(224 days)
Ti-Base for individual Zirconium Abutments: The devices covered by this submission are abultments which are placed into a dental implant to provide support for a prosthetic restoration.
The Ti-Base for individual Zirconium Abutments are intended for use to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.
The Ti-Base abutments are indicated for use with the following implant systems:
- Nobel Biocare® Replace Select® .
- Nobel Biocare NobelActive TM .
- Biomet 3i® Osseotite® .
- Biomet 3i® Osseotite® Certain® .
- Nobel Biocare Branemark® ●
- Straumann® synOcta® .
- Straumann® Bone Level® .
- Zimmer® Tapered Screw-vent® .
- Astra Tech OsseoSpeed® .
- Dentsply-Friadent® Frialit® .
2-CONnect Abutment for Bridges and Bars: 2-CONnect for Bridges and Bars is indicated for use to provide support for prosthetic restorations such as bars and bridges. The 2-CONnect abutments can be used in multiple tooth restorations. The 2-CONnect abulment can be used together with cemented bridges and bar constructions for functional and aesthetical reconstruction. The 2-CONnect abutments are indicated for use with the following implant systems:
- Nobel Biocare® Replace Select® .
- Straumann® synOcta® .
- Straumann® BoneLevel® .
The Ti-Base Abutment is a premanufactured prosthetic component supplied in two parts, the abutment and screw, for fixation onto dedicated endosseous dental implants and is intended for use as an aid in prosthetic rehabilitation.
The 2-CONnect Abutment consists of 1 Abutment with screw (for fixation of abutment to the implant) and 1 titanium cap with 1 tiny screw (fixed into the hollow Abutment screw). The cap on top fits exactly to the abutment-geometry and does not have a rotation fixation, so it is easier to work with (not indicated for single crowns but strictly for bridges). The 2-CONnect is intended for use as an aid in prosthetic rehabilitation.
The NT-Trading Ti-Base and 2-CONnect is compatible, with commercially available dental CAD/CAM systems, such as 3Shape, Exocad, Dental Wings. Such systems must be validated by the user.
This K111935 510(k) submission describes the acceptance criteria and study for the NT-Trading Ti-Base Abutment and 2-CONnect Abutment, which are dental abutments.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (Summary of Testing) |
|---|---|
| Fatigue Testing according to ISO 14801 Dentistry - Implants - Dynamic fatigue test for endosseous implants | Fatigue testing was performed on the abutments with the implants they are intended to fit. The results demonstrated compatibility and substantial equivalence to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Testing was performed on the abutments in this submission with the implants that they are intended to fit." However, the exact sample size (number of abutments/implants tested) and the data provenance (e.g., country of origin of the data, retrospective or prospective) are not specified in the provided 510(k) summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This submission pertains to a medical device (dental abutments) and relies on engineering and performance testing (fatigue testing) rather than a clinical study with a "ground truth" established by human experts in the context of diagnostic performance. Therefore, the concept of "experts establishing ground truth" as it applies to diagnostic studies is not applicable here. The "ground truth" for this device is its physical performance under specified standards.
4. Adjudication Method for the Test Set
As this is a performance study based on engineering standards (fatigue testing), an adjudication method in the context of human expert disagreement is not applicable. The results are based on objective measurements and predefined pass/fail criteria according to ISO 14801.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This is a performance study for a physical device, not a diagnostic or AI-assisted interpretation study. Therefore, the concept of human readers improving with or without AI assistance is not applicable.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
No, a standalone "algorithm only" performance study was not done. This device is a physical dental abutment, not an algorithm or AI system.
7. The Type of Ground Truth Used
The ground truth used for this study is based on engineering standards and objective physical measurements in a laboratory setting, specifically fatigue testing according to ISO 14801 Dentistry - Implants - Dynamic fatigue test for endosseous implants.
8. The Sample Size for the Training Set
The provided document describes a device subject to performance testing, not a machine learning model. Therefore, the concept of a "training set" and its sample size is not applicable.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for this device, the question of how its ground truth was established is not applicable.
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. ·
| 510(k) Summary | K111935 | FEB 17 2012 | ||
|---|---|---|---|---|
| Submitter Name:Submitter Address: | NT-Trading GmbH & Co. KGEssostrasse 1676187 KarlsruheGermany | |||
| Phone Number:Fax Number: | +49-721-915471 60+49-721-915471 61 | |||
| Contact Person: | Dirk Jahn | |||
| Date Prepared: | June 29, 2011 | |||
| Device Trade Name: | Ti-Base Abutment2-CONnect Abutment | |||
| Common Name: | Dental Abutments | |||
| Classification Name,Number &Product Code: | Abutment, Implant, Dental, Endosseous872.3630NHA | |||
| Predicate Devices: | (K100152) Sirona Dental Systems Sirona Dental CAD/CAM System, (K083871)Atlantis™ Straumann Bone Level Abutment, (K093483) Atlantis™ Abutment forNobel Active Implant, (K072642) Biomet 3I Dental Abutments And RestorativeComponents, (K990342) synOcta® Prosthetics, (K080239) P.004 Abutments,(K072570) NobelActive™ Multi Unit Abutment | |||
| Device Description andStatement of Intended Use | The Ti-Base Abutment is a premanufactured prosthetic component supplied in twoparts, the abutment and screw, for fixation onto dedicated endosseous dentalimplants and is intended for use as an aid in prosthetic rehabilitation. | |||
| The 2-CONnect Abutment consists of 1 Abutment with screw (for fixation of abutmentto the implant) and 1 titanium cap with 1 tiny screw (fixed into the hollow Abutmentscrew). The cap on top fits exactly to the abutment-geometry and does not have arotation fixation, so it is easier to work with (not indicated for single crowns but strictlyfor bridges). The 2-CONnect is intended for use as an aid in prosthetic rehabilitation. | ||||
| The NT-Trading Ti-Base and 2-CONnect is compatible, with commercially availabledental CAD/CAM systems, such as 3Shape, Exocad, Dental Wings. Such systemsmust be validated by the user. | ||||
| Indication for use:Ti-Base Abutments: The devices covered by this submission are abutments whichare placed into a dental implant to provide support for a prosthetic restoration. | ||||
| The Ti-Base abutments are intended for use to support a prosthetic device in apartially or completely edentulous patient. It is intended for use to support single andmultiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cementretained to the abutment. The abutment screw is intended to secure the abutment tothe endosseous implant. | ||||
| The Ti-Base abutments are indicated for use with the following implant systems: |
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.
| Nobel Biocare® Replace Select® Nobel Biocare NobelActive™ Biomet 3i® Osseotite® Biomet 3i® Osseotite® Certain® Nobel Biocare Branemark® Straumann® synOcta® Straumann® Bone Level® Zimmer® Tapered Screw-vent® Astra Tech OsseoSpeed® Dentsply-Friadent® Frialit® | |
|---|---|
| 2-CONnect Abutments: 2-CONnect abutment is indicated for use to provide supportfor prosthetic restorations such as bars and bridges. The 2-CONnect abutments canbe used in multiple tooth restorations. The 2-CONnect abutment can be usedtogether with cemented bridges and bar constructions for functional and aestheticalreconstruction.The 2-CONnect abutments are indicated for use with the following implant systems: Nobel Biocare® Replace Select® Straumann® synOcta® Straumann® BoneLevel® | |
| Summary of TechnologicalCharacteristics | The proposed Ti-Base abutments and 2-CONnect abutments are substantiallyequivalent to the currently cleared devices. They are substantially equivalent inintended use, material and connection interfaces to the implants are identical for eachindividual diameter and connection type. Comparison Demonstrating SubstantialEquivalence follows at the end of this section.Testing Summary |
| In order to demonstrate compatibility of Ti-Base and 2-CONnect abutments to eachimplant system, fatigue testing was performed according to ISO 14801 Dentistry-Implants-Dynamic fatigue test for endosseous implants. Testing was performed onthe abutments in this submission with the implants that they are intended to fit. Seesection 18. | |
| Conclusion | The information discussed above demonstrates that the NT-Trading Ti-Base DentalAbutments and 2-CONnect Abutments are substantially equivalent to the predicatedevices. |
