(324 days)
The NobelProcera Overdenture Bar is indicated for use as an overdenture bar that attaches to implants or abutments in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function.
NobelProcera Overdenture Bars are computer aided design (CAM) precision milled, individually designed Superstructures manufactured for each patient. The NobelProcera Overdenture Bar provides retention and support for a removable or fixed denture made of standard laboratory dental materials such as resin composite or porcelain veneer.
The Superstructures can be either Fixed Shaped Bars such as Dolder, Hader, Round, or Free Form Shaped Bars such as Free Form Milled, Montreal, Paris, Wrap-around; or a combination of shapes. The Overdenture Bar shapes and design parameters remain unchanged from the predicate device, Procera Implant Bridge Overdenture (K090069). Additionally, the Superstructure can also be designed per specific prescription order by qualified health care professionals.
The Superstructure is a multiple unit restoration for fixed or removeable dental prosthetic framework milled from one solid piece of material. The NobelProcera Overdenture Bar accommodates commercially available denture attachments for removable dental prosthesis, or retention elements for fixed dental prosthesis.
The many abutment and implant interfaces that can be used in the Superstructure are precision milled and are an integral part of the Overdenture Bar.
The NobelProcera Overdenture Bar is packaged as non-sterile, and delivered to a dental laboratory for completion. Once received at the laboratory, the NobelProcera Overdenture Bar is matched to a denture for final placement.
The provided text describes a 510(k) summary for the NobelProcera Overdenture Bar, which is a dental device. The primary purpose of this submission is to demonstrate substantial equivalence to a predicate device, Procera® Implant Bridge Overdenture (K090069), and to expand the list of compatible implant and abutment interfaces. The information provided focuses on the device's design, materials, manufacturing, intended use, and a comparison with the predicate device, along with the results of non-clinical testing.
Based on the information provided, here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic / Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety and Effectiveness for additional implant and abutment interfaces | Established through a retrospective study of NobelProcera Overdenture Bars placed globally since 2010. The data set of compatible interfaces was generated through measurements of original manufacturer's bar interfaces. |
| Fatigue Performance | Demonstrated through non-clinical fatigue testing in accordance with "FDA Guidance Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments." |
| MR Safety and Compatibility | Conducted according to "FDA Guidance Document 'Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment'." (Details of specific performance metrics are not provided in the summary, only that testing was conducted.) |
| Design/Construction | Patient specific / machined (no change from predicate) |
| Device Material | Titanium alloy (no change from predicate) |
| Bar Shape | Fixed shaped bars (Dolder, Hader, Round) and Free form shaped bars (Milled, Montreal, Paris, Victoria, Wrap-around) - (no change from predicate) |
| Manufacturing Process | Utilizes CAD/CAM and CNC milling from scanned master casts or design files, with inspection for fit. (Similar to predicate, with minor process details mentioned for both) |
| Packaging | Plastic bag and cardboard box (no change from predicate) |
| Sterility | Non-sterile (no change from predicate) |
| Intended Use | Removable or fixed superstructure (no change from predicate) |
| Indications for Use | Expanded to include additional manufacturers' implant and abutment interfaces, while maintaining the predicate's core indication for restoring chewing function in partially or totally edentulous jaws. |
| Substantial Equivalence | Conclusion: Device is substantially equivalent to the predicate device (Procera Implant Bridge Overdenture, K090069). |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Description: The "test set" for demonstrating safety and effectiveness of additional implant and abutment interfaces was a retrospective study of NobelProcera Overdenture Bars placed in the market globally since 2010.
- Sample Size: The exact number of overdenture bars or patients included in this retrospective study is not specified in the provided text.
- Data Provenance:
- Country of Origin: Globally since 2010.
- Retrospective or Prospective: Retrospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts to establish ground truth for the retrospective study on compatible interfaces. The "data set of compatible implant and abutment interfaces were generated through measurements of original manufacturer's bar interfaces." This implies engineering measurements and specification comparisons, rather than clinical expert consensus on outcomes.
4. Adjudication Method for the Test Set
Not applicable. The study described is based on measurements and a retrospective review of market performance, not on a clinical assessment by experts requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The provided text does not describe an MRMC comparative effectiveness study where human readers improve with or without AI assistance. This device is a physical dental overdenture bar, not an AI-assisted diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device is a physical product, not an algorithm, and thus does not have a "standalone" or "human-in-the-loop" performance as typically understood for AI/software devices. The "algorithm" aspect refers to the CAD/CAM manufacturing process, which is inherent to creating the physical device.
7. Type of Ground Truth Used
- For the additional implant and abutment interfaces: Measurements of original manufacturer's bar interfaces. This refers to engineering specifications and compatibility checks.
- For overall safety and effectiveness: The retrospective study implicitly relies on real-world performance data of the device in the market, although the specific metrics or "ground truth" for assessing this performance retrospectively are not detailed (e.g., lack of reported failures, successful chewing function, etc.).
- For fatigue and MR safety: Standards compliance and non-clinical test results were used as ground truth.
8. Sample Size for the Training Set
Not applicable. As this is a physical medical device manufactured via CAD/CAM, there isn't a "training set" in the context of machine learning algorithms. The design parameters are based on established dental anatomy, engineering principles, and the specific interfaces of compatible implants/abutments.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of AI/machine learning. The design and manufacturing process relies on:
- Clinical and engineering specifications: Defining the various bar shapes (Dolder, Hader, Round, etc.) and their dimensions.
- Compatibility standards: Ensuring precision milling to fit specific implant and abutment interfaces.
- Established dental principles: For restoring chewing function in edentulous jaws.
The "ground truth" for the manufacturing process would be the accurate replication of the patient-specific design within specified tolerances, which is verified through quality control and fit checks against the master cast.
{0}------------------------------------------------
1111 2 4 2014 432749
1.4 510(k) Summary
| Submitted by: | Phuong Nguyen SonSenior Regulatory Affairs ManagerNobel Biocare USA LLC22715 Savi Ranch ParkwayYorba Linda, CA 92887 |
|---|---|
| Submitted for: | Nobel Biocare ABVästra Hamngatan 1Goteborg, SE 411 17Sweden |
| Telephone: | (714) 282-4800 x7830 |
| Facsimile: | (714) 998-9348 |
| Date of Submission: | August 30, 2013 |
| Classification Name:Product Code: | Endosseous Dental Implant Abutment (21 CFR 872.3630)NHA |
| Trade or Proprietaryor Model Name: | NobelProcera Overdenture Bar |
| Legally Marketed Devices: | Procera® Implant Bridge Overdenture (K090069) |
Device Description:
NobelProcera Overdenture Bars are computer aided design (CAM) precision milled, individually designed Superstructures manufactured for each patient. The NobelProcera Overdenture Bar provides retention and support for a removable or fixed denture made of standard laboratory dental materials such as resin composite or porcelain veneer.
The Superstructures can be either Fixed Shaped Bars such as Dolder, Hader, Round, or Free Form Shaped Bars such as Free Form Milled, Montreal, Paris, Wrap-around; or a combination of shapes. The Overdenture Bar shapes and design parameters remain unchanged from the predicate device, Procera Implant Bridge Overdenture (K090069). Additionally, the Superstructure can also be designed per specific prescription order by qualified health care professionals.
The Superstructure is a multiple unit restoration for fixed or removeable dental prosthetic framework milled from one solid piece of material. The NobelProcera Overdenture Bar accommodates commercially available denture attachments for removable dental prosthesis, or retention elements for fixed dental prosthesis.
The many abutment and implant interfaces that can be used in the Superstructure are precision milled and are an integral part of the Overdenture Bar.
The NobelProcera Overdenture Bar is packaged as non-sterile, and delivered to a dental laboratory for completion. Once received at the laboratory, the NobelProcera Overdenture Bar is matched to a denture for final placement.
Nobel Biocare Traditional 510(k) Notification NobelProcera Overdenture Bar August 2013
{1}------------------------------------------------
Indications for Use:
The NobelProcera Overdenture Bar is indicated for use as an overdenture bar that attaches to implants or abutments in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function.
