
SSO 3.5 | 6284231 | 3.5 mm | inCoris ZI | ||
meso L | 62 31 810 | ||||
62 31 836 | F0.5 | ||||
F2 | |||||
SSO 4.8 | 6284249 | 4.8 mm | inCoris Zl | ||
meso L | 62 31 810 | ||||
62 31 836 | F0.5 | ||||
F2 | |||||
SSO 6.5 | 6284256 | 6.5 mm | inCoris ZI | ||
meso L | 62 31 810 | ||||
62 31 836 | F0.5 | ||||
F2 | |||||
ATOS | |||||
3.5/4.0 | 6282532 | 3.5 S / 4.0 | |||
S mm | inCoris ZI | ||||
meso L | 62 31 810 | ||||
62 31 836 | F0.5 | ||||
F2 | |||||
ATOS | |||||
4.5/5.0 | 6282540 | 4.5 / 5.0 | |||
mm | inCoris ZI | ||||
meso L | 62 31 810 | ||||
62 31 836 | F0.5 | ||||
F2 | |||||
FX 3.4 | 6282433 | 3.4 mm | inCoris ZI | ||
meso S | 62 31 802 | ||||
62 31 828 | F0.5 | ||||
F2 | |||||
FX 3.8 | 6282441 | 3.8 mm | inCoris ZI | ||
meso S | 62 31 802 | ||||
62 31 828 | F0.5 | ||||
F2 | |||||
FX 4.5 | 6282458 | 4.5 mm | inCoris ZI | ||
meso L | 62 31 810 | ||||
62 31 836 | F0.5 | ||||
F2 | |||||
FX 5.5 | 6282466 | 5.5 mm | inCoris ZI | ||
meso L | 62 31 810 | ||||
62 31 836 | F0.5 | ||||
F2 | |||||
BO 3.4 | 6282557 | 3.4 mm | inCoris ZI | ||
meso L | 62 31 810 | ||||
62 31 836 | F0.5 | ||||
F2 | |||||
BO 4.1 | 6282565 | 4.1 mm | inCoris ZI | ||
meso L | 62 31 810 | ||||
62 31 836 | F0.5 | ||||
F2 | |||||
Titanium Base | Ceramic Block | ||||
TiBase | |||||
(Sirona) | REF | Diameter | inCoris ZI | ||
meso | |||||
(Sirona) | REF | Color | |||
inCoris ZI | |||||
meso | |||||
(Sirona) | |||||
BO 5.0 | 6282573 | 5.0 mm | inCoris ZI | ||
meso L | 62 31 810 | ||||
62 31 836 | F0.5 | ||||
F2 | |||||
ZTSV 3.5 | 6282581 | 3.5 mm | inCoris ZI | ||
meso L | 62 31 810 | ||||
62 31 836 | F0.5 | ||||
F2 | |||||
ZTSV 4.5 | 6282599 | 4.5 mm | inCoris ZI | ||
meso L | 62 31 810 | ||||
62 31 836 | F0.5 | ||||
F2 | |||||
ZTSV 5.7 | 6282607 | 5.7 mm | inCoris ZI | ||
meso L | 62 31 810 | ||||
62 31 836 | F0.5 | ||||
F2 |
Table 3: Sirona inCoris ZI meso - TiBase Devices Compatibility
Sirona Dental 510(k) Summary
October 20, 2010
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October 20, 2010
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APPENDIX N • Page 8 of 27
8
Table 4: Sirona inCoris ZI meso - Camlog Devices Compatibility
Titanium Base | Ceramic Block | ||||
---|---|---|---|---|---|
Camlog | REF | Dia- | |||
meter | inCoris ZI | ||||
meso | |||||
(Sirona) | REF | Color | |||
inCoris ZI | |||||
meso | |||||
(Sirona) | |||||
K2244.3348 | K2244.3348 | 3.3 | inCoris ZI | ||
meso S | 62 31 802 | ||||
62 31 828 | F0.5 | ||||
F2 | |||||
K2244.3848 | K2244.3848 | 3.8 | inCoris ZI | ||
meso S | 62 31 802 | ||||
62 31 828 | F0.5 | ||||
F2 | |||||
K2244.4348 | K2244.4348 | 4.3 | inCoris ZI | ||
meso S | 62 31 802 | ||||
62 31 828 | F0.5 | ||||
F2 | |||||
K2244.5048 | K2244.5048 | 5.0 | inCoris ZI | ||
meso L | 62 31 810 | ||||
62 31 836 | F0.5 | ||||
F2 |
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APPENDIX N • Page 9 of 27
9
Titanium Base | Ceramic Block | ||||
---|---|---|---|---|---|
Camlog | REF | Diameter | inCoris ZI | ||
meso | |||||
(Sirona) | REF | Color | |||
inCoris ZI | |||||
meso | |||||
(Sirona) | |||||
K2244.6048 | K2244.6048 | 6.0 | inCoris ZI | ||
meso L | 62 31 810 | ||||
62 31 836 | F0.5 | ||||
F2 |
5.2.3.2 Material Used
The inCoris ZI meso are pre-sintered zirconium oxide ceramic blocks. The metal block holder is made of aluminum. The material is composed of:
ZrO2+HfO2+Y2O3 > 99.0% .900 MPa |
| Fracture toughness (KIC): | 5.9 MPa·m¹/² |
Sirona Dental CAD/CAM Design and fabrication Devices 5.3
Device Description 5.3.1
The Sirona Dental CAD/CAM Design and fabricating devices for processing mesostructures perform and consist of
- Optical acquisition or recording of the topographical characteristics of dental . impressions, or stone models using the devices Acquisition unit CEREC 3, CEREC AC and stationary scanning system inEos Blue
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October 20, 2010
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APPENDIX N • Page 10 of 27
10
- Design of mesostructures and processing the acquired or recorded data for this purposes using Sirona Dental CAD/CAM Software which runs on a CEREC 3, CEREC AC or PC. Design is performed by a dentist or dental technician
- Milling of the mesostructure using CEREC MCXL or inLab MCXL milling . machines from ceramic blocks intended for dental restorations and mesostructures
This Sirona Dental CAD/CAM Design and fabricating devices also process other dental restorations like crowns, bridge-frameworks, inlays, onlays and regulated under 21 CFR 872.3661, Optical Impression Systems for CAD/CAM, for such intended use.
Scientific Concept 5.3.2
The underlying scientific concept is the use of CAD/CAM technology for the optical acquisition or recording of the topographical characteristics of dental impressions, or stone models, the design of individual mesostructures using recorded data (CAD), and eventually fabricating (milling) these designed mesostructures (CAM).
Physical and Performance Characteristics 5.3.3
5.3.3.1 Design
Acquisition unit: the device consists of a camera for taking topographical characteristics of dental impressions optically. The recorded data are used for the design of individual mesostructures using specific CAD techniques for the dental field.
Fabricating devices: the devices mill the individual designed mesostructures from incoris ZI meso blocks. For this purpose the chucked block and the milling tools move according to the prescribed trajectories respectively the shape which is intended to be milled.
Materials Used 5.3.3.2
Not applicable.
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5.3.3.3 Physical Properties
Not applicable.
Summary of the technological characteristics ર્ભ
6.1 TiBase
All proposed and predicates titanium bases and screws are made of Ti6Al4V, medical grade 5. Connection interfaces to the implants are identical for each individual diameter and connection type. Connection interfaces for dental restorations differ in that proposed devices have a notch in addition.
An extensive list is provided in Table 5.
inCoris ZI meso 6.2
Proposed and predicates device are to be bonded to titanium bases for supporting further dental restorations.
InCoris ZI meso material properties are practically identical to the properties available for the predicate device and are made of zirconium oxide and have practically the same composition. Because the composition of inCoris ZI meso blocs fulfils the standard ISO 13356:1997, "Implants for surgery, Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP)" they are classified as biocompatible by this standard ..
The devices share the same thickness restrictions to be maintained.
Shape and bonding surface of connection interfaces to Camlog and Sirona Tibase are similar for Sirona inCoris ZI meso blocs and Camlog ceramic sleeves.
Same bonding material is used for proposed and predicate device.
An extensive list is provided in Table 6.
Sirona Dental CAD/CAM Design and fabrication Devices 6.3
Both, Sirona Dental CAD/CAM Design and fabricating devices and the LAVA system, uses their own devices for taking optical impressions to record topographical characteristics of teeth, dental impressions, or stone models for use in the computer aided design and fabricates dental restorative prosthetic devices used
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APPENDIX N . Page 12 of 27
12
in conjunction with endosseous dental implant abutments, i.e. it is an accessory to it. Both systems have the feature to transfer data of the optical impression to a remote milling machine via internet or exportation/importation of milling data.
An extensive list is provided in Table 7.
