(224 days)
Not Found
No
The device description and intended use focus on physical dental abutments and their compatibility with existing CAD/CAM systems. There is no mention of AI or ML in the provided text.
No.
The devices are intended to provide support for prosthetic restorations in a partially or completely edentulous patient, which is a supportive rather than therapeutic function.
No
Explanation: The device is a "Ti-Base for individual Zirconium Abutments" and "2-CONnect Abutment for Bridges and Bars" which are prosthetic components used to support dental restorations. Their intended use is to provide support for a prosthetic device, not to diagnose a condition or disease.
No
The device description clearly states it is a premanufactured prosthetic component supplied in two parts (abutment and screw) and a titanium cap with a screw, which are physical hardware components. While it mentions compatibility with CAD/CAM systems, the device itself is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an abutment placed into a dental implant to support a prosthetic restoration in a patient. This is a surgical/dental device used directly on or in the patient's body.
- Device Description: The description details a physical component (abutment and screw/cap) used for prosthetic rehabilitation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a structural component for dental prosthetics.
N/A
Intended Use / Indications for Use
Indication for use:
Ti-Base Abutments: The devices covered by this submission are abutments which are 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 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™ 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 support for prosthetic restorations such as bars and bridges. The 2-CONnect abutments can be used in multiple tooth restorations. The 2-CONnect abutment 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®
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandible or maxilla
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
In order to demonstrate compatibility of Ti-Base and 2-CONnect abutments to each implant system, fatigue testing was performed according to ISO 14801 Dentistry-Implants-Dynamic fatigue test for endosseous implants. Testing was performed on the abutments in this submission with the implants that they are intended to fit. See section 18.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K100152, K083871, K093483, K072642, K990342, K080239, K072570
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.)
0
. ·
| 510(k) Summary | K111935 | FEB 17 2012 | ||
|---|---|---|---|---|
| Submitter Name: | ||||
| Submitter Address: | NT-Trading GmbH & Co. KG | |||
| Essostrasse 16 | ||||
| 76187 Karlsruhe | ||||
| Germany | ||||
| 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 Abutment | |||
| 2-CONnect Abutment | ||||
| Common Name: | Dental Abutments | |||
| Classification Name, | ||||
| Number & | ||||
| Product Code: | Abutment, Implant, Dental, Endosseous | |||
| 872.3630 | ||||
| NHA | ||||
| Predicate Devices: | (K100152) Sirona Dental Systems Sirona Dental CAD/CAM System, (K083871) | |||
| Atlantis™ Straumann Bone Level Abutment, (K093483) Atlantis™ Abutment for | ||||
| Nobel Active Implant, (K072642) Biomet 3I Dental Abutments And Restorative | ||||
| Components, (K990342) synOcta® Prosthetics, (K080239) P.004 Abutments, | ||||
| (K072570) NobelActive™ Multi Unit Abutment | ||||
| Device Description and | ||||
| Statement of Intended Use | 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. | ||||
| Indication for use: | ||||
| Ti-Base Abutments: The devices covered by this submission are abutments which | ||||
| are 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 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: |
1
.
| 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 support | |
| for prosthetic restorations such as bars and bridges. The 2-CONnect abutments can | |
| be used in multiple tooth restorations. The 2-CONnect abutment 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® | |
| Summary of Technological | |
| Characteristics | The proposed Ti-Base abutments and 2-CONnect abutments are substantially |
| equivalent to the currently cleared devices. They are substantially equivalent in | |
| intended use, material and connection interfaces to the implants are identical for each | |
| individual diameter and connection type. Comparison Demonstrating Substantial | |
| Equivalence follows at the end of this section. |
Testing Summary |
| | In order to demonstrate compatibility of Ti-Base and 2-CONnect abutments to each
implant system, fatigue testing was performed according to ISO 14801 Dentistry-
Implants-Dynamic fatigue test for endosseous implants. Testing was performed on
the abutments in this submission with the implants that they are intended to fit. See
section 18. |
| Conclusion | The information discussed above demonstrates that the NT-Trading Ti-Base Dental
Abutments and 2-CONnect Abutments are substantially equivalent to the predicate
devices. |
| 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. |
2
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 | 872.3630
NHA | Ti-Base
Abutments: The
devices covered by
this submission are
abutments which
are 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
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 | | | | | | | | | | | | | |
| Sirona Dental
Systems Sirona
Dental CAD/CAM
System | K083871 | Sirona Dental
Systems GmbH | 872.3630
NHA | The Sirona Dental
CAD/CAM System
is intended for use
in partially or fully
edentulous
mandibles and
maxillae in support
of single or
multiple-unit
cement retained
restorations.
