(393 days)
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).
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.
Here's a breakdown of the acceptance criteria and study information based on the provided text, recognizing that this document is a 510(k) premarket notification summary for dental implants, not a clinical study report for an AI device. Therefore, many standard AI study criteria will not be applicable.
The document discusses two distinct dental implant systems: the OT-F2 and the OT-F3, each with its own predicate device comparison. I will treat them separately for clarity, as the provided text presents them as essentially two separate 510(k) submissions consolidated under the same K-number.
OT-F2 Dental Implant System (K113113 - Part 1)
1. Table of Acceptance Criteria and Reported Device Performance
For the OT-F2 system, the acceptance criteria are implicitly defined by substantial equivalence to the predicate device (Pitt-Easy Dental Implant System, K053242). The reported device performance is presented as a comparison of technological characteristics.
| Acceptance Criteria (Based on Predicate) | OT-F2 Reported Performance |
|---|---|
| Material: Titanium Grade 4 acc. to ASTM-F67 | Titanium Grade 4 acc. to ASTM-F67 |
| Exterior geometry: cylindrical, threaded | cylindrical, threaded |
| Maximum diameter [mm]: 3.8/4.1/4.9 | 3.8/4.1/5.0 (Slight variation, likely deemed equivalent) |
| Implant lengths [mm]: 8/10/12/14/16 | 8/10/12/14/16 |
| Surface treatment: acid etched or Titanium Plasma Spray | acid etched |
| Pretreatment: non (without sand blasting) | non (without sand blasting) |
| Sterilization: gamma radiation with Co60, min dose 25.0 kGy, SAL 10-6 | gamma radiation with Co60, min dose 25.0 kGy, SAL 10-6 |
| Packaging: blister packaging in double - sterile condition | blister packaging in double - sterile condition |
| Abutments: Titanium (0°), Ball Head (0°), Temporary (0°), Bar (0°) | NaturalLine (0°), TecLine (0°), CreativeLine (0°), ProfiLine (0°) (Comparable types and angles) |
| Accessories for implants: cover screws | cover screws for each implant, anodised |
| Accessories for abutments: abutment screw | abutment screw for each abutment |
| Indications for Use: Support for fixed or removable dental prostheses | Same broad indication, including immediate loading with good primary stability |
| Fatigue Test (ISO 14801:2003): Stable screw joint | Stable screw joint at the highest forces tested |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of an "AI device" test set. For the engineering studies, standard test samples were used per ISO 14801:2003, but specific numbers are not provided.
- Data Provenance: The document is from Germany (OT medical GmbH, Bremen/Germany). The non-clinical testing appears to be a mix of internal testing ("SEM Pictures F2") and external lab reports (e.g., MDS, Duddeck, IGMHS). The tests listed are for material properties, sterilization validation, aging, and fatigue.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not applicable. The device is a physical dental implant, not an AI diagnostic tool. Ground truth is established through engineering and material testing standards, and comparison to a predicate device.
4. Adjudication Method for the Test Set
Not applicable in the context of expert adjudication for an AI device. Compliance is assessed against established engineering standards and comparison to a predicate device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This is not an AI device.
6. Standalone (Algorithm Only) Performance Study
No. This is not an AI device.
7. Type of Ground Truth Used
The ground truth for the OT-F2 system is established through:
- Comparison of technological characteristics to a legally marketed predicate device (510(k) pathway).
- Compliance with international standards for dental implants (e.g., ISO 14801:2003 for fatigue testing).
- Results from non-clinical tests on material properties, sterilization efficacy, and aging.
8. Sample Size for the Training Set
Not applicable. This is not an AI device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI device.
OT-F3 Dental Implant System (K113113 - Part 2)
1. Table of Acceptance Criteria and Reported Device Performance
For the OT-F3 system, the acceptance criteria are implicitly defined by substantial equivalence to the predicate devices (K926354, K971196, K032140 Endopore Dental Implant System). The reported device performance is presented as a comparison of technological characteristics.
| Acceptance Criteria (Based on Predicate) | OT-F3 Reported Performance |
|---|---|
| Material: Titanium Grade 5 acc. to ASTM-F136 | Titanium Grade 5 acc. to ASTM-F136 |
| Exterior geometry: conical | conical |
| Angulation of corpus: 10° | 12° (Slight variation, likely deemed equivalent) |
| Implant lengths [mm]: 5/7/9 | 5/7/9 |
| Maximum diameter [mm]: 4.1 / 5.0 | 4.1 / 5.0 |
| Uncoated area [mm]: 1 or 2 | 1.2 (Within range or comparable) |
| Surface treatment: sintered surface | sintered surface |
| Pretreatment: non (without sand blasting) | non (without sand blasting) |
| Material for surface treatment: Titanium powder Grade 4, grain size 50-150μm | Titanium powder Grade 4, grain size 50-150μm |
| Sintering process: high vacuum at 1250° | high vacuum at 1250° |
| Sterilization: gamma radiation with Co60, min dose 25.0 kGy, SAL 10-6 | gamma radiation with Co60, min dose 25.0 kGy, SAL 10-6 |
| Packaging: pouches in double - sterile condition | blister packaging in double - sterile condition (Difference noted, but acceptable for equivalence) |
| Accessories for implants: cover screws | cover screws for each implant |
| Indications for Use: Support for fixed or removable dental prostheses | Same broad indication, suitable for completely healed jaw bone (late implantation) |
| Fatigue Test (ISO 14801:2003): Stable screw joint | Stable screw joint at the highest forces tested |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable for an "AI device" test set. For the engineering studies, standard test samples were used per ISO 14801:2003, but specific numbers are not provided.
