Predicate Devices

K103339, K091026, K132219, K123491, K110778

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the materials, manufacturing process (CAD software and milling), and mechanical testing of a dental abutment. There is no mention of AI or ML in the intended use, device description, or performance studies.

Therapeutic

No.
The device is described as a support for dental prostheses rather than actively treating a disease or condition itself.

Diagnostic

No

The device is a dental abutment, a restorative component for dental implants, not a diagnostic tool. Its function is to support prostheses, and the provided text focuses on its structural properties and compatibility.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a two-piece abutment made of physical materials (Titanium-Base and Zirconium coping/crown) and includes details about material composition and mechanical testing. While CAD software is used in the design process, the device itself is a physical implant component.

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 device is for supporting dental prostheses in the maxilla or mandible. This is a structural and mechanical function within the body.
Device Description: The description details the physical components (Titanium-Base, Zirconium coping/crown, abutment screw) and their materials. It describes a physical device used in a surgical and restorative procedure.
Lack of Diagnostic Function: There is no mention of the device being used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of disease. IVDs are used to test samples like blood, urine, or tissue.

The device is a dental abutment, which is a component used in dental implant procedures to connect the implant to the prosthetic tooth. This falls under the category of medical devices used for treatment and restoration, not in vitro diagnosis.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Biodenta Customized Abutment - Hybrid is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.

The Biodenta Customized Abutment - Hybrid is compatible with the following dental implant systems:

Implant Brand, Type	Implant Platform Name: Implant Diameter
Biodenta, Bone Level and Tapered	B1: 3.5 mm; B2: 4.1, 4.8, 6.0 mm
Nobel Biocare, Nobel Replace straight and tapered	NP: 3.5 mm; RP: 4.3 mm; WP: 5.0 mm; 6.0: 6.0 mm
Nobel Biocare, NobelActive	NP: 3.5 mm; RP: 4.3, 5.0 mm
Biomet 3i, Certain Internal	3.4: 3.25, 4.0 mm; 4.1: 4.0, 5.0 mm; 5.0: 5.0, 6.0 mm; 6.0: 6.0 mm
Dentsply, Astra Tech OsseoSpeed	3.5/4.0: 3.5, 4.0 mm; 4.5/5.0: 4.5, 5.0 mm
Straumann, Bone Level	NC: 3.3 mm; RC: 4.1, 4.8 mm
Zimmer, Screw Vent and Screw Vent Tapered	3.5: 3.3, 3.7, 4.1 mm; 4.5: 4.7 mm; 5.7: 6.0 mm

Product codes

NHA

Device Description

The Biodenta Customized Abutment - Hybrid is a two-piece abutment, which contains a premanufactured (stock) Titanium-Base and a Zirconium coping and/or crown that is designed by a dental technician using CAD software and manufactured at Biodenta milling centers.

The Biodenta Customized Abutment - Hybrid utilizes an Abutment Screw for abutment retention. The final cement retained restoration is constructed in the lab according to the dentist's specifications.

The Biodenta Customized Abutment - Hybrid is compatible with the following dental implant systems: Biomet 3i, Certain Internal; Dentsply, AstraTech OsseoSpeed; Zimmer, Screw Vent; Nobel Biocare, Nobel Biocare, NobelReplace; Straumann, Bone Level; Biodenta, Bone Level and Tapered

The Titanium-Base and the Abutment Screw of the Biodenta Customized Abutment - Hybrid are made of biocompatible Ti-6AI-4V ELI conforming to ISO 3852-3 and ASTM F136.

The Zirconium coping and/or crown of the Biodenta Customized Abutment - Hybrid are made of biocompatible ZrO2 conforming to ISO 13356 Implants for surgery - Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

maxilla or mandible

Indicated Patient Age Range

Not Found

Intended User / Care Setting

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)

Fatigue testing was conducted according to FDA Guide: Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments -Guidance for Industry and FDA Staff. The worst case scenario for the Biodenta Customized Abutment - Hybrid and implant was tested. The results show that the Biodenta Customized Abutment - Hybrid has sufficient mechanical strength for the intended clinical application.

The compatibility of the Biodenta Customized Abutment - Hybrid compatible to the implants Biomet 3i, Certain Internal; Dentsply, AstraTech OsseoSpeed; Zimmer, Screw Vent; Nobel Biocare, NobelActive; Nobel Biocare, NobelReplace; and Straumann, Bone Level implants has been verified by and Engineering and Compatibility analysis

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

Not Found

Predicate Device(s)

K103339, K091026, K132219, K123491, K110778

Reference Device(s)

Not Found

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 features a stylized depiction of three human profiles facing right, stacked on top of each other. Above the profiles are three curved lines, resembling flowing hair or abstract shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.

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

July 2, 2015

Biodenta Swiss AG Mr. David Elier Regulatory Manager Tramstrasse 16 CH-9442 Berneck Switzerland

Re: K150296

Trade/Device Name: Biodenta Customized Abutment - Hybrid Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: May 28, 2015 Received: June 1, 2015

Dear Mr. Elier:

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.

1

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 (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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours,

Tina
Kiang -S

for Erin 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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Image /page/2/Picture/1 description: The image shows the logo for "biodenta". The word "biodenta" is written in gray, lowercase letters. Above the word is a curved shape that is gray on the left and green on the right. To the right of the word "biodenta" is a small circle with an "R" inside, indicating that the logo is a registered trademark.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K150296

Device Name

Biodenta Customized Abutment - Hybrid

Indications for Use (Describe)

The Biodenta Customized Abutment - Hybrid is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.

The Biodenta Customized Abutment - Hybrid is compatible with the following dental implant systems:

Implant Brand, Type	Implant Platform Name: Implant Diameter
Biodenta, Bone Level and Tapered	B1: 3.5 mm; B2: 4.1, 4.8, 6.0 mm
Nobel Biocare, Nobel Replace straight and tapered	NP: 3.5 mm; RP: 4.3 mm; WP: 5.0 mm; 6.0: 6.0 mm
Nobel Biocare, NobelActive	NP: 3.5 mm; RP: 4.3, 5.0 mm
Biomet 3i, Certain Internal	3.4: 3.25, 4.0 mm; 4.1: 4.0, 5.0 mm; 5.0: 5.0, 6.0 mm; 6.0: 6.0 mm
Dentsply, Astra Tech OsseoSpeed	3.5/4.0: 3.5, 4.0 mm; 4.5/5.0: 4.5, 5.0 mm
Straumann, Bone Level	NC: 3.3 mm; RC: 4.1, 4.8 mm
Zimmer, Screw Vent and Screw Vent Tapered	3.5: 3.3, 3.7, 4.1 mm; 4.5: 4.7 mm; 5.7: 6.0 mm

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/14)

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Image /page/3/Picture/1 description: The image shows the logo for Biodenta. The logo consists of the word "biodenta" in gray lowercase letters, with a registered trademark symbol to the right of the word. Above the word is a curved design in gray and light green.

K150296

510(k) Summary

Owner's name:	Biodenta Swiss AG
Address:	Tramstrasse 16
9442 Berneck
Switzerland
Phone:	+41 71 747 11 11
Fax number:	+ 41 71 747 11 12
Contact person:	Mr. David Eiler, Regulatory Manager
Date summary prepared:	January 30, 2015
Trade / proprietary name:	Biodenta Customized Abutment - Hybrid
Common name:	Endosseous dental implant abutment
Device classification name:	Endosseous Dental Implant Abutment
Product code:	NHA
Regulation number :	21 CFR 872.3630
Device class:	II

Legally marketed device to which equivalence is claimed (predicate device):

1. Company:	Pou Yu Biotechnology Co., Ltd.
Device name:	TDS Abutment for Nobel Biocare Replace
510(k) number:	K091026 – Reference Predicate

2. Company:	Pou Yu Biotechnology Co., Ltd
Device name:	TDS Abutment for Friadent Xive,
510(k) number:	K103339 - Primary Predicate

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Image /page/4/Picture/1 description: The image shows the logo for Biodenta. The logo consists of the word "biodenta" in gray lowercase letters, with a registered trademark symbol to the right of the "a". Above the word is a curved design in light gray and light green.

3. Company:	Straumann USA, LILO
Device name:	Straumann® Variobase™ Abutments
510(k) number:	K132219 – Reference Predicate
4. Company:	Biodenta Swiss Ag
Device name:	Biodenta Dental Implant System - Multi-Use Abutment
510(k) number:	K123491 – Reference Predicate
5. Company:	Biodenta Swiss Ag
Device name:	Biodenta Customized Abutment
510(k) number:	K110778 – Reference Predicate

Indications for Use:

The Biodenta Customized Abutment - Hybrid is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.

