(303 days)
No
The device description and performance studies focus on the mechanical properties and compatibility of a dental abutment, with no mention of AI/ML or related concepts.
No
Explanation: The device is a prosthetic component (abutment) for dental implants, which aids in prosthetic rehabilitation by connecting aprosthesis to an endosseous dental implant. It is not designed to treat or cure a disease or condition itself, but rather to support a prosthetic restoration.
No
The device is described as a "premanufactured prosthetic component intended for use as an aid in prosthetic rehabilitation," which indicates it is a therapeutic or reconstructive device, not a diagnostic one.
No
The device description clearly states it is a premanufactured prosthetic component made from titanium, indicating it is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "as an aid in prosthetic rehabilitation," specifically for use with an endosseous dental implant system. This is a therapeutic or restorative purpose, not a diagnostic one.
- Device Description: The device is a premanufactured prosthetic component (an abutment) made of titanium. This is a physical component used in a surgical/dental procedure.
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) or to provide information about a patient's health status or disease.
- Anatomical Site: The anatomical site is an "Endosseous Dental Implant System," which is a physical location in the body where the device is implanted or attached.
- Performance Studies: The performance studies mentioned are engineering studies related to fatigue testing, which are relevant to the structural integrity of a physical implant component, not the diagnostic accuracy of a test.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The 4plus6Line Abutment is a premanufactured prosthetic component intended for use as an aid in prosthetic rehabilitation.
Product codes
NHA
Device Description
The abutment is available in several diameters and angulations. The straight and the 17° angled versions are available as compatible with implant bodies in diameters of 3.8mm, 4.1, and 5.0. A 30° angled version is also available for the 4.1mm and 5.0 diameter implant bodies. All abutments are made from titanium grad 5 acc. to ASTM F-136. The abutments are compatible with implant bodies contained in the OT-F" Implant System. The abutment system contains both titanium and POM cylinders as well as healing abutments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Brief Discussion of Clinical Studies were not conducted, or deemed necessary, for the purpose of this 510(k) submission.
Engineering studies were conducted as per ISO standard 14801:2003 (E) – (Dentistry – Fatigue test for endosseous dental implants). Testing revealed a stable screw joint at the highest forces tested.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three faces in profile, stacked on top of each other, forming a stylized human figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 13, 2016
OT medical GmbH Ms. Martina Behlau Quality Manager/Manager Regulatory Affairs Konsul-Smidt-Straße 8b Bremen 28217 GERMANY
Re: K151608
Trade/Device Name: 4plus6Line Abutment System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: March 15, 2016 Received: March 16, 2016
Dear Ms. Martina Behlau:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 vours.
Erin | Keith -S
Erin I. 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
2
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) K151608
Device Name
4plus6Line Abutment System for Endosseous Dental Implant System OT-F2
Indications for Use (Describe)
The 4plus6Line Abutment is a premanufactured prosthetic component intended for use as an aid in prosthetic rehabilitation.
Type of Use (Select one or both, as applicable)
X 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."
3
510(K) PREMARKET NOTIFICATION SUMMARY K151608
Name/Address of submitter: OT medical GmbH Konsul-Smidt-Str. 8b D-28217 Bremen/Germany
Establishment Registration Number: 10033109
Contact Person: Martina Behlau Phone ++49-421-557161-15 Fax ++49-421-557161-95
Date Summary Prepared: April 11, 2016
Trade Name: 4plus6Line Abutment System
Common name: Dental Abutment
Device Classification Name: Endosseous dental implant abutment
Device Classification Regulation Number: CFR 872.3630
Classification Product code: NHA
Device Regulatory Status: Class II Special Controls
Purpose: The purpose of this 510(k) is to obtain clearance for sale in the U.S.A. for the 4plus6Line Abutment System as an extension of the dental abutments previously cleared in the OT-F2 Dental Implant System.