| Declarations | This summary includes only information that is also covered in the body of the 510(k). This summary does not contain any puffery or unsubstantiated labeling claims. This summary does not contain any raw data, i.e., contains only summary data. This summary does not contain any trade secret or confidential commercial information. This summary does not contain any patient identification information. |
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Submitter:
NT-Trading GmbH & Co. KG
Summary of Technical Characteristics
| Feature | 510(k) Number | Manufacturer | Classification #& Product Code | Intended Use | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ti-Base and 2-CONnect | K100152 | Nt-Trading GmbH& Co. KG | 872.3630NHA | Ti-BaseAbutments: Thedevices covered bythis submission areabutments whichare placed into adental implant toprovide support fora prostheticrestoration.The Ti-Baseabutments areintended for use tosupport aprosthetic device ina partially orcompletelyedentulous patient.It is intended foruse to supportsingle and multipletooth prosthesis, inthe mandible ormaxilla. Theprosthesis can becement retained tothe abutment. The | |||||||||||||
| Sirona DentalSystems SironaDental CAD/CAMSystem | K083871 | Sirona DentalSystems GmbH | 872.3630NHA | The Sirona DentalCAD/CAM Systemis intended for usein partially or fullyedentulousmandibles andmaxillae in supportof single ormultiple-unitcement retainedrestorations.The systemconsists of threemajor parts:TiBase, InCorismesostructure, andCAD/CAMsoftware.Specifically, theInCorismesostructure andTiBasecomponents makeup a two-pieceabutment which isused in conjunctionwith endosseousdental implants torestore the function | |||||||||||||
| Atlantis ™StraumannBone LevelAbutment | K083871 | Astra Tech Inc. | 872.3630NHA | The devicescovered by thissubmission areabutments whichare placed into adental implant toprovide supportfor a prostheticreconstruction.The AtlantisAbutment isintended for usewith anendosseousimplant tosupport aprosthetic devicein a partially orcompletelyedentulouspatient. It isintended for useto support singleand multipletooth prosthesis,in the mandibleor maxilla. Theprosthesis can | |||||||||||||
| Atlantis ™™Abutment forNobel ActiveImplant | K093483 | Astra Tech Inc. | 872.3630NHA | The AtlantisAbutment isintended for usewith anendosseousimplant tosupport aprosthetic devicein a partially orcompletelyedentulouspatient. It isintended for useto support singleand multipletooth prosthesis,in the mandibleor maxilla. Theprosthesis canbe cementretained to theabutment. Theabutment screwis intended tosecure theabutment to theendosseousimplant. | |||||||||||||
| Biomet 3iDentalAbutments AndRestorativeComponents | K072642 | Biomet 3i, Inc. | 872.3630NHA | BIOMET 3iDentalAbutments andOverdentureBars areintended for useas an accessoryto endosseousdental implantsto support aprosthetic devicein a partially oredentulouspatient. Theseare intended foruse to supportsingle andmultiple toothprostheses, inthe mandible ormaxilla. Theprosthesescan be screw orcement retainedto the abutment. | |||||||||||||
| synOcta®Prosthetics | K990342 | Straumann®USA | 872.3630NHA | ITI Dentalimplants areintended to beplaced in themaxillary and/ormandibulararch to supportcrowns, bridgesor overdenturesin edentulousor partiallyedentulouspatients. Theprostheticaccessories todental implantsare used eitherin the processof fabricatingthe prostheticrestoration forthe implant oras part of theprostheticrestoration. | |||||||||||||
| P.004Abutments | K080239 | Straumann®Manufacturing,Inc | 872.3630NHA | Abutments areplaced intodental implantsto providesupport forprostheticrestorationssuch ascrowns,bridges andoverdentures.Abutments canbe used insingle toothreplacementsand multipletoothrestorations.The subjectabutments arefor permanentscrew-retainedbridges andbar-retainedimplant-bornedentures.Permanentcopings areintended to | |||||||||||||
| Nobel Active™Multi UnitAbutment | K072570 | Nobel Biocare®AB | 872.3630NHA | Nobel Biocare'sMulti-Unit is apremanufacturedprostheticcomponentdirectlyconnected toendosseousdental implantsand isintended for useas an aid inprostheticrehabilitation. |
Section 5.0: 510(k) Summary
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Submitter:
NT-Trading GmbH & Co. KG
Section 5.0: 510(k) Summary
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Submitter:
NT-Trading GmbH & Co. KG
Dental Abutments
Premarket Notification: Traditional 510(k)