- Data Provenance: The document is from Germany (OT medical GmbH, Bremen/Germany). The non-clinical testing appears to be a mix of internal testing ("SEM Pictures F2", "IfW Report 4451 Metallographie") and external lab reports (e.g., MDS, Duddeck, Endolab, IMA Test Report). The tests listed are for material properties, sterilization validation, aging, and fatigue.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not applicable. The device is a physical dental implant, not an AI diagnostic tool. Ground truth is established through engineering and material testing standards, and comparison to a predicate device.
4. Adjudication Method for the Test Set
Not applicable in the context of expert adjudication for an AI device. Compliance is assessed against established engineering standards and comparison to a predicate device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This is not an AI device.
6. Standalone (Algorithm Only) Performance Study
No. This is not an AI device.
7. Type of Ground Truth Used
The ground truth for the OT-F3 system is established through:
- Comparison of technological characteristics to legally marketed predicate devices (510(k) pathway).
- Compliance with international standards for dental implants (e.g., ISO 14801:2003 for fatigue testing).
- Results from non-clinical tests on material properties, sterilization efficacy, aging, surface analysis, shear bonding strength, tension testing, and biocompatibility.
8. Sample Size for the Training Set
Not applicable. This is not an AI device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI device.
Overall Note: The provided text is a 510(k) Premarket Notification Summary for dental implants, which are physical medical devices, not AI-powered software or diagnostic tools. As such, the typical "acceptance criteria" and "study types" for AI devices (like sample size for test sets, expert ground truth, adjudication, MRMC studies, standalone performance, training sets) are not relevant to this document. The "study" here refers to non-clinical engineering and materials testing, and the "acceptance criteria" are demonstrating substantial equivalence to predicate physical devices.
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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:
{1}------------------------------------------------
| OT-F2 | Pitt-Easy (K053242) | |
|---|---|---|
| Specification of Material | Titanium Grade 4 acc. to ASTM-F67 | Titanium Grade 4 acc. to ASTM-F67 |
| 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 PlasmaSpray |
| pretreatment | non (without sand blasting) | non (without sand blasting) |
| Sterilization | gamma radiation with x-raysusing Co60 irradiation, with aminimum dose of 25.0 kGy (2.5 mrads), creating a SterilityAssurance Level of 10-6. | gamma radiation with x-raysusing Co60 irradiation, with aminimum dose of 25.0 kGy (2.5 mrads), creating a SterilityAssurance Level of 10-6. |
| packaging | blister packaging in double -sterile condition | blister packaging in double -sterile condition |
| Abutments | Titanium Abutment: NaturalLine | Titanium Abutment: VDLAnatomic |
| Abutment Angle: | 0° | 0° |
| Ball head Abutment: TecLine | Ball head Abutment: Kugelkopf | |
| Abutment Angle: | 0° | 0° |
| Temporary Abutment: CreativeLine | 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,anodised | cover screws for each implant,anodised |
| Accessories for abutments | abutment screw for eachabutment | abutment screw for eachabutment |
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}------------------------------------------------
-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-analysisof 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.
3
{3}------------------------------------------------
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-F3 | Endopore | |
|---|---|---|
| Specification of Material | Titanium Grade 5 acc. to ASTM-F136 | Titanium Grade 5 acc. to ASTM-F136 |
| 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 titaniumgrade 4 and grain size of 50-150μm | Titanium powder from titaniumgrade 4 and grain size of 50-150μm |
| sintering process | high vacuum at 1250° | high vacuum at 1250° |
| Sterilization | gamma radiation with x-raysusing Co60 irradiation, with aminimum dose of 25.0 kGy (2.5 mrads), creating a SterilityAssurance Level of 10-6. | gamma radiation with x-raysusing Co60 irradiation, with aminimum dose of 25.0 kGy (2.5 mrads), creating a SterilityAssurance Level of 10-6. |
| packaging | blister packaging in double -sterile condition | pouches in double - sterilecondition |
| 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 |
{5}------------------------------------------------
| Surface analysis: | |
|---|---|
| Duddeck, D.: Quantitative and qualitative element-analysisof 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.
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 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. RunnerDN: c=US, o=U.S. Government, ou=HHS,ou=FDA, ou=People, cn=Mary S. Runner,0.9.2342.19200300.100.1.1=1300087950 | |
|---|---|
| -- | ------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| 510(k) Number: | __________ |
|---|---|
| ---------------- | ------------ |
§ 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.