(273 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:
- 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)
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 .
This is a 510(k) premarket notification for a dental device, not a study evaluating performance against acceptance criteria with a test set and ground truth. Therefore, many of the requested elements (acceptance criteria table, sample size, data provenance, expert adjudication, MRMC study, standalone performance, training set details) are not applicable or not explicitly stated in the provided document.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices through comparisons of intended use, indications, construction materials, principles of operation, features, and technical data.
Here's the relevant information that can be extracted:
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) submission and not a performance study against specific acceptance criteria, a table directly outlining clinical acceptance criteria and device performance is not provided in this format. The "performance" is implicitly demonstrated through the device's technical specifications aligning with those of the predicate devices and existing standards.
| Component | Acceptance Criteria (Implicit/Standard) | Reported Device Performance |
|---|---|---|
| TiBase | - Material: Ti6Al4V, medical grade 5 (ISO 5832-3:1996) | - Made of Ti6Al4V. |
| - Compatible connection interfaces, anti-rotational features, and screw geometry with specific implant systems. | - Compatibility demonstrated with various Nobel Biocare, Straumann, Astra Tech, Friadent, Biomet 3i, and Zimmer implant systems (as detailed in Table 1, 2, and 5). - Connection interfaces, anti-rotational features, and screw geometry are "identical" or "same" as predicate devices for each corresponding implant system (as detailed in Table 5). | |
| inCoris ZI meso blocks | - Material Composition & Properties: Complies with ISO 13356:1997 for yttria-stabilized tetragonal zirconia (Y-TZP). - Specific physical properties (Density, CTE, Flexural strength, Fracture toughness, Grain Size) meet or exceed specified values. | - Made of zirconium oxide; composition aligns with ISO 13356:1997. - 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 (K100152 listed 5.8 MPa·m¹/² for predicate) - Grain Size: about 0.5 µm - Bonding Material: Panavia F 2.0 |
| CAD/CAM System (Software) | - Functionality for optical impression, data processing, design, milling data export, patient data administration, calibration, online capabilities, and implant interface scanning, consistent with predicate. | - No modification from predicate (K100152) in core functionalities: optical impressions, CAD/CAM design, milling data export, patient data administration, calibration, online capabilities, scanning implant interface, custom wax-up, meso-structure preparation, bonding milled zirconia/ceramic, and creation of fitting crown (Table 7). - Software database of titanium bases extended to cover new additional titanium bases. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable. This document does not describe a clinical performance study with a test set. It describes non-clinical testing for material properties and mechanical fatigue.
- Data Provenance: Not applicable for a clinical test set. Nonclinical testing implicitly performed by the manufacturer, Sirona Dental Systems GmbH (Germany).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. There was no clinical test set for which ground truth would be established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. There was no clinical test set requiring adjudication.
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 dental CAD/CAM system for fabricating restorations, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a CAD/CAM system, which involves human design and fabrication alongside machine processes. "Standalone" performance in the sense of a diagnostic algorithm is not relevant here. The nonclinical testing for the components (TiBase and inCoris ZI meso) and software functionality demonstrate their individual performance characteristics.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For Nonclinical Tests: The "ground truth" for the material and mechanical tests would be defined by the relevant ISO standards (e.g., ISO 5832-3:1996 for TiBase, ISO 13356:1997 for inCoris ZI meso blocks) and engineering specifications for fatigue analysis and dimensional accuracy. The software validation followed IEC 62304:2006 for medical device software.
8. The sample size for the training set
- Not applicable. This document describes a new device for which manufacturing and material specifications are compared to predicate devices and standards, not an AI/ML model that requires a training set. The "software database of titanium bases has been extended," which implies data was added, but not in the context of "training data" for a machine learning model.
9. How the ground truth for the training set was established
- Not applicable. No training set for a machine learning model is mentioned.
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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(Connec-tion type:Ex. Hex) | 3.4 mm |
| BO 4.1 | Biomet 3i | Osseotite(Connec-tion type:Ex. Hex) | 4.1 mm |
| Sirona TiBase | Compatible System | ||
| Manufacturer | System | Diameter | |
| BO 5.0 | Osseotite(Connec-tion type:Ex. Hex) | 5.0 mm | |
| 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 | |
| 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(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 ZI | 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 | |||
| NBB 4.1 | 6282524 | 4.1 mm | inCoris ZImeso L | 62 31 81062 31 836 | F0.5F2 |
| 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 ZImeso 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 |
| Titanium Base | Ceramic Block | ||||
| TiBase(Sirona) | REF | Diameter | inCoris ZImeso(Sirona) | REF | ColorinCoris ZImeso(Sirona) |
| BO 4.1 | 6282565 | 4.1 mm | inCoris ZImeso L | 62 31 81062 31 836 | F0.5F2 |
| 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 |
| NB A 4.5 | 6308188 | 3.5mm | inCoris ZImeso L | 62 31 81062 31 836 | F0.5F2 |
| NB A 5.0 | 6308253 | 4.3 / 5.0mm | inCoris ZImeso L | 62 31 81062 31 836 | F0.5F2 |
| S BL 3.3 | 6308154 | 3.3mm | inCoris ZImeso L | 62 31 81062 31 836 | F0.5F2 |
| S BL 4.1 | 6308337 | 4.1 / 4.8mm | inCoris ZImeso L | 62 31 81062 31 836 | F0.5F2 |
| B C 3.4 | 6308048 | 3.4mm | inCoris ZImeso S | 62 31 80262 31 828 | F0.5F2 |
| B C 4.1 | 6308097 | 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) |
| B C 5.0 | 6308121 | 5.0mm | inCoris ZImeso L | 62 31 81062 31 836 | F0.5F2 |
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-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 |
| 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:
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
{13}------------------------------------------------
Sirona Dental CAD/CAM System
May 06, 2011
Sirona Dental 510(k) Summar
APPENDIX H • Page 14 of 32
| ProposedDeviceTiBase | Predicate Device | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Manufacturer | System | Diameter | Titanium Base | PredicateDevicesK-Number | AbutmentandScrewmadeofTi6Al4V | Identicalconnectiongeometrytoabutments | ConnectiongeometryType | Anti-rotationalfeatures | Screwgeometry | |
| NBRS 3.5 | Nobel Biocare | Replace® NP | 3,5 mm | Nobel Biocareproduct catalog page14.Product-No. 32376 | K091756 | yes | yes | Internal3 te-nons | yes | same |
| NBRS 4.3 | Nobel Biocare | Replace® RP | 4.3 mm | Product-No. 32377 | K091756 | yes | yes | Internal3 te- | yes | same |
ble 5: Comparison of Sirona TiBase to Predicate Device
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-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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Sirona Dental 510(k) Summary
・
| ProposedDevice | Predicate Device | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| TiBase | Manufacturer | System | Diameter | Titanium Base | Predicate DevicesK-Number | AbutmentandScrewmadeofTi6Al4V | Identicalconnectiongeometrytoabutments | ConnectiongeometryType | ConnectiongeometryAntirotationalfeatures | Screwgeometry |
| NBB 3.4 | Nobel Biocare | Brånemark® | 3.4 mm | Nobel Biocareproduct catalog page14.Product-No. 32396 | K091756 | yes | yes | ExternalHexagonal | yes | same |
| NBB 4.1 | Nobel Biocare | Brånemark® | 4.1 mm | Product-No. 32397 | K091756 | yes | yes | ExternalHexagonal | yes | same |
| Predicate Device | AbutmentandScrewmadeofTi6Al4V | Identicalconnectiongeometrytoabutments | ConnectiongeometryType | ConnectiongeometryAnti-rotationalfeatures | Screwgeometry | |||||
| Manufacturer | System | Diameter | Titanium Base | PredicateDevicesK-Number | ||||||
| Straumann | Tissue level NN | 3.5 mm | Straumann product catalog page 51.Product-No. 048.505 | K081005 | yes | yes | external | yes | same | |
| Straumann | Tissue level RN | 4.8 mm | Product-No. 048.600(p 55) | K081005 | yes | yes | InternalOctagonal | yes | same | |
| Straumann | Tissue level WN | 6.5 mm | Product-No. 048.606 | K081005 | yes | yes | InternalOctagonal | yes | same |
: :
:
{16}------------------------------------------------
Sirona Dental CAD/CAM System
May 06, 201 1
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
:
PPENDIX H • Page 18 of
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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
PENDIX H • Page 19 of
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Sirona Dental 510(k) Summar
| Predicate Device | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ProposedDevice | TiBase | Abut-mentandScrewmadeofTi6Al4V | Identicalconnectiongeometrytoabutments | ConnectiongeometryType | ConnectiongeometryAnti-rotationalfeatures | Screwgeometry | Manufacturer | System | Diameter | Titanium Base | PredicateDevicesK-Number | |
| FX 4.5 | yes | InternalHexagonal | yes | same | Friadent | Frialit®/Xive® | 4.5 mm | Product-No. 46-2152 | K032158 | |||
| FX 5.5 | yes | InternalHexagonal | yes | same | Friadent | Frialit®/Xive® | 5.5 mm | Product-No. 46-2162 | K032158 | |||
| BO 3.4 | yes | External | yes | same | Biomet 3i | Osseotite(Connec-tion) | 3.4 mm | 3i Biomet productcatalog page 25. | K072642 |
APPENDIX H • Page 20 of 32
{20}------------------------------------------------
| Predicate Device | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Proposed DeviceTiBase | Manufacturer | System(type: Ex. Hex) | Diameter | Titanium Base | Predicate DevicesK-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(Connec-tion type: Ex. Hex) | 4.1 mm | Product-No.APP452G | K072642 | yes | yes | Hexagonal | External | yes | same |
| BO 5.0 | Biomet 3i | Osseotite(Connec-tion type: Ex. Hex) | 5.0 mm | Product-No.WPP552G | K072642 | yes | yes | Hexagonal | External | yes | same |
| ProposedDeviceTiBase | Manufacturer | System | Diameter | Titanium Base | Predicate DeviceK-Number | AbutmentandScrewmadeofTi6Al4V | Identicalconnectiongeometrytoabutments | ConnectiongeometryType | Anti-rotationalfeatures | Connectiongeometry | Screwgeometry |
| ZTSV 3.5 | Zimmer | Tapered Screw-Vent® | 3.5 mm | Zimmer productcatalog page 9.Product-No.ZOA342S | K060880 | yes | yes | InternalHexagonal | yes | yes | same |
| ZTSV 4.5 | Zimmer | Tapered Screw-Vent® | 4.5 mm | Product-No.ZOA442S | K060880 | yes | yes | InternalHexagonal | yes | yes | same |
| Proposed DeviceTiBase | Predicate Device | ||||||||||
| Manufacturer | System | Diameter | Titanium Base | Predicate DevicesK-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 productCatalog page 71.Product-No. 34194 | K102436 | yes | yes | InternalHexagonal | 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 | ||||||||||
| StraumannS BL 3.3 ® | Straumann | Bone Level NC | 3,3mm | Product-No. 022.2102 | K062129 | yes | yes | yes | same |
APPENDIX H • Page 21 of 32
May 06, 201 1
Sirona Dental CAD/CAM System
Sirona Dental 510(k) Summar
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{22}------------------------------------------------
Sirona Dental CAD/CAM System
rona Dental 510(k) Summar
May 06, 201 l
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: :
May 06, 2011
Sirona Dental CAD/CAM System
Sirona Dental 510(k) Summar
APPENDIX H • Page 24 of 32
{24}------------------------------------------------
Sirona Dental CAD/CAM System
May 06, 2011
Sirona Dental 510(k) Summary
| Predicate Device | ||||||||
|---|---|---|---|---|---|---|---|---|
| System | Diameter | Titanium Base | Predicate DevicesK-Number | AbutmentandScrewmadeofTi6Al4V | Identicalconnectiongeometrytoabutments | ConnectiongeometryType | Connectiongeometry | Screwgeometry |
| Bone Level RC | 4,1 /4,8mm | Product-No.022.4102 | K062129 | yes | yes | Internal 4slots | yes | same |
| Certain® | 3,4mm | Biomet productCatalog page 5Product-No.IMAP32G | K073345 | yes | yes | InternalHexagonal | yes | same |
| Certain® | 4,1mm | Biomet product | K073345 | yes | yes | Internal | yes | same |
ﺍ
{25}------------------------------------------------
May 06, 201 l
Sirona Dental CAD/CAM System
Sirona Dental 510(k) Summar
| ProposedDevice | Predicate Device | Abut-mentandScrewmadeofTi6Al4V | Iden-ticalcon-nec-tiongeo-metrytoabut-ments | Con-nec-tiongeo-metry | Con-nec-tiongeo-metry | Screwgeo-metry | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| TiBase | Type | Anti-rota-tionalfea-tures | |||||||||
| Manu-facturer | System | Diameter | Titanium Base | PredicateDevices | K-Number | ||||||
| Catalog page 5Product-No.IAPP452G | Hexagonal | ||||||||||
| B C 5.0 | Biomet 3i | Certain® | 5,0mm | Biomet productCatalog page 5Product-No.IWPP562G | K073345 | yes | yes | yes | Internal | Hexagonal | same |
APPENDIX H • Page 26 of 32
{26}------------------------------------------------
| InCoris ZI meso | InCoris ZI meso(K100152) | |
|---|---|---|
| Intended use | inCoris ZI meso blocks are usedin manufacturing individuallydesigned mesostructures, whichare glued to a fitting titaniumbase after milling and sintering. | inCoris ZI meso blocks are usedin manufacturing individuallydesigned mesostructures, whichare glued to a fitting titaniumbase after milling and sintering. |
| Application | inCoris ZI mesostructures canonly be used for the intendedtitanium bases or implants.Allocation of the connection sizeto the respective titanium basecan be determined by thescanbody set of the respectiveimplant system. | inCoris ZI mesostructures canonly be used for the intendedtitanium bases or implants.Allocation of the connection sizeto the respective titanium basecan be determined by thescanbody set of the respectiveimplant system. |
| Please observe the indicationsand contraindications of theimplant. | Please observe the indicationsand contraindications of theimplant. | |
| Contra-Indications | Insufficient oral hygiene Insufficient space available Bruxism For mesostructure-geometrywith angulation correctiongreater than 20° to theimplant axis For mesostructure-geometrywith angulation correctionto the implant axis forCamlog only For individual toothrestorations with free endsaddle For restorations with alength to implant lengthratio of more than 1:1.25 | Insufficient oral hygiene Insufficient space available Bruxism For restorations withangulation correction to theimplant axis For individual toothrestorations with free endsaddle For restorations with alength to implant lengthratio of more than 1:1.25 |
| Technical Data | ||
| Block-Material Composition | ZrO2+HfO2+Y2O3:> 99.0% Y2O3: 5.2% | ZrO2+HfO2+Y2O3:> 99.0% Y2O3: 5.2% HfO2: 2% |
| InCoris ZI meso | InCoris ZI meso(K100152) | |
| • Al2O3: ≤ 0.05%• Fe2O3: 0.3% | • Al2O3: ≤ 0.05%• Fe2O3: 0.3% | |
| Density (sintered) | 6.06 g/cm³ | 6.06 g/cm³ |
| Coefficient of thermalexpansion (CTE) | 11.0*10⁻⁶ K⁻¹(20 °C - 500 °C) | 11.0*10⁻⁶ K⁻¹(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(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
May 06, 2011
{27}------------------------------------------------
{28}------------------------------------------------
Table 7: Comparison of Sirona Dental CAD/CAM Design and fabricating Devices to Predicate Devices
| SironaDental CAD/CAM Design andfabricating Devices | SironaDental CAD/CAM Design andfabricating Devices(K100152) | |
|---|---|---|
| Used for | The Sirona Dental CAD/CAM-System is indicated for takingoptical impressions to record thetopographical characteristics ofteeth, dental impressions, or stonemodels by computer aided designand fabrication in patients thatrequire dental restorativeprosthetic devices. The systemalso features the processing ofmesostructures, a dentalrestorative prosthetic device usedin conjunction with endosseousdental implant abutments. | The Sirona Dental CAD/CAM-System is indicated for takingoptical impressions to record thetopographical characteristics ofteeth, dental impressions, or stonemodels by computer aided designand fabrication in patients thatrequire dental restorativeprosthetic devices. The systemalso features the processing ofmesostructures, a dentalrestorative prosthetic device usedin conjunction with endosseousdental implant abutments. |
| Sirona Dental CAD/CAM Designand fabricating devices feature theprocessing of mesostructures, adental restorative prostheticdevice used in conjunction withendosseous dental implantabutments, i.e. it is an accessoryto it. Devices which feature theprocessing of mesostructurescomprises CEREC3, CEREC AC,inEos, inEos Blue, CERECMCXL and inLab MCXL | Sirona Dental CAD/CAM Designand fabricating devices feature theprocessing of mesostructures, adental restorative prostheticdevice used in conjunction withendosseous dental implantabutments, i.e. it is an accessoryto it. Devices which feature theprocessing of mesostructurescomprises CEREC3, CEREC AC,inEos, inEos Blue, CERECMCXL and inLab MCXL | |
| Used with | Sirona Dental CAI/CAMHardware | Sirona Dental CAI/CAMHardware |
| Controlling of recordingprocess (CAI)(optical impression) | Yes | Yes |
| Processing the recorded | Yes | Yes |
| SironaDental CAD/CAM Design andfabricating Devices | SironaDental CAD/CAM Design andfabricating Devices(K100152) | |
| data (data of opticalimpression) (CAD) | ||
| Export of milling data tomilling machine | Yes | Yes |
| Administration ofpatient data | Yes | Yes |
| Further functions | Calibration of CAI/CAMhardware | Calibration of CAI/CAMhardware |
| Online capability | Option to upload/download thedata from a web portal (CerecConnect), to have CAI and CAMoperating on two differentlocations connected via Internet | Option to upload/download thedata from a web portal (CerecConnect), to have CAI and CAMoperating on two differentlocations connected via Internet |
| Scan ImplantInterface/surface | Yes(or with mounted scanbody) | Yes(or with mounted scanbody) |
| Scan custom wax-up | Yes | Yes |
| Preparation ofindividual restoration("meso-structure") to bemounted on theabutment | Yes | Yes |
| Bond of milledzirconia/ceramicindividual meso-structure to metalabutment | Yes | Yes |
| Creation of fitting crownto be mounted on top ofmeso-structure | Yes | Yes |
| Used with | Sirona Dental CAI/CAMHardware | Sirona Dental CAI/CAMHardware |
| SironaDental CAD/CAM Design andfabricating Devices | SironaDental CAD/CAM Design andfabricating Devices(K100152) | |
| Used for | CAD creation of dentalrestorations including inlays,onlay, venners, crowns, bridgesand meso-structure to be mountedon top of abutments | CAD creation of dentalrestorations including inlays,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 | Calibration of CAI/CAMhardware |
Sirona Dental 510(k) Summary
May 06, 2011
{29}------------------------------------------------
{30}------------------------------------------------
7 Nonclinical Testing
According to FDA Guidance "Class II Special Controls Guidance Document: Rootform Endosseous Dental Implants and Endosseous Dental Implant Abutments", May 12, 2004, fatigue testing has been performed for angled abutments. A reverseengineering analysis has demonstrated that the devices are identical with their predicates and compatible with their mating implants.
Software validation testing has been performed according to IEC 62304:2006. A warning has been added warning the user that abutments with an angle of greater than 20° are out of specification.
Clinical Testing 8
Clinical testing is not required and has not been performed.
{31}------------------------------------------------
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 intended use and perform as well as and are substantially equivalent to their Predicate Devices.
{32}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/32/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, enclosed in a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Fritz Kolle Sirona Dental Systems GmbH Fabrikstrasse 31 Bensheim Germany D-64625
FEB 1 7 2012
Re: K111421
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: February 14, 2012 Received: February 16, 2012
Dear Mr. 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.
{33}------------------------------------------------
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 yours,
Wh for
Anthony D. Watson, BS, MS, MBA
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{34}------------------------------------------------
510(k) Number (if known):
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 implant 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) .
- Biomet 3i Certain (K014235) .
- Nobel Biocare Active (K071370)
Botz DOS (Division Sign-Off) Division of Anesthesiology, General Hospital
KII1421 510(k) Number:
Infection Control, Dental Devices
OR Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sirona Dental Systems 510(k) Sirona Dental CAD/CAM System May 06, 2011
§ 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.)