SIRONA DENTAL CAD/CAM SYSTEM

• K Number: K111421
• Device Name: SIRONA DENTAL CAD/CAM SYSTEM
• Manufacturer: SIRONA DENTAL SYSTEMS GMBH
• Date Cleared: 2012-02-17 ( 273 days)
• Product Code: NHA
• Regulation Number: 872.3630

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) - Straumann Bone Level (K053088, K062129, K060958) . - Biomet 3i Certain (K014235, K061629) . - . Nobel Biocare Active (K071370)

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 .

Predicate Devices

K091756, K081005, K081666, K032158, K072642, K060880, K102436, K062129, K073345, K100152

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard CAD/CAM system for dental prosthetics, focusing on optical impressions, design software, and fabrication. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies.

Therapeutic

No.
The device is described as a CAD/CAM system for fabricating dental restorative prosthetic devices, specifically mesostructures and abutments for dental implants, not a device that directly treats a disease or condition. Its purpose is to create components for restoration, not therapeutic intervention itself.

Diagnostic

No

The device is intended for designing and fabricating dental restorative prosthetic devices (mesostructures and two-piece abutments) for cement-retained restorations, using optical impressions for topographical characteristics. It does not perform a diagnostic function.

SaMD (Software as a Medical Device)

No

The device is described as a "System" consisting of three major parts: TiBase, inCoris mesostructure, and CAD/CAM software. It also mentions "Sirona Dental CAD/CAM Design and fabricating devices" as part of the system, indicating hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use clearly states the system is for designing and fabricating dental restorative prosthetic devices (abutments) used in conjunction with dental implants to restore function and aesthetics in the oral cavity. This is a therapeutic and restorative purpose, not a diagnostic one.
• Device Description: The description focuses on the process of taking optical impressions, designing, and fabricating physical dental devices. It does not mention any analysis of biological samples or diagnostic testing.
• Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
  • Analyzing biological samples (blood, urine, tissue, etc.)
  • Detecting or measuring substances in biological samples
  • Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on the analysis of biological samples.

The Sirona Dental CAD/CAM System is a dental device used for the fabrication of custom dental prosthetics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes (comma separated list FDA assigned to the subject device)

NHA

Device Description

The Sirona Dental CAD/CAM-System takes optical impressions and records the topographical characteristics of teeth, dental impressions, or stone models. Dental restorative prosthetic devices are manufactured using computer aided design and fabrication. The system also features the processing of mesostructures, a dental restorative prosthetic device used in conjunction with endosseous dental implant abutments.

The system that features the processing of mesostructures comprises

• Titanium bases TiBase and Camlog .
• . inCoris ZI meso blocks
• Sirona Dental CAD/CAM Design and fabricating devices .

Titanium bases are used as an implant prosthetic titanium base for adhesion to mesostructures to restore function and aesthetics in the oral cavity.

inCoris ZI meso blocks are used in manufacturing individually designed mesostructures, which are glued to a fitting titanium base after milling and sintering.

Sirona Dental CAD/CAM design and fabricating devices feature the processing of mesostructures, a dental restorative prosthetic device used in conjunction with endosseous dental implant abutments, i.e. it is an accessory to it. This component consists of the devices CEREC3, CEREC AC, inEos, inEos Blue, CEREC MCXL and inLab MCXL.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Optical impressions

Anatomical Site

partially or fully edentulous mandibles and maxillae

Indicated Patient Age Range

Not Found

Intended User / Care Setting

dentist or dental technician

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K091756, K081005, K081666, K032158, K072642, K060880, K102436, K062129, K073345, K100152

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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.)

Summary

0

K111421

510(k) Summary

FEB 1 7 2012

for

Sirona Dental Systems

Sirona Dental CAD/CAM System

1 Sponsor

Sirona Dental Systems GmbH

Fabrikstrasse 31

D-64625 Bensheim Germany

Contact Person: Fritz Kolle Telephone: [phone]

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

1

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

2

• . 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

3

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

.

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.

