(124 days)
The ORA Implant Abutment System is indicated for use with dental implants to support and/or retain removable dental prostheses in the treatment of partially edentulous patients to restore chewing function. The abutment screws directly into endosseous implants or they screw into SFI Abutments which are screwed into endosseous implants.
The ORA Implant Abutment is a precision machined ball shaped abutment that connects a compatible dental implant system with a removable partial or complete overdenture. The implant abutment is screwed into the dental implant. Connection to and retention of a denture is provided by a rubber o-ring, which may or may not be held within a metal housing. There are two color o-rings, a red processing o-ring and a white final o-ring. The retaining ring (metal housing) comes with the red o-ring (which is a firm rubber) inside. The retaining ring (metal housing) with the red o-ring is pushed over the wide part of the ball until seated. The stiffness of the red o-ring holds the housing in position. Any exposed areas of the abutment are blocked out so that only the metal housing is exposed. The retaining ring (metal housing) is then processed into the denture. After the material has cured, the denture is removed. The red o-ring is pulled out of the metal housing and the white o-ring is inserted into its place. The white o-ring is more flexible making insertion and removal easier. The bottom portion of the abutment (cuff area to end of threads) is an exact replica of the SFI Implant Abutments previously cleared by K130183 and K132814. ORA Implant Abutments are available in sixteen different platforms and each platform is compatible with one or more implant types.
Here's a breakdown of the acceptance criteria and the study information for the ORA Implant Abutment System, based on the provided text:
ORA Implant Abutment System
1. Table of Acceptance Criteria and Reported Device Performance
This 510(k) summary does not explicitly state quantitative performance acceptance criteria (e.g., specific thresholds for force, displacement, or reliability percentages). Instead, the acceptance criterion for the ORA Implant Abutment System is substantial equivalence to its predicate devices in terms of design, materials, intended use, operating principles, and manufacturing.
The reported device performance is that it meets this criterion through application and functional testing.
| Attribute | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Overall Performance | Substantially equivalent to predicate devices in form and function | Equivalent in performance characteristics to predicate devices. |
| Design/Construction | Machined, screw-retained | Machined, screw-retained |
| Anatomical Site | Oral Cavity | Oral Cavity |
| Device Material | Wrought Titanium-6AL-4 Vanadium ELI Alloy | Wrought Titanium-6AL-4 Vanadium ELI Alloy |
| Indications for Use | Matches predicate device indications for use. | Matches predicate device indications for use. |
| Operating Principle | Abutment Implant connection: Screw fixation; Retentive system for overdenture. | Same as predicate devices. |
| Cleaning Procedures | Common procedure for oral hygiene | Same as predicate devices. |
| Patient Handling | Common cleaning and insertion of denture | Same as predicate devices. |
| Manufacturing/Packaging | Produced in controlled CNC process, pouch, non-sterile | Same as predicate devices. |
| Cuff Sizes | Within range or comparable to predicate devices. | 0.4, 1.0, 1.25, 2.0, 3.0, 4.0, 5.0mm (Predicate ranges also provided). |
| Prosthetic Connection Types | Matches predicate devices. | RP, Conical, NP, WP, 3.5 Head, 4.0 Head, 4.1 Head, 4.5 Head, 4.8 Head |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "non-clinical test data" and "application and functional testing" to evaluate performance characteristics.
- Sample Size for Test Set: Not explicitly stated as a number of devices tested. The testing involved "tolerance analysis of platforms to identify worst case test samples." This suggests a selection of representative samples based on design variations, rather than a large statistical sample size of identical units.
- Data Provenance: The document does not specify the country of origin of the data. The testing appears to be internal (conducted by or for Sterngold Dental, LLC) and is retrospective in the sense that it's comparing a new device to existing predicate devices' performance characteristics, rather than collecting new clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This section is not applicable as the study described is non-clinical performance testing for substantial equivalence, not a study involving human expert interpretation for ground truth.
4. Adjudication Method for the Test Set
This section is not applicable as the described study is non-clinical performance testing, not a study requiring expert adjudication of results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not necessary." The comparison is for substantial equivalence to predicate devices based on technical characteristics and non-clinical performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as the ORA Implant Abutment System is a physical medical device (implant abutment), not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this submission is demonstration of equivalent performance characteristics to legally marketed predicate devices through non-clinical testing. The predicate devices themselves represent established safe and effective designs in the market.
8. The Sample Size for the Training Set
This section is not applicable as the ORA Implant Abutment System is a physical device and no machine learning algorithm was described that would require a "training set."
