(163 days)
The SFI-Bar® Implant Abutments are indicated to be used with dental implants as a prosthetic framework to support and /or retain removable or fixed dental prostheses in the treatment of partially or totally edentulous patients to restore chewing function. The abutment screws are intended to secure the bar to the endosseous implants.
The SFI Bar® Implant Abutments provide the connection between compatible dental implant systems for the fixation of removable overdentures. The SFI Bar® Implant Abutments consist of an abutment, which is attached to a stress free bar for the fixation of removable overdentures. The implant abutment is screwed into the dental abutment. The implant abutments fit Nobel Biocare Brånemark System®. Nobel Biocare (Steri-Oss®), Keystone (Lifecore), 3i Implant Inovations®, Sterngold-ImplaMed®, Interpore IMZ™, Osstem, Zimmer (Paragon, Centerpulse), OIC, IMTEC Corporation®, MIS Implants, Minimatic/Stryker, Bud, Straumann, Biolok International, INNOVA, Implant Direct, Zimmer (Calcitek® Centerpulse), BioHorizons®. See table 1 for platform compatibility.
There are seven (7) different platforms and each platform is compatible with one or more implant types. The platforms of the abutments are [A], [B], [C], [S], [X], [X], [Z]. Table 1 specifies which dental implants are compatible with these platforms. The difference between each platform is the internal connection with the specific implant. The devices are supplied non-sterile, therefore there is no shelf life.
The provided text describes the SFI Bar® Implant Abutments, a medical device for dental use. It outlines the device's characteristics and its equivalence to predicate devices, supported by non-clinical performance data.
Here's an analysis of the acceptance criteria and study information, based only on the provided text, and noting what information is not present:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sufficiently large safety margin for fracture to occur when tightening. | "Torque test results indicated that there is sufficiently large safety margin for fracture of the SFI Bar® Implant Abutments specified on this submission to occur when tightening." |
| No risk or possibility of harm to the patient (related to torque). | "There is no risk or possibility of harm to the patient." |
| Performance characteristics equivalent to predicate SFI Barto. | "Testing has shown that the SFI Bar® Implant Abutments included in this application are equivalent in performance characteristics to the predicate SFI Barto." |
| Acceptance criteria were met. | "The acceptance criteria were met." |
2. Sample size used for the test set and data provenance:
- Sample size: Not specified. The text only mentions "Test samples torqued above 50 Ncm".
- Data provenance: The studies were non-clinical tests conducted by the manufacturer, Sterngold Dental, LLC. The country of origin is not explicitly stated. It is a retrospective analysis of the device's performance against established standards and predicate devices.
3. Number of experts used to establish the ground truth for the test set and their qualifications:
- Number of experts: Not applicable for this type of testing. The 'ground truth' for mechanical performance tests like torque is typically defined by engineering specifications and industry standards rather than expert consensus on subjective evaluations.
- Qualifications: Not applicable.
4. Adjudication method for the test set:
- Not applicable. Mechanical tests for medical devices are typically assessed against pre-defined quantitative thresholds and standards, not through adjudication by experts.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. An MRMC study is relevant for diagnostic imaging or similar devices where human readers interpret results. This device is a dental implant abutment, and its performance is evaluated through mechanical testing.
6. If a standalone (i.e., algorithm-only without human-in-the-loop performance) was done:
- Yes, in essence. The testing described ("Torque tests, application and functional testing") is a standalone assessment of the physical device's performance characteristics. This is a mechanical device, not an algorithm, so the "standalone" concept translates to evaluating the device itself without human intervention affecting its inherent mechanical properties.
7. The type of ground truth used:
- Engineering specifications and regulatory guidance. The ground truth for this device's performance, particularly torque, is based on "implant manufacturer's recommended torque value" and likely general engineering standards for mechanical strength and durability. The evaluation also refers to "FDA guidance 'Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments.'"