Predicate Devices: K072570 Nobelactive Multi Unit Abutment (primary predicate) K113113 OT medical Endosseous Dental Implant System as reference predicate K151432 OT medical NaturalLine Abutment (Endosseous Dental Implant Abutment) as reference predicate for fatigue testing
Device Description: The abutment is available in several diameters and angulations. The straight and the 17° angled versions are available as compatible with implant bodies in diameters of 3.8mm, 4.1, and 5.0. A 30° angled version is also available for the 4.1mm and 5.0 diameter implant bodies. All abutments are made from titanium grad 5 acc. to ASTM F-136. The abutments are compatible with implant bodies contained in the OT-F" Implant System. The abutment system contains both titanium and POM cylinders as well as healing abutments.
Indication for Use: The 4plus6 Line Abutment is a premanufactured prosthetic component intended for use as an aid in prosthetic rehabilitation.
Technological Characteristics: The physical properties and designs of the abutment for the 4plus6Line Abutment System were compared with the legally marketed predicate devices. The technological characteristics were comparable:
4
Comparison of Properties and Features of OT medical's 4plus6Line Abutment System to Predicate device
| OT-F2 4plus6Line | Multi Unit Abutment (K072570) | |
|---|---|---|
| Specification of Material | All abutments: Titanium Grade 5 | |
| acc. to ASTM-F 136 | Angled Abutments: Titanium Grade | |
| 5 acc. to ASTM-F 136 | ||
| Straight abutments and Temporary | ||
| Coping: Titan Grade 1 (pure | ||
| Titanium) | ||
| Abutment Angle: | 0° / 17° / 30° | 0° / 17° / 30° |
| Exterior geometry: | Straight abutments non-engaging | Straight abutments non-engaging |
| Angled abutments engaging | Angled abutments engaging | |
| Socket heights | 1,5 / 3mm | 1,5 / 2,5 / 3,5 / 4,5 mm |
| surface treatment | Pure machined surface with | |
| anodization in the implant- | ||
| connecting-area | Pure machined surface | |
| Sterilization | 0°, 17° and 30° abutments are | |
| sterilized by irradiation | 0°, 17° and 30° abutments are | |
| sterilized by irradiation | ||
| Cylinder Titan is sold unsterile | Temporary Coping is sold unsterile | |
| Accessories for abutments | abutment screw for each | |
| abutment included | abutment screw for each abutment | |
| included | ||
| Cylinder Titan inclusive Prosthetic | ||
| screw | Temporary Coping Multi-unit | |
| Abutment (with Prosthetic screw) | ||
| Indications | The 4plus6 Line Abutment is a | |
| premanufactured | ||
| prosthetic | ||
| component intended for use as | ||
| an aid in prosthetic | ||
| rehabilitation. | NobelActive Multi Unit Abutment is | |
| a pre-manufactured prosthetic | ||
| component directly connected to | ||
| the endosseous dental implant and | ||
| is intended for use as an aid in | ||
| prosthetic rehabilitation. |
Brief Discussion of Clinical Studies were not conducted, or deemed necessary, for the purpose of this 510(k) submission.
Non-Clinical Testing:
| Submitted on | |
|---|---|
| Validation Sterilization | |
| - Microbiological Performance MDS Test 103706-10 | Oct. 19, 2011 |
| - Dose mapping | Dec 04, 2012 |
| Packaging validation | |
| - Ageing Study over 5 years by MDS, Test 094466-10 | Oct. 19, 2011 |
| - Ageing Study real time aging 5 years by MDS, Test 142775-10 (dye penetration test) | June 04, 2014 |
| - Ageing Study real time aging 5 years by MDS, Test 151504-10 (microbial properties) | April 09, 2015 |
| Surface analysis: |
5
| - Test Cytotoxicity abutments, MDS report no. 123335-20 | July 30, 2012 |
|---|---|
| - Report cleaning validation_2013RV02-2010 | Sept 18, 2013 |
6
Brief Discussion of Engineering Studies: Engineering studies were conducted as per ISO standard 14801:2003 (E) – (Dentistry – Fatigue test for endosseous dental implants). Testing revealed a stable screw joint at the highest forces tested.
Conclusions Drawn: The OT-F² 4plus6Line Abutment System and associated components have the same intended use as, and technological characteristics similar to, the legally marketed predicate devices. The information and data provided in the submission demonstrates that the proposed device is substantially equivalent to its declared predicate.