K Number
K113113
Device Name
ENDOSSEOUS DENTAL IMPLANT
Manufacturer
Date Cleared
2012-11-16

(393 days)

Product Code
Regulation Number
872.3640
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The OT-F2 Implant System is intended to be implanted in the upper or lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It further adds the option for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. The OT-F3 Implant System is intended to be implanted in the upper or lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It is suitable for insertion in completely healed jaw bone (late implantation).
Device Description
The OT-F implants are available in the diameters 3.8, 4.1 and 5.0mm. For the diameter 3.8 and 4.1mm there are 5 lengths: 8, 10, 12, 14 and 16 mm, for the diameter 5.0mm only 4 lengths: 8, 10, 12 and 14 mm. The implants are made from titanium grad 4 acc. to ASTM F-67. For prosthetic construction we offer a temporary abutment CreativeLine, titanium abutments straight NaturalLine, ball head abutments TecLine and a bar connection with ProfiLine. All abutments are made from titanium grad 5 acc. to ASTM F-136. The OT-F3 implants are available in the diameters 4.1 and 5.0mm. For each diameter there are 3 lengths: 5, 7 and 9 mm. For prosthetic construction we offer a temporary abutment CreativeLine, titanium abutments straight NaturalLine, ball head abutments TecLine and a bar connection with ProfiLine. All implants are made from titanium grad 5 acc. to ASTM F-136.
More Information

Not Found

No
The summary describes a dental implant system made of titanium with various sizes and abutment options. There is no mention of software, algorithms, image processing, or any terms related to AI or ML.

Yes
The device is described as an implant system intended to provide support for fixed or removable dental prostheses, which restores chewing function after implantation. This indicates a therapeutic purpose.

No

Explanation: The device is an implant system designed to support dental prostheses, not to diagnose a condition or disease.

No

The device description clearly details physical implants and abutments made of titanium, indicating it is a hardware medical device.

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 implant system designed to be surgically placed in the jawbone to support dental prostheses. This is a direct therapeutic intervention, not a diagnostic test performed on samples taken from the body.
  • Device Description: The description details the physical components of the implant system (implants, abutments) made from titanium. This aligns with a medical device intended for implantation, not a reagent or instrument used for in vitro testing.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition.

Therefore, the OT-F2 and OT-F3 Implant Systems are medical devices intended for surgical implantation, not in vitro diagnostic devices.

N/A

Intended Use / Indications for Use

The OT-F2 Implant System is intended to be implanted in the upper or lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It further adds the option for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.

The OT-F3 Implant System is intended to be implanted in the upper or lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It is suitable for insertion in completely healed jaw bone (late implantation).

Product codes (comma separated list FDA assigned to the subject device)

DZE, NHA

Device Description

The OT-F implants are available in the diameters 3.8, 4.1 and 5.0mm. For the diameter 3.8 and 4.1mm there are 5 lengths: 8, 10, 12, 14 and 16 mm, for the diameter 5.0mm only 4 lengths: 8, 10, 12 and 14 mm. The implants are made from titanium grad 4 acc. to ASTM F-67. For prosthetic construction we offer a temporary abutment CreativeLine, titanium abutments straight NaturalLine, ball head abutments TecLine and a bar connection with ProfiLine. All abutments are made from titanium grad 5 acc. to ASTM F-136.

The OT-F3 implants are available in the diameters 4.1 and 5.0mm. For each diameter there are 3 lengths: 5, 7 and 9 mm. For prosthetic construction we offer a temporary abutment CreativeLine, titanium abutments straight NaturalLine, ball head abutments TecLine and a bar connection with ProfiLine. All implants are made from titanium grad 5 acc. to ASTM F-136.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

upper or lower jaw arches

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)

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): 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.

K053242 Pitt-Easy Dental Implant System; K926354 Endopore Dental Implant System (Innova); K971196 Endopore Dental Implant System (Innova); K032140 Endopore Dental Implant System (Innova)

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

§ 872.3640 Endosseous dental implant.

(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.

0

K. 113113

Revised 510(K) PREMARKET NOTIFICATION SUMMARY

Name/Address of submitter: OT medical GmbH Konsul-Smidt-Str. 8b D-28217 Bremen/Germany

NOV 1 6 2012

Establishment Registration Number: 10033109

Contact Person: Sabine Schmahl Phone ++49-421-557161-15 Fax ++49-421-557161-95

Date Revised Summary Prepared: November 14, 2012

Device Classification Name: Endosseous Implant and Accessories

Device Classification Regulation Number: 21 CFR 872.3640 and CFR 872.3630

Device Regulatory Status: Class II Special Controls

Trade Name: Endosseous Dental Implant system

Purpose: The purpose of this 510(k) is to obtain clearance for sale in the U.S.A. for theOT-F2 Dental Implant System.

Predicate Devices: K053242 Pitt-Easy Dental Implant System

Device Description: The OT-F implants are available in the diameters 3.8, 4.1 and 5.0mm. For the diameter 3.8 and 4.1mm there are 5 lengths: 8, 10, 12, 14 and 16 mm, for the diameter 5.0mm only 4 lengths: 8, 10, 12 and 14 mm. The implants are made from titanium grad 4 acc. to ASTM F-67. For prosthetic construction we offer a temporary abutment CreativeLine, titanium abutments straight NaturalLine, ball head abutments TecLine and a bar connection with ProfiLine. All abutments are made from titanium grad 5 acc. to ASTM F-136.

