Who is the manufacturer of SIRONA CAD/CAM SYSTEM?

Sirona Dental Systems GmbH filed the 510(k) submission for SIRONA CAD/CAM SYSTEM (K100152).

What is the FDA product code for SIRONA CAD/CAM SYSTEM?

NHA. It is classified under 21 CFR 872.3630 as a Class 2 device in the Dental panel.

What is the regulatory pathway for SIRONA CAD/CAM SYSTEM?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like SIRONA CAD/CAM SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

SIRONA CAD/CAM SYSTEM

Q: What are the predicate devices for SIRONA CAD/CAM SYSTEM?

Replace® NP (K091756); Brånemark® (K091756); Tissue level NN (K081005); OsseoSpeed™ (K081666); Frialit® / Xive® (K032158); Osseotite (K072642); Tapered Screw-Vent® (K060880).

K100152 · Sirona Dental Systems GmbH · NHA · Oct 22, 2010 · Dental

Device Facts

Record ID	K100152
Device Name	SIRONA CAD/CAM SYSTEM
Applicant	Sirona Dental Systems GmbH
Product Code	NHA · Dental
Decision Date	Oct 22, 2010
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3630
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Sirona Dental CAD/CAM System is intended for use in partially or fully edentulous mandibles and maxillae in support of single or multiple-unit cement retained restorations. 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)

Device Story

System captures optical impressions of teeth, impressions, or stone models; processes data via CAD/CAM software to design and mill custom ceramic mesostructures. Components include TiBase (titanium alloy base), InCoris ZI meso (zirconium oxide block), and CAD/CAM hardware (CEREC/inLab units). Used in dental clinics/labs by dentists or technicians. Scanbody (ABS plastic) aids in calculating implant position. Milled mesostructure is sintered and bonded to TiBase using adhesive; two-piece abutment is screwed into endosseous implant. Output is a patient-specific prosthetic abutment restoring oral function and aesthetics. System supports remote data transfer for milling.

Clinical Evidence

No clinical data performed. Substantial equivalence established via bench testing, reverse-engineering analysis, and comparison of material properties (density, flexural strength, fracture toughness) against predicate devices.

Technological Characteristics

Materials: Ti6Al4V (ISO 5832-3) for TiBase; Y-TZP zirconium oxide (ISO 13356) for InCoris ZI meso. Sensing: Optical impression camera. Energy: Electric milling machines. Connectivity: Networked/Internet for data export. Sterilization: Non-sterile, single-use components.

Indications for Use

Indicated for partially or fully edentulous patients requiring single or multiple-unit cement-retained restorations supported by endosseous dental implants.

Regulatory Classification

Identification

An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.

Special Controls

*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)

Predicate Devices

Replace® NP (K091756)
Brånemark® (K091756)
Tissue level NN (K081005)
OsseoSpeed™ (K081666)
Frialit® / Xive® (K032158)
Osseotite (K072642)
Tapered Screw-Vent® (K060880)

Reference Devices

Zirconium oxide sleeve for Camlog titanium bases (K032448)
Lava Software (K062493)

Related Devices

K111421 — SIRONA DENTAL CAD/CAM SYSTEM · Sirona Dental Systems GmbH · Feb 17, 2012
K181520 — Sirona Dental CAD/CAM System · Dentsply Sirona · Oct 11, 2018
K200191 — Sirona Dental CAD/CAM System with InLab Software · Dentsply Sirona · Aug 19, 2020
K193408 — Sirona Dental CAD/CAM System with CEREC Chairside Software · Dentsply Sirona · Aug 16, 2020
K250639 — DESS Dental Smart Solutions · Terrats Medical SL · May 22, 2025

Submission Summary (Full Text)

