SIRONA DENTAL CAD/CAM SYSTEM
Device Facts
| Record ID | K111421 |
|---|---|
| Device Name | SIRONA DENTAL CAD/CAM SYSTEM |
| Applicant | Sirona Dental Systems GmbH |
| Product Code | NHA · Dental |
| Decision Date | Feb 17, 2012 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3630 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended 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. For the titanium bases SSO 3.5 L and SBL 3.3 L, the indication is restricted for replacement of single lateral incisors in the maxilla and lateral and central incisors in the mandible. 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) . Straumann Bone Level (K053088, K062129, K060958) . Biomet 3i Certain (K014235, K061629) . . Nobel Biocare Active (K071370)
Device Story
System captures optical impressions of teeth, impressions, or stone models; records topographical data. CAD/CAM software designs individual mesostructures; milling machines (CEREC/inLab MCXL) fabricate mesostructures from inCoris ZI meso blocks. Two-piece abutment consists of TiBase (Ti6Al4V) and milled ceramic mesostructure; bonded together and fixed to endosseous dental implant via screw. Used in dental clinics by dentists or technicians. Scanbody (ABS plastic) aids in calculating implant position. Output is a custom prosthetic abutment restoring oral function and aesthetics. Benefits include patient-specific restorative fit and aesthetic outcomes.
Clinical Evidence
No clinical data performed. Evidence based on bench testing, including fatigue testing for angled abutments per FDA guidance, and reverse-engineering analysis demonstrating compatibility with mating implants.
Technological Characteristics
Materials: Ti6Al4V (ISO 5832-3) for TiBase; Y-TZP Zirconia (ISO 13356) for mesostructures. Sensing: Optical impression camera. Fabrication: CAD/CAM milling (CEREC/inLab MCXL). Connectivity: Networked/Internet for data transfer. Software: CAD design and CAM milling control. Sterilization: Non-sterile.
Indications for Use
Indicated for partially or fully edentulous patients requiring single or multiple-unit cement-retained restorations supported by endosseous dental implants. Specific restriction for SSO 3.5 L and SBL 3.3 L bases: replacement of single lateral incisors in maxilla and lateral/central incisors in mandible.
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
- Replace® NP (K091756)
- Brånemark® (K091756)
- Tissue level NN (K081005)
- OsseoSpeed™ (K081666)
- Frialit® / Xive® (K032158)
- Osseotite (K072642)
- Tapered Screw-Vent® (K060880)
- Nobel Active NP (K102436)
- Bone Level NC (K062129)
- Certain® (K073345)
- Sirona Dental CAD/CAM System (K100152)
Reference Devices
- 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)
- Straumann Bone Level (K053088, K062129, K060958)
- Biomet 3i Certain (K014235, K061629)
- Nobel Biocare Active (K071370)
- Camlog Titanium base CAD/CAM (K083496)
Related Devices
- K100152 — SIRONA CAD/CAM SYSTEM · Sirona Dental Systems GmbH · Oct 22, 2010
- K181520 — Sirona Dental CAD/CAM System · Dentsply Sirona · Oct 11, 2018
- K193408 — Sirona Dental CAD/CAM System with CEREC Chairside Software · Dentsply Sirona · Aug 16, 2020
- K231455 — Implant-One System · Implant Logistics, Inc. · Aug 15, 2023
- K211225 — MIS Ti-base abutment · Dentsply Sirona · Jul 28, 2021
Submission Summary (Full Text)
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K111421
# 510(k) Summary
FEB 1 7 2012
for
# Sirona Dental Systems
# Sirona Dental CAD/CAM System
#### 1 Sponsor
Sirona Dental Systems GmbH
Fabrikstrasse 31
D-64625 Bensheim Germany
Contact Person: Fritz Kolle Telephone: 49 6251 16 32 94
Date Prepared: May 06, 2011
#### 2 Device Name
| Proprietary Name: | Sirona Dental CAD/CAM-System |
|-----------------------|---------------------------------------|
| Common/Usual Name: | Abutment, implant, dental, endosseous |
| Classification Names: | Endosseous dental implant abutment |
#### 3 Predicate Devices
Replace® NP, K091756, Brånemark®, K091756, Tissue level NN, K081005, OsseoSpeed™, K081666, Frialit® / Xive®, K032158, Osseotite K072642, Tapered Screw-Vent®, K060880, Nobel Active NP, K102436, Bone Level NC, K062129, Certain®, K073345.
Sirona Dental CAD/CAM System (K100152)
Sirona Dental 510(k) Summary
May 06, 2011
Sirona Dental CAD/CAM System
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#### Intended Use 4
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. For the titanium bases SSO 3.5 L and SBL 3.3 L, the indication is restricted for replacement of single lateral incisors in the maxilla and lateral and central incisors in the mandible. 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)
- Straumann Bone Level (K053088, K062129, K060958) .
- Biomet 3i Certain (K014235, K061629) .