8. The sample size for the training set:
- Not applicable. This device is not an AI/ML algorithm that requires a training set. The "training" here would refer to the design and manufacturing processes, which are guided by established engineering principles and past experience with similar devices (the predicate devices).
9. How the ground truth for the training set was established:
- Not applicable. As noted above, this is not an AI/ML algorithm. The "ground truth" for the design and manufacturing of such a device is rooted in engineering principles, material science, and regulatory standards for dental implants and abutments. The text states, "The implant abutments were designed and developed, and manufactured according to manufacturer's specifications and controlled procedures," and they conform to "ASTM F136, Wrought Titanium 6 Aluminum-4 Vanadium ELI Alloy."
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March 13, 2013 SFI Bar® Implant Abutments
510(k) Summary
| Sponsor: | Sterngold Dental, LLC23 Frank Mossberg DriveAttleboro, MA 02703 |
|---|---|
| Contact: | Maria Rao, QA/RA DirectorPh: 508-226-5660 ext 1206 |
| Trade Name: | SFI Bar® Implant Abutments |
| Common Name: | Implant Abutments |
| Classification Name: | Endosseous Dental Implant Abutment |
| Classification: | According to Section 513 of the Federal Food, Drug, andCosmetic Act, the device classification is Class II |
| Product Code: | NHA (21CFR 872.3630) |
| Legally Marketed Device to which Equivalence is claimed (Predicate Devices): | Predicate Device(s): K083876 |
| K083876 | SFI Bar® System Complete 2-Implant and 4-Implant |
|---|---|
| K102382 | SFI Bar® Implant Adapter Straumann, SFI Bar® Implant Adapter Neo- |
Description of Device:
Device Description: The SFI Bar® Implant Abutments provide the connection between compatible dental implant systems for the fixation of removable overdentures. The SFI Bar® Implant Abutments consist of an abutment, which is attached to a stress free bar for the fixation of removable overdentures. The implant abutment is screwed into the dental abutment. The implant abutments fit Nobel Biocare Brånemark System®. Nobel Biocare (Steri-Oss®), Keystone (Lifecore), 3i Implant Inovations®, Sterngold-ImplaMed®, Interpore IMZ™, Osstem, Zimmer (Paragon, Centerpulse), OIC, IMTEC Corporation®, MIS Implants, Minimatic/Stryker, Bud, Straumann, Biolok International, INNOVA, Implant Direct, Zimmer (Calcitek® Centerpulse), BioHorizons®. See table 1 for platform compatibility.
There are seven (7) different platforms and each platform is compatible with one or more implant types. The platforms of the abutments are [A], [B], [C], [S], [X], [X], [Z]. Table 1 specifies which dental implants are compatible with these platforms. The difference between each platform is the internal connection with the specific implant. The devices are supplied non-sterile, therefore there is no shelf life.
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Abutment Insertion
Choose the abutment with the proper cuff height that fits on the existing implant. Abutment platforms should be 1 to 2 mm above the gingival level and approximately parallel to the occlusal plane. However, to allow the subsequent placement of the sections of SFI-Bar® on top of these abutments so that the bars are approximately parallel to the occlusal plane, it may be necessary to choose some abutments with different heights. Abutments are screwed into each implant.
Intended Use of the Device:
The SFI-Bar® Implant Abutments are indicated to be used with dental implants as a prosthetic framework to support and /or retain removable or fixed dental prostheses in the treatment of partially or totally edentulous patients to restore chewing function. The abutment screws are intended to secure the bar to the endosseous implants.
