(321 days)
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No
The document describes dental implant abutments and their materials, intended use, and performance testing. There is no mention of AI or ML technology in the device description, intended use, or performance studies.
No.
The device description and intended use indicate that the abutments are used to support a prosthesis on dental implants and aid in tissue contouring, which are structural and functional support roles, not direct therapeutic treatment. The performance studies describe mechanical testing and healing patterns, not therapeutic efficacy.
No
Explanation: This device is described as an abutment, which is a component used to support a prosthesis in dental implant systems. Its intended use and description focus on its mechanical function and material composition, not on diagnosing medical conditions or diseases.
No
The device description explicitly states the abutments are comprised of physical materials like titanium alloy, zirconia ceramic, gold alloy, and PEEK. It also describes physical processing (Laser-Lok) and packaging for sterilization. This indicates a physical medical device, not a software-only one.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly states that these are abutments for supporting a prosthesis in dental implant procedures. This is a surgical/restorative application, not a diagnostic one.
- Device Description: The description details the materials and manufacturing of dental implant abutments. There is no mention of reagents, calibrators, controls, or any components typically associated with in vitro diagnostic tests.
- Lack of IVD-related information: The document does not mention any of the key characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device is a medical device used in a surgical procedure to support a dental prosthesis.
N/A
Intended Use / Indications for Use
BioHorizons Abutments for Zimmerare abutments that include healing abutments for contouring tissue and final restorative abutments to support a prosthesis. The contouring tissue and final rootena.vo and restoration and are compatible for abuthents may be assurfor a Single of the nal implant systems and Zimmer use with Blondons internal and Tapered Screw-Vent® implants with 3.5mm and 5.7mm internal hex-connection mating platform diameters.
BioHorizons Titanium Base Abutments and Laser-Lok Titanium Base Abutments are intended to be used to be used as straight abutments.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
BioHorizons Abutments for Zimmer are comprised of endosseous dental implant healing abutments and final restorative abutments supplied in platform diameters of 3.5mm, 4.5mm and 5.7mm. Abutment materials are titanium alloy as specified in ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401), zirconia ceramic as specified in ISO 13356 Implants for surgery - Ceramic materials based on yttriastabilized tetragonal zirconia (Y-TZP), Gold Alloy 6019 and PEEK as specified in ASTM F2026 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications (temporary abutments only).
Select abutments are further processed by applying patterns of micro-machined grooves or channels, known as Laser-Lok, to a specified portion of the abutment margin. Abutments provided sterile are packaged using materials known in the industry to be appropriate for medical device packaging and are provided with a minimum sterility assurance level of 108, validated in compliance with ANSI/AAMI/ISO 11137-1 Sterilization of healthcare products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices and ANSI/AAMI/ISO 11137-2 Sterilization of healthcare products -- Radiation -- Part 2: Establishing the sterilization dose.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A prospective study was conducted in a canine model to evaluate bone and soft tissue healing patterns when Laser-Lok microgrooves are applied to dental implant abutments. The study consisted of four cohorts - Group A: Laser-Lok healing abutment on an RBT implant; Group B: Laser-Lok healing abutment on an RBT implant with a machined area; Group C: Machined healing abutment on an RBT implant; and Group D: Machined healing abutment on an RBT implant with a machined area. Laser-Lok and machined-surface healing abutments were randomly assigned to internalconnection implants that were either fully RBT-treated with a 0.3mm machined collar. Each group received nine implants with abutments placed at the time of surgery. The results demonstrate significant improvement in peri-implant hard and soft tissue healing on the Laser-Lok healing abutments as compared to traditional machined abutment surfaces.
Nevins et al concluded that the presence of the laser-ablated microchanneled zone consistently enabled intense fibroblastic activity to occur on the abutment-grooved surface, resulting in an interlacing complex of connective tissue fibers oriented perpendicular to the abutment surface that served as a physiologic barrier to apical JE migration.
Mechanical testing has been performed on the subject devices in accordance with the Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments, May 12, 2004 and ISO 14801. The results of the maximum load and fatigue load testing demonstrate that the subject devices are substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K100985, K073268, K071638, K013227, K092403, K073553, K071838, K083496, K100152, K102804
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.)
0
510(k) Summary 21 CFR 807.92
Submitter's Name & Address
| Manufacturer: | BioHorizons Implant Systems, Inc.