5

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

6

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 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	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
NBB 4.1	6282524	4.1 mm	inCoris ZI
meso L	62 31 810
62 31 836	F0.5
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 ZI
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
	Titanium Base			Ceramic Block
TiBase
(Sirona)	REF	Diameter	inCoris ZI
meso
(Sirona)	REF	Color
inCoris ZI
meso
(Sirona)
BO 4.1	6282565	4.1 mm	inCoris ZI
meso L	62 31 810
62 31 836	F0.5
F2
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
NB A 4.5	6308188	3.5mm	inCoris ZI
meso L	62 31 810
62 31 836	F0.5
F2
NB A 5.0	6308253	4.3 / 5.0mm	inCoris ZI
meso L	62 31 810
62 31 836	F0.5
F2
S BL 3.3	6308154	3.3mm	inCoris ZI
meso L	62 31 810
62 31 836	F0.5
F2
S BL 4.1	6308337	4.1 / 4.8mm	inCoris ZI
meso L	62 31 810
62 31 836	F0.5
F2
B C 3.4	6308048	3.4mm	inCoris ZI
meso S	62 31 802
62 31 828	F0.5
F2
B C 4.1	6308097	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)
B C 5.0	6308121	5.0mm	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

7

May 06, 2011

Sirona Dental CAD/CAM System

8

9

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
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:

Sirona Dental 510(k) Summary

10

ZrO2+HfO2+Y2O3	> 99.0%
Al2O3	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

12

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

| Proposed
Device

TiBase	Predicate Device
	Manufacturer	System	Diameter	Titanium Base	Predicate
Devices
K-Number	Abutment
and
Screw
made
of
Ti6Al4
V	Identical
connection
geometry
to
abutments	Connection
geometry
Type	Anti-
rotational
features	Screw
geometry
NBRS 3.5	Nobel Biocare	Replace® NP	3,5 mm	Nobel Biocare
product catalog page

Product-No. 32376 | K091756 | yes | yes | Internal
3 te-nons | yes | same |
| NBRS 4.3 | Nobel Biocare | Replace® RP | 4.3 mm | Product-No. 32377 | K091756 | yes | yes | Internal
3 te- | yes | same |

ble 5: Comparison of Sirona TiBase to Predicate Device

14

same പ്രാമത
ക്ഷേത്ര
ശ്രീക്ഷം ആര same പ്രവർത്തിച്ചു.
2001
2001
2001
2001
2001
2001
2001 yes yes Type nons pri prip
-taug suou
-al E ្រមួយ
ប្រជាជន្ suou
-al E പുറത്തിനു
അവലംബം
അറ്റു
അറ്റു
അറ 을 좋습니다. 그러나 그 후 할 yes yes 흥콜걸 출장 > yes yes K-Number Predicate
Devices K091756 K091756 roduct-No. 3237 roduct-No. 3237 Titanlum Base . redicate Device Diameter 6.0 mm 5.0 mm Replace® WP Replace® 6.0 System Nobel Biocare Nobel Biocare Manufacturer NBRS 5.0 NBRS 6.0 Proposed
Device TiBase

.

ﺎﺑ

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May 06, 201

rona Dental CAD/CAM Syste

ona Dental 510(k) Summa

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15

May 06, 2011

Sirona Dental CAD/CAM System

Sirona Dental 510(k) Summary

・

| Proposed

Device	Predicate Device
TiBase	Manufacturer	System	Diameter	Titanium Base	Predicate Devices
K-Number	Abutment
and
Screw
made
of
Ti6Al4
V	Identical
connection
geometry
to
abutments	Connection
geometry
Type	Connection
geometry
Antirotational
features	Screw
geometry
NBB 3.4	Nobel Biocare	Brånemark®	3.4 mm	Nobel Biocare
product catalog page

Product-No. 32396 | K091756 | yes | yes | External
Hexagonal | yes | same |
| NBB 4.1 | Nobel Biocare | Brånemark® | 4.1 mm | Product-No. 32397 | K091756 | yes | yes | External
Hexagonal | yes | same |
| Predicate Device | | | | | Abutment
and
Screw
made
of
Ti6Al4
V | Identical
connection
geometry
to
abutments | Connection
geometry
Type | Connection
geometry
Anti-
rotational
features | Screw
geometry | |
| Manufacturer | System | Diameter | Titanium Base | Predicate
Devices
K-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 | Internal
Octagonal | yes | same | |
| Straumann | Tissue level WN | 6.5 mm | Product-No. 048.606 | K081005 | yes | yes | Internal
Octagonal | 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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na Dental 510(k) Summa