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Table 5: Comparison of Sirona TiBase to Predicate Devices
| 4: "
: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :
Screw
geo-
metry | ﺔ ﺗﻮﻓ | same | same | same | |
---|---|---|---|---|---|
- | |||||
metry geo | |||||
" | |||||
Anti- |
- Anti- Trota:
iztures
tional
ea-
: | | yes | yes | yes | |
| 【Beon 【deallery】【dealers】 【dealers 】desar - The County County of the County 【deally of the country The Court of the Count
Type :
ਾ ਕਿ ਅ
19381
ないよ
. | 1. 1. 2. 2. 2. | nter-
nons
3 te-
nal | nter-
nons
3 te-
na | nter- | |
| ារបស់ពួកគេ បានប្រជាជន្ម ប្រជាជន្ម ប្រជាជន្ម ប្រជាជន្ម ប្រជាជន្ម ប្រជាជន្ម ប្រជាជន្ម ប្រជាជន្ម
metry | ్లో ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమి | yes | yes | yes | |
| Abut
andi Screw : } made
STORES
( -
.
me | | yes | yes | yes | |
| | ర్చారు. నిర్మాలు నిర్మాలు నిర్మాలు నాలు
2017-02-2017 11:38 | correction to
the implan
angulation
axis
no | correction to
the implan
angulation
axis
no | angulatior.
no | |
| | | K091756 | K091756 | K091756 | |
| Predicate Device Region Program Program Program Predicate Prediction Program Program Program President | CaTitanium Base | roduct-No. 323'
Nobel Biocare
oroduct catalo
page 14. | roduct-No. 3237 | oduct-No. 32 | |
| | Diameter | 3,5 mm | 4.3 mm | 5.0 mm | |
| | | eplace® NP | eplace® RP | Replace® WP | |
| | cture،
Manu- | Biocare
Nobel | Nobel Biocare | Nobe | |
| roposed Device TiBase | | NBRS 3.5 | NBRS 4.3 | MBRS 5.0 | |
| geo- -
Screw
metry
"""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""
్ వై | .
ు వైద్యశాల ప్రాథమిక వైద్యశాల ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక | | same | same | same |
| rota- tional
ាមស្ថិតនៅក្នុងស្រុក ប្រជាជាប្រជាជាប្រជាជាតិ ប្រជាជាប្រជាជាប្រជាជាប្រជាជាប្រជាជាតិ ប្រជាជាប្រជាជាប្រជាជាប្រជាជាប្រជាជាតិ ប្រជាជាប្រជាជាប្រជាជាតិ ប្រជាជាប្រជាជាប្រជាជាតិ
Con-
fea-
nec-
tures | িন্দুস্থ
్లాల్లో ప్రా
ﻨﺘﺸﺎ | | yes | yes | yes |
| .
::::: - metro - metro - metro - metro - metro - metro - metro - metro - metro - metro - metro - metro - metro - metro - metro - metro - metro - metro - metro - metro - metro - metr
ﺔ
. 1
Con-
Type
tion
·nec-
s: " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " "
: "
. . | ਾ ਦੁਆਰ
:
:
・ : | nons
3 te-
nal | nons
nter-
3 te-
na | Exter-
Hexa-
gona
nal | Exter- |
| to
tical con-
geo- metry
lden-
nec-
tion
ﺗﺰﻳﺮ ﺍﻟﻤﺪﻳﻨﺔ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻒ ﺍﻟﻤﺘﻮﻗﻒ | ﺍ - ﺍ
尔 · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · | | yes | yes | yes |
| ·············································································································································································
: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :
:
i6Al .
of --
and
Screw
. made
Abut-
ment
: | : | | yes | yes | yes |
| | | correction to
the implan
axis | correction to
the implant
angulation
axis
no | correction to
the implant
angulation
axis
no | angulation
no |
| | Predicate Devices K-Number, S-Number, | | K091756 | 99.0% Al2O3 99.0% Y2O3: 4.5 - 5.4% HfO2: 6.00 g/cm3 |
| Coefficient of thermal
expansion (CTE) | 11.0*10-6 K-1
(20 °C - 500 °C) | No specification |
| Flexural strength | > 900MPa | > 800MPa |
| Fracture toughness (KIC) | 5.8 MPa·m1/2 | No specification |
| Grain Size | about 0.5 µm | Susan Runne |
| | (Division Sign-Off) |
| Sirona Dental Systems 510(k) Additional Information K100152 | October 20, 2009 Division of Anesthesiology, General Hospital Infection Control, Dental Devices |
| 510(k) Number: | K100152 |