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the same reasons as point 8.
{0}------------------------------------------------
April 14, 2014 ORA Implant Abutment System
510(k) Summary
APR 1 6 2014
| Sponsor: | Sterngold Dental, LLC23 Frank Mossberg DriveAttleboro, MA 02703 |
|---|---|
| ---------- | ------------------------------------------------------------------------- |
- Contact: Maria Rao, QA/RA Director Ph: 508-226-5660 ext 1206
- Trade Name: ORA Implant Abutments System
- Common Name: Implant Abutments
Classification Name: Endosseous Dental Implant Abutment
- Classification: According to Section 513 of the Federal Food, Drug, and Cosmetic 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): K900099, K130183, K132814.
| K900099 | The O-Ring System - ORS |
|---|---|
| K130183 | SFI Bar® Implant Abutments for 7 Platforms |
| K132814 | SFI Bar® Implant Abutments for 9 Platforms |
Description of Device:
The ORA Implant Abutment is a precision machined ball shaped abutment that connects a compatible dental implant system with a removable partial or complete overdenture. The implant abutment is screwed into the dental implant. Connection to and retention of a denture is provided by a rubber o-ring, which may or may not be held within a metal housing. There are two color o-rings, a red processing o-ring and a white final o-ring.
The retaining ring (metal housing) comes with the red o-ring (which is a firm rubber) inside. The retaining ring (metal housing) with the red o-ring is pushed over the wide part of the ball until seated. The stiffness of the red o-ring holds the housing in position. Any exposed areas of the abutment are blocked out so that only the metal housing is exposed. The retaining ring (metal housing) is then processed into the denture. After the material has cured, the denture is removed. The red o-ring is pulled out of the metal housing and the white o-ring is inserted into its place. The white o-ring is more flexible making insertion and removal easier. The bottom portion of the abutment (cuff area to end of threads) is an exact replica of the SFI Implant Abutments previously cleared by K130183 and K132814.
ORA Implant Abutments are available in sixteen different platforms and each platform is compatible with one or more implant types. Table 1 demonstrates implant/abutment compatibility. The difference between each platform is the internal connection with the specific implant. This connection has been previously cleared by K130183 and K132814— SFI Implant Abutments.
{1}------------------------------------------------
The devices are supplied non-sterile, and there is no shelf life.
Intended Use of the Device:
The ORA Implant Abutment System is indicated for use with dental implants to support and/or retain removable dental prostheses in the treatment of partially edentulous patients to restore chewing function. The abutment screws directly into endosseous implants or they screw into SFI Abutments which are screwed into 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, 4.0MkII Self-tapping Fixture | ||
| Sterngold-ImpiaMed | 3.3 Hex Cylinder, 4.0 Hex Cylinder, 3.75 Standard Hex Screw, 3.75 Self-tapping Hex Screw, 3.75Self-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 RPAcid 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 HexScrew, 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, 4.2Sustain® 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 CylinderMiniplant®, 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, 4.0OSSEOTITE®, 4.0 Standard Threaded, 4.25 External Hex Cylinder, TG OSSEOTITE® (4.8Platform), 4.0 OSSEOTITE® Certain™, 4.0 OSSEOTITE® NTCertain™, 4.0OSSEOTITE®CERTAIN PREVAIL, 5.0 Osseotite® Certain, 5.0 Osseotite® NT Certain, 5.0Osseotite®Certain Prevail | ||
| IMTEC Corporation® | 3.3 Universal Flare Cylinder, 3.75 Universal Self-tapping, 3.75 Universal Self-tapping Coated, 4.0Spike 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 HexCylinder | ||
| Osstem | 4.1 US II, III, II Plus, III Plus, SS II, III (4.8 head) | ||
| Zimmer Dental | 3.5 Bio-Vent® X™, 3.75 Swede-Vent™ Conical Neck CST, 3.75 Swede-Vent™ Standard, 4.0Swede-Vent™ Standard, 4.0 Bio-Vent® X™, 3.25 Micro-Vent® (3.5 head), 3.3 Screw-Vent® (3.5head), 3.5 Bio-Vent® (3.5 head), 3.7 Screw-Vent® (3.5 head), 3.75 Screw-Vent® (3.5 head), 4.3Core-Vent® (3.5 head), 4.25 Micro-Vent® (4.5 head), 4.5 Bio-Vent® (4.5 head), 4.7 Screw-Vent® (4.5head), 5.3 Core-Vent® (4.5 head), 3.7 Tapered Swiss Plus™ (4.8 platform), 4.8 Tapered SwissPlus™ 4.1 Straight Swiss Plus™, 4.8 Straight Swiss Plus™ | ||
| Zimmer (Calcitek®, Centerpulse) | 3.75 ThreadLoc™ | ||
| Straumann | ITI TE™ 3.3 (4.8 head), ITI 3.3 Std & Std Plus (4.8 head), ITI TE™ 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, 3.3Micro-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, RePlant™ 4.3mm, RePlant™ 3.5mm, 3.7mm ScrewPlant, 4.7mmScrewPlant | ||
| Minimatic/Stryker | 3.3 External Hex Cylinder, 3.75 External Hex Screw, 4.0 External Hex Cylinder, 4.0 External HexScrew, 4.75 External Hex Screw, 5.0 External Hex Cylinder | ||
| Straumann | Straumann Bone Level RC, Blue Sky Bio Square Taper RC | ||
| Straumann | Straumann Bone Level NC, Blue Sky Bio Square Taper NC | ||
| Ankylos | Ankylos | ||
| Nobel Biocare | Nobel Replace WP, Nobel Replace Select WP, NobelSpeedy Replace WP, Implant Direct 5.0RePlant, BlueSky Bio 5.0 Trilobe | ||
| Nobel Biocare | Nobel Conical Connection RP | ||
| Nobel Biocare | Nobel Conical Connection NP, Blue Sky Bio Max | ||
| Astra Dental | Astra 4.5 / 5.0, Blue Sky Bio Conus 12 4.5 / 5.0 | ||
| Astra Dental | Astra 3.5 / 4.0, Blue Sky Bio Conus 12 3.5 / 4.0 |
2 of 4
{2}------------------------------------------------
Technical 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.
| Attribute | Candidate | Predicate Device | Predicate Device |
|---|---|---|---|
| The ORA Implant AbutmentSterngold Dental, LLC | The O-Ring System - ORSAttachments International,Inc.K900099 | SFI Implant AbutmentsSterngold Dental, LLCK130183, K132814 | |
| Design/Construction | Machined, screw-retained | Machined, screw-retained | Machined, screw-retained |
| Anatomical Site | Oral Cavity | Oral Cavity | Oral Cavity |
| Device Material | Wrought Titanium-6AL-4Vanadium ELI Alloy | Wrought Titanium-6AL-4Vanadium ELI Alloy | Wrought Titanium-6AL-4Vanadium ELI Alloy |
| Indications for Use | Indicated for use with dentalimplants to support and/or retainremovable dental prostheses inthe treatment of partially ortotally edentulous patients torestore chewing function. Theabutment screws directly intoendosseous implants. | The ORS Implant Abutments areintended for use with dentalimplants as a support orattachment for prostheticrestoration. The abutment screwsdirectly into the implant. | The SFI-Bar® ImplantAbutments are indicated foruse with dental implantbodies/fixtures to support and/or retain removable dentalprostheses for partially ortotally edentulous patients torestore chewing function. |
| Operating Principle/Basic Design | Abutment Implant connection:Screw fixation | Abutment Implant connection:Screw fixation | Abutment Implant connection:Screw fixation |
| Connecting principle tooverdenture: Retentive system | Connecting principle tooverdenture: Retentive system | Connecting principle tooverdenture: Retentive system | |
| Cleaning procedures for patient:Common procedure for oralhygiene | Cleaning procedures for patient:Common procedure for oralhygiene | Cleaning procedures forpatient: Common procedurefor oral hygiene | |
| Patient handling: Commoncleaning and insertion of denture | Patient handling: Commoncleaning and insertion of denture | Patient handling: Commoncleaning and insertion ofdenture | |
| Packaging,materials andprocesses | Produced in a controlled CNCmachine process, previouslyvalidatedPackaging: PouchNon-sterile | Produced in a controlled CNCmachine process, previouslyvalidatedPackaging: PouchNon-sterile | Produced in a controlled CNCmachine process, previouslyvalidatedPackaging: PouchNon-sterile |
| Cuff Sizes | 0.4, 1.0, 1.25, 2.0, 3.0, 4.0,5.0mm | 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0mm | 1.0, 1.5,1.75, 2.0, 2.2, 2.5, 3.0,3.5, 4.0, 4.5, 5.0, 5.5mm |
| ProstheticConnection | RP, Conical, NP, WP, 3.5 Head,4.0 Head, 4.1 Head, 4.5 Head,4.8 Head | RP, Conical, NP, WP, 3.5 Head,4.0 Head, 4.1 Head, 4.5 Head,4.8 Head | RP, Conical, NP, WP, 3.5Head, 4.0 Head, 4.1 Head, 4.5Head, 4.8 Head |
{3}------------------------------------------------
Performance Date:
Application and functional testing have been conducted to evaluate the performance characteristics of the ORA Implant Abutments. The test methods used were the same as in predicate devices. Testing has shown that the ORA Implant Abutments included in this application are equivalent in performance characteristics to its predicate devices.
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 tolerance 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 summary of technological characteristics as well as application and functional testing indicate that the device is substantially equivalent to the declared predicate devices.
{4}------------------------------------------------
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 stylized eagle with three stripes forming its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 16, 2014
Sterngold Dental, LLC Ms. Maria Rao Director, Quality and Regulatory Affairs 23 Frank Mossberg Drive Attleboro, MA 02703
Re: K133791
Trade/Device Name: ORA Implant Abutments System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: March 17, 2014 · Received: March 19, 2014
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.
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
{5}------------------------------------------------
Page 2 - Ms. Rao
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/Resourcesfor YowIndustry/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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Image /page/5/Picture/7 description: The image shows the word "Erin" followed by a logo that is difficult to decipher. The logo appears to be a combination of letters and symbols, possibly representing a company or organization. The text and logo are in black and white, and the overall image has a simple, clean design. The last part of the image shows the letters "h-S".
Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{6}------------------------------------------------
Sterngold Dental, LLC Abbreviated 510(k) Premarket Notification
April 14, 2014 ORA Implant Abutment System
| 510(k) Number (if known): | K133791 |
|---|---|
| --------------------------- | --------- |
Device Name: ORA Implant Abutment System
Indications for Use:
The ORA Implant Abutment System is indicated for use with dental implants to support and/or retain removable dental prostheses in the treatment of partially edentulous patients to restore chewing function. The abutment screws directly into endosseous implants or they screw into SFI Abutments which are screwed into 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) |
| Zimmer Dental | 3.5 Bio-Vent® X™, 3.75 Swede-Vent™ Conical Neck CST, 3.75 Swede-Vent™ Standard, 4.0 Swede-Vent™ Standard, 4.0 Bio-Vent® X™, 3.25 Micro-Vent® (3.5 head), 3.3 Screw-Vent® (3.5 head), 3.5 Bio-Vent® (3.5 head), 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 Plus™ (4.8 platform), 4.8 Tapered Swiss Plus™ 4.1 Straight Swiss Plus™, 4.8 Straight Swiss Plus™ |
| Zimmer (Calcitek®, Centerpulse) | 3.75 ThreadLoc™ |
| Straumann | ITI TE™ 3.3 (4.8 head), ITI 3.3 Std & Std Plus (4.8 head), ITI TE™ 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, RePlant™ 4.3mm, RePlant™ 3.5mm, 3.7mm ScrewPlant, 4.7mm |
{7}------------------------------------------------
Sterngold Dental, LLC Abbreviated 510(k) Premarket Notification
| ScrewPlant | |
|---|---|
| Minimatic/Stryker | 3.3 External Hex Cylinder, 3.75 External Hex Screw, 4.0 External Hex Cylinder, 4.0 External Hex |
| Minimatic/Stryker | Screw, 4.75 External Hex Screw, 5.0 External Hex Cylinder |
| Straumann | Straumann Bone Level RC, Blue Sky Bio Square Taper RC |
| Straumann | Straumann Bone Level NC, Blue Sky Bio Square Taper NC |
| Ankylos | Ankylos |
| Nobel Biocare | Nobel Replace WP, Nobel Replace Select WP, NobelSpeedy Replace WP, Implant Direct 5.0 |
| Nobel Biocare | RePlant, BlueSky Bio 5.0 Trilobe |
| Nobel Biocare | Nobel Conical Connection RP |
| Nobel Biocare | Nobel Conical Connection NP, Blue Sky Bio Max |
| Astra Dental | Astra 4.5 / 5.0, Blue Sky Bio Conus 12 4.5 / 5.0 |
| Astra Dental | Astra 3.5 / 4.0, Blue Sky Bio Conus 12 3.5 / 4.0 |
| Zimmer Dental | Zimmer TSV 5.7mm, Implant Direct Legacy 5.7, BioHorizon 5.7 |
(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-S
2014.04.16 11:34:03 -04'00'
§ 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.)