{0}------------------------------------------------ ## 510(k) Summary_ OCT 2 2 2010 ## for ## Sirona Dental Systems ## Sirona Dental CAD/CAM System Sponsor 1 1100152 Sirona Dental Systems GmbH Fabrikstrasse 31 D-64625 Bensheim Germany Contact Person: Fritz Kolle 49 6251 16 32 94 Telephone: Date Prepared: O October 20, 2010 ### 2 Device Name Sirona Dental CAD/CAM-System Proprietary Name: Abutment, implant, dental, endosseous Common/Usual Name: Endosseous dental implant abutment Classification Names: #### Predicate Devices 3 Replace® NP, K091756, Brånemark®, K091756, Tissue level NN, K081005, OsseoSpeed™, K081666, Frialit® / Xive®, K032158, Osseotite K072642, Tapered Screw-Vent®, K060880. Zirconium oxide sleeve for Camlog titanium bases (K032448). Lava Software (K062493). Sirona Dental 510(k) Summary October 20, 2010 Sirona Dental CAD/CAM System APPENDIX N • Page 1 of 27 {1}------------------------------------------------ #### Intended Use ব The Sirona Dental CAD/CAM System is intended for use in partially or fully edentulous mandibles and maxillae in support of single or multiple-unit cement retained restorations. The system consists of three major parts: TiBase, InCoris mesostructure, and CAD/CAM software. Specifically, the InCoris mesostructure and TiBase components make up a two-piece abutment which is used in conjunction with endosseous dental implants to restore the function and aesthetics in the oral cavity. The InCoris mesostructure may also be used in conjunction with the Camlog Titanium base CAD/CAM (types K2244.xxxx) (K083496) in the Camlog Implant System. The CAD/CAM software is intended to design and fabricate the InCoris mesostructure. The InCoris mesostructure and TiBase two-piece abutment is compatible with the following implants systems: - Nobel Biocare Replace (K020646) - Nobel Biocare Branemark (K022562) - Friadent Xive (K013867) . - Biomet 3i Osseotite (K980549) � - Astra Tech Osseospeed (K091239) ● - Zimmer Tapered Screw-Vent (K061410) . - Straumann SynOcta (K061176) ● #### 5 Device Description The Sirona Dental CAD/CAM-System takes optical impressions and records the topographical characteristics of teeth, dental impressions, or stone models. Dental restorative prosthetic devices are manufactured using computer aided design and fabrication. The system also features the processing of mesostructures, a dental restorative prosthetic device used in conjunction with endosseous dental implant abutments. The system that features the processing of mesostructures comprises - Titanium bases TiBase and Camlog . - inCoris ZI meso blocks . - Sirona Dental CAD/CAM Design and fabricating devices . · Titanium bases are used as an implant prosthetic titanium base for adhesion to mesostructures to restore function and aesthetics in the oral cavity. Sirona Dental 510(k) Summary October 20, 2010 Sirona Dental CAD/CAM System APPENDIX N • Page 2 of 27 {2}------------------------------------------------ blocks are used in manufacturing individually designed inCoris ZI meso mesostructures, which are glued to a fitting titanium base after milling and sintering. Sirona Dental CAD/CAM design and fabricating devices feature the processing of mesostructures, a dental restorative prosthetic device used in conjunction with endosseous dental implant abutments, i.e. it is an accessory to it. This component consists of the devices CEREC3, CEREC AC, inEos, inEos Blue, CEREC MCXL and inLab MCXL. #### 5.1 TiBase ### Device Function 5.1.1 The Sirona TiBase is a premanufactured prosthetic component directly connected to dedicated endosseous dental implants and is intended for use as an aid in prosthetic rehabilitation. The Sirona offering consists of the titanium base TiBase, the abutment screw and the scanbody. The parts are marketed non-steril and for single use only. The Sirona TiBase is bonded to an individually designed mesostructure, a