Biodenta Customized Abutment-Hybrid
Device Facts
| Record ID | K150296 |
|---|---|
| Device Name | Biodenta Customized Abutment-Hybrid |
| Applicant | Biodenta Swiss AG |
| Product Code | NHA · Dental |
| Decision Date | Jul 2, 2015 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3630 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
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: 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 Story
Two-piece dental abutment system; consists of pre-manufactured titanium-base and CAD/CAM-designed zirconium coping/crown. Used in dental clinics; designed by dental technicians using CAD software; manufactured at Biodenta milling centers. Titanium-base and abutment screw made of Ti-6Al-4V ELI; zirconium coping/crown made of Y-TZP. Abutment screw provides retention. Final cement-retained restoration constructed in lab per dentist specifications. Compatible with various third-party implant systems. Provides structural support for prosthetic restorations; benefits patients by enabling customized, stable tooth replacement.
Clinical Evidence
Bench testing only. Fatigue testing conducted per ISO 14801:2007 and FDA guidance for root-form endosseous dental implants and abutments. Engineering and compatibility analysis verified interface fit with specified third-party implant systems.
Technological Characteristics
Two-piece abutment; Ti-6Al-4V ELI (ASTM F136, ISO 3852-3) titanium base and screw; Y-TZP zirconium (ISO 13356) coping/crown. CAD/CAM manufacturing. Non-sterile, single-use. Compatible with various internal hex/tapered implant platforms.
Indications for Use
Indicated for partially or fully edentulous patients requiring single or multiple tooth prostheses supported by dental implants in the maxilla or mandible.
Regulatory Classification
Identification
An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.
Special Controls
*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)
Predicate Devices
Reference Devices
- Straumann Variobase Abutments (K132219)
- Biodenta Dental Implant System - Multi-Use Abutment (K123491)
- Biodenta Customized Abutment (K110778)
Submission Summary (Full Text)
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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.
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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 (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)
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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<br>9442 Berneck<br>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<br>Tapered | B1: 3.5 mm; B2: 4.1, 4.8, 6.0 mm |
| Nobel Biocare, Nobel Replace<br>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;<br>5.0: 5.0, 6.0 mm; 6.0: 6.0 mm |
| Dentsply, Astra Tech<br>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<br>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<br>Co., Ltd. | Pou Yu Biotechnology Co.,<br>Ltd. | Straumann USA, LILO | Biodenta Swiss Ag | Biodenta Swiss AG |
| Device<br>Name | Biodenta Customized<br>Abutment - Hybrid | TDS Abutment for<br>Nobel Biocare Replace | TDS Abutment for Friadent<br>Xive, | Straumann®<br>Variobase™ Abutments | Biodenta Dental Implant<br>System - Multi-Use<br>Abutment | Biodenta Customized<br>Abutment |
| 510(k)<br>Number | New device | K091026 | K103339 | K132219 | K123491 | K110778 |
| Intended use | The Biodenta Customized<br>Abutment - Hybrid is<br>intended for use with<br>dental implants as a<br>support for single or<br>multiple tooth prostheses<br>in the maxilla or mandible<br>of a partially or fully<br>edentulous patient. The<br>Biodenta Customized<br>Abutment - Hybrid is<br>compatible with the<br>following dental implant<br>systems: -Biodenta, Bone<br>Level and Tapered B1: 3.5<br>mm; B2: 4.1, 4.8, 6.0 mm<br>-Nobel Biocare, Nobel<br>Replace straight and<br>tapered NP: 3.5 mm; RP:<br>4.3 mm; WP: 5.0 mm; 6.0:<br>6.0 mm -Nobel Biocare,<br>NobelActive NP: 3.5 mm;<br>RP: 4.3, 5.0 mm -Biomet<br>3i, Certain Internal 3.4:<br>3.25, 4.0 mm; 4.1: 4.0, 5.0<br>mm; 5.0: 5.0, 6.0 mm; 6.0:<br>6.0 mm -Dentsply, Astra<br>Tech OsseoSpeed<br>3.5/4.0: 3.5, 4.0 mm;<br>4.5/5.0: 4.5, 5.0 mm -<br>Straumann, Bone Level<br>NC: 3.3 mm; RC: 4.1, 4.8<br>mm -Zimmer, Screw Vent<br>and Screw Vent Tapered<br>3.5: 3.3, 3.7, 4.1 mm; 4.5:<br>4.7 mm; 5.7: 6.0 mm | TDS Abutment for<br>Nobel Biocare Replace<br>is intended for use with<br>dental implants as a<br>support for single or<br>multiple tooth<br>prostheses in the<br>maxilla or mandible of<br>a partially or fully<br>edentulous patient. | TDS Abutment for Friadent Xive<br>is intended for use with dental<br>implants as a support for single<br>or multiple tooth prostheses in<br>the maxilla or mandible of a<br>partially or fully edentulous<br>patient. This device is<br>compatible with the following<br>implant systems which have an<br>internal hex with flat-to-flat<br>dimensions of 1.78mm or<br>greater: Firadent: FRIALIT<br>Implant, XiVA Implant; 3i:<br>Internal Connect Type; Astra:<br>Osseospeed Implant,<br>Osseospeed TX Implant;<br>Biohorizons: Internal Implant<br>System, Tapered Internal<br>Implant System, Single-Stage<br>Implant System, Laser-lok® 3.0<br>implant system; Lifecore:<br>Lifecore RENOVA™ Internal<br>Hex Implant System; Zimmer:<br>Tapered Screw-Vent Implant<br>System, Screw-Vent Implant<br>System, AdVent Implant<br>System; Osstem: GS System;<br>Nobel Biocare: Active Implant. | The Straumann®<br>Variobase™ Abutment is<br>a titanium base placed<br>onto Straumann dental<br>implants to provide<br>support for customized<br>prosthetic restorations.