- . Nobel Biocare Active (K071370)
#### 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 .
May 06, 2011
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- . 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.
#### 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-sterile 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 Dental 510(k) Summary
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Sirona TiBase devices are compatible with following systems (Table 1):
| 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<br>(Connec-tion type:<br>Ex. Hex) | 3.4 mm |
| BO 4.1 | Biomet 3i | Osseotite<br>(Connec-tion type:<br>Ex. Hex) | 4.1 mm |
| Sirona TiBase | Compatible System | | |
| | Manufacturer | System | Diameter |
| BO 5.0 | | Osseotite<br>(Connec-tion type:<br>Ex. Hex) | 5.0 mm |
| ZTSV 3.5 | | Tapered Screw-<br>Vent® | 3.5 mm |
| ZTSV 4.5 | Zimmer | Tapered Screw-<br>Vent® | 4.5 mm |
| ZTSV 5.7 | | Tapered Screw-<br>Vent® | 5.7 mm |
| NB A 4.5 | Nobel Biocare | Nobel Active NP | 3.5mm |
| NB A 5.0 | Nobel Biocare | Nobel Active NP | 4.3 / 5.0mm |
| S BL 3.3 | Straumann® | Bone Level NC | 3.3mm |
| S BL 4.1 | Straumann® | Bone Level NC | 4.1 / 4.8mm |
| B C 3.4 | | Certain® | 3.4mm |
| B C 4.1 | Biomet 3i | Certain® | 4.1mm |
| B C 5.0 | | Certain® | 5.0mm |
Table 1: Sirona TiBase Devices Compatibility
Sirona Dental 510(k) Summary
.
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#### 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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| 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 |
| NB A | Nobel Biocare | Nobel Active | K071370 |
| S BL | Straumann® | Bone Level | K053088 |
| BC | Biomet 3i | Certain® | K014235 |
### Table 2: Implant Compatibility
### 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.
#### inCoris ZI meso 5.2
### 5.2.1 Device Description
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
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abutment which comprises a titanium base and a zirconium oxide mesostructure. The connection geometries are prefabricated.
#### 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<br>(Sirona) | REF | Diameter | inCoris ZI<br>meso<br>(Sirona) | REF | Color<br>inCoris ZI<br>meso<br>(Sirona) |
| NBRS 3.5 | 6282474 | 3,5 mm | inCoris ZI<br>meso L | 62 31 810<br>62 31 836 | F0.5<br>F2 |
| NBRS 4.3 | 6282482 | 4.3 mm | inCoris ZI<br>meso L | 62 31 810<br>62 31 836 | F0.5<br>F2 |
| NBRS 5.0 | 6282490 | 5.0 mm | inCoris ZI<br>meso L | 62 31 810<br>62 31 836 | F0.5<br>F2 |
| NBRS 6.0 | 6282508 | 6.0 mm | inCoris ZI<br>meso L | 62 31 810<br>62 31 836 | F0.5<br>F2 |
| NBB 3.4 | 6282516 | 3.4 mm | inCoris ZI | 62 31 810 | F0.5 |
| Titanium Base | | | Ceramic Block | | |
| TiBase<br>(Sirona) | REF | Diameter | inCoris ZI<br>meso<br>(Sirona) | REF | Color<br>inCoris ZI<br>meso<br>(Sirona) |
| | | | meso L | 62 31 836 | F2 |
| NBB 4.1 | 6282524 | 4.1 mm | inCoris ZI<br>meso L | 62 31 810<br>62 31 836 | F0.5<br>F2 |
| SSO 3.5 | 6284231 | 3.5 mm | inCoris ZI<br>meso L | 62 31 810<br>62 31 836 | F0.5<br>F2 |
| SSO 4.8 | 6284249 | 4.8 mm | inCoris ZI<br>meso L | 62 31 810<br>62 31 836 | F0.5<br>F2 |
| SSO 6.5 | 6284256 | 6.5 mm | inCoris ZI<br>meso L | 62 31 810<br>62 31 836 | F0.5<br>F2 |
| ATOS<br>3.5/4.0 | 6282532 | 3.5 S / 4.0<br>S mm | inCoris ZI<br>meso L | 62 31 810<br>62 31 836 | F0.5<br>F2 |
| ATOS<br>4.5/5.0 | 6282540 | 4.5 / 5.0<br>mm | inCoris ZI<br>meso L | 62 31 810<br>62 31 836 | F0.5<br>F2 |
| FX 3.4 | 6282433 | 3.4 mm | inCoris ZI<br>meso S | 62 31 802<br>62 31 828 | F0.5<br>F2 |
| FX 3.8 | 6282441 | 3.8 mm | inCoris ZI<br>meso S | 62 31 802<br>62 31 828 | F0.5<br>F2 |
| FX 4.5 | 6282458 | 4.5 mm | inCoris ZI<br>meso L | 62 31 810<br>62 31 836 | F0.5<br>F2 |