Indication for Use: The OT-F2 Implant System is intended to be implanted in the upper or lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It further adds the option for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.

Technological Characteristics: The physical properties and designs of the additional implants and accessories in the OT-F2 Implant System were compared with legally marketed predicate devices. The technological characteristics were comparable:

1

OT-F2Pitt-Easy (K053242)
Specification of MaterialTitanium Grade 4 acc. to ASTM-F
67Titanium Grade 4 acc. to ASTM-F
67
Exterior geometrycylindrical, threadedcylindrical, threaded
Maximum diameter [mm]3.8/4.1/5.03.8/4.1/4.9
Implant lengths [mm]8/10/12/14/168/10/12/14/16
surface treatmentacid etchedacid etched or Titanium Plasma
Spray
pretreatmentnon (without sand blasting)non (without sand blasting)
Sterilizationgamma radiation with x-rays
using Co60 irradiation, with a
minimum dose of 25.0 kGy (2.5 m
rads), creating a Sterility
Assurance Level of 10-6.gamma radiation with x-rays
using Co60 irradiation, with a
minimum dose of 25.0 kGy (2.5 m
rads), creating a Sterility
Assurance Level of 10-6.
packagingblister packaging in double -
sterile conditionblister packaging in double -
sterile condition
AbutmentsTitanium Abutment: NaturalLineTitanium Abutment: VDL
Anatomic
Abutment Angle:
Ball head Abutment: TecLineBall head Abutment: Kugelkopf
Abutment Angle:
Temporary Abutment: Creative
LineTemporary Abutment: A.G.T
Abutment Angle:
Bar Abutment: ProfiLineBar Abutment: Paracentric
Abutment Angle:
Accessories for implants:cover screws for each implant,
anodisedcover screws for each implant,
anodised
Accessories for abutmentsabutment screw for each
abutmentabutment screw for each
abutment

Comparison of Properties and Features of OT medical's OT-F2 dental implant to Predicate device

Indications and contraindications:

Because of the comprehensive range of implant diameters (3.80/4.10/5.00 mm) and lengths (8/10/12/14/16), there is a broad spectrum of indications for use provided there is sufficient vertical bone height and horizontal bone width. This means that even where there is extensive atrophy of the jaw up to a minimal height of 10 mm and minimal width of at least 2 mm greater than the planned implant diameter, OT-F implants can still be used both in the upper and lower jaws. Here too the indication spectrum can be made even greater by means of surgical measures such as augmentation, bone spreading or splitting. The OT-F implant is not only suitable for insertion into jaw bones where complete healing has already taken place (late implantation), but also for delayed insertion (6 - 8 weeks following tooth extraction) and also if the conditions are suitable for immediate implantation (directly following tooth extraction). In so doing the implant diameter must be chosen so that it completely fills the profile of the empty alveolus or ideally slightly expands it while taking account of the specifications of the prosthesis. Even with an immediate implantation, solid primary stability should always be achieved.

2

K113113

-Clinical Tosting

OT-F- implants are particularly suitable for use in the region of the lower central and lateral and upper lateral . incisors.

  • A balance function during articulation should generally be avoided. .
    Brief Discussion of Clinical Studies were not conducted, or deemed necessary, for the purpose of this 510(k) submission.
Submitted on
Validation Sterilization
- Microbiological Performance MDS Test 103706-10Oct. 19, 2011
- Dose mapping 3xOct. 19, 2011
Ageing Study over 5 years by MDS, Test 094466-10Oct. 19, 2011
Surface analysis:
Duddeck, D.: Quantitative and qualitative element-analysis
of implant-surfaces by SEMJune 26, 2012
IGMHS Surface Test PB119-09July 30, 2012
SEM Pictures F2Oct. 26, 2012
Test Cytotoxicity abutments, MDS report no. 123335-20July 30, 2012
MDS Report cleaning validation 116360-10June 26, 2013

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 implant 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 substancially equivalent to its declared predicate.

3

3

K113113

Revised 510(K) PREMARKET NOTIFICATION SUMMARY

Name/Address of submitter: OT medical GmbH Konsul-Smidt-Str. 8b D-28217 Bremen/Germany

Establishment Registration Number: 10033109

Contact Person: Sabine Schmahl Phone: ++49-421-55 71 61-15 Fax: ++49-421-55 71 61-95

Date Revised Summary Prepared: November 14, 2012

Device Classification Name: Endosseous Implant and Accessories

Device Classification Regulation Number: 21 CFR 872.3640 and CFR 872.3630

Device Regulatory Status: Class II Special Controls

Trade Name: Endosseous Dental Implant System

Purpose: The purpose of this 510(k) is to obtain clearance for sale in the U.S.A. for the OT-F3 Dental Implant System.