The Biodenta Customized Abutment - Hybrid is compatible with the following dental implant systems:

Implant Brand, Type	Implant Platform Name: Implant Diameter
Biodenta, Bone Level and
Tapered	B1: 3.5 mm; B2: 4.1, 4.8, 6.0 mm
Nobel Biocare, Nobel Replace
straight and tapered	NP: 3.5 mm; RP: 4.3 mm; WP: 5.0 mm; 6.0: 6.0 mm
Nobel Biocare, NobelActive	NP: 3.5 mm; RP: 4.3, 5.0 mm
Biomet 3i, Certain Internal	3.4: 3.25, 4.0 mm; 4.1: 4.0, 5.0 mm;
5.0: 5.0, 6.0 mm; 6.0: 6.0 mm
Dentsply, Astra Tech
OsseoSpeed	3.5/4.0: 3.5, 4.0 mm; 4.5/5.0: 4.5, 5.0 mm
Straumann, Bone Level	NC: 3.3 mm; RC: 4.1, 4.8 mm
Zimmer, Screw Vent and Screw
Vent Tapered	3.5: 3.3, 3.7, 4.1 mm; 4.5: 4.7 mm; 5.7: 6.0 mm

Device Description:

The Biodenta Customized Abutment - Hybrid is a two-piece abutment, which contains a premanufactured (stock) Titanium-Base and a Zirconium coping and/or crown that is designed by a dental technician using CAD software and manufactured at Biodenta milling centers.

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Image /page/5/Picture/1 description: The image shows the logo for "biodenta". The logo features the word "biodenta" in a gray, sans-serif font. Above the word is a curved design in gray and light green, resembling a smile or a wave. The registered trademark symbol is present to the right of the word.

The Biodenta Customized Abutment - Hybrid utilizes an Abutment Screw for abutment retention. The final cement retained restoration is constructed in the lab according to the dentist's specifications.

The Biodenta Customized Abutment - Hybrid is compatible with the following dental implant systems: Biomet 3i, Certain Internal; Dentsply, AstraTech OsseoSpeed; Zimmer, Screw Vent; Nobel Biocare, Nobel Biocare, NobelReplace; Straumann, Bone Level; Biodenta, Bone Level and Tapered

The Titanium-Base and the Abutment Screw of the Biodenta Customized Abutment - Hybrid are made of biocompatible Ti-6AI-4V ELI conforming to ISO 3852-3 and ASTM F136.

The Zirconium coping and/or crown of the Biodenta Customized Abutment - Hybrid are made of biocompatible ZrO2 conforming to ISO 13356 Implants for surgery - Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP).

Non-clinical Testing Data:

Fatigue testing was conducted according to FDA Guide: Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments -Guidance for Industry and FDA Staff. The worst case scenario for the Biodenta Customized Abutment - Hybrid and implant was tested. The results show that the Biodenta Customized Abutment - Hybrid has sufficient mechanical strength for the intended clinical application.

The compatibility of the Biodenta Customized Abutment - Hybrid compatible to the implants Biomet 3i, Certain Internal; Dentsply, AstraTech OsseoSpeed; Zimmer, Screw Vent; Nobel Biocare, NobelActive; Nobel Biocare, NobelReplace; and Straumann, Bone Level implants has been verified by and Engineering and Compatibility analysis

Equivalence to marketed device:

Biodenta Swiss AG demonstrated that, for the purposes of FDA's regulation of medical devices, the Biodenta Customized Abutment - Hybrid is substantially equivalent to the predicate devices in intended use, material composition, fundamental scientific technology, principles of operation, and basic design.

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Image /page/6/Picture/1 description: The image shows the logo for "biodenta". The logo consists of the word "biodenta" in gray, with a registered trademark symbol to the right of the word. Above the word is a curved design in gray and light green.

Summary Substantial Equivalence Comparison to predicate devices:

	Subject Device			Predicate Devices
Company	Biodenta Swiss AG	Pou Yu Biotechnology
Co., Ltd.	Pou Yu Biotechnology Co.,
Ltd.	Straumann USA, LILO	Biodenta Swiss Ag	Biodenta Swiss AG
Device
Name	Biodenta Customized
Abutment - Hybrid	TDS Abutment for
Nobel Biocare Replace	TDS Abutment for Friadent
Xive,	Straumann®
Variobase™ Abutments	Biodenta Dental Implant
System - Multi-Use
Abutment	Biodenta Customized
Abutment
510(k)
Number	New device	K091026	K103339	K132219	K123491	K110778
Intended use	The Biodenta Customized
Abutment - Hybrid is
intended for use with
dental implants as a
support for single or
multiple tooth prostheses
in the maxilla or mandible
of a partially or fully
edentulous patient. The
Biodenta Customized
Abutment - Hybrid is
compatible with the
following dental implant
systems: -Biodenta, Bone
Level and Tapered B1: 3.5
mm; B2: 4.1, 4.8, 6.0 mm
-Nobel Biocare, Nobel
Replace straight and
tapered NP: 3.5 mm; RP:
4.3 mm; WP: 5.0 mm; 6.0:
6.0 mm -Nobel Biocare,
NobelActive NP: 3.5 mm;
RP: 4.3, 5.0 mm -Biomet
3i, Certain Internal 3.4:
3.25, 4.0 mm; 4.1: 4.0, 5.0
mm; 5.0: 5.0, 6.0 mm; 6.0:
6.0 mm -Dentsply, Astra
Tech OsseoSpeed
3.5/4.0: 3.5, 4.0 mm;
4.5/5.0: 4.5, 5.0 mm -
Straumann, Bone Level
NC: 3.3 mm; RC: 4.1, 4.8
mm -Zimmer, Screw Vent
and Screw Vent Tapered
3.5: 3.3, 3.7, 4.1 mm; 4.5:
4.7 mm; 5.7: 6.0 mm	TDS Abutment for
Nobel Biocare Replace
is intended for use with
dental implants as a
support for single or
multiple tooth
prostheses in the
maxilla or mandible of
a partially or fully
edentulous patient.	TDS Abutment for Friadent Xive
is intended for use with dental
implants as a support for single
or multiple tooth prostheses in
the maxilla or mandible of a
partially or fully edentulous
patient. This device is
compatible with the following
implant systems which have an
internal hex with flat-to-flat
dimensions of 1.78mm or
greater: Firadent: FRIALIT
Implant, XiVA Implant; 3i:
Internal Connect Type; Astra:
Osseospeed Implant,
Osseospeed TX Implant;
Biohorizons: Internal Implant
System, Tapered Internal
Implant System, Single-Stage
Implant System, Laser-lok® 3.0
implant system; Lifecore:
Lifecore RENOVA™ Internal
Hex Implant System; Zimmer:
Tapered Screw-Vent Implant
System, Screw-Vent Implant
System, AdVent Implant
System; Osstem: GS System;
Nobel Biocare: Active Implant.	The Straumann®
Variobase™ Abutment is
a titanium base placed
onto Straumann dental
implants to provide
support for customized
prosthetic restorations.
Straumann®
Variobase™ Abutments
are indicated for screw-
retained single tooth or
cement-retained single
tooth and bridge
restorations.	Biodenta Dental Implant
System Multi Use
Abutments are intended
for terminal or
intermediate abutment
support for fixed or
removable crown,
bridgework and to retain
overdentures.	The Biodenta Customized
Abutment is intended for use
with dental implants as a
support for single or multiple
tooth prostheses in the maxilla
or mandible of a partially or
fully edentulous patient. The
Biodenta Customized
Abutment is compatible with
the following implant systems:

Internal hex systems with
flat-to-flat dimensions of
1.78mm or greater: Firadent:
FRIALIT Implant, XiVA
Implant; 3i: Certain Internal
Connect Type; Astra:
Osseospeed Implant,
Osseospeed TX Implant;
BioHorizons: Internal Implant
System, Tapered Internal
Implant System, Single-Stage
Implant System; Lifecore:
Lifecore RENOVAT™ Internal
Hex Implant System; Zimmer:
Tapered Screw-Vent Implant
System, Screw-Vent Implant
System, AdVent Implant
System .- Nobel Biocare
Replace: NobelReplace
Straight, NobelReplace
Tapered: Replace Select
Tapered, Replace Select
Straight; for the NP, RP, WP
and 6.0 implants.- External
hex systems with flat-to-flat
dimensions of 2.4mm or
greater: Nobel Biocare
Branemark, 3i, BioHorizons,
and Lifecore. |

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Image /page/7/Picture/1 description: The image shows the logo for Biodenta. The logo consists of the word "biodenta" in gray font, with a curved gray and green graphic above the word. The registered trademark symbol is to the right of the word.

| Compatible
implant
types | - Biomet 3i, Certain Internal

Dentsply, AstraTech
OsseoSpeed
Zimmer, Screw Vent
Nobel Biocare, NobelActive
Nobel Biocare,
NobelReplace
Straumann, Bone Level
Biodenta, Bone Level and
Tapered | - Nobel Biocare,
NobelReplace | - Biomet 3i, Certain Internal
Dentsply, AstraTech
OsseoSpeed
Zimmer, Screw Vent
Nobel Biocare, NobelActive | - Straumann, Bone Level | - Biodenta, Bone Level
and Tapered | - Biomet 3i, Certain Internal
Dentsply, AstraTech
OsseoSpeed
Zimmer, Screw Vent |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|-------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| Custom Design | | | | | | |
| Abutment
Angulation | 0 - 30° | 0 - 30° | 0 - 30° | 0 - 30° | 0, 18, 30° | 0 - 30° |
| Abutment
Diameter | 4.5 - 15 mm | 5 - 10 mm | 5 - 10 mm | 3.8 - 7.0 mm | 4.5 - 5.0 mm | 5 - 10 mm |
| Zr Crown/
Coping
Height | 5.0 - 10 mm | 3.0 - 7.5 mm | 3.0 - 7.5 mm | unknown | Not Applicable
(one-piece stock Ti
abutment) | Not Applicable
(one-piece customized Ti
abutment) |
| Final Abutment
Height | 5.5 - 12.3 mm | 3.5 - 8.0 mm | 3.5 - 8.0 mm | 3.5 mm - unknown | 2.0 - 5.5 mm | 3.0 - 7.5 mm |
| Abutment
fixation | Abutment Screw | Abutment Screw | Abutment Screw | Abutment Screw | Abutment Screw | Abutment Screw |
| 2 Piece | 2 piece:
pre-manufactured
(stock) titanium-Base and
-CAD/CAM Zirconium
coping/crown | 2 piece:
pre-manufactured
(stock) titanium-Base and
-CAD/CAM Zirconium
coping/crown | 2 piece:
pre-manufactured (stock)
titanium-Base and
-CAD/CAM Zirconium
coping/crown | 2 piece:
pre-manufactured (stock)
titanium-Base and
-CAD/CAM Zirconium
coping/crown | 1 piece:
pre-manufactured (stock)
titanium abutment | 1 piece:
titanium CAD/CAM
abutment |
| CAD/CAM
Processing | Yes - Zirconium part
milled in Biodenta milling
center under QSR control | Yes - Zirconium part
milled in manufacturers
milling center under QSR
control | Yes - Zirconium part milled in
manufacturers milling center
under QSR control | Yes - Zirconium part milled
in Straumann milling center
under QSR control | No | YES - Titanium abutment
milled in Biodenta Milling
Center under QSR control |
| Material | | | | | | |
| Metal Base | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Ti-6Al-7Nb | Ti-6Al-4V ELI | Ti-6Al-4V ELI |
| Coping | ZrO2 | ZrO2 | ZrO2 | ZrO2 | Not applicable | Not applicable |
| Screw | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Ti-6Al-7Nb | Ti-6Al-4V ELI | Ti-6Al-4V ELI |
| Mechanical | | | | | | |
| Mechanical
Testing | Completed Fatigue
Testing according to ISO
14801:2007 | Completed Fatigue
Testing according to ISO
14801:2007 | Completed Fatigue Testing
according to ISO 14801:2007 | Completed Fatigue Testing
according to ISO
14801:2007 | Completed Fatigue Testing
according to ISO
14801:2007 | Completed Fatigue Testing
according to ISO 14801:2007 |
| Sterile / Reuse | | | | | | |
| Sterile | Delivered Non Sterile | Delivered Non Sterile | Delivered Non Sterile | Delivered Non Sterile | Delivered Non Sterile | Delivered Non Sterile |
| Reusable | no | no | no | no | no | no |