ceramic prosthetic/restoration, that supports the final restoration .. The mesostructure is milled from an inCoris ZI meso block with Sirona CAD/CAM milling machines CEREC or inLab, and sintered afterwards. The two piece abutment is mounted onto the implant and fixed with a screw. The scope of delivery contains a scanbody (ABS plastic) which is mounted on a TiBase in order to acquire the topographical surface of the area where the endosseous dental implant abutment is located with Sirona Dental CAD/CAM fabricating devices. From the acquired data the position of the implant can be calculated. After an optical impression has been taken the scanbody is removed. Sirona TiBase devices are compatible with following systems (Table 1): Sirona Dental 510(k) Summary October 20, 2010 Sirona Dental CAD/CAM System APPENDIX N . Page 3 of 27 {3}------------------------------------------------ | Sirona TiBase | Compatible System | | | |---------------|-------------------|---------------------------------------------|------------------| | | Manufacturer | System | Diameter | | NBRS 3.5 | Nobel Biocare | Replace® NP | 3,5 mm | | NBRS 4.3 | Nobel Biocare | Replace® RP | 4.3 mm | | NBRS 5.0 | Nobel Biocare | Replace® WP | 5.0 mm | | NBRS 6.0 | Nobel Biocare | Replace® 6.0 | 6.0 mm | | NBB 3.4 | Nobel Biocare | Brånemark® | 3.4 mm | | NBB 4.1 | Nobel Biocare | Brånemark® | 4.1 mm | | SSO 3.5 | Straumann | Tissue level NN | 3.5 mm | | SSO 4.8 | Straumann | Tissue level RN | 4.8 mm | | SSO 6.5 | Straumann | Tissue level WN | 6.5 mm | | ATOS 3.5/4.0 | Astra Tech | OsseoSpeed™ | 3.5 S / 4.0 S mm | | ATOS 4.5/5.0 | Astra Tech | OsseoSpeed™ | 4.5 / 5.0 mm | | FX 3.4 | Friadent | Frialit® / Xive® | 3.4 mm | | FX 3.8 | Friadent | Frialit® / Xive® | 3.8 mm | | FX 4.5 | Friadent | Frialit® / Xive® | 4.5 mm | | FX 5.5 | Friadent | Frialit® / Xive® | 5.5 mm | | BO 3.4 | Biomet 3i | Osseotite (Connec-tion type: Ex. Hex) | 3.4 mm | | BO 4.1 | Biomet 3i | Osseotite (Connec-tion type: Ex. Hex) | 4.1 mm | | BO 5.0 | Biomet 3i | Osseotite (Connec-tion type: | 5.0 mm | | Sirona TiBase | Compatible System | | | | | Manufacturer | System | Diameter | | | | Ex. Hex) | | | ZTSV 3.5 | | Tapered Screw- Vent® | 3.5 mm | | ZTSV 4.5 | Zimmer | Tapered Screw- Vent® | 4.5 mm | | ZTSV 5.7 | | Tapered Screw- Vent® | 5.7 mm | # Table 1: Sirona TiBase Devices Compatibility Sirona Dental 510(k) Summary . · October 20, 2010 Sirona Dental CAD/CAM System APPENDIX N • Page 4 of 27 {4}------------------------------------------------ ### Scientific Concept 5.1.2 The underlying scientific concept is the use of an already introduced technology of a titanium base abutment combined with individually CAD/CAM fabricated ceramic prosthetics. ### Physical and Performance Characteristics 5.1.3 ## 5.1.3.1 Design The TiBase devices have various diameters, are compatible with dedicated implant systems, and fit to compatible implants as provided in Table 2. Sirona Dental 510(k) Summary October 20, 2010 Sirona Dental CAD/CAM System APPENDIX N • Page 5 of 27 {5}------------------------------------------------ Table 2: Implant Compatibility | TiBase | Implant- Manufacturer | Implant-System | 510(k) Implant | |--------|--------------------------|--------------------|----------------| | NBRS | Nobel Biocare | Replace | K020646 | | NBB | Nobel Biocare | Branemark | K022562 | | FX | Friadent | Xive | K013867 | | BO | Biomet 3i | Osseotite | K980549 | | ATOS | Astra Tech | OsseoSpeed | K091239 | | ZTSV | Zimmer | Tapered Screw-Vent | K061410 | | SSO | Straumann | SynOcta | K061176 | ## 5.1.3.2 Material Used TiBase and abutment screw are made of Ti6Al4V. ## 5.1.3.3 Physical Properties TiBase material composition and mechanical properties comply with ISO 5832-3:1996, Implants for surgery -- Metallic materials -- Part 3: Wrought titanium 6aluminium 4-vanadium alloy Sirona TiBase devices are compatible with systems listed in Table 1. ### 5.2 inCoris ZI meso ### Device Description 5.2.1 The inCoris ZI meso offerings are blocks of various sizes from which individual dental mesostructures are grinded by milling machines (inLab MCXL, CEREC MCXL). The mesostructure is a part of a 2 part endosseous dental implant abutment which comprises a titanium base and a zirconium oxide mesostructure. The connection geometries are prefabricated. Sirona Dental 510(k) Summary October 20, 2010 Sirona Dental CAD/CAM System APPENDIX N • Page 6 of 27 {6}------------------------------------------------ ### _5.2.2 __ Scientific Concept__________________________________________________________________________________________________________________________________________________ The underlying scientific concept is the use of an already introduced technology of a titanium base abutment combined with individually CAD/CAM fabricated ceramic prosthetics. ### Physical and Performance Characteristics 5.2.3 ## 5.2.3.1 Design The inCoris ZI meso are blocks of various sizes. The marketed ceramic is presintered. One side of a block is mounted to a mandrel that will be inserted in the spindle's clamping chuck of the grinding machine. The connection geometry to titanium bases is prefabricated, i.e. already included in the shipped block. Connection geometries fit on Camlog (type K2244.xxxx) and Sirona (Tibase) titanium bases (Table 3 and Table 4). | Titanium Base | | | Ceramic Block | | | |--------------------|---------|---------------------|--------------------------------|------------------------|-----------------------------------------| | TiBase (Sirona) | REF | Diameter | inCoris ZI meso (Sirona) | REF | Color inCoris ZI meso (Sirona) | | NBRS 3.5 | 6282474 | 3,5 mm | inCoris ZI meso L | 62 31 810 62 31 836 | F0.5 F2 | | NBRS 4.3 | 6282482 | 4.3 mm | inCoris ZI meso L | 62 31 810 62 31 836 | F0.5 F2 | | NBRS 5.0 | 6282490 | 5.0 mm | inCoris ZI meso L | 62 31 810 62 31 836 | F0.5 F2 | | NBRS 6.0 | 6282508 | 6.0 mm | inCoris ZI meso L | 62 31 810 62 31 836 | F0.5 F2 | | NBB 3.4 | 6282516 | 3.4 mm | inCoris ZI meso L | 62 31 810 62 31 836 | F0.5 F2 | | NBB 4.1 | 6282524 | 4.1 mm | inCoris ZI meso L | 62 31 810 | F0.5 | | Titanium Base | | Ceramic Block | | | | | TiBase (Sirona) | REF | Diameter | inCoris ZI meso (Sirona) | REF | Color inCoris ZI meso (Sirona) | | | | | meso L | 62 31 836 | F2 | | SSO 3.5 | 6284231 | 3.5 mm | inCoris ZI meso L | 62 31 810 62 31 836 | F0.5 F2 | | SSO 4.8 | 6284249 | 4.8 mm | inCoris Zl meso L | 62 31 810 62 31 836 | F0.5 F2 | | SSO 6.5 | 6284256 | 6.5 mm | inCoris ZI meso L | 62 31 810 62 31 836 | F0.5 F2 | | ATOS 3.5/4.0 | 6282532 | 3.5 S / 4.0 S mm | inCoris ZI meso L | 62 31 810 62 31 836 | F0.5 F2 | | ATOS 4.5/5.0 | 6282540 | 4.5 / 5.0 mm | inCoris ZI meso L | 62 31 810 62 31 836 | F0.5 F2 | | FX 3.4 | 6282433 | 3.4 mm | inCoris ZI meso S | 62 31 802 62 31 828 | F0.5 F2 | | FX 3.8 | 6282441 | 3.8 mm | inCoris ZI meso S | 62 31 802 62 31 828 | F0.5 F2 | | FX 4.5 | 6282458 | 4.5 mm | inCoris ZI meso L | 62 31 810 62 31 836 | F0.5 F2 | | FX 5.5 | 6282466 | 5.5 mm | inCoris ZI meso L | 62 31 810 62 31 836 | F0.5 F2 | | BO 3.4 | 6282557 | 3.4 mm | inCoris ZI meso L | 62 31 810 62 31 836 | F0.5 F2 | | BO 4.1 | 6282565 | 4.1 mm | inCoris ZI meso L | 62 31 810 62 31 836 | F0.5 F2 | | Titanium Base | | | Ceramic Block | | | | TiBase (Sirona) | REF | Diameter | inCoris ZI meso (Sirona) | REF | Color inCoris ZI meso (Sirona) | | BO 5.0 | 6282573 | 5.0 mm | inCoris ZI meso L | 62 31 810 62 31 836 | F0.5 F2 | | ZTSV 3.5 | 6282581 | 3.5 mm | inCoris ZI meso L | 62 31 810 62 31 836 | F0.5 F2 | | ZTSV 4.5 | 6282599 | 4.5 mm | inCoris ZI meso L | 62 31 810 62 31 836 | F0.5 F2 | | ZTSV 5.7 | 6282607 | 5.7 mm | inCoris ZI meso L | 62 31 810 62 31 836 | F0.5 F2 | Table 3: Sirona inCoris ZI meso - TiBase Devices Compatibility Sirona Dental 510(k) Summary October 20, 2010 Sirona Dental CAD/CAM System {7}------------------------------------------------ Sirona Dental 510(k) Summary ・・ : October 20, 2010 Sirona Dental CAD/CAM System . APPENDIX N • Page 8 of 27 {8}------------------------------------------------ # Table 4: Sirona inCoris ZI meso - Camlog Devices Compatibility | Titanium Base | | | Ceramic Block | | | |---------------|------------|---------------|--------------------------------|------------------------|-----------------------------------------| | Camlog | REF | Dia- meter | inCoris ZI meso (Sirona) | REF | Color inCoris ZI meso (Sirona) | | K2244.3348 | K2244.3348 | 3.3 | inCoris ZI meso S | 62 31 802 62 31 828 | F0.5 F2 | | K2244.3848 | K2244.3848 | 3.8 | inCoris ZI meso S | 62 31 802 62 31 828 | F0.5 F2 | | K2244.4348 | K2244.4348 | 4.3 | inCoris ZI meso S | 62 31 802 62 31 828 | F0.5 F2 | | K2244.5048 | K2244.5048 | 5.0 | inCoris ZI meso L | 62 31 810 62 31 836 | F0.5 F2 | Sirona Dental 510(k) Summary October 20, 2010 Sirona Dental CAD/CAM System APPENDIX N • Page 9 of 27 {9}------------------------------------------------ | Titanium Base | | | Ceramic Block | | | |---------------|------------|----------|--------------------------------|------------------------|-----------------------------------------| | Camlog | REF | Diameter | inCoris ZI meso (Sirona) | REF | Color inCoris ZI meso (Sirona) | | K2244.6048 | K2244.6048 | 6.0 | inCoris ZI meso L | 62 31 810 62 31 836 | F0.5 F2 | ### 5.2.3.2 Material Used The inCoris ZI meso are pre-sintered zirconium oxide ceramic blocks. The metal block holder is made of aluminum. The material is composed of: ZrO2+HfO2+Y2O3 > 99.0% < 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 Sirona Dental 510(k) Summary October 20, 2010 Sirona Dental CAD/CAM System APPENDIX N • Page 10 of 27 {10}------------------------------------------------ - Design of mesostructures and processing the acquired or recorded data for this purposes using Sirona Dental CAD/CAM Software which runs on a CEREC 3, CEREC AC or PC. Design is performed by a dentist or dental technician - Milling of the mesostructure using CEREC MCXL or inLab MCXL milling . machines from ceramic blocks intended for dental restorations and mesostructures This Sirona Dental CAD/CAM Design and fabricating devices also process other dental restorations like crowns, bridge-frameworks, inlays, onlays and regulated under 21 CFR 872.3661, Optical Impression Systems for CAD/CAM, for such intended use. ### Scientific Concept 5.3.2 The underlying scientific concept is the use of CAD/CAM technology for the optical acquisition or recording of the topographical characteristics of dental impressions, or stone models, the design of individual mesostructures using recorded data (CAD), and eventually fabricating (milling) these designed mesostructures (CAM). ### Physical and Performance Characteristics 5.3.3 ### 5.3.3.1 Design Acquisition unit: the device consists of a camera for taking topographical characteristics of dental impressions optically. The recorded data are used for the design of individual mesostructures using specific CAD techniques for the dental field. Fabricating devices: the devices mill the individual designed mesostructures from incoris ZI meso blocks. For this purpose the chucked block and the milling tools move according to the prescribed trajectories respectively the shape which is intended to be milled. ### Materials Used 5.3.3.2 Not applicable. Sirona Dental 510(k) Summary October 20, 2010 Sirona Dental CAD/CAM System APPENDIX N • Page 11 of 27 {11}------------------------------------------------ ### 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 Sirona Dental 510(k) Summary October 20, 2010 Sirona Dental CAD/CAM System APPENDIX N . Page 12 of 27 {12}------------------------------------------------ in conjunction with endosseous dental implant abutments, i.e. it is an accessory to it. Both systems have the feature to transfer data of the optical impression to a remote milling machine via internet or exportation/importation of milling data. An extensive list is provided in Table 7. Sirona Dental 510(k) Summary October 20, 2010 Sirona Dental CAD/CAM System APPENDIX N • Page 13 of 27 {13}------------------------------------------------ Table 5: Comparison of Sirona TiBase to Predicate Devices | 4: " : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : Screw geo- metry | ﺔ ﺗﻮﻓ | same | same | same | | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|----------------------------------------------------------|------------------------------------------------------------------|------------------| | - metry geo " Anti- - Anti- Trota: iztures tional ea- : | | yes | yes | yes | | | 【Beon 【deallery】【dealers】【dealers 】desar - The County County of the County 【deally of the country The Court of the Count Type : ਾ ਕਿ ਅ 19381 ないよ . | 1. 1. 2. 2. 2. | nter- nons 3 te- nal | nter- nons 3 te- na | nter- | | | ារបស់ពួកគេ បានប្រជាជន្ម ប្រជាជន្ម ប្រជាជន្ម ប្រជាជន្ម ប្រជាជន្ម ប្រជាជន្ម ប្រជាជន្ម ប្រជាជន្ម metry | ్లో ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమి | yes | yes | yes | | | Abut andi Screw : } made STORES ( - . me | | yes | yes | yes | | | | ర్చారు. నిర్మాలు నిర్మాలు నిర్మాలు నాలు 2017-02-2017 11:38 | correction to the implan angulation axis no | correction to the implan angulation axis no | angulatior. no | | | | | K091756 | K091756 | K091756 | | | Predicate Device Region Program Program Program Predicate Prediction Program Program Program President | CaTitanium Base | roduct-No. 323' Nobel Biocare oroduct catalo page 14. | roduct-No. 3237 | oduct-No. 32 | | | | Diameter | 3,5 mm | 4.3 mm | 5.0 mm | | | | | eplace® NP | eplace® RP | Replace® WP | | | | cture، Manu- | Biocare Nobel | Nobel Biocare | Nobe | | | roposed Device TiBase | | NBRS 3.5 | NBRS 4.3 | MBRS 5.0 | | | geo- - Screw metry """"""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""" ్ వై | . ు వైద్యశాల ప్రాథమిక వైద్యశాల ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక | | same | same | same | | rota- tional ាមស្ថិតនៅក្នុងស្រុក ប្រជាជាប្រជាជាប្រជាជាតិ ប្រជាជាប្រជាជាប្រជាជាប្រជាជាប្រជាជាតិ ប្រជាជាប្រជាជាប្រជាជាប្រជាជាប្រជាជាតិ ប្រជាជាប្រជាជាប្រជាជាតិ ប្រជាជាប្រជាជាប្រជាជាតិ Con- fea- nec- tures | িন্দুস্থ ్లాల్లో ప్రా ﻨﺘﺸﺎ | | yes | yes | yes | | . ::::: - metro - metro - metro - metro - metro - metro - metro - metro - metro - metro - metro - metro - metro - metro - metro - metro - metro - metro - metro - metro - metro - metr ﺔ . 1 Con- Type tion ·nec- s: " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " : " . . | ਾ ਦੁਆਰ : : 1. ・ : | nons 3 te- nal | nons nter- 3 te- na | Exter- Hexa- gona nal | Exter- | | to tical con- geo- metry lden- nec- tion ﺗﺰﻳﺮ ﺍﻟﻤﺪﻳﻨﺔ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻒ ﺍﻟﻤﺘﻮﻗﻒ | ﺍ - ﺍ - 尔 · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · | | yes | yes | yes | | ············································································································································································· : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : i6Al . of -- and Screw . made Abut- ment : | : | | yes | yes | yes | | | | correction to the implan axis | correction to the implant angulation axis no | correction to the implant angulation axis no | angulation no | | | Predicate Devices K-Number, S-Number, | | K091756 | <091756 | <091756 | | | - System And - Diameters - Titanlum Base - System - System - Albert - Pitanlum Base - Reference - Research - Research - Program - Province - Particle - | | roduct-No. 3237 | roduct-No. 32396 product catalog Nobel Biocare page 14. | roduct-No. 3239 | | | | | 6.0 mm | 3.4 mm | 4.1 mm | | | | | Replace® 6.0 | Bránemark® | Branemark® | | | Manuf. Nasfacturer Nasfacturer Nasifacturer November | Biocare | Biocare Nobel | Biocare Nobel | 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}------------------------------------------------ | Proposed Device TiBase | Predicate Device | | | | | | | | | | | |------------------------------|------------------|-------------------------|----------|-------------------------------------------------------------|----------------------------------|----------------------------------------------------------|------------------------------------------------|---------------------------------------------------------------|--------------------------------|-----------------------------------------------------------|-------------------| | | Manufacturer | System | Diameter | Titanium Base | Predicate Devices K-Number | Intended Use/ Differences | Abutment Screw made of Ti6Al 4V | Identical and connection geometry to abutments | Connection geometry Type | Connection geometry Anti- rotational features | Screw geometry | | ZTSV 3.5 | Zimmer | Tapered Screw- Vent® | 3.5 mm | Zimmer product catalog page 9. Product-No. ZOA342S | K060880 | no angulation correction to the implant axis | yes | yes | gonal | Internal | same | | ZTSV 4.5 | Zimmer | Tapered Screw- Vent® | 4.5 mm | Product-No. ZOA442S | K060880 | no angulation correction to the implant axis | yes | yes | Hexagonal | Internal | same | | ZTSV 5.7 | Zimmer | Tapered Screw- Vent® | 5.7 mm | Product-No. ZOA562S | K060880 | no angulation correction to the implant axis | 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}------------------------------------------------ | : | . * | | | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|--|--------------------------------------------------------------| | Screw metry geo- . . ୍ଦ୍ଦ ﺮ | 국 지방 . ! · | | | | tures meny Con- geo- , tiốn : | | | APPENDIX N • Page 21 of 27 | | metry geo- Con- | gonal | | | | 등록 등 일 들 용 할 때 를 | | | | | 분들을 통해 일을 받았다. 그래서 1000 년 1월 20일 사용자 대표 1 | | | | | intended ۰۰ ﺗﺎ | ::::: ・・・・ | | | | | | | | | | | | October 20, 2010 | | | | | | | | | | | | | | | | | | | | | | | | | Sirona Dental CAD/CAM System Sirona Dental 510(k) Summary | | Proposed Device . TiBase 、………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………… | | | | : {21}------------------------------------------------ | | InCoris ZI meso | Camlog Ceramic sleeves K032448 | |-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended use | inCoris ZI meso blocks are used in manufacturing individually designed mesostructures, which are glued to a fitting titanium base after milling and sintering. | ALTATEC BIOTECHNOLOGIES implants are indicated for single tooth replacement, as immediate abutments on long span to bridgework, as distal abutments on free-end edentulous areas to be restored with fixed bridgework, to support overdentures in totally or partially edentulous arches, and as abutments supporting a full arch fixed prosthesis in the totally edentulous mandible or maxila. The Ti-Ceramic abutment is used with the mentioned implant supported restorations where high aesthetics are desired. | | Application | inCoris ZI mesostructures can only be used for the intended titanium bases or implants. Allocation of the connection size to the respective titanium base can be determined by the scanbody set of the respective implant system. Please observe the indications and contraindications of the implant. | Bonded/cemented all- ceramic crown Abutments 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-Material Composition | 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 thermal expansion (CTE) | 11.0*10-6 K-1 (20 °C - 500 °C) | No specification | | Flexural strength | > 900MPa | > 800MPa | | Fracture toughness (KIC) | 5.8 MPa·m1/2 | No specification | | Grain Size | about 0.5 µm | < 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…