| Manufacturer | Name | Sizes |
|---|---|---|
| 3i® (BioMet) | (Certain) Internal | 3.4, 3.75/4.0, 5.0, 6.0 |
| Conical Abutment | 3.4, 4.1/5.0, 6.0 | |
| External (hex) | 3.4, 4.1, 5.0, 6.0 | |
| IOL® Abutment | - | |
| Low Profile abutments | - | |
| Standard abutment | - | |
| AB Dental Devices | Narrow Platform | - |
| Alpha Bio | Internal Hex | 4.5 |
| TCT System | ||
| Anthogyr | Anthofit® HE System Conical Abutment | 4.1 |
| Anthofit® Ol System | 3.5 | |
| Anthofit® OI System Conical Abutment | 3.5 | |
| Axiom REG/PX Platform | 4.0 | |
| Axiom REG/PX Straight Conical Abutment | - | |
| BEGO Semados® | S/RI-Line | 3.25/3.75/4.1/4.5, 5.5 |
| BioHorizons® | Abutment for Screw | 3.5/4.0, 5.0 |
| Conical internal connection | 3.0, 3.5, 4.5, 5.7 | |
| External implant system | 3.5, 4.0, 5.0, 6.0 | |
| Single Stage Restoration | 3.5, 4.5, 5.7 | |
| Biotech DentalImplants | B.I.S. Conic | 3.5/3.9, 4.0/4.4, 5/5.4 |
| B.I.S. Conic Base Analog | 4.4 | |
| BTI® | Externa® Platform (abutment level) | 4.1 |
| Externa® Platform (implant level) | 4.1 | |
| Interna® Platform | 4.1 | |
| Tiny® Platform | 3.5 | |
| Camlog® | Camlog Bar Abutment | 3.3, 3.8, 6.0 |
| Camlog Implant System | 3.3, 3.8, 4.3, 5.0, 6.0 | |
| CONELOG Implant System | 3.8 | |
| Dentsply (Ankylos®) | Balance Base Abutment | - |
| Balance Base Abutment Narrow | - | |
| Balance Base C | - | |
| Regular C/X Abutment | - | |
| Dentsply (AstraTech®) | 20° UniAbutment | 3.5/4.0 |
| 45° UniAbutment | 3.5/4.0 | |
| Astra ST | 3.5 | |
| Astra Tech | Yellow, Aqua, Lilac | |
| Dentsply (XIVE®) | FRIADENT® | 3.0, 3.4, 3.8, 4.5, 5.5 |
| FRIADENT® MP | 3.8, 4.5, 5.5 | |
| TG Platform | 3.4-4.5 | |
| Hiossen | ET III SA | mini, regular |
| HI-TEC implants | Universal Unit System | - |
| Implant Direct | Attachment International | 3.25, 3.3 |
| Legacy™ | 3.0, 3.5, 4.5, 5.7 | |
| RePlant®/RePlus® | 3.5, 4.3, 5.0 | |
| ScrewIndirect | - | |
| ScrewIndirect | 5.0 | |
| Manufacturer | Name | Sizes |
| Implant Direct(Sybron) | ScrewPlant®/ScrewPlus® | 3.7, 4.7, 5.7 |
| Endopore® Internal Hex | 4.1 | |
| Entegra™ External Hex | 3.5, 4.1, 5.0 | |
| PITT-EASY® Paracentric Line | 3.75, 4.0, 4.9 | |
| SybronPRO™ Series Hex | 3.5, 4.1 | |
| LifeCore Dental(Keystone) | Genesis System | 3.8, 4.5, 5.5 |
| PrimaConnex® System | 3.5, 4.1, 5.0/7.0/8.0 | |
| PrimaConnex® System Multi-unit | 3.5/4.1, WD | |
| Renova® Implant System | SDI 3.75, RDI 4.5 | |
| Restore® Implant System | SD 3.3, RD 3.75/4.0, WD | |
| MIS® | Stage-1 system RDS | - |
| Internal Hex | - | |
| Multi-Unit system | - | |
| Standard Platform | - | |
| Wide Interial Hex | - | |
| Neoss | Access Abutment | - |
| Neoss Implant System | 3.25 | |
| Nobel Biocare | Brånemark System (External Hex) | NP, RP, WP |
| Hex | 2.0 | |
| Internal Hexagon | - | |
| Multi-Unit Abutment | NP/RP, WP | |
| Nobel Novum | - | |
| Nobel Replace (Internal Trilobe) | NP, RP, WP, 6.0 | |
| NobelActive (Conical Connection) | NP, RP, WP | |
| Replace Hex Abutment | 3.5, 4.3, 3.25HL,3.8/4.5 HL, 5.0 HL, 6.0 HL | |
| Osstem | TS & GS System | Mini 4.0, standard 4.5 |
| US System Esthetic Low | - | |
| US System Regular platform | - | |
| SIC Implants | Sic Platform | 3.3, 4.2 |
| Simpler Implants | Implant Analog | 3.25, 4.0 |
| Southern Implants | External Hex | 4.0, 5.0 |
| Straumann® | Bone Level | 3.3, 4.1/4.8 |
| Multi-base | NC 3.5, RC 4.5, RC 6.5 | |
| Octagon | 3.5, 4.8, 6.5 | |
| Ortho System | 4.2 | |
| SynOcta® | RN, WN | |
| Thommen Medical | SPI®RETAIN DIRECT System | - |
| SPI®VARIOmulti System | 4.0, 4.5, 5.0 | |
| VARIOeco system | 3.5, 4.0, 4.5, 5.0, 6.0 | |
| Titan implant | Internal Hex platform | 4.5, 5.7 |
| Zimmer® Dental | AdVent | 4.5 |
| Calcitek | 3.25, 4.0 | |
| Screw-Vent | 3.5, 4.5, 5.7 | |
| Specta-Cone | - | |
| Spline® Implant System | 3.25, 3.75/4.0, 5.0 | |
| SwissPlus® Implant System | 3.8, 4.8 |
The NobelProcera Overdenture Bar is compatible with the below implants and abutments:
ﺮ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ Nobel Biocare Traditional 510(k) Notification NobelProcera Overdenture Bar
August 2013
{2}------------------------------------------------
Nobel Biocare Traditional 510(k) Notification
NobelProcera Overdenture Bar