| used in multipletooth restorations.The 2-CONnectabutment can beused together withcemented bridgesand barconstructions forfunctional andaestheticalreconstruction.The 2-CONnectabutments areindicated for usewith the followingimplant systems:• Nobel Biocare®• Replace Select®• Straumann®synOcta®• Straumann®BoneLevel® | Same | Same | Same | Same | Same | Same | Same | ||
|---|---|---|---|---|---|---|---|---|---|
| AbutmentDiameter min.Diameter max.Abutment Height | 3.5 mm6.5 mmTi-Base: 4 mm2-CONnect: 2.3 / 4.3 mm | Same | Same | 4/ 5.5 mm | 6.6 mm | 7.0 | 1.5 / 6.0 | 1.5 / 6.0 | 1.0 / 5.5 mm |
| Mode of Action | Screw-retained orcement retained | Screw-retained orcement retained | Screw-retainedor cementretained | Screw-retainedor cementretained | Screw-retainedor cementretained | Screw-retainedor cementretained | Screw retained | Screw retained | Screw retained |
| Reusable | No | No | No | No | No | No | No | No | No |
| Material | Ti-6Al-4V | Ti-6Al-4V | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Ti-6A1- 4V ELI | Ti-6Al-4V | Ti-6Al-4V | Titanium,Titanium alloy | Titanium Alloy |
For the reasons stated above, we believe a determination of substantial equivalence between the Ti-Base and 2-CONnect and these predicate
devices is appropriate.
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Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three swooping lines representing its wings. The eagle is positioned in the center of a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
NT-Trading GmbH & Company AG C/O Mr. William Greenrose President Oserve America, Inc. 220 River Road Claremont, New Hampshire 03743
FEB 1 7 2012
Re: K111935
Trade/Device Name: Ti-Base for Individual milled Zirconium Abutment, 2-CONnect Abutment for Bridges and Bars Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: November 28, 2011 Received: February 14, 2012
Dear Mr. Greenrose:
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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Page 2 – Mr. Greenrose
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. or the Fet of all, I outh all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing (reporting of medical as not to 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), n you desire specific as for JAboutFDA/CentersOffices/CDRH/CDRHOffices /ucm 1 1580 htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to Compilance: "Thiso, preace now as a 807.97). For questions regarding the reporting of premainer wonter the MDR regulation (21 CFR Part 803), please go to auverse events under the NDR rogalasate('/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 Touring of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Nh foc
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, 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): | K111935 |
|---|---|
| --------------------------- | --------- |
Ti-Base for individual milled Zirconium Abutment, 2-CONnect Abutment for Bridges Device Name: and Bars
Indications For Use:
Ti-Base for individual Zirconium Abutments: The devices covered by this submission are abultments which are placed into a dental implant to provide support for a prosthetic restoration.
The Ti-Base for individual Zirconium Abutments are intended for use to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.
The Ti-Base abutments are indicated for use with the following implant systems:
- Nobel Biocare® Replace Select® .
- Nobel Biocare NobelActive TM .
- Biomet 3i® Osseotite® .
- Biomet 3i® Osseotite® Certain® .
- Nobel Biocare Branemark® ●
- Straumann® synOcta® .
- Straumann® Bone Level® .
- Zimmer® Tapered Screw-vent® .
- Astra Tech OsseoSpeed® .
- Dentsply-Friadent® Frialit® .
2-CONnect Abutment for Bridges and Bars: 2-CONnect for Bridges and Bars is indicated for use to provide support for prosthetic restorations such as bars and bridges. The 2-CONnect abutments can be used in multiple tooth restorations. The 2-CONnect abulment can be used together with cemented bridges and bar constructions for functional and aesthetical reconstruction. The 2-CONnect abutments are indicated for use with the following implant systems:
- Nobel Biocare® Replace Select® .
- Straumann® synOcta® .
- Straumann® BoneLevel® .
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number:
§ 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.)