2300 Riverchase Center
Birmingham, AL 35244
Phone (205) 967-7880
Fax (205) 870-0304 |
|-------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Official contact: | Michael Davis, Regulatory Affairs Manager |
| Date prepared: | November 4, 2011 |
Name of the Device
| Trade Name: | BioHorizons Abutments for Zimmer® |
|---|---|
| Common or Usual Name: | Dental implant abutment |
| Classification Name: | Endosseous dental implant abutment |
| Classification Number: | Class II (21 CFR 872.3630) |
Predicate Devices
-
- BioHorizons Simple Solutions with Laser-Lok, documented under 510(k) number K100985, concurrence date September 9, 2010.
-
- BioHorizons Internal Implant System, documented under 510(k) number K073268, concurrence date of February 8, 2008.
-
- BioHorizons Tapered Internal Implant System, documented under 510(k) number K071638, concurrence date of October 10, 2007.
-
- Zimmerly Dental (formerly Sulzer Dental) Screw-Vent® and Tapered Screw-Vente systems, documented under 510(k) number K013227, concurrence date of November 19, 2001.
-
- Zimmer Dental Ti Prepable Abutment, documented under 510(k) number K092403, concurrence date of October 30, 2009.
-
- Altatec GmbH CAMLOG Implant System Abutments, documented under 510(k) number K073553, concurrence date of March 5, 2008.
-
- Neoss Ltd. various Titanium Abutments, documented under 510(k) number K071838, concurrence date of October 19, 2007.
-
- Altatec GmbH CAMLOG Implant System Modified Implants and Abutments, documented under 510(k) number K083496, concurrence date of January 30, 2009.
-
- Sirona Dental CAD/CAM System, documented under 501(k) number K100152, concurrence date of October 22, 2010.
-
- Thommen Medical AG SPI Titanium Base for CAD/CAM, documented under 510(k) number K102804, concurrence date of April 20, 2011.
Device Description
BioHorizons Abutments for Zimmer are comprised of endosseous dental implant healing abutments and final restorative abutments supplied in platform diameters of 3.5mm, 4.5mm and 5.7mm. Abutment materials are titanium alloy as specified in ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401), zirconia ceramic as specified in ISO 13356 Implants for surgery - Ceramic materials based on yttriastabilized tetragonal zirconia (Y-TZP), Gold Alloy 6019 and PEEK as specified in ASTM
1
F2026 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications (temporary abutments only).
Select abutments are further processed by applying patterns of micro-machined grooves or channels, known as Laser-Lok, to a specified portion of the abutment margin. Abutments provided sterile are packaged using materials known in the industry to be appropriate for medical device packaging and are provided with a minimum sterility assurance level of 108, validated in compliance with ANSI/AAMI/ISO 11137-1 Sterilization of healthcare products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices and ANSI/AAMI/ISO 11137-2 Sterilization of healthcare products -- Radiation -- Part 2: Establishing the sterilization dose.
Intended Use
BioHorizons Abutments for Zimmer are abutments that include healing abutments for contouring tissue and final restorative abutments to support a prosthesis. The abutments may be used for a single or multiple unit restoration and are compatible for use with BioHorizons Internal and Tapered Internal implant systems and Zimmer Dental Screw-Vent® and Tapered Screw-Vent® implants with 3.5mm, 4.5mm and 5.7mm internal hex-connection mating platform diameters.
BioHorizons Titanium Base Abutments and Laser-Lok Titanium Base Abutments are intended to be used as straight abutments.
Compatibility Testing
Compatibility testing was performed on a representative subset of Zimmer® Screw-Vent® and Tapered Screw-Vent® implants. The subset included the following Zimmer TSVB8. TSV4B11. TSV4B13. TSVH13. TSV4H10. TSV4H11. item numbers: TSV4H16, TSVWH10, TSVWH11, TSVWH13, TSVWH16, TSV6B8, TSV6H8, TSV6H10, TSV6H11 and TSV6H13. This testing verifies compatibility of BioHorizons Abutments for Zimmer® with all Zimmer® Screw-Vent® and Tapered Screw-Vent® items listed in the following table based on equivalent mating platform geometry.
| Platform | Zimmer® Tapered Screw-Vent®
Implants* | Zimmer® Screw-Vent® Implants* |
|------------------------------|------------------------------------------|--------------------------------|
| 3.5mm Internal
Connection | TSVBx
TSV4Bx
TSVHx
TSV4Hx | SVMBx
SVBx
SVMHx
SVHx |
| 4.5mm Internal
Connection | TSVWBx
TSVWHx | SVWBx
SVWHx |
| 5.7mm Internal
Connection | TSV6Bx
TSV6Hx | N/A |
- Where variable x = implant length
Technological Characteristics
The fundamental scientific technology of the BioHorizons Abutments for Zimmer® is substantially equivalent to the existing abutments that are designed to mate with the implant components of the referenced predicate devices. Select devices are further processed by applying Laser-Lok to a specified region of the abutment margin.