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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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May 06, 201

na Dental 510(k) Summa

19

May 06, 2011

Sirona Dental CAD/CAM System

Sirona Dental 510(k) Summar

Predicate Device
Proposed
Device	TiBase	Abut-
ment
and
Screw
made
of
Ti6Al4
V	Identical
connection
geometry
to
abutments	Connection
geometry
Type	Connection
geometry
Anti-rotational
features	Screw
geometry	Manufacturer	System	Diameter	Titanium Base	Predicate
Devices
K-Number
	FX 4.5	yes	Internal
Hexagonal	yes	same	Friadent	Frialit®/Xive®	4.5 mm	Product-No. 46-2152	K032158
	FX 5.5	yes	Internal
Hexagonal	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 product
catalog page 25.	K072642

APPENDIX H • Page 20 of 32

20

Predicate Device
Proposed Device
TiBase	Manufacturer	System
(type: Ex. Hex)	Diameter	Titanium Base	Predicate Devices
K-Number	Abutment and Screw made of Ti6Al4 V	Identical connection geometry to abutments	Connection geometry	Type	Anti-rotational features	Screw geometry
BO 4.1	Biomet 3i	Osseotite
(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
Proposed
Device
TiBase	Manufacturer	System	Diameter	Titanium Base	Predicate Device
K-Number	Abutment
and
Screw
made
of
Ti6Al4
V	Identical
connection
geometry
to
abutments	Connection
geometry
Type	Anti-rotational
features	Connection
geometry	Screw
geometry
ZTSV 3.5	Zimmer	Tapered Screw-
Vent®	3.5 mm	Zimmer product
catalog page 9.
Product-No.
ZOA342S	K060880	yes	yes	Internal
Hexagonal	yes	yes	same
ZTSV 4.5	Zimmer	Tapered Screw-
Vent®	4.5 mm	Product-No.
ZOA442S	K060880	yes	yes	Internal
Hexagonal	yes	yes	same
Proposed Device
TiBase	Predicate Device
	Manufacturer	System	Diameter	Titanium Base	Predicate Devices
K-Number	Abutment and Screw made of Ti6Al4 V	Identical connection geometry to abutments	Connection geometry Type	Anti-rotational features	Screw geometry Connection geometry
ZTSV 5.7	Zimmer	Tapered Screw-Vent®	5.7 mm	Product-No. ZOA562S	K060880	yes	yes	Internal	yes	same
NB A 4.5	Nobel Biocare	Nobel Active NP	3,5mm	Nobel Biocare product
Catalog page 71.
Product-No. 34194	K102436	yes	yes	Internal
Hexagonal	yes	same
Proposed Device	Predicate Device								Screw geometry
	Manufacturer	System	Diameter	Titanium Base	Predicate Devices	Abutment and Screw made of Ti6Al4 V	Identical connection geometry to abutments	Connection geometry Type	Anti-rotational features	Connection geometry
iBase	Nobel Biocare	Nobel Active RP	4,3 / 5,0mm	Product-No. 34198	K-Number K102436	yes	yes	Internal Hexagonal	yes	same
				Straumann product Catalog				Internal 4 slots
Straumann
S BL 3.3 ®	Straumann	Bone Level NC	3,3mm	Product-No. 022.2102	K062129	yes	yes		yes	same

APPENDIX H • Page 21 of 32

May 06, 201 1

Sirona Dental CAD/CAM System

Sirona Dental 510(k) Summar

21

22

Sirona Dental CAD/CAM System

rona Dental 510(k) Summar

May 06, 201 l

23

: :

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 Devices
K-Number	Abutment
and
Screw
made
of
Ti6Al4
V	Identical
connection
geometry
to
abutments	Connection
geometry
Type	Connection
geometry	Screw
geometry
Bone Level RC	4,1 /
4,8mm	Product-No.
022.4102	K062129	yes	yes	Internal 4
slots	yes	same
Certain®	3,4mm	Biomet product
Catalog page 5
Product-No.
IMAP32G	K073345	yes	yes	Internal
Hexagonal	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