August 2013
:
・
{3}------------------------------------------------
Summary of testing to demonstrate Substantial Equivalence
A retrospective study of NobelProcera Overdenture Bar placed in the market globally since 2010 was performed to establish the safety and effectiveness of the additional implant and abutment interfaces. The NobelProcera Overdenture Bar data set of compatible implant and abutment interfaces were generated through measurements of original manufacturer's bar interfaces. Additionally, non-clinical test data was used to demonstrate substantial equivalence. Non-clinical testing consisted of performance of fatigue testing in accordance with the FDA guidance Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments.
MR conditional testing was conducted according to FDA Guidance Document "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment".
{4}------------------------------------------------
| CHARACTERISTIC | CANDIDATE | PREDICATE |
|---|---|---|
| Trade Name | NobelProcera Overdenture Bar | Procera Implant Bridge Overdenture (K090069) |
| Anatomical Site | Oral Cavity | Oral Cavity |
| Design/Construction | Patient specific / machined | Patient specific / machined |
| Device Material | Titanium alloy | Titanium alloy |
| Design MethodBar Order | Individually designed for each patient by order ofprescription | Individually designed for each patient by order ofprescription |
| Bar Shape | Fixed shaped barsDolder, Hader, Round | Fixed shaped barsDolder, Hader, Round |
| Platform Compatibility | Free form shaped barsMilled, Montreal, Paris, Victoria, Wrap-around | Free form shaped barsMilled, Montreal, Paris, Victoria, Wrap-around |
| See 'Indications for use statement' | Branemark System NP, RP, WPNobelReplace NP, RP, WP, 6.0NobelActive NP, RPMulti-unit NP/RP, WPAstra Tech Yellow, Aqua, LilacStraumman Octagon 3.5,4.8, 6.5Straumman Bone Level 3.3, 4.1/4.8BioMet 3i Internal 3.4, 3.75/4.0, 5.0, 6.0BioMet 3i External 3.4, 4.1, 5.0, 6.0Zimmer Screw-Vent 3.5, 4.5, 5.7Zimmer AdVent 4.5 | |
| RACTERISTIC | CANDIDATE | PREDICATE |
| Manufacturing | Nobel Procera Overdenture BarA master cast is received with the patient's impression.The Nobel Biocare's manufacturing facility scans themaster cast to create the manufacturing files. Then thedesign files are compiled for CAM using a CNC millingsystem. The machined Overdenture bar is inspected forfit against the master cast.The overdenture bar is sent to the laboratory forverification of fit and integration with a denture. | Procera Implant Bridge Overdenture(K090069).Procera Implant bridges can be designed either usingtraditional wax-up technique or by using Nobel's ProceraSoftware. When the wax-up technique is used, either themaster cast or a scan of the master cast can be sent toNobel for production. If the Procera Software is used, thedesign information is transmitted to Nobel for production.If necessary Nobel Biocare's manufacturing facility scansthe master cast to create the manufacturing files. Thenthe design files are compiled for CAM using a CNC millingsystem. The machined overdenture bar is sent to thelaboratory for verification and integration with a denture. |
| Denture Bar/AbutmentInterface | Nobel Biocare and additional manufacturers' implantand abutment interfaces | Nobel Biocare and other manufacturers' implant interfaces |
| Packaging | Plastic bag and cardboard box | Plastic bag and cardboard box |
| Sterility | Non-sterile | Non-sterile |
| Intended Use | Removable or fixed superstructure | Removable or fixed superstructure |
| Indications for Use | Compatible platforms added to indications for use. | The Procera Implant Bridge Overdenture is indicated foruse as an overdenture bar that attaches to implants orabutments in the treatment of partially or totallyedentulous jaws for the purpose of restoring chewingfunction. |
| MR Safety Information | No MR Safety information |
Comparison of Technological Characteristics
Nobel Biocare Traditional 510(k) Notification
NobelProcera Overdenture Bar
August 2013
{5}------------------------------------------------
Conclusion provided in this submission demonstrates that the device is substantially equivalent to the predicate device.
Nobel Biocare Traditional 510(K) Notification
NobelProcera Overdenture Bar
August 2013
{6}------------------------------------------------
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 24, 2014
Nobel Biocare AB C/O Ms. Phuong Nguyen Son Senior Regulatory Affairs Manager Nobel Biocare USA, Limited Liability Company 22715 Savi Ranch Parkway Yorba Linda. CA 92887
Re: K132749
Trade/Device Name: NobelProcera Overdenture Bar Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: June 26, 2014 Received: June 26, 2014
Dear Ms. Son:
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 - Ms. Son
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 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 You/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.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/7/Picture/7 description: The image shows the text "Mary Sumner - FDA". The text is in a bold, sans-serif font. The letters are black and the background is white. The letters are slightly distorted, as if they were printed on a textured surface. The text is arranged in a single line, with the words "Mary Sumner" on the left and "FDA" on the right. There is a hyphen between the words "Sumner" and "FDA".
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{8}------------------------------------------------
Indications for Use
510(k) Number (if known): K132749
Device Name: NobelProcera Overdenture Bar
Indications For Use:
The NobelProcera Overdenture Bar is indicated for use as an overdenture bar that attaches to implants or abutments in the treatment of partially edentulous jaws for the purpose of restoring chewing function.
The NobelProcera Overdenture Bar is compatible with the below implants and abutments:
| Manufacturer | Name | Sizes |
|---|---|---|
| 3I® (BioMet) | (Certain) Internal | 3.4, 3.75/4.0, 5.0, 6.0 |
| Conical Abutment | 3.4, 4.1/5.0, 6.0 | |
| External (hex) | 3.4, 4.1, 5.0, 6.0 | |
| AB Dental Devices | Narrow Platform | - |
| Alpha Bio | Internal Hex | 4.5 |
| TCT System | - | |
| Anthogyr | Anthofit® HE System Conical Abutment | 4.1 |
| Anthofit® OI System | 3.5 | |
| Anthofit® OI System Conical Abutment | 3.5 | |
| Axiom REG/PX Platform | 4.0 | |
| Axiom REG/PX Straight Conical Abutment | - | |
| BEGO Semados® | S/RI-Line | 3.25/3.75/4.1/4.5, 5.5 |
| BioHorizons® | Abutment for Screw | 3.5/4.0, 5.0 |
| Conical internal connection | 3.0, 3.5, 4.5, 5.7 | |
| External implant system | 3.5, 4.0, 5.0, 6.0 | |
| Single Stage Restoration | 3.5, 4.5, 5.7 | |
| Biotech DentalImplants | B.I.S. Conic | 3.5/3.9, 4.0/4.4, 5/5.4 |
| B.I.S. Conic Base Analog | 4.4 |
AND/OR Over-The-Counter Use Prescription Use X (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 3
{9}------------------------------------------------
| Manufacturer | Name | Sizes |
|---|---|---|
| BTI® | Externa® Platform (abutment level) | 4.1 |
| Externa® Platform (implant level) | 4.1 | |
| Interna® Platform | 4.1 | |
| Tiny® Platform | 3.5 | |
| Camlog® | Camlog Bar Abutment | 3.3, 3.8, 6.0 |