| FX 5.5 | 6282466 | 5.5 mm | inCoris ZI<br>meso L | 62 31 810<br>62 31 836 | F0.5<br>F2 |
| BO 3.4 | 6282557 | 3.4 mm | inCoris ZI<br>meso L | 62 31 810<br>62 31 836 | F0.5<br>F2 |
| | Titanium Base | | | Ceramic Block | |
| TiBase<br>(Sirona) | REF | Diameter | inCoris ZI<br>meso<br>(Sirona) | REF | Color<br>inCoris ZI<br>meso<br>(Sirona) |
| BO 4.1 | 6282565 | 4.1 mm | inCoris ZI<br>meso L | 62 31 810<br>62 31 836 | F0.5<br>F2 |
| BO 5.0 | 6282573 | 5.0 mm | inCoris ZI<br>meso L | 62 31 810<br>62 31 836 | F0.5<br>F2 |
| ZTSV 3.5 | 6282581 | 3.5 mm | inCoris ZI<br>meso L | 62 31 810<br>62 31 836 | F0.5<br>F2 |
| ZTSV 4.5 | 6282599 | 4.5 mm | inCoris ZI<br>meso L | 62 31 810<br>62 31 836 | F0.5<br>F2 |
| ZTSV 5.7 | 6282607 | 5.7 mm | inCoris ZI<br>meso L | 62 31 810<br>62 31 836 | F0.5<br>F2 |
| NB A 4.5 | 6308188 | 3.5mm | inCoris ZI<br>meso L | 62 31 810<br>62 31 836 | F0.5<br>F2 |
| NB A 5.0 | 6308253 | 4.3 / 5.0mm | inCoris ZI<br>meso L | 62 31 810<br>62 31 836 | F0.5<br>F2 |
| S BL 3.3 | 6308154 | 3.3mm | inCoris ZI<br>meso L | 62 31 810<br>62 31 836 | F0.5<br>F2 |
| S BL 4.1 | 6308337 | 4.1 / 4.8mm | inCoris ZI<br>meso L | 62 31 810<br>62 31 836 | F0.5<br>F2 |
| B C 3.4 | 6308048 | 3.4mm | inCoris ZI<br>meso S | 62 31 802<br>62 31 828 | F0.5<br>F2 |
| B C 4.1 | 6308097 | 4.1 mm | inCoris ZI<br>meso L | 62 31 810<br>62 31 836 | F0.5<br>F2 |
| Titanium Base | | | Ceramic Block | | |
| TiBase<br>(Sirona) | REF | Diameter | inCoris ZI<br>meso<br>(Sirona) | REF | Color<br>inCoris ZI<br>meso<br>(Sirona) |
| B C 5.0 | 6308121 | 5.0mm | inCoris ZI<br>meso L | 62 31 810<br>62 31 836 | F0.5<br>F2 |
### Table 3: Sirona inCoris ZI meso - TiBase Devices Compatibility
Sirona Dental 510(k) Summary
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May 06, 2011
Sirona Dental CAD/CAM System
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### Table 4: Sirona inCoris ZI meso - Camlog Devices Compatibility
| | Titanium Base | | | Ceramic Block | |
|------------|---------------|---------------|--------------------------------|------------------------|-----------------------------------------|
| Camlog | REF | Dia-<br>meter | inCoris ZI<br>meso<br>(Sirona) | REF | Color<br>inCoris ZI<br>meso<br>(Sirona) |
| K2244.3348 | K2244.3348 | 3.3 | inCoris ZI<br>meso S | 62 31 802<br>62 31 828 | F0.5<br>F2 |
| K2244.3848 | K2244.3848 | 3.8 | inCoris ZI<br>meso S | 62 31 802<br>62 31 828 | F0.5<br>F2 |
| K2244.4348 | K2244.4348 | 4.3 | inCoris ZI<br>meso S | 62 31 802<br>62 31 828 | F0.5<br>F2 |
| K2244.5048 | K2244.5048 | 5.0 | inCoris ZI<br>meso L | 62 31 810<br>62 31 836 | F0.5<br>F2 |
| K2244.6048 | K2244.6048 | 6.0 | inCoris ZI<br>meso L | 62 31 810<br>62 31 836 | F0.5<br>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:
Sirona Dental 510(k) Summary
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| ZrO2+HfO2+Y2O3 | > 99.0% |
|----------------|---------|
| Al2O3 | < 0.5% |
| Other oxides | < 0.5% |
#### Physical Properties 5.2.3.3
The final technical data of inCoris ZI meso are (after final sintering):
| Density: | 6.06 g/cm³ |
|-----------------------------------------|------------------------|
| Coefficient of thermal expansion (CTE): | $11.0*10^{-6} K^{-1}$ |
| Flexural strength: | > 900 MPa |
| Fracture toughness (KIC): | $5.9 MPa\cdot m^{1/2}$ |
#### 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 includes
- 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
- Design of mesostructures and processing the acquired or recorded data for . these 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
The Sirona Dental CAD/CAM Design and fabricating devices also processes other dental restorations like crowns, bridge-frameworks, inlays, onlays all regulated under 21 CFR 872.3661, Optical Impression Systems for CAD/CAM, for such intended use.