K926354 Endopore Dental Implant System (Innova) Predicate Devices: K971196 Endopore Dental Implant System (Innova) K032140 Endopore Dental Implant System (Innova)

Device Description: The OT-F3 implants are available in the diameters 4.1 and 5.0mm. For each diameter there are 3 lengths: 5, 7 and 9 mm. For prosthetic construction we offer a temporary abutment CreativeLine, titanium abutments straight NaturalLine, ball head abutments TecLine and a bar connection with ProfiLine. All implants are made from titanium grad 5 acc. to ASTM F-136.

Indications for Use: The OT-F3 Implant System is intended to be implanted in the upper or lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It is suitable for insertion in completely healed jaw bone (late implantation).

Technological Characteristics: The physical properties and designs of the additional implants and accessories in the OT-P Implant System were compared with legally marketed predicate devices. The technological characteristics were comparable:

4

OT-F3Endopore
Specification of MaterialTitanium Grade 5 acc. to ASTM-F
136Titanium Grade 5 acc. to ASTM-F
136
Exterior geometryconicalconical
Angulation of corpus12°10°
Implant lengths [mm]5/7/95/7/9
Maximum diameter [mm]4.1 / 5.04.1 / 5.0
Uncoated area [mm]1.21 respect. 2
surface treatmentsintered surfacesintered surface
pretreatmentnon (without sand blasting)non (without sand blasting)
material for surface treatmentTitanium powder from titanium
grade 4 and grain size of 50-
150μmTitanium powder from titanium
grade 4 and grain size of 50-
150μm
sintering processhigh vacuum at 1250°high vacuum at 1250°
Sterilizationgamma radiation with x-rays
using Co60 irradiation, with a
minimum dose of 25.0 kGy (2.5 m
rads), creating a Sterility
Assurance Level of 10-6.gamma radiation with x-rays
using Co60 irradiation, with a
minimum dose of 25.0 kGy (2.5 m
rads), creating a Sterility
Assurance Level of 10-6.
packagingblister packaging in double -
sterile conditionpouches in double - sterile
condition
Accessories for implants:cover screws for each implantcover screws for each implant

Comparison of Properties and Features of OT medical's OT-F³ dental implant to Predicate Device

Brief summary on OT-F3:

The OT-F3 implants are available in diameters 4.10/5.00 mm and lengths of 5/7/9 mm. This presents a special indication range at sufficient available horizontal bone quantity.

Surgical measures such as augmentation, bone spreading or bone splitting and bone grafts should not be applied simultaneously with the implantation, but the bone should have finally healed completely prior to implant insertion. The OT-F implant is suitable only for insertion into completely long-term healed bone (late implantation). OT-F³ implants should not be inserted into strong cortical bone (D1) due to limited blood support.

Brief Discussion of Clinical Studies were not conducted, or deemed necessary, for the purpose of this 510(k) submission.

Overview on Non-Clinical Testing:

submitted on
Validation Sterilization
- Microbiological Performance MDS Test 103706-10Oct. 19, 2011
- Dose mapping 3xOct. 19, 2011
Ageing Study over 5 years by MDS, Test 094466-10Oct. 19, 2011

5

K113113

Surface analysis:
Duddeck, D.: Quantitative and qualitative element-analysis
of implant-surfaces by SEMJune 26, 2012
Material data:
Endolab Shear Bonding strength ASTM F1044June 26, 2012
IMA Test Report Tension Testing ENGLISHJune 26, 2012
IfW Report 4451 MetallographieJuly 30, 2012
Biocompatibility:
Test Cytotoxicity abutments, MDS report no. 123335-20July 30, 2012
MDS Report cleaning validation_116360-10June 26, 2012

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-F³ implant 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 substancially equivalent to its declared predicate.

3

6

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and three curved lines extending from the eagle's body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

November 16, 2012

Mrs. Sabine Schmahl Export Manager and Foreign Registrations OT Medical GmbH Konsul-Smidt-Str. 8B Bremen, Germany D-28217

Re: K113113

Trade/Device Name: Endosseous Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: October 24, 2012 Received: November 7, 2012

Dear Mrs. Schmahl:

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.

7

Page 2 - Mr. Schmahl

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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.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 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 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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

ON: c=US, p=U.S. Government, ou=HHS 0.9.2342.19200300.100.1.1=1300092402

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Respiratory, Infection Control and

Dental Devices

Office of Device Evaluation

Center for Devices and

Radiological Health

Enclosure

8

Indication for Use

510(k) Number: K113113

Device Name: Endosseous Dental Implant System

Indication for Use: The OT-F³ Implant System is intended to be implanted in the upper or lower muneution TOT 'O'CO'r movable dental prostheses in a single tooth, partially jaw arches to provide support for horostheses. It is suitable for insertion in completely healed jaw bone (late implantation).

Concurrence of CDRH Office of Device Evaluation

Prescription UseX (per 21 CFR801.109)
OR
Over-the-counter Use__________
Mary S. Runner
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices

| | Digitally signed by Mary S. Runner
DN: c=US, o=U.S. Government, ou=HHS,
ou=FDA, ou=People, cn=Mary S. Runner,
0.9.2342.19200300.100.1.1=1300087950 |

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510(k) Number:__________
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