(146 days)
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
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).
The provided text is a 510(k) premarket notification for a medical device called the "Biodenta Customized Abutment - Hybrid." This document is a regulatory submission to the FDA proving substantial equivalence to existing devices, rather than a clinical study evaluating the device's performance against specific acceptance criteria.
Therefore, the document does not contain the acceptance criteria or a study that proves the device meets specific performance criteria in the format requested by the user. The information provided focuses on demonstrating substantial equivalence through non-clinical testing (fatigue testing and engineering/compatibility analysis) and comparison to predicate devices, rather than a clinical trial with acceptance criteria for device performance.
However, I can extract the information that is present concerning non-clinical testing:
Device: Biodenta Customized Abutment - Hybrid
1. A table of acceptance criteria and the reported device performance:
Since this is a 510(k) submission and not a clinical study with performance acceptance criteria, the document does not present a table of acceptance criteria and reported device performance directly. Instead, it states that "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."
This implies that the acceptance criteria for fatigue testing were met, but the specific numerical criteria and comparative results are not detailed in this summary.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
The document mentions "Fatigue testing" and "Engineering and Compatibility analysis" as non-clinical testing data.
- Sample Size: Not specified for either fatigue testing or compatibility analysis.
- Data Provenance: Not specified. As the submitting company is "Biodenta Swiss AG" based in Switzerland, it's plausible the testing was conducted in Switzerland or a country with recognized standards. This information is typically found in the full test reports, not the summary.
- Retrospective or Prospective: Not applicable for non-clinical, in-vitro testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable as the testing described is non-clinical (mechanical and compatibility analysis), not a study requiring expert clinical adjudication of ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable as the testing described is non-clinical.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a dental abutment, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done:
Not applicable. This device is a dental abutment.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For the non-clinical tests:
- Fatigue Testing: "Ground truth" would be established by the industry standard (ISO 14801:2007) indicating acceptable mechanical loads and cycles without failure.
- Compatibility Analysis: "Ground truth" would be established by engineering specifications and physical fit/interaction with specified implant systems.
8. The sample size for the training set:
Not applicable. This is not a machine learning or AI device.
9. How the ground truth for the training set was established:
Not applicable. This is not a machine learning or AI device.
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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.
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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)
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 169442 BerneckSwitzerland |
| 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 andTapered | B1: 3.5 mm; B2: 4.1, 4.8, 6.0 mm |
| Nobel Biocare, Nobel Replacestraight 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 TechOsseoSpeed | 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 ScrewVent 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 BiotechnologyCo., Ltd. | Pou Yu Biotechnology Co.,Ltd. | Straumann USA, LILO | Biodenta Swiss Ag | Biodenta Swiss AG |
| DeviceName | Biodenta CustomizedAbutment - Hybrid | TDS Abutment forNobel Biocare Replace | TDS Abutment for FriadentXive, | Straumann®Variobase™ Abutments | Biodenta Dental ImplantSystem - Multi-UseAbutment | Biodenta CustomizedAbutment |
| 510(k)Number | New device | K091026 | K103339 | K132219 | K123491 | K110778 |
| Intended use | The Biodenta CustomizedAbutment - Hybrid isintended for use withdental implants as asupport for single ormultiple tooth prosthesesin the maxilla or mandibleof a partially or fullyedentulous patient. TheBiodenta CustomizedAbutment - Hybrid iscompatible with thefollowing dental implantsystems: -Biodenta, BoneLevel and Tapered B1: 3.5mm; B2: 4.1, 4.8, 6.0 mm-Nobel Biocare, NobelReplace straight andtapered 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 -Biomet3i, Certain Internal 3.4:3.25, 4.0 mm; 4.1: 4.0, 5.0mm; 5.0: 5.0, 6.0 mm; 6.0:6.0 mm -Dentsply, AstraTech OsseoSpeed3.5/4.0: 3.5, 4.0 mm;4.5/5.0: 4.5, 5.0 mm -Straumann, Bone LevelNC: 3.3 mm; RC: 4.1, 4.8mm -Zimmer, Screw Ventand Screw Vent Tapered3.5: 3.3, 3.7, 4.1 mm; 4.5:4.7 mm; 5.7: 6.0 mm | TDS Abutment forNobel Biocare Replaceis intended for use withdental implants as asupport for single ormultiple toothprostheses in themaxilla or mandible ofa partially or fullyedentulous patient. | TDS Abutment for Friadent Xiveis intended for use with dentalimplants as a support for singleor multiple tooth prostheses inthe maxilla or mandible of apartially or fully edentulouspatient. This device iscompatible with the followingimplant systems which have aninternal hex with flat-to-flatdimensions of 1.78mm orgreater: Firadent: FRIALITImplant, XiVA Implant; 3i:Internal Connect Type; Astra:Osseospeed Implant,Osseospeed TX Implant;Biohorizons: Internal ImplantSystem, Tapered InternalImplant System, Single-StageImplant System, Laser-lok® 3.0implant system; Lifecore:Lifecore RENOVA™ InternalHex Implant System; Zimmer:Tapered Screw-Vent ImplantSystem, Screw-Vent ImplantSystem, AdVent ImplantSystem; Osstem: GS System;Nobel Biocare: Active Implant. | The Straumann®Variobase™ Abutment isa titanium base placedonto Straumann dentalimplants to providesupport for customizedprosthetic restorations.Straumann®Variobase™ Abutmentsare indicated for screw-retained single tooth orcement-retained singletooth and bridgerestorations. | Biodenta Dental ImplantSystem Multi UseAbutments are intendedfor terminal orintermediate abutmentsupport for fixed orremovable crown,bridgework and to retainoverdentures. | The Biodenta CustomizedAbutment is intended for usewith dental implants as asupport for single or multipletooth prostheses in the maxillaor mandible of a partially orfully edentulous patient. TheBiodenta CustomizedAbutment is compatible withthe following implant systems:- Internal hex systems withflat-to-flat dimensions of1.78mm or greater: Firadent:FRIALIT Implant, XiVAImplant; 3i: Certain InternalConnect Type; Astra:Osseospeed Implant,Osseospeed TX Implant;BioHorizons: Internal ImplantSystem, Tapered InternalImplant System, Single-StageImplant System; Lifecore:Lifecore RENOVAT™ InternalHex Implant System; Zimmer:Tapered Screw-Vent ImplantSystem, Screw-Vent ImplantSystem, AdVent ImplantSystem .- Nobel BiocareReplace: NobelReplaceStraight, NobelReplaceTapered: Replace SelectTapered, Replace SelectStraight; for the NP, RP, WPand 6.0 implants.- Externalhex systems with flat-to-flatdimensions of 2.4mm orgreater: Nobel BiocareBranemark, 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.
| Compatibleimplanttypes | - Biomet 3i, Certain Internal- Dentsply, AstraTechOsseoSpeed- Zimmer, Screw Vent- Nobel Biocare, NobelActive- Nobel Biocare,NobelReplace- Straumann, Bone Level- Biodenta, Bone Level andTapered | - Nobel Biocare,NobelReplace | - Biomet 3i, Certain Internal- Dentsply, AstraTechOsseoSpeed- Zimmer, Screw Vent- Nobel Biocare, NobelActive | - Straumann, Bone Level | - Biodenta, Bone Leveland Tapered | - Biomet 3i, Certain Internal- Dentsply, AstraTechOsseoSpeed- Zimmer, Screw Vent |
|---|---|---|---|---|---|---|
| Custom Design | ||||||
| AbutmentAngulation | 0 - 30° | 0 - 30° | 0 - 30° | 0 - 30° | 0, 18, 30° | 0 - 30° |
| AbutmentDiameter | 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/CopingHeight | 5.0 - 10 mm | 3.0 - 7.5 mm | 3.0 - 7.5 mm | unknown | Not Applicable(one-piece stock Tiabutment) | Not Applicable(one-piece customized Tiabutment) |
| Final AbutmentHeight | 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 |
| Abutmentfixation | Abutment Screw | Abutment Screw | Abutment Screw | Abutment Screw | Abutment Screw | Abutment Screw |
| 2 Piece | 2 piece:- pre-manufactured(stock) titanium-Base and-CAD/CAM Zirconiumcoping/crown | 2 piece:- pre-manufactured(stock) titanium-Base and-CAD/CAM Zirconiumcoping/crown | 2 piece:- pre-manufactured (stock)titanium-Base and-CAD/CAM Zirconiumcoping/crown | 2 piece:- pre-manufactured (stock)titanium-Base and-CAD/CAM Zirconiumcoping/crown | 1 piece:- pre-manufactured (stock)titanium abutment | 1 piece:- titanium CAD/CAMabutment |
| CAD/CAMProcessing | Yes - Zirconium partmilled in Biodenta millingcenter under QSR control | Yes - Zirconium partmilled in manufacturersmilling center under QSRcontrol | Yes - Zirconium part milled inmanufacturers milling centerunder QSR control | Yes - Zirconium part milledin Straumann milling centerunder QSR control | No | YES - Titanium abutmentmilled in Biodenta MillingCenter 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 | ||||||
| MechanicalTesting | Completed FatigueTesting according to ISO14801:2007 | Completed FatigueTesting according to ISO14801:2007 | Completed Fatigue Testingaccording to ISO 14801:2007 | Completed Fatigue Testingaccording to ISO14801:2007 | Completed Fatigue Testingaccording to ISO14801:2007 | Completed Fatigue Testingaccording 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 |
§ 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.)