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#### 5.3.2 Scientific Concept
The underlying scientific concept is the use of CAD/CAM technology for the optical acquisition of the topographical characteristics of dental impressions, and models, the design of individual mesostructures using recorded data (CAD), and eventually fabricating (milling) these designed mesostructures (CAM).
#### 5.3.3 Physical and Performance Characteristics
### 5.3.3.1 Design
Acquisition unit: the device consists of a camera for acquiring optical topographical characteristics of dental impressions. The recorded data are used for the design of individual mesostructures using CAD techniques specific to 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 prescribed trajectories to generate the shape which is intended to be milled.
### 5.3.3.2 Materials Used
Not applicable.
### 5.3.3.3 Physical Properties
Not applicable.
#### Summary of the technological characteristics 6
#### 6.1 TiBase
All proposed and predicate titanium bases and screws are made of Ti6AI4V, medical grade 5. Connection interfaces to the implants are identical for each defined diameter and connection type. Connection interfaces to dental restorations differ in that proposed devices have an additional notch.
An extensive list is provided in Table 5.
#### inCoris ZI meso 6.2
Proposed and predicate (K100152) device are inCoris ZI meso.
Sirona Dental 510(k) Summary
May 06, 2011
Sirona Dental CAD/CAM System
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There has been no modification to inCoris ZI meso from Premarket Notification K100152. Specifically, the following aspects remain identical:
- Composition .
- Material properties .
- Thickness / design restrictions .
- Shape and bonding surface of connection interfaces to Camlog and Sirona . Tibase for Sirona inCoris ZI meso blocks
- Bonding material .
InCoris ZI meso is bonded to titanium bases for supporting further dental restorations.
InCoris ZI meso material is made of zirconium oxide. The composition of inCoris complies with ISO standard 13356:1997, "Implants for surgery, Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP)". Such compositions are classified as biocompatible by this standard.
An extensive list is provided in Table 6.
#### Sirona Dental CAD/CAM Design and fabrication Devices 6.3
There has been no modification to the Sirona Dental CAD/CAM Design and fabricating devices from Premarket Notification K100152. Specifically, the following aspects remain identical:
- optical impressions record topographical characteristics of teeth, dental . impressions, or stone models for use in the computer aided design and fabrication of dental restorative prosthetic devices in conjunction with endosseous dental implant abutments, i.e. it is an accessory
- features the transfer of data of the optical impression to a remote milling . machine via internet or exportation/importation of milling data
The software database of titanium bases has been extended to cover new additional titanium bases.
An extensive list is provided in Table 7.
Sirona Dental 510(k) Summary
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Sirona Dental CAD/CAM System
May 06, 2011
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Sirona Dental 510(k) Summar
APPENDIX H • Page 14 of 32
| Proposed<br>Device<br>TiBase | Predicate Device | | | | | | | | | |
|------------------------------|------------------|-------------|----------|-------------------------------------------------------------------|----------------------------------|-------------------------------------------------------|--------------------------------------------------------|--------------------------------|---------------------------------|-------------------|
| | Manufacturer | System | Diameter | Titanium Base | Predicate<br>Devices<br>K-Number | Abutment<br>and<br>Screw<br>made<br>of<br>Ti6Al4<br>V | Identical<br>connection<br>geometry<br>to<br>abutments | Connection<br>geometry<br>Type | Anti-<br>rotational<br>features | Screw<br>geometry |
| NBRS 3.5 | Nobel Biocare | Replace® NP | 3,5 mm | Nobel Biocare<br>product catalog page<br>14.<br>Product-No. 32376 | K091756 | yes | yes | Internal<br>3 te-nons | yes | same |
| NBRS 4.3 | Nobel Biocare | Replace® RP | 4.3 mm | Product-No. 32377 | K091756 | yes | yes | Internal<br>3 te- | yes | same |
ble 5: Comparison of Sirona TiBase to Predicate Device
{14}------------------------------------------------
same പ്രാമത
ക്ഷേത്ര
ശ്രീക്ഷം ആര same പ്രവർത്തിച്ചു.
2001
2001
2001
2001
2001
2001
2001 yes yes Type nons pri prip
-taug suou
-al E ្រមួយ
ប្រជាជន្ suou
-al E പുറത്തിനു
അവലംബം
അറ്റു
അറ്റു
അറ 을 좋습니다. 그러나 그 후 할 yes yes 흥콜걸 출장 > yes yes K-Number Predicate
Devices K091756 K091756 roduct-No. 3237 roduct-No. 3237 Titanlum Base . redicate Device Diameter 6.0 mm 5.0 mm Replace® WP Replace® 6.0 System Nobel Biocare Nobel Biocare Manufacturer NBRS 5.0 NBRS 6.0 Proposed
Device TiBase
.