| Implant Brand | Model |
|---|---|
| Nobel Biocare Brånemark System | 3.3 Fixture, 3.75 Fixture, 4.0 Fixture, 5.0 Fixture (Old Version), 3.75 MkII Self-tapping Fixture, 4.0 MkII Self-tapping Fixture |
| Sterngold-ImplaMed | 3.3 Hex Cylinder, 4.0 Hex Cylinder, 3.75 Standard Hex Screw, 3.75 Self-tapping Hex Screw, 3.75 Self-tapping "SST" Hex Screw, 4.0 Standard Hex Screw, 4.0 Self-tapping Hex Screw, 4.0 Self-tapping "SST" Hex Screw, 4.0 Self-tapping "SST" Hex Screw, 5.0 RP "SST" Hex Screw, 3.75 RP Acid Etched, 4.0 RP Acid Etched, 5.0 RP Acid Etched, 4.1 Stern IC (4.8 head), 3.3 Stern IC (4.8 head) |
| Nobel Biocare (Steri-Oss®) | 3.8 HL Cylinder, 3.8 HL Threaded, 4.5 HL Threaded, 3.5 NobelReplace™, Replace® Select (NP), 4.0 NobelReplace Straight, (RP), 4.3Replace®Select&NobelReplace™ (RP) |
| Keystone (Lifecore) | 3.75 Restore® Self-tapping Screw, 4.0 Restore® Self-tapping Screw, 3.75 Restore® External Hex Screw, 4.0 Restore® External Hex Screw, 4.0 Restore® External Hex Cylinder, 4.2 Sustain® External Hex Cylinder, 3.75 Sustain® External Hex Screw, 4.0 Sustain® External Hex Screw, 4.2 Sustain® External Hex MC Cylinder, Stage-1TM (3.3 and 4.0 fixtures) |
| 3i Implant Inovations | 3.25 External Hex Miniplant®, 3.25 ICE™ Miniplant®, 3.25 OSSEOTITE® Miniplant®, 3.3 Cylinder Miniplant®, 3.3 External Hex Cylinder, 3.75 ICE™ Self-tapping, 3.75 OSSEOTITE®, 3.75 Self-tapping Threaded, 3.75 Standard Threaded, 4.0 External Hex Cylinder, 4.0 ICE™ Self-tapping, 4.0 OSSEOTITE®, 4.0 Standard Threaded, 4.25 External Hex Cylinder, TG OSSEOTITE® (4.8 Platform), 4.0 OSSEOTITE® Certain™, 4.0 OSSEOTITE® NTCertain™, 4.0 OSSEOTITE®CERTAIN PREVAIL, 5.0 Osseotite® Certain, 5.0 Osseotite® NT Certain, 5.0 Osseotite®Certain Prevail |
| IMTEC Corporation® | 3.3 Universal Flare Cylinder, 3.75 Universal Self-tapping, 3.75 Universal Self-tapping Coated, 4.0 Spike Cylinder, 4.0 Universal Cylinder |
| Interpore IMZ™ | 3.3 Hex Cylinder, 3.75 Self-tapping Threaded, 4.0 Hex Cylinder, 4.0 Self-tapping Threaded, 4.25 Hex Cylinder |
| Osstem | 4.1 US II, III, II Plus, III Plus, SS II, III (4.8 head) |
The SFI-Bar® Implant Abutments are compatible with the following implant systems:
{2}------------------------------------------------
| Zimmer Dental | 3.5 Bio-Vent® X TM, 3.75 Swede-VentTM Conical Neck CST, 3.75 Swede-VentTM Standard, 4.0 Swede-VentTM Standard, 4.0 Bio-Vent® XTM, 3.25 Micro-Vent® (3.5 head), 3.3 Screw-Vent® (3.5 head), 3.5 Bio-Vent® (3.5head), 3.7 Screw-Vent® (3.5 head), 3.75 Screw-Vent® (3.5 head), 4.3 Core-Vent® (3.5 head), 4.25 Micro-Vent® (4.5 head), 4.5 Bio-Vent® (4.5 head), 4.7 Screw-Vent® (4.5 head), 5.3 Core-Vent® (4.5 head),3.7 Tapered Swiss PlusTM (4.8 platform), 4.8 Tapered Swiss PlusTM 4.1 StraightSwiss PlusTM, 4.8 Straight Swiss PlusTM |
|---|---|
| Zimmer (Calcitek®, Centerpulse)Straumann | 3.75 ThreadLocTMITI TETM 3.3 (4.8 head), ITI 3.3 Std & Std Plus (4.8 head), ITI TETM 4.1 (4.8 head),ITI 4.1 Std. & Std. Plus (4.8 head), ITI, 4.8 Std. & Std. Plus (4.8 head) |
| Biolok International | 4.5 Silhouette Screw, 4.0 Micro-Lok Screw, 4.0 Micro-Lok Cylinder, 3.75 Micro-Lok Screw, 3.3 Micro-Lok Cylinder |
| Bud | 3.25 Bud Screwvent, 3.75 Bud Screwvent |
| INNOVA | 4.1 ENDOPORE® External Connection, 4.0 ENTEGRATM External Connection |
| OIC | 3.0 Osteo Standard ST, 3.25 Osteo Standard ST, 3.75 Osteo Standard ST |
| MIS IMPLANTS | 3.3mm Internal Hex, 3.75mm Internal Hex, 4.20mm Internal Hex, 5.0mm Internal Hex |
| BioHorizons® | 3.5 Internal, 4.0 Internal, 4.5 Internal, 3.5 Single Stage, 4.5 Single Stage |
| Implant Direct | Legacy 3.5mm, Legacy 4.5mm, RePlantTM 4.3mm, RePlantTM 3.5mm, 3.7mm ScrewPlant, 4.7mm ScrewPlant |
| Minimatic/Stryker | 3.3 External Hex Cylinder, 3.75 External Hex Screw, 4.0 External Hex Cylinder,4.0 External Hex Screw, 4.75 External Hex Screw, 5.0 External Hex Cylinder |
Summary Technological Characteristics:
The proposed implant abutments are substantially equivalent to the currently marketed predicate devices. The intended use, basic design, fundamental operating principles and manufacturing procedures are the same as the predicate devices.
The material of the implant abutments conform to ASTM F136, Wrought Titanium 6 Aluminum-4 Vanadium ELI Alloy.
Comparison/Compatibility
Substantial Equivalence:
The proposed implant abutments are substantially equivalent to the currently marketed predicate devices. The intended use, basic design, fundamental operating principles and manufacturing procedures are the same as the predicate devices.
To ensure compatibility the following process was carried out: The implant abutments were designed and developed, and manufactured according to manufacturer's specifications and controlled procedures. A validation protocol was done in accordance with Design Control requirements per FDA CFR820.30.
Table 2 summarizes the substantial equivalence comparison to the predicate devices.
{3}------------------------------------------------
Performance Data:
Torque tests, application and functional testing have been conducted to evaluate the performance characteristics of the SFI Bar® Implant Abutments. The test methods used were the same as in predicate devices. Testing has shown that the SFI Bar® Implant Abutments included in this application are equivalent in performance characteristics to the predicate SFI Barto. The acceptance criteria were met.
Torque test results indicated that there is sufficiently large safety margin for fracture of the SF1 Bar® Implant Abutments specified on this submission to occur when tightening. Test samples torqued above 50 Ncm, well above the implant manufacturer's recommended torque value. There is no risk or possibility of harm to the patient.
Summary of Testing to Demonstrate
Safety and Effectiveness / Conclusion:
Non-clinical test data was used to support the substantially equivalence claim. Clinical testing was not necessary. The non-clinical testing consisted of analysis of platforms to identify worst case test samples. Fatigue testing was not done as the basic design is the same as the predicate devices. The evaluation was based on FDA guidance "Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments." Torque tests, application and functional tests have been carried out.
The summary of technological characteristics as well as the torque test, application and functional testing indicate that the device is safe and effective for its intended use and performs as well or better than the predicate devices.
{4}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird-like figure with its wings spread, symbolizing protection and care.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002
July 3, 2013
Sterngold Dental, Limited Liability Company C/O Ms. Maria Rao Director of Regulatory Affairs 23 Frank Mossberg Drive ATTLEBORO MA 02703
Re: K130183
Trade/Device Name: SFI Bar® Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: May 30, 2013 Received: June 3, 2013
Dear Ms. Rao:
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.
{5}------------------------------------------------
Page 2 - Ms. Rao
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 devicerelated 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/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.hum 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Lester W. Schultheis Jr 2013.07.03 13:53:09 -04'00'
Acting for Kwame Ulmer, M.S. Acting Division 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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Sterngaid Dental, LLC
Abbreviated SIO(k) Premarket Notiflention
March 13, 2013 8F1 Barto Impiant Abutments
510(k) Number (if known):
Device Name: SFI Bar@ Abutments
Indications for Use:
The SFI-Bar® Implant Abutments are indicated to be used with dental implants as a prosthetic framework to support and /or retain removable or fixed dental prostheses in the treatment of partially or totally edentulous patients to restore chewing function. The abutment screws are intended to secure the bar to the endosseous implants.
The SFI-Bar® Implant Abutments are compatible with the following implant systems:
| Implant Brand | Model |
|---|---|
| Nobel Biocare Branemark System | 3.3 Fixture, 3.75 Fixture, 4.0 Fixture, 5.0 Fixture (Old Version), 3.75 Mkll Self-tapping Fixture, 4.0 Mkll Self-tapping Fixture |
| Sterngold-ImplaMed | 3.3 Hex Cylinder, 4.0 Hex Cylinder, 3.75 Standard Hex Screw, 3.75 Self-tappingHex Screw, 3.75 Self-tapping "SST" Hex Screw, 4.0 Standard Hex Screw, 4.0Self-tapping Hex Screw, 4.0 Self-tapping "SST" Hex Screw, 4.0 Self-tapping"SST" Hex Screw, 5.0 RP "SST" Hex Screw, 3.75 RP Acid Etched, 4.0 RP AcidEtched, 5.0 RP Acid Etched, 4.1 Stern IC (4.8 head), 3.3 Stern IC (4.8 head) |
| Nobel Biocare (Steri-Oss®) | 3.8 HL Cylinder, 3.8 HL Threaded, 4.5 HL Threaded, 3.5 NobelReplace™,Replace® Select (NP), 4.0 NobelReplace Straight, (RP),4.3Replace®Select&NobelReplace™ (RP) |
| Keystone (Lifecore) | 3.75 Restore® Self-tapping Screw, 4.0 Restore® Self-tapping Screw, 3.75Restore® External Hex Screw, 4.0 Restore® External Hex Screw, 4.0 Restore®External Hex Cylinder, 4.2 Sustain® External Hex Cylinder, 3.75 Sustain®External Hex Screw, 4.0 Sustain® External Hex Screw, 4.2 Sustain® ExternalHex MC Cylinder, Stage-1TM (3.3 and 4.0 fixtures) |
| 3i Implant Inovations | 3.25 External Hex Miniplant®, 3.25 ICE™ Miniplant®, 3.25 OSSEOTITE®Miniplant®, 3.3 Cylinder Miniplant®, 3.3 External Hex Cylinder, 3.75 ICE™Self-tapping, 3.75 OSSEOTITE®, 3.75 Self-tapping Threaded, 3.75 StandardThreaded, 4.0 External Hex Cylinder, 4.0 ICE™ Self-tapping, 4.0OSSEOTITE®, 4.0 Standard Threaded, 4.25 External Hex Cylinder, TGOSSEOTITE® (4.8 Platform), 4.0 OSSEOTITE® Certain™, 4.0OSSEOTITE® NTCertain™, 4.0 OSSEOTITE®CERTAIN PREVAIL, 5.0Osseotite® Certain, 5.0 Osseotite® NT Certain, 5.0 Osseotite®Certain Prevail |
| IMTEC Corporation® | 3.3 Universal Flare Cylinder, 3.75 Universal Self-tapping, 3.75 Universal Self-tapping Coated, 4.0 Spike Cylinder, 4.0 Universal Cylinder |
| Interpore IMZ™ | 3.3 Hex Cylinder, 3.75 Self-tapping Threaded, 4.0 Hex Cylinder, 4.0 Self-tapping Threaded, 4.25 Hex Cylinder |
| Osstem | 4.1 US II, III, II Plus, III Plus, SS II, III (4.8 head) |
{7}------------------------------------------------
Sterngold Deztal, LLC Abbrevisted 510(k) Premarket Notification
March 13, 2013 SFI Bar® Implant Abutments
| Zimmer Dental | 3.5 Bio-Vent® XTM, 3.75 Swede-VentTM Conical Neck CST, 3.75 Swede-VentTM Standard, 4.0 Swede-VentTM Standard, 4.0 Bio-Vent® XTM, 3.25 Micro-Vent® (3.5 head), 3.3 Screw-Vent® (3.5 head), 3.5 Bio-Vent® (3.5head), 3.7 Screw-Vent® (3.5 head), 3.75 Screw-Vent® (3.5 head), 4.3 Core-Vent® (3.5 head), 4.25 Micro-Vent® (4.5 head), 4.5 Bio-Vent® (4.5 head), 4.7 Screw-Vent® (4.5 head), 5.3 Core-Vent® (4.5 head),3.7 Tapered Swiss PlusTM (4.8 platform), 4.8 Tapered Swiss PlusTM 4.1 StraightSwiss PlusTM, 4.8 Straight Swiss PlusTM |
|---|---|
| Zimmer (Calcitek®, Centerpulse) | 3.75 ThreadLocTM |
| Straumann | ITI TETM 3.3 (4.8 head), ITI 3.3 Std & Std Plus (4.8 head), ITI TETM 4.1 (4.8 head),ITI 4.1 Std. & Std. Plus (4.8 head), ITI, 4.8 Std. & Std. Plus (4.8 head) |
| Biolok International | 4.5 Silhouette Screw, 4.0 Micro-Lok Screw, 4.0 Micro-Lok Cylinder, 3.75 Micro-Lok Screw, 3.3 Micro-Lok Cylinder |
| Bud | 3.25 Bud Screwvent, 3.75 Bud Screwvent |
| INNOVA | 4.1 ENDOPORE® External Connection, 4.0 ENTEGRATM External Connection |
| OIC | 3.0 Osteo Standard ST, 3.25 Osteo Standard ST, 3.75 Osteo Standard ST |
| MIS IMPLANTS | 3.3mm Internal Hex, 3.75mm Internal Hex, 4.20mm Internal Hex, 5.0mm Internal Hex |
| BioHorizons® | 3.5 Internal, 4.0 Internal, 4.5 Internal, 3.5 Single Stage, 4.5 Single Stage |
| Implant Direct | Legacy 3.5mm, Legacy 4.5mm, RePlantTM 4.3mm, RePlantTM 3.5mm,3.7mm ScrewPlant, 4.7mm ScrewPlant |
| Minimatic/Stryker | 3.3 External Hex Cylinder, 3.75 External Hex Screw, 4.0 External Hex Cylinder,4.0 External Hex Screw, 4.75 External Hex Screw, 5.0 External Hex Cylinder |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X (Part 21 CFR 801 Subparts D)
AND/OR
Over-the -Counter Use (21 CFR 807 Subpart D)
Sheena A. Green -5 2013.07.03 08:48:41 -04/00'
for M. Susan Runner, DDS, MA
(Division Sign-Off) (Division Sign-Off)
Division of Anesthestlology, Genèral Hospital
Division of Anesthestology, Genèral Devices Olvision of Antosthosionology.
Infection Control, Dental Devices K130183
510(k) Number:_
§ 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.)