2
Laser-Lok is a surface feature in which patterns of micro-machined grooves are applied to the abutment margin, providing a roughened surface to establish a physical. connective tissue attachment (unlike Sharpey fiber attachment). This tissue connection:
-
- is functionally oriented,
-
- inhibits epithelial cell downgrowth and
-
- enables crestal bone attachment adjacent to the implant.
All materials, suppliers, processing, packaging and sterilization methods remain the same as those utilized for the predicate BioHorizons implant systems (K073268 and K071638), and the Laser-Lok feature is substantially equivalent to that cleared for the BioHorizons Simple Solutions with Laser-Lok (K100985). The BioHorizons Abutments for Zimmer®, which are the subject of this 510(k), are substantially equivalent to all features of the predicate abutment and implant devices which could affect safety or effectiveness because of the similarities in design, materials and intended use.
Summary of Testing
In addition to the compatibility testing described previously, the data presented in this 510(k) submission supports the substantial equivalence of the BioHorizons Abutments for Zimmer® to the specified predicate devices with respect to performance, safety and effectiveness. A prospective study was conducted in a canine model to evaluate bone and soft tissue healing patterns when Laser-Lok microgrooves are applied to dental implant abutments. The study consisted of four cohorts - Group A: Laser-Lok healing abutment on an RBT implant; Group B: Laser-Lok healing abutment on an RBT implant with a machined area; Group C: Machined healing abutment on an RBT implant; and Group D: Machined healing abutment on an RBT implant with a machined area. Laser-Lok and machined-surface healing abutments were randomly assigned to internalconnection implants that were either fully RBT-treated with a 0.3mm machined collar. Each group received nine implants with abutments placed at the time of surgery. The results demonstrate significant improvement in peri-implant hard and soft tissue healing on the Laser-Lok healing abutments as compared to traditional machined abutment surfaces.
Nevins et al concluded that the presence of the laser-ablated microchanneled zone consistently enabled intense fibroblastic activity to occur on the abutment-grooved surface, resulting in an interlacing complex of connective tissue fibers oriented perpendicular to the abutment surface that served as a physiologic barrier to apical JE migration.
Mechanical testing has been performed on the subject devices in accordance with the Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments, May 12, 2004 and ISO 14801. The results of the maximum load and fatigue load testing demonstrate that the subject devices are substantially equivalent to the predicate devices.
Conclusion
The clinical and nonclinical data presented in this submission indicates that the new devices are safe and effective for their intended use and perform as well or better than the referenced predicate devices.
Zimmer and Screw-Vent are trademarks of Zimmer, Inc. and/or one of its subsidiaries.
3
Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three curved lines that resemble a human figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DEC - 8 2011
BioHorizons Implant Systems, Inc. Michael Davis Regulatory Affairs Manager 2300 Riverchase Center Birmingham, AL 35244
Re: K103691
Trade/Device Name: BioHorizons Abutments for Zimmer Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: June 30, 2011 Received: July 1, 2011
Dear Mr. Davis:
This letter corrects our substantially equivalent letter of November 3, 2011
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 (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.
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 in Register.
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Page - 2 Mr. Davis
ー.. 10.000 ... 10.000
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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Antmony D. aratan
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
5
Indications for Use
510(k) Number: K103691
Device Name: BioHorizons Abutments for Zimmer®
Indications for Use:
BioHorizons Abutments for Zimmer® are abutments that include healing abutments for contouring tissue and final restorative abutments to support a prosthesis. The contouring tissue and final rootena.vo and restoration and are compatible for abuthents may be assurfor a Single of the nal implant systems and Zimmer use with Blondons internal and Tapered Screw-Vent® implants with 3.5mm and 5.7mm internal hex-connection mating platform diameters.
BioHorizons Titanium Base Abutments and Laser-Lok Titanium Base Abutments are intended to be used to be used as straight abutments.
Prescription Use __ x (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runser
(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital
Division of Anesthesion of Anesthesion of Anesther Division of Antrol, Dental Devices
510(k) Number: K103691