ﺎﺑ
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| Proposed<br>Device | Predicate Device | | | | | | | | | |
|--------------------|------------------|------------|-----------------------------------------------------------|-------------------------------------------------------------------|-------------------------------------------------------|--------------------------------------------------------|--------------------------------------------------------|-----------------------------------------------------------|------------------------------------------------------|-------------------|
| TiBase | Manufacturer | System | Diameter | Titanium Base | Predicate Devices<br>K-Number | Abutment<br>and<br>Screw<br>made<br>of<br>Ti6Al4<br>V | Identical<br>connection<br>geometry<br>to<br>abutments | Connection<br>geometry<br>Type | Connection<br>geometry<br>Antirotational<br>features | Screw<br>geometry |
| NBB 3.4 | Nobel Biocare | Brånemark® | 3.4 mm | Nobel Biocare<br>product catalog page<br>14.<br>Product-No. 32396 | K091756 | yes | yes | External<br>Hexagonal | yes | same |
| NBB 4.1 | Nobel Biocare | Brånemark® | 4.1 mm | Product-No. 32397 | K091756 | yes | yes | External<br>Hexagonal | yes | same |
| Predicate Device | | | | | Abutment<br>and<br>Screw<br>made<br>of<br>Ti6Al4<br>V | Identical<br>connection<br>geometry<br>to<br>abutments | Connection<br>geometry<br>Type | Connection<br>geometry<br>Anti-<br>rotational<br>features | Screw<br>geometry | |
| Manufacturer | System | Diameter | Titanium Base | Predicate<br>Devices<br>K-Number | | | | | | |
| Straumann | Tissue level NN | 3.5 mm | Straumann product catalog page 51.<br>Product-No. 048.505 | K081005 | yes | yes | external | yes | same | |
| Straumann | Tissue level RN | 4.8 mm | Product-No. 048.600<br>(p 55) | K081005 | yes | yes | Internal<br>Octagonal | yes | same | |
| Straumann | Tissue level WN | 6.5 mm | Product-No. 048.606 | K081005 | yes | yes | Internal<br>Octagonal | yes | same | |
: :
:
{16}------------------------------------------------
Sirona Dental CAD/CAM System
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Sirona Dental 510(k) Summary
APPENDIX H • Page 17 of 32
{17}------------------------------------------------
same same ជាបរិវេលា
ពុក្យ
១៣០
ជាចំនួន ១៣០
Children ົນລາຍ
-0.68 yes yes Hexa-និងទារ
ខេត្តព្រៃ និងប្រព្រះពុទ្ធសន្តិ
អ្នកន្លង րոյ
-{}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}
{{{{{{{{{}}}}}}}}}}}}}}}}}}}}}}}}}}
{{{{{{{{}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}
{{{{{{{{}}} Гуре pril
- muj ക്കം
അ
1998
1991
1991 1991
1991 1991 1991
1991 1991 1991 1991
1991 1991 1991 1991 1991
1991 1991 1991 1991
1991 1991 1991
1991 1991 1991
1991 19 nal 를 좀 ㅎㅎㅎㅎㅎㅎㅎㅎㅎ yes yes 흥 합류 등 일 ~ 일 ~ 2 ~ 2 ~ 2 ~ 2 ~ 2 ~ 2 ~ 2 ~ 2 ~ 2 ~ 2 ~ 2 ~ 2 ~ 2 ~ 2 ~ 2 ~ 2 ~ 2 ~ 2 ~ 2 ~ 2 ~ 2 ~ 2 ~ 2 ~ 2 ~ 2 ~ 2 ~ 2 ~ 2 ~ 2 ~ 2 ~ 2 ~ 2 ~ 2 ~ 2 ~ 2 ~ 2 ~ 2 ~ 2 ~ 2 ~ 2 yes ycs Predicate
Devices K-Number 1081666 K081666 . roduct-No. 2428: roduct-No. 2423. Titanium Base (p 62) : redicate Device 3.5 S / 4.0
S mm Diameter 4.5 / 5.0
: OsseoSpeed™ OsseoSpeed™ System Astra Tech Astra Tech Manufacturer . · Proposed
Device ATOS
4.5/5.0 TiBase soly
:
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same same ជាមួយ
പ്രവർത്തിച്ചു.
അവലംബം
പാല
സ്വാത്രം
അവലംബം
സ്വാത്ര yes yes ប្រជាជន៍បតិបតិបតិបតិបតិបតិបតិបតិបតិបតិបតិបតិបតិបតិបតិបតិបតិបតិបតិបតិបតិបតិបតិបតិបតិបតិបតិបតិបតិបតិបតិបត្តិសាសនា
English Type gonal ព្រះពុទ្ធសន្តិ
អូសន្តអ្វី Teu പാലിക്കുമ
തുടർ
കാലാണ്
1980 pus
Jupur 을 줄 수 있는 글 목록 글 목록 할 yes SSA 일 출발 : 2017-02-08 10:22:20
2017-02-04 10:00
2017-02-04 10:00
2017-02-04 10:00
2019-02-04 10:00
2017-02-04 10:00
2019-02-04 10:00
2019-02-04 10:00
2019-08-08 10:00 10-02-20
2 yes yes Predicate
Devices K-Number K032158 K032158 oduct-No. 46-2132 oduct-No. 46-2141 riadent product
catalog page 32. Titanium Base . . redicate Device Diameter 3.8 mm 3.4 mm rialit® / Xive® rialit® / Xive® System Friadent Manufacturer Friadent ·· Proposed
Device FX 3.8 TiBase FX 3.4
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| Predicate Device | | | | | | | | | | | | |
|--------------------|--------|------------------------------------------------------------|--------------------------------------------------------|--------------------------------|-------------------------------------------------------|-------------------|----------------------------|--------|---------------------------------------|---------------|----------------------------------|--|
| Proposed<br>Device | TiBase | Abut-<br>ment<br>and<br>Screw<br>made<br>of<br>Ti6Al4<br>V | Identical<br>connection<br>geometry<br>to<br>abutments | Connection<br>geometry<br>Type | Connection<br>geometry<br>Anti-rotational<br>features | Screw<br>geometry | Manufacturer | System | Diameter | Titanium Base | Predicate<br>Devices<br>K-Number | |
| | FX 4.5 | yes | Internal<br>Hexagonal | yes | same | Friadent | Frialit®/Xive® | 4.5 mm | Product-No. 46-2152 | K032158 | | |
| | FX 5.5 | yes | Internal<br>Hexagonal | yes | same | Friadent | Frialit®/Xive® | 5.5 mm | Product-No. 46-2162 | K032158 | | |
| | BO 3.4 | yes | External | yes | same | Biomet 3i | Osseotite<br>(Connec-tion) | 3.4 mm | 3i Biomet product<br>catalog page 25. | K072642 | | |
APPENDIX H • Page 20 of 32
{20}------------------------------------------------
| Predicate Device | | | | | | | | | | | |
|------------------------------|------------------|------------------------------------------|-------------|----------------------------------------------------------------|-------------------------------|-------------------------------------------------------|--------------------------------------------------------|--------------------------------|-----------------------------|------------------------------------|-------------------|
| Proposed Device<br>TiBase | Manufacturer | System<br>(type: Ex. Hex) | Diameter | Titanium Base | Predicate Devices<br>K-Number | Abutment and Screw made of Ti6Al4 V | Identical connection geometry to abutments | Connection geometry | Type | Anti-rotational features | Screw geometry |
| BO 4.1 | Biomet 3i | Osseotite<br>(Connec-tion type: Ex. Hex) | 4.1 mm | Product-No.<br>APP452G | K072642 | yes | yes | Hexagonal | External | yes | same |
| BO 5.0 | Biomet 3i | Osseotite<br>(Connec-tion type: Ex. Hex) | 5.0 mm | Product-No.<br>WPP552G | K072642 | yes | yes | Hexagonal | External | yes | same |
| Proposed<br>Device<br>TiBase | Manufacturer | System | Diameter | Titanium Base | Predicate Device<br>K-Number | Abutment<br>and<br>Screw<br>made<br>of<br>Ti6Al4<br>V | Identical<br>connection<br>geometry<br>to<br>abutments | Connection<br>geometry<br>Type | Anti-rotational<br>features | Connection<br>geometry | Screw<br>geometry |
| ZTSV 3.5 | Zimmer | Tapered Screw-<br>Vent® | 3.5 mm | Zimmer product<br>catalog page 9.<br>Product-No.<br>ZOA342S | K060880 | yes | yes | Internal<br>Hexagonal | yes | yes | same |
| ZTSV 4.5 | Zimmer | Tapered Screw-<br>Vent® | 4.5 mm | Product-No.<br>ZOA442S | K060880 | yes | yes | Internal<br>Hexagonal | yes | yes | same |
| Proposed Device<br>TiBase | Predicate Device | | | | | | | | | | |
| | Manufacturer | System | Diameter | Titanium Base | Predicate Devices<br>K-Number | Abutment and Screw made of Ti6Al4 V | Identical connection geometry to abutments | Connection geometry Type | Anti-rotational features | Screw geometry Connection geometry | |
| ZTSV 5.7 | Zimmer | Tapered Screw-Vent® | 5.7 mm | Product-No. ZOA562S | K060880 | yes | yes | Internal | yes | same | |
| NB A 4.5 | Nobel Biocare | Nobel Active NP | 3,5mm | Nobel Biocare product<br>Catalog page 71.<br>Product-No. 34194 | K102436 | yes | yes | Internal<br>Hexagonal | yes | same | |
| Proposed Device | Predicate Device | | | | | | | | Screw geometry | | |