| Camlog Implant System | 3.3, 3.8, 4.3, 5.0, 6.0 | |
| CONELOG Implant System | 3.8 | |
| Dentsply (Ankylos®) | Balance Base Abutment | - |
| Balance Base Abutment Narrow | - | |
| Balance Base C | - | |
| Regular C/X Abutment | - | |
| Dentsply (Astra Tech®) | 20° UnlAbutment | 3.5/4.0 |
| 45° UniAbutment | 3.5/4.0 | |
| Astra ST | 3.5 | |
| Astra Tech | Yellow, Aqua, Lilac | |
| Dentsply (XIVE®) | FRIADENT® | 3.0, 3.4, 3.8, 4.5, 5.5 |
| FRIADENT® MP | 3.8, 4.5, 5.5 | |
| TG Platform | 3.4-4.5 | |
| Hiossen | ET III SA | mini, regular |
| HI-TEC Implants | Universal Unit System | - |
| Implant Direct | Attachment International | 3.25, 3.3 |
| Legacy™ | 3.0, 3.5, 4.5, 5.7 | |
| RePlant®/RePlus® | 3.5, 4.3, 5.0 | |
| Screwindirect | - | |
| Screwindirect | 5.0 | |
| ScrewPlant®/ScrewPlus® | 3.7, 4.7, 5.7 | |
| Implant Direct(Sybron) | Endopore® Internal Hex | 4.1 |
| Entegra™ External Hex | 3.5, 4.1, 5.0 | |
| PITT-EASY® Paracentric Line | 3.75, 4.0, 4.9 | |
| SybronPRO™ Series Hex | 3.5, 4.1 | |
| LifeCore Dental(Keystone) | Genesis System | 3.8, 4.5, 5.5 |
| PrimaConnex® System | 3.5, 4.1, 5.0/7.0/8.0 | |
| PrimaConnex® System Multi-unit | 3.5/4.1, WD | |
| Renova® Implant System | SDI 3.75, RDI 4.5 | |
| Restore® Implant System | SD 3.3, RD 3.75/4.0, WD | |
| Stage-1 system RDS | - | |
| MIS® | Internal Hex | - |
| Multi-Unit system | - | |
| Standard Platform | - | |
| Wide Interial Hex | - |
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 2 of 3
{10}------------------------------------------------
| Manufacturer | Name | Sizes |
|---|---|---|
| Neoss | Access Abutment | - |
| Neoss Implant System | 3.25 | |
| Nobel Blocare | Brånemark System (External Hex) | NP, RP, WP |
| Hex | 2.0 | |
| Internal Hexagon | - | |
| Multi-Unit Abutment | NP/RP, WP | |
| Nobel Novum | - | |
| Nobel Replace (Internal Trilobe) | NP, RP, WP, 6.0 | |
| NobelActive (Conical Connection) | NP, RP, WP | |
| Replace Hex Abutment | 3.5, 4.3, 3.25HL, 3.8/4.5HL, 5.0 HL, 6.0 HL | |
| Osslem | TS & GS System | Mini 4.0, standard 4.5 |
| US System Esthetic Low | - | |
| US System Regular platform | - | |
| SIC Implants | Sic Platform | 3.3, 4.2 |
| Simpler Implants | Implant Analog | 3.25, 4.0 |
| Southern Implants | External Hex | 4.0, 5.0 |
| Straumann® | Bone Level | 3.3, 4.1/4.8 |
| Multi-base | NC 3.5, RC 4.5, RC 6.5 | |
| Octagon | 3.5, 4.8, 6.5 | |
| Ortho System | 4.2 | |
| SynOcta® | RN, WN | |
| Thommen Medical | SPI®RETAIN DIRECT System | - |
| SPI®VARIOmulti System | 4.0, 4.5, 5.0 | |
| VARIOeco system | 3.5, 4.0, 4.5, 5.0, 6.0 | |
| Titan Implant | Internal Hex platform | 4.5, 5.7 |
| Zimmer® Dental | AdVent | 4.5 |
| Calcitek | 3.25, 4.0 | |
| Screw-Vent | 3.5, 4.5, 5.7 | |
| Specta-Cone | - | |
| Spline® Implant System | 3.25, 3.75/4.0, 5.0 | |
| SwissPlus® Implant System | 3.8, 4.8 | |
| Tapered abutment | 4.5 |
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NÈEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sheena A. Green
2014.07.24 14:04'00'
Page 3 of 3
§ 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.)