ENDOSSEOUS DENTAL IMPLANT
Device Facts
| Record ID | K113113 |
|---|---|
| Device Name | ENDOSSEOUS DENTAL IMPLANT |
| Applicant | Ot Medical GmbH |
| Product Code | DZE · Dental |
| Decision Date | Nov 16, 2012 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3640 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended 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).
Device Story
Endosseous dental implant system comprising titanium implants and prosthetic abutments (temporary, straight, ball head, bar). OT-F2 implants (cylindrical, threaded) and OT-F3 implants (conical) are surgically placed into the jaw bone by dental professionals to support fixed or removable prostheses. OT-F2 supports immediate or delayed loading; OT-F3 is restricted to late implantation in healed bone. Implants are placed to restore chewing function. Clinical benefit derived from providing stable anchorage for dental restorations. Device is used in clinical dental settings.
Clinical Evidence
No clinical studies were conducted or deemed necessary. Evidence consists of bench testing: ISO 14801 fatigue testing, microbiological sterilization validation, 5-year aging studies, surface element analysis (SEM), cytotoxicity testing, and cleaning validation.
Technological Characteristics
Materials: Titanium Grade 4 (ASTM F-67) or Grade 5 (ASTM F-136). Geometry: Cylindrical/threaded (OT-F2) or conical (OT-F3). Surface: Acid-etched or sintered (titanium powder). Sterilization: Gamma radiation (Co60, min 25 kGy, SAL 10^-6). Packaging: Double-sterile blister. Fatigue testing per ISO 14801:2003.
Indications for Use
Indicated for patients requiring dental prostheses (single tooth, partially edentulous, or full arch) in the upper or lower jaw. Suitable for late implantation in completely healed jaw bone. Contraindicated for insertion into strong cortical bone (D1) for the OT-F3 system.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- Pitt-Easy Dental Implant System (K053242)
- Endopore Dental Implant System (K926354)
- Endopore Dental Implant System (K971196)
- Endopore Dental Implant System (K032140)
Related Devices
- K133510 — NEODENT IMPLANT SYSTEM · Jj Industria E Comercio DE Materiais Dentarios SA · Feb 24, 2014
- K162482 — A.B. DENTAL DEVICES Dental Implants System · A.B. Dental Device , Ltd. · Sep 15, 2017
- K151588 — maxFit II Dental Implant System · Taiwan Implant Technology Company, Ltd. · Apr 25, 2016
- K150388 — Dental Implant System · Bio Concept Co., Ltd. · Nov 12, 2015
- K170372 — SpiralTech Dental Implant System · Spiraltech Superior Dental Implants, Inc. · Jun 30, 2017
Submission Summary (Full Text)
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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:
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| | OT-F2 | Pitt-Easy (K053242) |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Specification of Material | Titanium Grade 4 acc. to ASTM-F<br>67 | Titanium Grade 4 acc. to ASTM-F<br>67 |
| Exterior geometry | cylindrical, threaded | cylindrical, threaded |
| Maximum diameter [mm] | 3.8/4.1/5.0 | 3.8/4.1/4.9 |
| Implant lengths [mm] | 8/10/12/14/16 | 8/10/12/14/16 |
| surface treatment | acid etched | acid etched or Titanium Plasma<br>Spray |
| pretreatment | non (without sand blasting) | non (without sand blasting) |
| Sterilization | gamma radiation with x-rays<br>using Co60 irradiation, with a<br>minimum dose of 25.0 kGy (2.5 m<br>rads), creating a Sterility<br>Assurance Level of 10-6. | gamma radiation with x-rays<br>using Co60 irradiation, with a<br>minimum dose of 25.0 kGy (2.5 m<br>rads), creating a Sterility<br>Assurance Level of 10-6. |
| packaging | blister packaging in double -<br>sterile condition | blister packaging in double -<br>sterile condition |
| Abutments | Titanium Abutment: NaturalLine | Titanium Abutment: VDL<br>Anatomic |
| Abutment Angle: | 0° | 0° |
| | Ball head Abutment: TecLine | Ball head Abutment: Kugelkopf |
| Abutment Angle: | 0° | 0° |
| | Temporary Abutment: Creative<br>Line | Temporary Abutment: A.G.T |
| Abutment Angle: | 0° | 0° |
| | Bar Abutment: ProfiLine | Bar Abutment: Paracentric |
| Abutment Angle: | 0° | 0° |
| Accessories for implants: | cover screws for each implant,<br>anodised | cover screws for each implant,<br>anodised |
| Accessories for abutments | abutment screw for each<br>abutment | abutment screw for each<br>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.
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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 103706-10 | Oct. 19, 2011 |
| - Dose mapping 3x | Oct. 19, 2011 |
| Ageing Study over 5 years by MDS, Test 094466-10 | Oct. 19, 2011 |
| Surface analysis: | |
| Duddeck, D.: Quantitative and qualitative element-analysis<br>of implant-surfaces by SEM | June 26, 2012 |
| IGMHS Surface Test PB119-09 | July 30, 2012 |
| SEM Pictures F2 | Oct. 26, 2012 |
| Test Cytotoxicity abutments, MDS report no. 123335-20 | July 30, 2012 |
| MDS Report cleaning validation 116360-10 | June 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.
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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:
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| | OT-F3 | Endopore |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Specification of Material | Titanium Grade 5 acc. to ASTM-F<br>136 | Titanium Grade 5 acc. to ASTM-F<br>136 |
| Exterior geometry | conical | conical |
| Angulation of corpus | 12° | 10° |
| Implant lengths [mm] | 5/7/9 | 5/7/9 |
| Maximum diameter [mm] | 4.1 / 5.0 | 4.1 / 5.0 |
| Uncoated area [mm] | 1.2 | 1 respect. 2 |
| surface treatment | sintered surface | sintered surface |
| pretreatment | non (without sand blasting) | non (without sand blasting) |
| material for surface treatment | Titanium powder from titanium<br>grade 4 and grain size of 50-<br>150μm | Titanium powder from titanium<br>grade 4 and grain size of 50-<br>150μm |
| sintering process | high vacuum at 1250° | high vacuum at 1250° |
| Sterilization | gamma radiation with x-rays<br>using Co60 irradiation, with a<br>minimum dose of 25.0 kGy (2.5 m<br>rads), creating a Sterility<br>Assurance Level of 10-6. | gamma radiation with x-rays<br>using Co60 irradiation, with a<br>minimum dose of 25.0 kGy (2.5 m<br>rads), creating a Sterility<br>Assurance Level of 10-6. |
| packaging | blister packaging in double -<br>sterile condition | pouches in double - sterile<br>condition |
| Accessories for implants: | cover screws for each implant | cover 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 103706-10 | Oct. 19, 2011 |
| - Dose mapping 3x | Oct. 19, 2011 |
| Ageing Study over 5 years by MDS, Test 094466-10 | Oct. 19, 2011 |
| | |
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K113113
| Surface analysis: | |
|------------------------------------------------------------------------------------------|---------------|
| Duddeck, D.: Quantitative and qualitative element-analysis<br>of implant-surfaces by SEM | June 26, 2012 |
| Material data: | |
| Endolab Shear Bonding strength ASTM F1044 | June 26, 2012 |
| IMA Test Report Tension Testing ENGLISH | June 26, 2012 |
| IfW Report 4451 Metallographie | July 30, 2012 |
| Biocompatibility: | |
| Test Cytotoxicity abutments, MDS report no. 123335-20 | July 30, 2012 |
| MDS Report cleaning validation_116360-10 | June 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.
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### 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.
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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
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# 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 Use | _X_ (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<br>DN: c=US, o=U.S. Government, ou=HHS,<br>ou=FDA, ou=People, cn=Mary S. Runner,<br>0.9.2342.19200300.100.1.1=1300087950 |
|--|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
|--|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number: | __________ |
|----------------|------------|
|----------------|------------|