The system
consists of three
major parts:
TiBase, InCoris
mesostructure, and
CAD/CAM
software.
Specifically, the
InCoris
mesostructure and
TiBase
components make
up a two-piece
abutment which is
used in conjunction
with endosseous
dental implants to
restore the function | | | | | | | | | | | | | |
| Atlantis ™
Straumann
Bone Level
Abutment | K083871 | Astra Tech Inc. | 872.3630
NHA | The devices
covered by this
submission are
abutments which
are placed into a
dental implant to
provide support
for a prosthetic
reconstruction.
The Atlantis
Abutment is
intended for use
with an
endosseous
implant 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 | | | | | | | | | | | | | |
| Atlantis ™™
Abutment for
Nobel Active
Implant | K093483 | Astra Tech Inc. | 872.3630
NHA | The Atlantis
Abutment is
intended for use
with an
endosseous
implant 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. | | | | | | | | | | | | | |
| Biomet 3i
Dental
Abutments And
Restorative
Components | K072642 | Biomet 3i, Inc. | 872.3630
NHA | BIOMET 3i
Dental
Abutments and
Overdenture
Bars are
intended for use
as an accessory
to endosseous
dental implants
to support a
prosthetic device
in a partially or
edentulous
patient. These
are intended for
use to support
single and
multiple tooth
prostheses, in
the mandible or
maxilla. The
prostheses
can be screw or
cement retained
to the abutment. | | | | | | | | | | | | | |
| synOcta®
Prosthetics | K990342 | Straumann®
USA | 872.3630
NHA | ITI Dental
implants are
intended to be
placed in the
maxillary and/or
mandibular
arch to support
crowns, bridges
or overdentures
in edentulous
or partially
edentulous
patients. The
prosthetic
accessories to
dental implants
are used either
in the process
of fabricating
the prosthetic
restoration for
the implant or
as part of the
prosthetic
restoration. | | | | | | | | | | | | | |
| P.004
Abutments | K080239 | Straumann®
Manufacturing,
Inc | 872.3630
NHA | Abutments are
placed into
dental implants
to provide
support for
prosthetic
restorations
such as
crowns,
bridges and
overdentures.
Abutments can
be used in
single tooth
replacements
and multiple
tooth
restorations.
The subject
abutments are
for permanent
screw-retained
bridges and
bar-retained
implant-borne
dentures.
Permanent
copings are
intended to | | | | | | | | | | | | | |
| Nobel Active™
Multi Unit
Abutment | K072570 | Nobel Biocare®
AB | 872.3630
NHA | Nobel Biocare's
Multi-Unit is a
premanufactured
prosthetic
component
directly
connected to
endosseous
dental implants
and is
intended for use
as an aid in
prosthetic
rehabilitation. | | | | | | | | | | | | | |
Section 5.0: 510(k) Summary
3
Submitter:
NT-Trading GmbH & Co. KG
Section 5.0: 510(k) Summary
4
Submitter:
NT-Trading GmbH & Co. KG
Dental Abutments
Premarket Notification: Traditional 510(k)
| used in multiple
tooth restorations.
The 2-CONnect
abutment 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® | Same | Same | Same | Same | Same | Same | Same | ||
|---|---|---|---|---|---|---|---|---|---|
| Abutment | |||||||||
| Diameter min. | |||||||||
| Diameter max. | |||||||||
| Abutment Height | 3.5 mm | ||||||||
| 6.5 mm | |||||||||
| Ti-Base: 4 mm | |||||||||
| 2-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 or | ||||||||
| cement retained | Screw-retained or | ||||||||
| cement retained | Screw-retained | ||||||||
| or cement | |||||||||
| retained | Screw-retained | ||||||||
| or cement | |||||||||
| retained | Screw-retained | ||||||||
| or cement | |||||||||
| retained | Screw-retained | ||||||||
| or cement | |||||||||
| retained | 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.
5
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.
6
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
7
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: