(153 days)
Not Found
No
The summary describes a physical dental abutment system with a specific surface treatment (Laser-Lok) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device itself does not actively treat a disease or condition; it is a component of a dental implant system used for restoration. While it aids in tissue healing, its primary function is structural.
No
The device description indicates it is an abutment system used for cementing prostheses and tissue contouring, which are restorative and therapeutic functions, not diagnostic.
No
The device description clearly states it is an "abutment system comprised of machined titanium endosseous dental implant healing abutments and final restorative abutments," indicating it is a physical hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The description clearly states that this device is an "abutment system comprised of machined titanium endosseous dental implant healing abutments and final restorative abutments." These are physical components implanted in the body to support dental prostheses.
- Intended Use: The intended use is for "cementing a prosthesis" and is compatible with dental implant systems. This is a restorative dental procedure, not a diagnostic test performed on a specimen.
- Lack of IVD Characteristics: The text does not mention any analysis of biological samples, reagents, or diagnostic purposes.
Therefore, the BioHorizons Simple Solutions with Laser-Lok abutment system is a medical device, specifically a dental implant component, but it is not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
BioHorizons Simple Solutions with Laser-Lok is an abutment system that includes healing abutments for contouring tissue and final restorative abutments for cementing a prositiesis. The abutment system may be used for a single or multiple unit restoration and is compatible for use with BioHorizons Internal and Tapered Internal implant systems and Zimmer Dental ScrewVent and Tapered ScrewVent implants with 3:5mm, 4.5mm and 5.7mm internal hex-connection, mating platform diameters.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
BioHorizons Simple Solutions with Laser-Lok is an abutment system comprised of machined titanium endosseous dental implant healing abutments and final restorative abutments supplied in platform diameters of 3.5mm, 4.5mm and 5.7mm with collar heights of 0.8mm, 1.8mm and 2.8mm. Abutment material is titanium alloy as specified in ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications.
The devices are further processed by applying patterns of micro-machined grooves or channels, known as Laser-Lok, to a specified portion of the abutment margin. The product is packaged using materials known in the industry to be appropriate for medical device packaging and is provided with a minimum sterility assurance level of 10°, 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
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
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 internal-connection implants that were either fully RBT treated or 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 0.7-mm laser-ablated microchanneled zone consistently enabled intense fibroblastic activity to occur on the abutment-orooved surface, resulting in an interlacing complex of connective tissue fibers onented perpendicular to the abutment surface that served as a physiologic barrier to apical JE migration.
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.
K073282, K073268, K071638, K013227, K093321
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).
Not Found
§ 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
KD0988
510(k) Premarket Notification
BioHorizons Simple Solutions with Laser-Lok
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 Specialist |
| Date prepared: | August 12, 2010 |
SEP 0 9 2010
Name of the Device
| Trade Name: | BioHorizons Simple Solutions with Laser-Lok® |
|---|---|
| Common or Usual Name: | Dental implant abutment |
| Classification Name: | Endosseous dental implant abutment |
| Classification Number: | Class II (21 CFR 872.3630) |
Predicate Devices
-
- BioHorizons Single-stage Implant System, documented under 510(k) number K073282, concurrence date of February 15, 2008.
-
- 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 3. K071638, concurrence date of October 10, 2007.
-
- Zimmer Dental (formerly Sulzer Dental) ScrewVent and Tapered ScrewVent systems, documented under 510(k) number K013227, concurrence date of November 19, 2001.
-
- BioHorizons Laser-Lok 3.0 Implant System, documented under K093321, concurrence date of April 2, 2010.
Device Description
BioHorizons Simple Solutions with Laser-Lok is an abutment system comprised of machined titanium endosseous dental implant healing abutments and final restorative abutments supplied in platform diameters of 3.5mm, 4.5mm and 5.7mm with collar heights of 0.8mm, 1.8mm and 2.8mm. Abutment material is titanium alloy as specified in ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications.
The devices are further processed by applying patterns of micro-machined grooves or channels, known as Laser-Lok, to a specified portion of the abutment margin. The product is packaged using materials known in the industry to be appropriate for medical device packaging and is provided with a minimum sterility assurance level of 10°, 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.
1
Intended Use
BioHorizons Simple Solutions with Laser-Lok is an abutment system that includes healing abutments for contouring tissue and final restorative abutments for cementing a prosthesis. The abutment system may be used for a single or multiple unit restoration and is compatible for use with BioHorizons Internal and Tapered Internal implant systems and Zimmer Dental ScrewVent and Tapered ScrewVent implants with 3.5mm. 4.5mm and 5.7mm internal hex-connection mating platform diameters.
Compatibility Testing
Compatibility testing was performed on a representative subset of Zimmer ScrewVent and Tapered ScrewVent implants. The subset included the following Zimmer item numbers: TSVB8, TSV4B11, TSV4B13, TSVH13, TSV4H10, TSV4H11, TSV4H16, TSVWH10, TSVWH11, TSVWH13, TSVWH16, TSV6B8, TSV6H8, TSV6H10, TSV6H11 and TSV6H13. This testing verifies compatibility with all Zimmer ScrewVent and Tapered ScrewVent items listed in the following table based on equivalent mating platform geometry.
| