(276 days)
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:
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 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.
The provided document is a 510(k) summary for a dental CAD/CAM system. It does not contain information about studies involving acceptance criteria in the traditional sense of AI/ML performance evaluation (e.g., sensitivity, specificity, accuracy, F1-score). Instead, this document focuses on demonstrating substantial equivalence to predicate devices through comparisons of intended use, materials, design, and physical/performance characteristics.
Therefore, many of the requested categories for AI/ML study details, such as sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and training set information, are not applicable to the content presented in this 510(k) summary.
The closest equivalent to "acceptance criteria" and "device performance" in this context are the physical and chemical properties of the materials and the design/functional equivalence to established predicate devices.
Here's an attempt to extract relevant information given the nature of the document:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail manner for overall device performance. Instead, it compares the new device's characteristics to those of predicate devices, arguing for "substantial equivalence." The performance characteristics listed are material properties and design features.
| Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (Sirona Dental CAD/CAM System Components) |
|---|---|
| TiBase: | |
| Material: Ti6Al4V (medical grade 5) | Made of Ti6Al4V (medical grade 5) |
| Connection interfaces to implants: Identical to predicates for each diameter/type | Identical to predicates; notch in addition for dental restorations |
| Abutment screw material: Ti6Al4V | Made of Ti6Al4V |
| Physical properties: Comply with ISO 5832-3:1996 | Complies with ISO 5832-3:1996 |
| inCoris ZI meso: | |
| Material: Zirconium oxide, similar composition to predicates | Zirconium oxide (ZrO2+HfO2+Y2O3 > 99.0%, Al2O3 < 0.5%, Other oxides < 0.5%) |
| Compliance with ISO 13356:1997 | Fulfils standard ISO 13356:1997 (classified biocompatible) |
| Density (sintered): > 6.00 g/cm³ (from predicate) | 6.06 g/cm³ |
| Flexural strength: > 800MPa (from predicate) | > 900MPa |
| Anti-rotational feature: Notch | Notch |
| Bonding Material: Panavia F 2.0 | Panavia F 2.0 |
| CAD/CAM Design & Fabrication Devices: | |
| Ability to take optical impressions | Yes (CEREC3, CEREC AC, inEos, inEos Blue) |
| Design mesostructures from recorded data (CAD) | Yes (Sirona Dental CAD/CAM Software) |
| Fabricate/mill mesostructures (CAM) | Yes (CEREC MCXL, inLab MCXL) |
| Transfer data to remote milling machine | Yes (via internet/exportation/importation) |
| Scan Implant Interface/surface | Yes (or with mounted scanbody) |
| Scan custom wax-up | Yes |
| Preparation of customized mesostructure | Yes |
| Bond milled mesostructure to metal abutment | Yes |
| Create fitting crown | Yes |
2. Sample size used for the test set and the data provenance
Not applicable. This document describes a medical device submission based on substantial equivalence to existing predicate devices, not a clinical or performance study with a test set of data. The "testing" referred to is nonclinical (fatigue analysis, reverse-engineering for design equivalence).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for a test set is not relevant in this context. The document relies on engineering analysis and comparison against established standards and predicate device specifications.
4. Adjudication method
Not applicable. Adjudication methods are used in studies involving expert review, which is not described here.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a CAD/CAM system for fabricating dental restorations, not an AI-assisted diagnostic or interpretive device involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The CAD/CAM system involves an optical acquisition unit, software for design (human-in-the-loop), and milling machines. It's not a standalone algorithm in the AI/ML sense.
7. The type of ground truth used
For the material and physical properties, the "ground truth" is established by adherence to recognized international standards (e.g., ISO 5832-3:1996 for TiBase material, ISO 13356:1997 for inCoris ZI meso material) and direct comparison to predicate device specifications.
8. The sample size for the training set
Not applicable. There is no mention of a "training set" as this is not an AI/ML algorithm requiring learning from data.
9. How the ground truth for the training set was established
Not applicable.
{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).
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{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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{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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| 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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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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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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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 ZImeso(Sirona) | REF | ColorinCoris ZImeso(Sirona) |
| NBRS 3.5 | 6282474 | 3,5 mm | inCoris ZImeso L | 62 31 81062 31 836 | F0.5F2 |
| NBRS 4.3 | 6282482 | 4.3 mm | inCoris ZImeso L | 62 31 81062 31 836 | F0.5F2 |
| NBRS 5.0 | 6282490 | 5.0 mm | inCoris ZImeso L | 62 31 81062 31 836 | F0.5F2 |
| NBRS 6.0 | 6282508 | 6.0 mm | inCoris ZImeso L | 62 31 81062 31 836 | F0.5F2 |
| NBB 3.4 | 6282516 | 3.4 mm | inCoris ZImeso L | 62 31 81062 31 836 | F0.5F2 |
| NBB 4.1 | 6282524 | 4.1 mm | inCoris ZImeso L | 62 31 810 | F0.5 |
| Titanium Base | Ceramic Block | ||||
| TiBase(Sirona) | REF | Diameter | inCoris ZImeso(Sirona) | REF | ColorinCoris ZImeso(Sirona) |
| meso L | 62 31 836 | F2 | |||
| SSO 3.5 | 6284231 | 3.5 mm | inCoris ZImeso L | 62 31 81062 31 836 | F0.5F2 |
| SSO 4.8 | 6284249 | 4.8 mm | inCoris Zlmeso L | 62 31 81062 31 836 | F0.5F2 |
| SSO 6.5 | 6284256 | 6.5 mm | inCoris ZImeso L | 62 31 81062 31 836 | F0.5F2 |
| ATOS3.5/4.0 | 6282532 | 3.5 S / 4.0S mm | inCoris ZImeso L | 62 31 81062 31 836 | F0.5F2 |
| ATOS4.5/5.0 | 6282540 | 4.5 / 5.0mm | inCoris ZImeso L | 62 31 81062 31 836 | F0.5F2 |
| FX 3.4 | 6282433 | 3.4 mm | inCoris ZImeso S | 62 31 80262 31 828 | F0.5F2 |
| FX 3.8 | 6282441 | 3.8 mm | inCoris ZImeso S | 62 31 80262 31 828 | F0.5F2 |
| FX 4.5 | 6282458 | 4.5 mm | inCoris ZImeso L | 62 31 81062 31 836 | F0.5F2 |
| FX 5.5 | 6282466 | 5.5 mm | inCoris ZImeso L | 62 31 81062 31 836 | F0.5F2 |
| BO 3.4 | 6282557 | 3.4 mm | inCoris ZImeso L | 62 31 81062 31 836 | F0.5F2 |
| BO 4.1 | 6282565 | 4.1 mm | inCoris ZImeso L | 62 31 81062 31 836 | F0.5F2 |
| Titanium Base | Ceramic Block | ||||
| TiBase(Sirona) | REF | Diameter | inCoris ZImeso(Sirona) | REF | ColorinCoris ZImeso(Sirona) |
| BO 5.0 | 6282573 | 5.0 mm | inCoris ZImeso L | 62 31 81062 31 836 | F0.5F2 |
| ZTSV 3.5 | 6282581 | 3.5 mm | inCoris ZImeso L | 62 31 81062 31 836 | F0.5F2 |
| ZTSV 4.5 | 6282599 | 4.5 mm | inCoris ZImeso L | 62 31 81062 31 836 | F0.5F2 |
| ZTSV 5.7 | 6282607 | 5.7 mm | inCoris ZImeso L | 62 31 81062 31 836 | F0.5F2 |
Table 3: Sirona inCoris ZI meso - TiBase Devices Compatibility
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Table 4: Sirona inCoris ZI meso - Camlog Devices Compatibility
| Titanium Base | Ceramic Block | ||||
|---|---|---|---|---|---|
| Camlog | REF | Dia-meter | inCoris ZImeso(Sirona) | REF | ColorinCoris ZImeso(Sirona) |
| K2244.3348 | K2244.3348 | 3.3 | inCoris ZImeso S | 62 31 80262 31 828 | F0.5F2 |
| K2244.3848 | K2244.3848 | 3.8 | inCoris ZImeso S | 62 31 80262 31 828 | F0.5F2 |
| K2244.4348 | K2244.4348 | 4.3 | inCoris ZImeso S | 62 31 80262 31 828 | F0.5F2 |
| K2244.5048 | K2244.5048 | 5.0 | inCoris ZImeso L | 62 31 81062 31 836 | F0.5F2 |
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| Titanium Base | Ceramic Block | ||||
|---|---|---|---|---|---|
| Camlog | REF | Diameter | inCoris ZImeso(Sirona) | REF | ColorinCoris ZImeso(Sirona) |
| K2244.6048 | K2244.6048 | 6.0 | inCoris ZImeso L | 62 31 81062 31 836 | F0.5F2 |
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% < 0.5% Al2O3 < 0.5% Other oxides
5.2.3.3 Physical Properties
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·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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- 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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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: ": : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :Screwgeo-metry | ﺔ ﺗﻮﻓ | same | same | same | |
|---|---|---|---|---|---|
| -metry geo"Anti-- Anti- Trota:izturestionalea-: | yes | yes | yes | ||
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| ារបស់ពួកគេ បានប្រជាជន្ម ប្រជាជន្ម ប្រជាជន្ម ប្រជាជន្ម ប្រជាជន្ម ប្រជាជន្ម ប្រជាជន្ម ប្រជាជន្មmetry | ్లో ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమి | yes | yes | yes | |
| Abutandi Screw : } madeSTORES( -.me | yes | yes | yes | ||
| ర్చారు. నిర్మాలు నిర్మాలు నిర్మాలు నాలు2017-02-2017 11:38 | correction tothe implanangulationaxisno | correction tothe implanangulationaxisno | angulatior.no | ||
| K091756 | K091756 | K091756 | |||
| Predicate Device Region Program Program Program Predicate Prediction Program Program Program President | CaTitanium Base | roduct-No. 323'Nobel Biocareoroduct catalopage 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- | BiocareNobel | Nobel Biocare | Nobe | ||
| roposed Device TiBase | NBRS 3.5 | NBRS 4.3 | MBRS 5.0 | ||
| geo- -Screwmetry"""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""్ వై | .ు వైద్యశాల ప్రాథమిక వైద్యశాల ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక | same | same | same | |
| rota- tionalាមស្ថិតនៅក្នុងស្រុក ប្រជាជាប្រជាជាប្រជាជាតិ ប្រជាជាប្រជាជាប្រជាជាប្រជាជាប្រជាជាតិ ប្រជាជាប្រជាជាប្រជាជាប្រជាជាប្រជាជាតិ ប្រជាជាប្រជាជាប្រជាជាតិ ប្រជាជាប្រជាជាប្រជាជាតិCon-fea-nec-tures | িন্দুস্থ్లాల్లో ప్రాﻨﺘﺸﺎ | yes | yes | yes | |
| .:::::- metro - metro - metro - metro - metro - metro - metro - metro - metro - metro - metro - metro - metro - metro - metro - metro - metro - metro - metro - metro - metro - metrﺔ. 1Con-Typetion·nec-s: " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " ": ". . | ਾ ਦੁਆਰ::1.・ : | nons3 te-nal | nonsnter-3 te-na | Exter-Hexa-gonanal | Exter- |
| totical con-geo- metrylden-nec-tionﺗﺰﻳﺮ 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 --andScrew. madeAbut-ment: | : | yes | yes | yes | |
| correction tothe implanaxis | correction tothe implantangulationaxisno | correction tothe implantangulationaxisno | angulationno | ||
| Predicate Devices K-Number, S-Number, | K091756 | <091756 | <091756 | ||
| - System And - Diameters - Titanlum Base - System - System - Albert - Pitanlum Base - Reference - Research - Research - Program - Province - Particle - | roduct-No. 3237 | roduct-No. 32396product catalogNobel Biocarepage 14. | roduct-No. 3239 | ||
| 6.0 mm | 3.4 mm | 4.1 mm | |||
| Replace® 6.0 | Bránemark® | Branemark® | |||
| Manuf. Nasfacturer Nasfacturer Nasifacturer November | Biocare | BiocareNobel | BiocareNobel | Nobel | |
| Proposed Device TiBase | NBRS 6.0 | NBB 3.4 | NBB 4.1 |
APPENDIX N • Page 14 of 27
October 20, 2010
CONSTITUENTS
Sirona Dental 510(k) Summar
Sirona Dental CAD/CAM System
{14}------------------------------------------------
IO
Sirona Dental CAD/CAM System
October 20, 2010
Data | CARAMS Sun
Sirona Dental 510(k) Summar
APPENDIX N • Page 15 of 27
{15}------------------------------------------------
same same same Screw metry geo rotational tures ນ ວັນ
ນັ້ນ ວັນນາ
ວັນເກີດ geo metry
yes yes Antiyes feaabut ments Octagonal octa-Intergonal Hexagonal յթն է կում է 1810
Տարա บอก
อ้อน
แมว external . nal , 'to ... - 60 - 60 - 60 - 60 - 60 - 60 - 60 - 60 - 60 - 60 - 60 - 60 - 60 - 60 - 60 - 60 - 60 - 60 - 60 - 60 - 60 - 60 - 60 - 60 - 60 - 60 - 60 - 60 - 60 - 60 - 60 - 60 - 60 - 60 - 6 metry yes yes yes kəsi yes yes ાં એ તું correction to
the implant correction to
the implant correction to
the implant
axis Intended Usel
Dif= angulation angulation angulation axis axis no no no , Predicate
Devices
K-Number
K-Number K081005 K081005 K081005 ctober 20, 201 R-Titanium Basei
Straumann product catalog page 51 Product-No Product-No Product-No 048.505 048.600 (p 55) Predicate Device 6.5 mm 4.8 mm 3.5 mm īssue level WN issue level RN ïssue level NN ona Dental 510(k) Summa Straumann Straumann Straumann Biocare SSO 4.8 SSO 6.5 SSO 3.5 roposed
Device TiBase
TiBase
Fi
APPENDIX • Page 16 of 22
October 20, 20
irona Dental CAD/CAM Syster
ental cancer
PPENDIX N • Page 16 of
- Page 16 of 27
{16}------------------------------------------------
same same same fëatures tures yes yes yes ్లో రెడ్డి
మూలాలు
nal · ・・・・・・ gonal Octagonal Inter-Hexa gonal nter-Hexa. Intergeometry nal uoji
-sau Con-Type ్లా ఒక nal nal . ments ് എന്നും എല്ലിം
കോട്ടികളുടെ കുട്ടിക്കുന്നു.
അവലംബം
ശരീ : - yes yes yes and , Abutg ment ానికి చేస్తున్నారు.
సాహిత్య శ్రీ yes yes yes angulation
correction to
the implant angulation
correction to
the implant angulation
correction to
the implant correction to
the implant 12 - 11 - 13 - 13 axis axis axis no no 1 no K032158 Predicate
Devices
K-Numbe
K-Numbe
C K081666 <081666 : Diameter - C. Titanium Base : Titanium Base :
S. T. J. - - - - - - - - - - - - - - - - - - - - - - - - -Product-No. 2423 Friadent product catalog page 32 oduct-No. 2428 100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000 048.606 (p 62) Predicate Device 3.5 S /
4.0 S mm 4.5 / 5.0 3.4 mm mm - System - 7 - System
- System - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 -OsseoSpeed ™ OsseoSpeed™ rialit® / Xive® na Dental 510(k) Summa Manu Tacturer
The facturer
The Children Astra Tech Astra Tech Friadent - 4, roposed
Device
TiBase FX 3.4 ATOS
3.5/4.0 ATOS
4.5/5.0
PPENDIX N • Page 17 •
ctober 20, 201
ona Dental CAD/CAM Syster
Corona Dental CAD/CAM
{17}------------------------------------------------
PPENDIX N • Page 18 •
ctober 20, 201
rona Dental CAD/CAM Syste
na Dental 510(k) Summ
same same ุกราช
ใน้อย
ออกจาก
คอมวร : : same ಿ ಸ್ಪಾಪಿ ﺩ – ﻏ fea{tures rotational -Anti-yes yes yes - N Hexagonal Hexagonal ւթյուններ
Հայա gonal Hexa րություններ
Բնակ Inter nal yes yes yes yes yes yes angulation
correction to
the implant angulation
correction to
the implant angulation
correction to
the implant axis axis axis no no no నాలు
సాహిత్య Predicate
Devices
K-Number
K-Number
1 <032158 <032158 : <032158 Carlitanium Base
Carlonia Product-No. 46 Product-No. 46
Product-No. 46 Product-No. 4 2142 2132 edicate Devi gran System, 5.5 mm 4.5 mm 3.8 mm ੱਚ ਕਿਹਾ ਹੈ।
ਹਵਾਲੇ
rialit® / Xive® frialit® / Xive® alit® / Xive® Friadent Friadent Friadent FX 3.8 · FX 5.5 FX 4.5
8
of 27
{18}------------------------------------------------
same geo -. same same Screw metry rotaional Anti- geometry feas
turës yes yes yes Hexa-Extergonal Hexa-Exter-Hexagonal .
Type Exter Hexa -วอม
-นิดวิ geometry gona nal tion nal nal ్లు మ ົວລັດ ្រី និងប្រើប្រជាជា
ក្រោយពី เชื่อวั
แอต yes yes yes ಿ 4V -్లు
మూలాలు
మూలాలు
మూలాలు
సంరక్షణ
మూలాలు
మూలాలు
మూలాలు
మూలాలు
మూలాలు
మూలాలు
సంరక్షణ కా TIGAI Screw
made Abutment and yes yes yes correction to correction to
the implant correction to
the implant Intended
the implant angulation angulation angulation - Difaxis axis axis axis no no no System K072642 K072642 K07264 catalog page 25 Biomet produ Product-No
WPP552G Product-No
APP452G Product-No MAP32G 5.0 mm 4.1 mm 3.4 mm (Connection
ype: Ex. Hex) Connec-tion Connec-tion ype: Ex. Hex ype: Ex. Hex )sseotite Osseotite Osseotite Manu-Biomet 3i Biomet 3i Biomet 3i ្រី ﻟﻨﺎ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍ Proposed BO 5.0 BO 3.4 BO 4.1 Device
TiBase
ctober 20, 201
rona Dental CAD/CAM Syster ona Dental 510(k) Summa
PPENDIX N • Page 19 of
Page 192
{19}------------------------------------------------
| ProposedDeviceTiBase | Predicate Device | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Manufacturer | System | Diameter | Titanium Base | PredicateDevicesK-Number | IntendedUse/Differences | AbutmentScrewmadeofTi6Al4V | Identicalandconnectiongeometrytoabutments | ConnectiongeometryType | ConnectiongeometryAnti-rotationalfeatures | Screwgeometry | |
| ZTSV 3.5 | Zimmer | Tapered Screw-Vent® | 3.5 mm | Zimmer productcatalog page 9.Product-No.ZOA342S | K060880 | noangulationcorrection tothe implantaxis | yes | yes | gonal | Internal | same |
| ZTSV 4.5 | Zimmer | Tapered Screw-Vent® | 4.5 mm | Product-No.ZOA442S | K060880 | noangulationcorrection tothe implantaxis | yes | yes | Hexagonal | Internal | same |
| ZTSV 5.7 | Zimmer | Tapered Screw-Vent® | 5.7 mm | Product-No.ZOA562S | K060880 | noangulationcorrection tothe implantaxis | yes | yes | Hexagonal | Internal | same |
APPENDIX N • Page 20 of 27
·
October 20, 2010
Anna Dental CAD/CAM Solutions
Sirona Dental 510(k) Summar
Sirona Dental CAD/CAM System
{20}------------------------------------------------
| : | . * | ||
|---|---|---|---|
| Screwmetrygeo-. .୍ଦ୍ଦﺮ | 국 지방. ! · | ||
| turesmenyCon-geo-, tiốn: | APPENDIX N • Page 21 of 27 | ||
| metrygeo-Con- | gonal | ||
| 등록 등 일 들 용 할 때 를 | |||
| 분들을 통해 일을 받았다. 그래서 1000 년 1월 20일 사용자 대표 1 | |||
| intended۰۰ ﺗﺎ | :::::・・・・ | ||
| October 20, 2010 | |||
| Sirona Dental CAD/CAM SystemSirona Dental 510(k) Summary | |||
| ProposedDevice .TiBase、………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………… |
:
{21}------------------------------------------------
| InCoris ZI meso | Camlog Ceramic sleevesK032448 | |
|---|---|---|
| Intended use | inCoris ZI meso blocks areused in manufacturingindividually designedmesostructures, which areglued to a fitting titanium baseafter milling and sintering. | ALTATECBIOTECHNOLOGIESimplants are indicated forsingle tooth replacement, asimmediate abutments on longspan to bridgework, as distalabutments on free-endedentulous areas to be restoredwith fixed bridgework, tosupport overdentures in totallyor partially edentulous arches,and as abutments supporting afull arch fixed prosthesis in thetotally edentulous mandible ormaxila.The Ti-Ceramic abutment isused with the mentionedimplant supported restorationswhere high aesthetics aredesired. |
| Application | inCoris ZI mesostructures canonly be used for the intendedtitanium bases or implants.Allocation of the connectionsize to the respective titaniumbase can be determined by thescanbody set of the respectiveimplant system.Please observe the indicationsand contraindications of theimplant. | Bonded/cemented all-ceramic crownAbutments with a 3.3 mm diameter for use only in the replacement of upper lateral incisors and lower incisorsDirect veneering with zirconium oxide dental ceramics |
| Contra-Indications | Insufficient oral hygieneInsufficient space availableBruxismFor restorations with angulation correction to the implant axisFor individual tooth | Primary abutment splintingRestorations with an angulation correction of more than 20° to the implant axisSingle restorations with attached free end pontic |
| InCoris-ZI meso | Camlog Ceramic sleeves | |
| K032448 | ||
| restorations with free end saddle For restorations with a length to implant length ratio of more than 1:1.25 | Restorations with a length relationship to the implant length greater than 1:1.25 | |
| Technical Data | ||
| Block-MaterialComposition | ZrO2+HfO2+Y2O3> 99.0% Al2O3 < 0.5% Other oxides < 0.5% | ZrO2+HfO2+Y2O3:> 99.0% Y2O3: 4.5 - 5.4% HfO2: < 5% Al2O3: <0.5%. Fe2O3: -- |
| Density (sintered) | 6.06 g/cm3 | > 6.00 g/cm3 |
| Coefficient of thermalexpansion (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 | < 0.6 µm |
| Anti-rotational feature | Notch | Notch |
| Bonding Material | Panavia F 2.0(www.kuraray-dental.de) | Panavia F 2.0(www.kuraray-dental.de) |
Table 6: Comparison of InCoris ZI meso to Predicate Device
Sirona Dental 510(k) Summary
October 20, 2010
Sirona Dental CAD/CAM System
:
,
.
APPENDIX N • Page 22 of 27
{22}------------------------------------------------
Sirona Dental 510(k) Summary
October 20, 2010
:
Sirona Dental CAD/CAM System
APPENDIX N • Page 23 of 27
·
.
{23}------------------------------------------------
Table 7: Comparison of Sirona Dental CAD/CAM Design and fabricating Devices to
Predicate Devices
| Sirona Dental CAD/CAM Design and fabricating Devices | Lava Software (K062493) | |
|---|---|---|
| Used for | The Sirona Dental CAD/CAM-System is indicated for taking optical impressions to record the topographical characteristics of teeth, dental impressions, or stone models by computer aided design and fabrication in patients that require dental restorative prosthetic devices. The system also features the processing of mesostructures, a dental restorative prosthetic device used in conjunction with endosseous dental implant abutments.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. Devices which feature the processing of mesostructures comprises CEREC3, CEREC AC, inEos, inEos Blue, CEREC MCXL and inLab MCXL | The Lava software is used with 3M ESPE's Lava system, an all-ceramic system for the CAD/CAM fabrication of dental restorations such as inlays, onlays, veneers, crowns and bridges. The software controls the measuring process, processing of the measurement data (3D-CAD tool), and export of the data to the milling machine. In addition, various patient and case information elements can be entered. Other functions are available for verification and service of the measuring system. The Lava software also facilitates the transfer of 3D data from a scanner to a remote milling machine via internet. |
| Used with | Sirona Dental CAI/CAM Hardware | 3M ESPE Lava System CAI/CAM Hardware |
| Controlling of recording process (CAI) (optical impression) | Yes | Yes |
| Processing the recorded data (data of optical | Yes | Yes |
| Sirona | Lava Software | |
| Dental CAD/CAM Design andfabricating Devices | (K062493) | |
| impression) (CAD) | ||
| Export of milling data tomilling machine | Yes | Yes |
| Administration ofpatient data | Yes | Yes |
| Further functions | Calibration of CAI/CAMhardware | Verification and service ofmeasuring system |
| Online capability | Option to upload/download thedata from a web portal (CerecConnect), to have CAI and CAMoperating on two differentlocations connected via Internet | Facilitates the transfer of the 3Ddata from a scanner to a remotemilling machine via Internet |
| Scan ImplantInterface/surface | Yes(or with mounted scanbody) | Yes |
| Scan custom wax-up | Yes | Yes |
| Preparation ofcustomized restoration("meso-structure") to bemounted on theabutment | Yes | Yes |
| Bond of milledziconia/ceramiccustomized meso-structure to metalabutment | Yes | Yes |
| Create of fitting crownto be mounted on top ofmeso-structure | Yes | Yes |
| Used with | Sirona Dental CAI/CAMHardware | 3M ESPE Lava SystemCAI/CAM Hardware |
| Used for | CAD creation of dentalrestorations including inlays, | CAD creation of dentalrestorations including inlays, |
| SironaDental CAD/CAM Design andfabricating Devices | Lava Software(K062493) | |
| onlay, venners, crowns, bridgesand meso-structure to be mountedon top of abutments | onlay, venners, crowns, bridgesand meso-structure to be mountedon top of abutments | |
| Controlling ofmeasurement process(CAI). | Yes | Yes |
| Processing themeasurement data(CAD) | Yes | Yes |
| Export to millingmachine | Yes | Yes |
| Administration ofpatient data | Yes | Yes |
| Further functions | Calibration of CAI/CAMhardware | Verification and service ofmeasuring system |
Sirona Dental 510(k) Summary
October 20, 2010
Sirona Dental CAD/CAM System
APPENDIX N • Page 24 of 27
{24}------------------------------------------------
Sirona Dental 510(k) Summary
October 20, 2010
.
Sirona Dental CAD/CAM System
APPENDIX N • Page 25 of 27
{25}------------------------------------------------
Nonclinical Testing 7
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 8
Clinical testing is not required and has not been performed.
9 Conclusion
Based on a comparison of intended use, indications, construction materials, principal of operations, features and technical data, the Sirona Dental CAD/CAM System which comprises of titanium bases TiBase, inCoris ZI meso blocks and Sirona Dental CAD/CAM Design and fabricating devices are safe and effective their
Sirona Dental 510(k) Summary
October 20, 2010
Sirona Dental CAD/CAM System
APPENDIX N • Page 26 of 27
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intended use and perform as well as and are substantially equivalent to their . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ﮨﮯ۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔۔ Predicate Devices. -
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Sirona Dental 510(k) Summary
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October 20, 2010 .
Sirona Dental CAD/CAM System
APPENDIX N • Page 27 of 27
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Image /page/27/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the eagle. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Fritz Kolle Quality Management/Regulatory Affairs Sirona Dental Systems GmbH Fabrikstrasse 31 64625 Bensheim GERMANY
OCT 2 2 2010
Re: K100152
Trade/Device Name: Sirona Dental CAD/CAM System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: October 6, 2010 Received: October 8, 2010
Dear Ms. Kolle:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2- Mr. Kolle
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 device-related 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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Wh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital,
Infection Control and Dental Devices Office of Device Evaluation .
Center for Devices and
Radiological Health
Enclosure
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510(k) Number (if known): 长\100 | ڪ2
OCT 2 2 2010
Sirona Dental CAD/CAM System Device Name:
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)
Prescription Use X (Part 21 CFR 801 Subpart D) OR
Over-The-Counter Use (21 CFR 807 Subpart C)
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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| 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 |
§ 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.)