VITA ENAMIC Implant Solutions (IS)

• K Number: K153645
• Device Name: VITA ENAMIC Implant Solutions (IS)
• Manufacturer: VITA ZAHNFABRIK H. RAUTER GMBH CO.
• Date Cleared: 2016-06-30 ( 192 days)
• Product Code: NHA
• Regulation Number: 872.3630

Intended Use

VITA ENAMIC Implant Solutions is indicated for use as a component of a two-piece abutment system, consisting of a tibase component, and a mesostructure or abutment crown. VITA ENAMIC Implant Solutions is intended for use in partially or fully edentulous mandible or maxillae for fabrication of permanent, anterior or posterior, single unit CAD/CAM abutments. VITA ENAMIC Implant Solutions is indicated for use in conjunction with the CAD/CAM component of the Sirona Dental CAD/CAM system and the following Tibase abutments and implant bodies: (See Table 1 in document for list of compatible Ti Base/Implant Systems).

Device Description

VITA ENAMIC Implant Solutions (IS) is a hybrid ceramic CAD/CAM block, consisting of ~86% (by weight) feldspar ceramic and ~14% polymer. The VITA ENAMIC Implant Solutions is milled then bonded to a titanium (Ti) base for a two-element solution with mesostructure or a single-element solution with abutment crown. The compatible Ti bases to VITA ENAMIC IS block interface size and CAD/CAM system are as follows: Ti Base: Sirona TiBase (K111421), CAD/CAM System: Sirona software – inlab 15.0 and above, Sirona software – CEREC 4.4 and above, Titanium Bases: Compatible titanium bases are shown in Table 1. VITA ENAMIC IS is offered in a block form, with a mandrel attachment, to permit securing it into a CAD/CAM machine for milling into its final form. The VITA ENAMIC IS blocks have a pre-drilled hole compatible with Sirona TiBase (K111421) to allow the mesostructure or abutment crown bonded to a titanium base to be connected to the implant. VITA ENAMIC IS blocks are identical to VITA ENAMIC blocks (K122269) in geometry, with the exception of a pre-drilled hole.

Predicate Devices

K111421, K122269, K132209

Reference Devices

K122269

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a physical material (hybrid ceramic block) used in a CAD/CAM system for fabricating dental abutments. There is no mention of software algorithms, image processing, or any other components that would typically incorporate AI/ML. The performance studies focus on material properties and mechanical testing.

Therapeutic

No.
The device is a material (hybrid ceramic CAD/CAM block) used to fabricate components of a dental abutment system, not a therapeutic device itself.

Diagnostic

No

This device is a hybrid ceramic CAD/CAM block used for fabricating dental abutments and crowns, which are restorative components. It is not described as performing any diagnostic functions.

SaMD (Software as a Medical Device)

No

The device description clearly states that the device is a "hybrid ceramic CAD/CAM block" and describes its physical composition and form, indicating it is a physical material, not software.

IVD (In Vitro Diagnostic)

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

Here's why:

• Intended Use: The intended use clearly states that the device is for the fabrication of permanent, anterior or posterior, single unit CAD/CAM abutments for use in partially or fully edentulous mandible or maxillae. This describes a device used in vivo (within the body) as a dental implant component.
• Device Description: The description details a hybrid ceramic block that is milled and bonded to a titanium base to create a dental abutment or abutment crown. This is a physical component used in dental restoration.
• Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.

In summary, the VITA ENAMIC Implant Solutions is a dental prosthetic component, not a device used for in vitro diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

VITA ENAMIC Implant Solutions is indicated for use as a component of a two-piece abutment system, consisting of a tibase component, and a mesostructure or abutment crown. VITA ENAMIC Implant Solutions is intended for use in partially or fully edentulous mandible or maxillae for fabrication of permanent, anterior or posterior, single unit CAD/CAM abutments. VITA ENAMIC Implant Solutions is indicated for use in conjunction with the CAD/CAM component of the Sirona Dental CAD/CAM system and the following Tibase abutments and implant bodies:

Table 1 - Compatible Sirona Ti Base/Implant System and VITA ENAMIC IS Interface
Sirona TiBase Type: NBRS 3.5, Abutment Screw: M1.8, Sirona Part #: 6282474, VITA ENAMIC IS Interface: L, Implant Manufacturer: Nobel Biocare, Implant System: Replace® NP, Implant Diameter: 3.5 mm
Sirona TiBase Type: NBRS 4.3, Abutment Screw: M2, Sirona Part #: 6282482, VITA ENAMIC IS Interface: L, Implant Manufacturer: Nobel Biocare, Implant System: Replace® RP, Implant Diameter: 4.3 mm
Sirona TiBase Type: NBRS 5.0, Abutment Screw: M2, Sirona Part #: 6282490, VITA ENAMIC IS Interface: L, Implant Manufacturer: Nobel Biocare, Implant System: Replace® WP, Implant Diameter: 5.0 mm
Sirona TiBase Type: NBRS 6.0, Abutment Screw: M2, Sirona Part #: 6282508, VITA ENAMIC IS Interface: L, Implant Manufacturer: Nobel Biocare, Implant System: Replace® 6.0, Implant Diameter: 6.0 mm
Sirona TiBase Type: NBB 3.4, Abutment Screw: M1.6, Sirona Part #: 6282516, VITA ENAMIC IS Interface: L, Implant Manufacturer: Nobel Biocare, Implant System: Brånemark®, Implant Diameter: 3.3 mm
Sirona TiBase Type: NBB 4.1, Abutment Screw: M2, Sirona Part #: 6282524, VITA ENAMIC IS Interface: L, Implant Manufacturer: Nobel Biocare, Implant System: Brånemark®, Implant Diameter: 3.75 / 4.0 mm
Sirona TiBase Type: NB A 4.5, Abutment Screw: M1.6, Sirona Part #: 6308188, VITA ENAMIC IS Interface: L, Implant Manufacturer: Nobel Biocare, Implant System: Nobel Active NP, Implant Diameter: 3.5 mm
Sirona TiBase Type: NB A 5.0, Abutment Screw: M2, Sirona Part #: 6308253, VITA ENAMIC IS Interface: L, Implant Manufacturer: Nobel Biocare, Implant System: Nobel Active RP, Implant Diameter: 4.3 / 5.0 mm
Sirona TiBase Type: SSO 3.5, Abutment Screw: M1.8, Sirona Part #: 6284231, VITA ENAMIC IS Interface: L, Implant Manufacturer: Straumann®, Implant System: Tissue level NN, Implant Diameter: 3.5 mm
Sirona TiBase Type: SSO 4.8, Abutment Screw: M2, Sirona Part #: 6284249, VITA ENAMIC IS Interface: L, Implant Manufacturer: Straumann®, Implant System: Tissue Level RN, Implant Diameter: 4.8 mm
Sirona TiBase Type: SSO 6.5, Abutment Screw: M2, Sirona Part #: 6284256, VITA ENAMIC IS Interface: L, Implant Manufacturer: Straumann®, Implant System: Tissue Level WN, Implant Diameter: 6.5 mm
Sirona TiBase Type: S BL 3.3, Abutment Screw: M1.6, Sirona Part #: 6308154, VITA ENAMIC IS Interface: L, Implant Manufacturer: Straumann®, Implant System: Bone Level NC, Implant Diameter: 3.3mm
Sirona TiBase Type: S BL 4.1, Abutment Screw: M1.6, Sirona Part #: 6308337, VITA ENAMIC IS Interface: L, Implant Manufacturer: Straumann®, Implant System: Bone Level NC, Implant Diameter: 4.1 / 4.8 mm
Sirona TiBase Type: ATOS 3.5/4.0, Abutment Screw: M1.6, Sirona Part #: 6282532, VITA ENAMIC IS Interface: L, Implant Manufacturer: Astra Tech, Implant System: OsseoSpeed™, Implant Diameter: 3.5 S/4.0 S mm
Sirona TiBase Type: ATOS 4.5/5.0, Abutment Screw: M1.6, Sirona Part #: 6282540, VITA ENAMIC IS Interface: L, Implant Manufacturer: Astra Tech, Implant System: OsseoSpeed™, Implant Diameter: 4.5 / 5.0 mm
Sirona TiBase Type: FX 3.4, Abutment Screw: M1.6, Sirona Part #: 6282433, VITA ENAMIC IS Interface: S, Implant Manufacturer: Friadent, Implant System: Frialit®Xive®, Implant Diameter: 3.4 mm
Sirona TiBase Type: FX 3.8, Abutment Screw: M1.6, Sirona Part #: 6282441, VITA ENAMIC IS Interface: S, Implant Manufacturer: Friadent, Implant System: Frialit®Xive®, Implant Diameter: 3.8 mm
Sirona TiBase Type: FX 4.5, Abutment Screw: M1.6, Sirona Part #: 6282458, VITA ENAMIC IS Interface: L, Implant Manufacturer: Friadent, Implant System: Frialit®Xive®, Implant Diameter: 4.5 mm
Sirona TiBase Type: FX 5.5, Abutment Screw: M1.6, Sirona Part #: 6282466, VITA ENAMIC IS Interface: L, Implant Manufacturer: Friadent, Implant System: Frialit®Xive®, Implant Diameter: 5.5 mm
Sirona TiBase Type: BO 3.4, Abutment Screw: M2, Sirona Part #: 6282557, VITA ENAMIC IS Interface: L, Implant Manufacturer: Biomet 3i, Implant System: Ex. hex, Implant Diameter: 3.4 mm
Sirona TiBase Type: BO 4.1, Abutment Screw: M2, Sirona Part #: 6282565, VITA ENAMIC IS Interface: L, Implant Manufacturer: Biomet 3i, Implant System: Ex. hex, Implant Diameter: 4.1 mm
Sirona TiBase Type: BO 5.0, Abutment Screw: M2, Sirona Part #: 6282573, VITA ENAMIC IS Interface: L, Implant Manufacturer: Biomet 3i, Implant System: Ex. hex, Implant Diameter: 5.0 mm
Sirona TiBase Type: B C 3.4, Abutment Screw: M1.6, Sirona Part #: 6308048, VITA ENAMIC IS Interface: S, Implant Manufacturer: Biomet 3i, Implant System: Certain®, Implant Diameter: 3.5 mm
Sirona TiBase Type: B C 4.1, Abutment Screw: M1.6, Sirona Part #: 6308097, VITA ENAMIC IS Interface: L, Implant Manufacturer: Biomet 3i, Implant System: Certain®, Implant Diameter: 4.5 mm
Sirona TiBase Type: B C 5.0, Abutment Screw: M1.6, Sirona Part #: 6308121, VITA ENAMIC IS Interface: L, Implant Manufacturer: Biomet 3i, Implant System: Certain®, Implant Diameter: 5.7 mm
Sirona TiBase Type: ZTSV 3.5, Abutment Screw: M1.8, Sirona Part #: 6282581, VITA ENAMIC IS Interface: L, Implant Manufacturer: Zimmer, Implant System: Tapered screw-Vent®, Implant Diameter: 3.5 mm
Sirona TiBase Type: ZTSV 4.5, Abutment Screw: M1.8, Sirona Part #: 6282599, VITA ENAMIC IS Interface: L, Implant Manufacturer: Zimmer, Implant System: Tapered screw-Vent®, Implant Diameter: 4.5 mm
Sirona TiBase Type: ZTSV 5.7, Abutment Screw: M1.8, Sirona Part #: 6282607, VITA ENAMIC IS Interface: L, Implant Manufacturer: Zimmer, Implant System: Tapered screw-Vent®, Implant Diameter: 5.7 mm

Product codes

NHA

Device Description

VITA ENAMIC Implant Solutions (IS) is a hybrid ceramic CAD/CAM block, consisting of ~86% (by weight) feldspar ceramic and ~14% polymer.

The VITA ENAMIC Implant Solutions is milled then bonded to a titanium (Ti) base for a two-element solution with mesostructure or a single-element solution with abutment crown. The compatible Ti bases to VITA ENAMIC IS block interface size and CAD/CAM system are as follows:
Ti Base: Sirona TiBase (K111421)
CAD/CAM System: Sirona software – inlab 15.0 and above; Sirona software – CEREC 4.4 and above
Titanium Bases: Compatible titanium bases are shown in Table 1
(Table 1 is repeated as in the Indications for Use section)

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

mandible or maxillae

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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)

Non-Clinical Performance Testing:
VITA ENAMIC IS meets the applicable requirements of the following FDA recognized standards:

• ISO 6872:2008 – Dentistry – Ceramic materials
• ISO 10477:2004(E) - Dentistry - Polymer-based crown and bridge materials standard.
• ISO 14801:2007 - Dentistry - Implants - Dynamic fatigue test for endosseous dental implants
  Key results: Bench test results allowed us to conclude that VITA ENAMIC IS is well suited for its intended use.

Biocompatibility:
A biocompatibility assessment was performed on VITA ENAMIC IS in accordance with ISO 10933-1:2009 – Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process, and ISO 7405:2008 – Dentistry – Evaluation of Biocompatibility of Medical Devices Used in Dentistry. Testing from reference device VITA ENAMIC was leveraged to support biocompatibility.
Key results: This assessment supports that VITA ENAMIC IS is biocompatible and concludes that the device is compatible for its intended use.

Clinical Performance Data:
Not applicable. No human clinical testing was performed to support the substantial equivalence of VITA ENAMIC IS.

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

Not Found

Predicate Device(s)

K111421, K122269, K132209

Reference Device(s)

K122269

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of three human profiles facing right, stacked on top of each other to create a sense of depth and unity. The profiles are rendered in a dark color, contrasting with the white background. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 30, 2016

Vita Zahnfabrik H. Rauter GmbH Co. % Ms. Nevine Erian Director, Regulatory Affairs & Compliance (consultant) Vita North America, Inc. 22705 Savi Ranch Parkway, Suite 100 Yorba Linda. California 92887

Re: K153645

Trade/Device Name: VITA ENAMIC® Implant Solutions (IS) Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: May 27, 2016 Received: June 3, 2016

Dear Ms. Erian:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina
Kiang -S

for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K153645

Device Name

VITA ENAMIC Implant Solutions (IS)

Indications for Use

VITA ENAMIC Implant Solutions is indicated for use as a component of a two-piece abutment system, consisting of a tibase component, and a mesostructure or abutment crown. VITA ENAMIC Implant Solutions is intended for use in partially or fully edentulous mandible or maxillae for fabrication of permanent, anterior or posterior, single unit CAD/CAM abutments. VITA ENAMIC Implant Solutions is indicated for use in conjunction with the CAD/CAM component of the Sirona Dental CAD/CAM system and the following Tibase abutments and implant bodies:

Table 1 - Compatible Sirona Ti Base/Implant System and VITA ENAMIC IS Interface
Sirona
TiBase Type	Abutment
Screw	Sirona
Part #	VITA ENAMIC
IS Interface	Implant
Manufacturer	Implant System	Implant
Diameter
NBRS 3.5	M1.8	6282474	L	Nobel Biocare	Replace® NP	3.5 mm
NBRS 4.3	M2	6282482	L	Nobel Biocare	Replace® RP	4.3 mm
NBRS 5.0	M2	6282490	L	Nobel Biocare	Replace® WP	5.0 mm
NBRS 6.0	M2	6282508	L	Nobel Biocare	Replace® 6.0	6.0 mm
NBB 3.4	M1.6	6282516	L	Nobel Biocare	Brånemark®	3.3 mm
NBB 4.1	M2	6282524	L	Nobel Biocare	Brånemark®	3.75 / 4.0 mm
NB A 4.5	M1.6	6308188	L	Nobel Biocare	Nobel Active NP	3.5 mm
NB A 5.0	M2	6308253	L	Nobel Biocare	Nobel Active RP	4.3 / 5.0 mm
SSO 3.5	M1.8	6284231	L	Straumann®	Tissue level NN	3.5 mm
SSO 4.8	M2	6284249	L	Straumann®	Tissue Level RN	4.8 mm
SSO 6.5	M2	6284256	L	Straumann®	Tissue Level WN	6.5 mm
S BL 3.3	M1.6	6308154	L	Straumann®	Bone Level NC	3.3mm
S BL 4.1	M1.6	6308337	L	Straumann®	Bone Level NC	4.1 / 4.8 mm
ATOS 3.5/4.0	M1.6	6282532	L	Astra Tech	OsseoSpeed™	3.5 S/4.0 S mm
ATOS 4.5/5.0	M1.6	6282540	L	Astra Tech	OsseoSpeed™	4.5 / 5.0 mm
FX 3.4	M1.6	6282433	S	Friadent	Frialit®Xive®	3.4 mm
FX 3.8	M1.6	6282441	S	Friadent	Frialit®Xive®	3.8 mm
FX 4.5	M1.6	6282458	L	Friadent	Frialit®Xive®	4.5 mm
FX 5.5	M1.6	6282466	L	Friadent	Frialit®Xive®	5.5 mm
BO 3.4	M2	6282557	L	Biomet 3i	Ex. hex	3.4 mm
BO 4.1	M2	6282565	L	Biomet 3i	Ex. hex	4.1 mm
BO 5.0	M2	6282573	L	Biomet 3i	Ex. hex	5.0 mm
B C 3.4	M1.6	6308048	S	Biomet 3i	Certain®	3.5 mm
B C 4.1	M1.6	6308097	L	Biomet 3i	Certain®	4.5 mm
B C 5.0	M1.6	6308121	L	Biomet 3i	Certain®	5.7 mm

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Table 1 – Compatible Sirona Ti Base/Implant System and VITA ENAMIC IS Interface
Sirona
TiBase Type	Abutment
Screw	Sirona
Part #	VITA ENAMIC
IS Interface	Implant
Manufacturer	Implant System	Implant
Diameter
ZTSV 3.5	M1.8	6282581	L	Zimmer	Tapered screw-Vent®	3.5 mm
ZTSV 4.5	M1.8	6282599	L	Zimmer	Tapered screw-Vent®	4.5 mm
ZTSV 5.7	M1.8	6282607	L	Zimmer	Tapered screw-Vent®	5.7 mm

Prescription Use _____X (21 CFR Part 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR Part 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON SEPARATE PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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K153645 510(k) Summary

| Submitter | Vita Zahnfabrik H.Rauter GmbH Co.
Spitelgasse 3
Bad Sackingen, D-79713
Germany
Establishment Reg. No. 1000625496 |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Bernd Walker
Head of Regulatory Affairs and Quality Systems
Phone [phone]
Fax [phone] |
| Official Correspondent | Nevine Erian
Director, Regulatory Affairs & Compliance (Consultant)
VITA North America, Inc.
22705 Savi Ranch Parkway, Suite 100
Yorba Linda, CA 92887
Establishment Reg. No. 2082832
Phone [phone]
Fax [phone]
E-mail: [e-mail] |
| Date Prepared | June 30, 2016 |
| Trade/Device Name
■ | VITA ENAMIC® Implant Solutions (IS) |
| ■
Common Name | Abutment, implant, dental, endosseous |

• Classification Name Endosseous Dental Implant Abutment
• Regulation Number 21 CFR 872.3630
• . Product Code NHA

Predicate Devices

inCoris ZI meso (Sirona Dental) – K111421 – Primary Predicate VITA ENAMIC® (VITA Zahnfabrik GmbH) – K122269 IPS e.max® CAD Abutment Solutions (Ivoclar Vivadent) – K132209

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Device Description

VITA ENAMIC Implant Solutions (IS) is a hybrid ceramic CAD/CAM block, consisting of ~86% (by weight) feldspar ceramic and ~14% polymer.

The VITA ENAMIC Implant Solutions is milled then bonded to a titanium (Ti) base for a two-element solution with mesostructure or a single-element solution with abutment crown. The compatible Ti bases to VITA ENAMIC IS block interface size and CAD/CAM system are as follows:

Ti Base:	Sirona TiBase (K111421)
CAD/CAM System:	Sirona software – inlab 15.0 and above
Sirona software – CEREC 4.4 and above
Titanium Bases:	Compatible titanium bases are shown in Table 1

Table 1 - Compatible Sirona Ti Base/Implant System and VITA ENAMIC IS Interface
Sirona
TiBase Type	Abutment
Screw	Sirona
Part #	VITA ENAMIC
IS Interface	Implant
Manufacturer	Implant System	Implant
Diameter
NBRS 3.5	M1.8	6282474	L	Nobel Biocare	Replace® NP	3.5 mm
NBRS 4.3	M2	6282482	L	Nobel Biocare	Replace® RP	4.3 mm
NBRS 5.0	M2	6282490	L	Nobel Biocare	Replace® WP	5.0 mm
NBRS 6.0	M2	6282508	L	Nobel Biocare	Replace® 6.0	6.0 mm
NBB 3.4	M1.6	6282516	L	Nobel Biocare	Brånemark®	3.3 mm
NBB 4.1	M2	6282524	L	Nobel Biocare	Brånemark®	3.75 / 4.0 mm
NB A 4.5	M1.6	6308188	L	Nobel Biocare	Nobel Active NP	3.5 mm
NB A 5.0	M2	6308253	L	Nobel Biocare	Nobel Active RP	4.3 / 5.0 mm
SSO 3.5	M1.8	6284231	L	Straumann®	Tissue level NN	3.5 mm
SSO 4.8	M2	6284249	L	Straumann®	Tissue Level RN	4.8 mm
SSO 6.5	M2	6284256	L	Straumann®	Tissue Level WN	6.5 mm
S BL 3.3	M1.6	6308154	L	Straumann®	Bone Level NC	3.3mm
S BL 4.1	M1.6	6308337	L	Straumann®	Bone Level NC	4.1 / 4.8 mm
ATOS 3.5/4.0	M1.6	6282532	L	Astra Tech	OsseoSpeed™	3.5 S/4.0 S mm
ATOS 4.5/5.0	M1.6	6282540	L	Astra Tech	OsseoSpeed™	4.5 / 5.0 mm
FX 3.4	M1.6	6282433	S	Friadent	Frialit®Xive®	3.4 mm
FX 3.8	M1.6	6282441	S	Friadent	Frialit®Xive®	3.8 mm
FX 4.5	M1.6	6282458	L	Friadent	Frialit®Xive®	4.5 mm
FX 5.5	M1.6	6282466	L	Friadent	Frialit®Xive®	5.5 mm
BO 3.4	M2	6282557	L	Biomet 3i	Ex. hex	3.4 mm
BO 4.1	M2	6282565	L	Biomet 3i	Ex. hex	4.1 mm
BO 5.0	M2	6282573	L	Biomet 3i	Ex. hex	5.0 mm
B C 3.4	M1.6	6308048	S	Biomet 3i	Certain®	3.5 mm
B C 4.1	M1.6	6308097	L	Biomet 3i	Certain®	4.5 mm
B C 5.0	M1.6	6308121	L	Biomet 3i	Certain®	5.7 mm
ZTSV 3.5	M1.8	6282581	L	Zimmer	Tapered screw-Vent®	3.5 mm
ZTSV 4.5	M1.8	6282599	L	Zimmer	Tapered screw-Vent®	4.5 mm
ZTSV 5.7	M1.8	6282607	L	Zimmer	Tapered screw-Vent®	5.7 mm

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Statement of Intended Use

VITA ENAMIC Implant Solutions is indicated for use as a component of a two-piece abutment system, consisting of a tibase component, and a mesostructure or abutment crown. VITA ENAMIC Implant Solutions is intended for use in partially or fully edentulous mandible or maxillae for fabrication of permanent, anterior or posterior, single unit CAD/CAM abutments. VITA ENAMIC Implant Solutions is indicated for use in conjunction with the CAD/CAM component of the Sirona Dental CAD/CAM system and the following Tibase abutments and implant bodies:

Table 1 - Compatible Sirona Ti Base/Implant System and VITA ENAMIC IS Interface
Sirona
TiBase Type	Abutment
Screw	Sirona
Part #	VITA ENAMIC
IS Interface	Implant
Manufacturer	Implant System	Implant
Diameter
NBRS 3.5	M1.8	6282474	L	Nobel Biocare	Replace® NP	3.5 mm
NBRS 4.3	M2	6282482	L	Nobel Biocare	Replace® RP	4.3 mm
NBRS 5.0	M2	6282490	L	Nobel Biocare	Replace® WP	5.0 mm
NBRS 6.0	M2	6282508	L	Nobel Biocare	Replace® 6.0	6.0 mm
NBB 3.4	M1.6	6282516	L	Nobel Biocare	Brånemark®	3.3 mm
NBB 4.1	M2	6282524	L	Nobel Biocare	Brånemark®	3.75 / 4.0 mm
NB A 4.5	M1.6	6308188	L	Nobel Biocare	Nobel Active NP	3.5 mm
NB A 5.0	M2	6308253	L	Nobel Biocare	Nobel Active RP	4.3 / 5.0 mm
SSO 3.5	M1.8	6284231	L	Straumann®	Tissue level NN	3.5 mm
SSO 4.8	M2	6284249	L	Straumann®	Tissue Level RN	4.8 mm
SSO 6.5	M2	6284256	L	Straumann®	Tissue Level WN	6.5 mm
S BL 3.3	M1.6	6308154	L	Straumann®	Bone Level NC	3.3mm
S BL 4.1	M1.6	6308337	L	Straumann®	Bone Level NC	4.1 / 4.8 mm
ATOS 3.5/4.0	M1.6	6282532	L	Astra Tech	OsseoSpeed™	3.5 S/4.0 S mm
ATOS 4.5/5.0	M1.6	6282540	L	Astra Tech	OsseoSpeed™	4.5 / 5.0 mm
FX 3.4	M1.6	6282433	S	Friadent	Frialit®Xive®	3.4 mm
FX 3.8	M1.6	6282441	S	Friadent	Frialit®Xive®	3.8 mm
FX 4.5	M1.6	6282458	L	Friadent	Frialit®Xive®	4.5 mm
FX 5.5	M1.6	6282466	L	Friadent	Frialit®Xive®	5.5 mm
BO 3.4	M2	6282557	L	Biomet 3i	Ex. hex	3.4 mm
BO 4.1	M2	6282565	L	Biomet 3i	Ex. hex	4.1 mm
BO 5.0	M2	6282573	L	Biomet 3i	Ex. hex	5.0 mm
B C 3.4	M1.6	6308048	S	Biomet 3i	Certain®	3.5 mm
B C 4.1	M1.6	6308097	L	Biomet 3i	Certain®	4.5 mm
B C 5.0	M1.6	6308121	L	Biomet 3i	Certain®	5.7 mm
ZTSV 3.5	M1.8	6282581	L	Zimmer	Tapered screw-Vent®	3.5 mm
ZTSV 4.5	M1.8	6282599	L	Zimmer	Tapered screw-Vent®	4.5 mm
ZTSV 5.7	M1.8	6282607	L	Zimmer	Tapered screw-Vent®	5.7 mm

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Material Composition

VITA ENAMIC IS is identical in composition to VITA ENAMIC (K122269).

Technological Characteristics

VITA ENAMIC IS is offered in a block form, with a mandrel attachment, to permit securing it into a CAD/CAM machine for milling into its final form.

The VITA ENAMIC IS blocks have a pre-drilled hole compatible with Sirona TiBase (K111421) to allow the mesostructure or abutment crown bonded to a titanium base to be connected to the implant. VITA ENAMIC IS blocks are identical to VITA ENAMIC blocks (K122269) in geometry, with the exception of a pre-drilled hole.

Because the subject device and its predicates inCoris Zl meso, IPS e.max CAD Abutment Solutions do not share similar chemical or physical properties, a reference device, VITA Enamic, was introduced by the sponsor. The differences between VITA ENAMIC IS and the predicate devices do not render the subject device not substantially equivalent for the following reasons:

• ı VITA ENAMIC IS has non-identical, but similar indications as the inCoris Zl meso and IPS e.max CAD Abutment Solutions, and meets the same biocompatibility, ISO 6872:2008 and ISO 14801:2007 test criteria. While the verbiage of the indications for use statements differs, the intended use for each is similar. All three are restorative blocks intended to serve as milled components of dental implant abutments and abutment crowns, and all three share implant compatibilities with the same Sirona TiBase devices.
• . VITA ENAMIC IS has the identical chemical composition and physical properties as VITA ENAMIC.

As such, the data supports the substantial equivalence of the subject and predicate devices.

Non-Clinical Performance Testing

VITA ENAMIC IS meets the applicable requirements of the following FDA recognized standards:

• . ISO 6872:2008 – Dentistry – Ceramic materials
• . ISO 10477:2004(E) - Dentistry - Polymer-based crown and bridge materials standard.

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• I ISO 14801:2007 - Dentistry - Implants - Dynamic fatigue test for endosseous dental implants
  Bench test results allowed us to conclude that VITA ENAMIC IS is well suited for its intended use.

Biocompatibility

A biocompatibility assessment was performed on VITA ENAMIC IS in accordance with ISO 10933-1:2009 – Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process, and ISO 7405:2008 – Dentistry – Evaluation of Biocompatibility of Medical Devices Used in Dentistry. Testing from reference device VITA ENAMIC was leveraged to support biocompatibility. This assessment supports that VITA ENAMIC IS is biocompatible and concludes that the device is compatible for its intended use.

Clinical Performance Data

Not applicable. No human clinical testing was performed to support the substantial equivalence of VITA ENAMIC IS.

Substantial Equivalence

Material

VITA ENAMIC IS has the identical chemical composition as the predicate device, VITA ENAMIC (K122269).

Physical Properties

VITA ENAMIC IS has identical physical properties as the predicate device, VITA ENAMIC (K122269).

| Technical
Attributes | VITA
ENAMIC IS | inCoris Zl meso | IPS e.max CAD
Abutment Solutions | VITA
ENAMIC |
|---------------------------|-------------------------------------------------------------|-------------------------------------------------------------|------------------------------------------------------------|----------------------------------|
| Indication | Implant Abutment
and Abutment
Crown | Implant Abutment
and Abutment
Crown | Implant Abutment and
Abutment Crown | Crown & Veneers |
| CAD/CAM
Material | Yes | Yes | Yes | Yes |
| Physical
Configuration | Block with a pre-
drilled hole and
mandrel attachment | Block with a pre-
drilled hole and
mandrel attachment | Block with a pre-drilled
hole and mandrel
attachment | Block with mandrel
attachment |

Technical Comparison of VITA ENAMIC IS to Predicate Devices

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| Technical
Attributes | VITA
ENAMIC IS | inCoris ZI meso | IPS e.max CAD
Abutment Solutions | VITA
ENAMIC |
|-------------------------------------|----------------------------------------------------------------------------|----------------------------------------------------|-------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|
| Block Sizes | 12 x 14 x 18 mm and
18 x 16 x 18 mm
with Small or Large
hole size | One block size with
Small or Large hole
size | 12.4 x 14.5 x 18.0 mm
and
17.8 x 15.8 x 18.0 mm
with Small or Large hole
size | 12 x 14 x 18 mm and
8 x 10 x 15 mm
with Small or Large
hole size |
| Shades &
Translucency | Different shades
Translucent &
High Translucent | Two shades | Different shades
Medium Opacity & Low
Translucency | Different shades
Translucent &
High Translucent |
| Bonds to
Titanium Base | Sirona TiBase with
Small & Large hole | Sirona TiBase with
Small & Large hole | Sirona TiBase with Small
& Large hole | No |
| Maximal
Abutment
Angulation | 20° | 20° | 20° | Not applicable |
| Abutment
Fixation | Screwed | Screwed | Screwed | Not applicable |
| Screw | Part of implant
system | Part of implant
system | Part of implant system | Not applicable |
| Compatible
Titanium Base | Sirona TiBase
(K11142) | Sirona TiBase
(K11142) | Sirona TiBase
(K11142) | Not applicable |
| 1 or 2 piece
Abutment | 2 piece — ENAMIC
IS to TiBase | 2 piece — Incoris ZI
to TiBase | 2 piece - IPS e.max
CAD to TiBase | Not applicable |
| Mechanical
Testing | Dynamic Fatigue
Testing per ISO
14801 | Dynamic Fatigue
Testing per ISO
14801 | Dynamic Fatigue
Testing per ISO 14801 | Not applicable |
| Flexural
Strength | 140 ± 10 MPa | > 900 MPa | 360 ± 60 MPa | 140 ± 10 MPa |
| Fracture
Toughness | 1.5 MPa m0.5 | 5.9 Mpa m0.5 | 2.0 – 2.5 MPa m0.5 | 1.5 MPa m0.5 |
| Young's
Modulus of
Elasticity | 30 GPa | Unknown | 95 ± 5 GPa | 30 GPa |

Conclusion

Information provided by VITA North America, Inc. demonstrates that VITA ENAMIC Implant Solutions is substantially equivalent to the predicate devices. VITA ENAMIC IS shares the same indications and similar physical properties as the nCoris ZI meso and IPS e.max CAD Abutment Solutions. VITA ENAMIC IS has identical chemical composition and physical properties as VITA ENAMIC. - Comparisons of the indications for use, chemical composition, technological characteristics and physical properties of VITA ENAMIC IS to the predicate devices all support the substantial equivalence of VITA ENAMIC Implant Solutions to its predicate devices.