| | Manufacturer | System | Diameter | Titanium Base | Predicate Devices | Abutment and Screw made of Ti6Al4 V | Identical connection geometry to abutments | Connection geometry Type | Anti-rotational features | Connection geometry | |
| iBase | Nobel Biocare | Nobel Active RP | 4,3 / 5,0mm | Product-No. 34198 | K-Number K102436 | yes | yes | Internal Hexagonal | yes | same | |
| | | | | Straumann product Catalog | | | | Internal 4 slots | | | |
| Straumann<br>S BL 3.3 ® | Straumann | Bone Level NC | 3,3mm | Product-No. 022.2102 | K062129 | yes | yes | | yes | same | |
APPENDIX H • Page 21 of 32
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| Predicate Device | | | | | | | | |
|------------------|----------------|------------------------------------------------------------|-------------------------------|-------------------------------------------------------|--------------------------------------------------------|--------------------------------|------------------------|-------------------|
| System | Diameter | Titanium Base | Predicate Devices<br>K-Number | Abutment<br>and<br>Screw<br>made<br>of<br>Ti6Al4<br>V | Identical<br>connection<br>geometry<br>to<br>abutments | Connection<br>geometry<br>Type | Connection<br>geometry | Screw<br>geometry |
| Bone Level RC | 4,1 /<br>4,8mm | Product-No.<br>022.4102 | K062129 | yes | yes | Internal 4<br>slots | yes | same |
| Certain® | 3,4mm | Biomet product<br>Catalog page 5<br>Product-No.<br>IMAP32G | K073345 | yes | yes | Internal<br>Hexagonal | yes | same |
| Certain® | 4,1mm | Biomet product | K073345 | yes | yes | Internal | yes | same |
ﺍ
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| Proposed<br>Device | | | | Predicate Device | | | Abut-<br>ment<br>and<br>Screw<br>made<br>of<br>Ti6Al4<br>V | Iden-<br>tical<br>con-<br>nec-<br>tion<br>geo-<br>metry<br>to<br>abut-<br>ments | Con-<br>nec-<br>tion<br>geo-<br>metry | Con-<br>nec-<br>tion<br>geo-<br>metry | Screw<br>geo-<br>metry |
|--------------------|-------------------|----------|----------|-------------------------------------------------------------|-------------------------------------------|----------|------------------------------------------------------------|---------------------------------------------------------------------------------|---------------------------------------|---------------------------------------|-------------------------------------------|
| TiBase | | | | | | | | | | Type | Anti-<br>rota-<br>tional<br>fea-<br>tures |
| | Manu-<br>facturer | System | Diameter | Titanium Base | Predicate<br>Devices | K-Number | | | | | |
| | | | | | Catalog page 5<br>Product-No.<br>IAPP452G | | | | | Hexagonal | |
| B C 5.0 | Biomet 3i | Certain® | 5,0mm | Biomet product<br>Catalog page 5<br>Product-No.<br>IWPP562G | K073345 | yes | yes | yes | Internal | Hexagonal | same |
APPENDIX H • Page 26 of 32
{26}------------------------------------------------
| | InCoris ZI meso | InCoris ZI meso<br>(K100152) |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | inCoris ZI meso blocks are used<br>in manufacturing individually<br>designed mesostructures, which<br>are glued to a fitting titanium<br>base after milling and sintering. | inCoris ZI meso blocks are used<br>in manufacturing individually<br>designed mesostructures, which<br>are glued to a fitting titanium<br>base after milling and sintering. |
| Application | inCoris ZI mesostructures can<br>only be used for the intended<br>titanium bases or implants.<br>Allocation of the connection size<br>to the respective titanium base<br>can be determined by the<br>scanbody set of the respective<br>implant system. | inCoris ZI mesostructures can<br>only be used for the intended<br>titanium bases or implants.<br>Allocation of the connection size<br>to the respective titanium base<br>can be determined by the<br>scanbody set of the respective<br>implant system. |
| | Please observe the indications<br>and contraindications of the<br>implant. | Please observe the indications<br>and contraindications of the<br>implant. |
| Contra-Indications | Insufficient oral hygiene Insufficient space available Bruxism For mesostructure-geometry<br>with angulation correction<br>greater than 20° to the<br>implant axis For mesostructure-geometry<br>with angulation correction<br>to the implant axis for<br>Camlog only For individual tooth<br>restorations with free end<br>saddle For restorations with a<br>length to implant length<br>ratio of more than 1:1.25 | Insufficient oral hygiene Insufficient space available Bruxism For restorations with<br>angulation correction to the<br>implant axis For individual tooth<br>restorations with free end<br>saddle For restorations with a<br>length to implant length<br>ratio of more than 1:1.25 |