<br>Straumann®<br>Variobase™ Abutments<br>are indicated for screw-<br>retained single tooth or<br>cement-retained single<br>tooth and bridge<br>restorations. | Biodenta Dental Implant<br>System Multi Use<br>Abutments are intended<br>for terminal or<br>intermediate abutment<br>support for fixed or<br>removable crown,<br>bridgework and to retain<br>overdentures. | The Biodenta Customized<br>Abutment is intended for use<br>with dental implants as a<br>support for single or multiple<br>tooth prostheses in the maxilla<br>or mandible of a partially or<br>fully edentulous patient. The<br>Biodenta Customized<br>Abutment is compatible with<br>the following implant systems:<br>- Internal hex systems with<br>flat-to-flat dimensions of<br>1.78mm or greater: Firadent:<br>FRIALIT Implant, XiVA<br>Implant; 3i: Certain Internal<br>Connect Type; Astra:<br>Osseospeed Implant,<br>Osseospeed TX Implant;<br>BioHorizons: Internal Implant<br>System, Tapered Internal<br>Implant System, Single-Stage<br>Implant System; Lifecore:<br>Lifecore RENOVAT™ Internal<br>Hex Implant System; Zimmer:<br>Tapered Screw-Vent Implant<br>System, Screw-Vent Implant<br>System, AdVent Implant<br>System .- Nobel Biocare<br>Replace: NobelReplace<br>Straight, NobelReplace<br>Tapered: Replace Select<br>Tapered, Replace Select<br>Straight; for the NP, RP, WP<br>and 6.0 implants.- External<br>hex systems with flat-to-flat<br>dimensions of 2.4mm or<br>greater: Nobel Biocare<br>Branemark, 3i, BioHorizons,<br>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<br>implant<br>types | - Biomet 3i, Certain Internal<br>- Dentsply, AstraTech<br>OsseoSpeed<br>- Zimmer, Screw Vent<br>- Nobel Biocare, NobelActive<br>- Nobel Biocare,<br>NobelReplace<br>- Straumann, Bone Level<br>- Biodenta, Bone Level and<br>Tapered | - Nobel Biocare,<br>NobelReplace | - Biomet 3i, Certain Internal<br>- Dentsply, AstraTech<br>OsseoSpeed<br>- Zimmer, Screw Vent<br>- Nobel Biocare, NobelActive | - Straumann, Bone Level | - Biodenta, Bone Level<br>and Tapered | - Biomet 3i, Certain Internal<br>- Dentsply, AstraTech<br>OsseoSpeed<br>- Zimmer, Screw Vent |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|-------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| Custom Design | | | | | | |
| Abutment<br>Angulation | 0 - 30° | 0 - 30° | 0 - 30° | 0 - 30° | 0, 18, 30° | 0 - 30° |
| Abutment<br>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/<br>Coping<br>Height | 5.0 - 10 mm | 3.0 - 7.5 mm | 3.0 - 7.5 mm | unknown | Not Applicable<br>(one-piece stock Ti<br>abutment) | Not Applicable<br>(one-piece customized Ti<br>abutment) |
| Final Abutment<br>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<br>fixation | Abutment Screw | Abutment Screw | Abutment Screw | Abutment Screw | Abutment Screw | Abutment Screw |
| 2 Piece | 2 piece:<br>- pre-manufactured<br>(stock) titanium-Base and<br>-CAD/CAM Zirconium<br>coping/crown | 2 piece:<br>- pre-manufactured<br>(stock) titanium-Base and<br>-CAD/CAM Zirconium<br>coping/crown | 2 piece:<br>- pre-manufactured (stock)<br>titanium-Base and<br>-CAD/CAM Zirconium<br>coping/crown | 2 piece:<br>- pre-manufactured (stock)<br>titanium-Base and<br>-CAD/CAM Zirconium<br>coping/crown | 1 piece:<br>- pre-manufactured (stock)<br>titanium abutment | 1 piece:<br>- titanium CAD/CAM<br>abutment |
| CAD/CAM<br>Processing | Yes - Zirconium part<br>milled in Biodenta milling<br>center under QSR control | Yes - Zirconium part<br>milled in manufacturers<br>milling center under QSR<br>control | Yes - Zirconium part milled in<br>manufacturers milling center<br>under QSR control | Yes - Zirconium part milled<br>in Straumann milling center<br>under QSR control | No | YES - Titanium abutment<br>milled in Biodenta Milling<br>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<br>Testing | Completed Fatigue<br>Testing according to ISO<br>14801:2007 | Completed Fatigue<br>Testing according to ISO<br>14801:2007 | Completed Fatigue Testing<br>according to ISO 14801:2007 | Completed Fatigue Testing<br>according to ISO<br>14801:2007 | Completed Fatigue Testing<br>according to ISO<br>14801:2007 | Completed Fatigue Testing<br>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 |