| Proposed
Device | | | | Predicate Device | | | Abut-
ment
and
Screw
made
of
Ti6Al4
V | Iden-
tical
con-
nec-
tion
geo-
metry
to
abut-
ments | Con-
nec-
tion
geo-
metry | Con-
nec-
tion
geo-
metry | Screw
geo-
metry |
|--------------------|-------------------|----------|----------|-------------------------------------------------------------|-------------------------------------------|----------|------------------------------------------------------------|---------------------------------------------------------------------------------|---------------------------------------|---------------------------------------|-------------------------------------------|
| TiBase | | | | | | | | | | Type | Anti-
rota-
tional
fea-
tures |
| | Manu-
facturer | System | Diameter | Titanium Base | Predicate
Devices | K-Number | | | | | |
| | | | | | Catalog page 5
Product-No.
IAPP452G | | | | | Hexagonal | |
| B C 5.0 | Biomet 3i | Certain® | 5,0mm | Biomet product
Catalog page 5
Product-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 used
in manufacturing individually
designed mesostructures, which
are glued to a fitting titanium
base after milling and sintering. | inCoris ZI meso blocks are used
in manufacturing individually
designed mesostructures, which
are glued to a fitting titanium
base after milling and sintering. |
| 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. | 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. | Please observe the indications
and contraindications of the
implant. |
| Contra-Indications | Insufficient oral hygiene Insufficient space available Bruxism For mesostructure-geometry
with angulation correction
greater than 20° to the
implant axis For mesostructure-geometry
with angulation correction
to the implant axis for
Camlog only For individual tooth
restorations with free end
saddle For restorations with a
length to implant length
ratio of more than 1:1.25 | Insufficient oral hygiene Insufficient space available Bruxism For restorations with
angulation correction to the
implant axis For individual tooth
restorations with free end
saddle For restorations with a
length to implant length
ratio 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 thermal
expansion (CTE) | 11.010⁻⁶ K⁻¹
(20 °C - 500 °C) | 11.010⁻⁶ 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

| | Sirona
Dental CAD/CAM Design and
fabricating Devices | Sirona
Dental CAD/CAM Design and
fabricating Devices
(K100152) |
|----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | 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 | 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 |
| Used with | Sirona Dental CAI/CAM
Hardware | Sirona Dental CAI/CAM
Hardware |
| Controlling of recording
process (CAI)
(optical impression) | Yes | Yes |
| Processing the recorded | Yes | Yes |
| | Sirona
Dental CAD/CAM Design and
fabricating Devices | Sirona
Dental CAD/CAM Design and
fabricating Devices
(K100152) |
| data (data of optical
impression) (CAD) | | |
| Export of milling data to
milling machine | Yes | Yes |
| Administration of
patient data | Yes | Yes |
| Further functions | Calibration of CAI/CAM
hardware | Calibration of CAI/CAM
hardware |
| Online capability | Option to upload/download the
data from a web portal (Cerec
Connect), to have CAI and CAM
operating on two different
locations connected via Internet | Option to upload/download the
data from a web portal (Cerec
Connect), to have CAI and CAM
operating on two different
locations connected via Internet |
| Scan Implant
Interface/surface | Yes
(or with mounted scanbody) | Yes
(or with mounted scanbody) |
| Scan custom wax-up | Yes | Yes |
| Preparation of
individual restoration
("meso-structure") to be
mounted on the
abutment | Yes | Yes |
| Bond of milled
zirconia/ceramic
individual meso-
structure to metal
abutment | Yes | Yes |
| Creation of fitting crown
to be mounted on top of
meso-structure | Yes | Yes |
| Used with | Sirona Dental CAI/CAM
Hardware | Sirona Dental CAI/CAM
Hardware |
| | Sirona
Dental CAD/CAM Design and
fabricating Devices | Sirona
Dental CAD/CAM Design and
fabricating Devices
(K100152) |
| Used for | CAD creation of dental
restorations including inlays,
onlay, venners, crowns, bridges
and meso-structure to be mounted
on top of abutments | CAD creation of dental
restorations including inlays,
onlay, venners, crowns, bridges
and meso-structure to be mounted
on top of abutments |
| Controlling of
measurement process
(CAI) | Yes | Yes |
| Processing the
measurement data
(CAD) | Yes | Yes |
| Export to milling
machine | Yes | Yes |
| Administration of
patient data | Yes | Yes |
| Further functions | Calibration of CAI/CAM
hardware | Calibration of CAI/CAM
hardware |

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 [phone] or [phone] 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)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Sirona Dental Systems 510(k) Sirona Dental CAD/CAM System May 06, 2011