| Technical Data | | |
| Block-Material Composition | ZrO2+HfO2+Y2O3:<br>> 99.0% Y2O3: 5.2% | ZrO2+HfO2+Y2O3:<br>> 99.0% Y2O3: 5.2% HfO2: 2% |
| | InCoris ZI meso | InCoris ZI meso<br>(K100152) |
| | • Al2O3: ≤ 0.05%<br>• Fe2O3: 0.3% | • Al2O3: ≤ 0.05%<br>• Fe2O3: 0.3% |
| Density (sintered) | 6.06 g/cm³ | 6.06 g/cm³ |
| Coefficient of thermal<br>expansion (CTE) | 11.0*10⁻⁶ K⁻¹<br>(20 °C - 500 °C) | 11.0*10⁻⁶ K⁻¹<br>(20 °C - 500 °C) |
| Flexural strength | > 900MPa | > 900MPa |
| Fracture toughness (KIC) | 5.8 MPa·m1/2 | 5.8 MPa·m1/2 |
| Grain Size | about 0.5 µm | about 0.5 µm |
| Bonding Material | Panavia F 2.0<br>(www.kuraray-dental.de) | Panavia F 2.0<br>(www.kuraray-dental.de) |
## Table 6: Comparison of InCoris ZI meso to Predicate Device
Sirona Dental 510(k) Summary
May 06, 2011
{27}------------------------------------------------
{28}------------------------------------------------
# Table 7: Comparison of Sirona Dental CAD/CAM Design and fabricating Devices to Predicate Devices
| | Sirona<br>Dental CAD/CAM Design and<br>fabricating Devices | Sirona<br>Dental CAD/CAM Design and<br>fabricating Devices<br>(K100152) |
|----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Used for | The Sirona Dental CAD/CAM-<br>System is indicated for taking<br>optical impressions to record the<br>topographical characteristics of<br>teeth, dental impressions, or stone<br>models by computer aided design<br>and fabrication in patients that<br>require dental restorative<br>prosthetic devices. The system<br>also features the processing of<br>mesostructures, a dental<br>restorative prosthetic device used<br>in conjunction with endosseous<br>dental implant abutments. | The Sirona Dental CAD/CAM-<br>System is indicated for taking<br>optical impressions to record the<br>topographical characteristics of<br>teeth, dental impressions, or stone<br>models by computer aided design<br>and fabrication in patients that<br>require dental restorative<br>prosthetic devices. The system<br>also features the processing of<br>mesostructures, a dental<br>restorative prosthetic device used<br>in conjunction with endosseous<br>dental implant abutments. |
| | Sirona Dental CAD/CAM Design<br>and fabricating devices feature the<br>processing of mesostructures, a<br>dental restorative prosthetic<br>device used in conjunction with<br>endosseous dental implant<br>abutments, i.e. it is an accessory<br>to it. Devices which feature the<br>processing of mesostructures<br>comprises CEREC3, CEREC AC,<br>inEos, inEos Blue, CEREC<br>MCXL and inLab MCXL | Sirona Dental CAD/CAM Design<br>and fabricating devices feature the<br>processing of mesostructures, a<br>dental restorative prosthetic<br>device used in conjunction with<br>endosseous dental implant<br>abutments, i.e. it is an accessory<br>to it. Devices which feature the<br>processing of mesostructures<br>comprises CEREC3, CEREC AC,<br>inEos, inEos Blue, CEREC<br>MCXL and inLab MCXL |
| Used with | Sirona Dental CAI/CAM<br>Hardware | Sirona Dental CAI/CAM<br>Hardware |
| Controlling of recording<br>process (CAI)<br>(optical impression) | Yes | Yes |
| Processing the recorded | Yes | Yes |
| | Sirona<br>Dental CAD/CAM Design and<br>fabricating Devices | Sirona<br>Dental CAD/CAM Design and<br>fabricating Devices<br>(K100152) |
| data (data of optical<br>impression) (CAD) | | |
| Export of milling data to<br>milling machine | Yes | Yes |
| Administration of<br>patient data | Yes | Yes |
| Further functions | Calibration of CAI/CAM<br>hardware | Calibration of CAI/CAM<br>hardware |
| Online capability | Option to upload/download the<br>data from a web portal (Cerec<br>Connect), to have CAI and CAM<br>operating on two different<br>locations connected via Internet | Option to upload/download the<br>data from a web portal (Cerec<br>Connect), to have CAI and CAM<br>operating on two different<br>locations connected via Internet |
| Scan Implant<br>Interface/surface | Yes<br>(or with mounted scanbody) | Yes<br>(or with mounted scanbody) |
| Scan custom wax-up | Yes | Yes |
| Preparation of<br>individual restoration<br>("meso-structure") to be<br>mounted on the<br>abutment | Yes | Yes |
| Bond of milled<br>zirconia/ceramic<br>individual meso-<br>structure to metal<br>abutment | Yes | Yes |
| Creation of fitting crown<br>to be mounted on top of<br>meso-structure | Yes…
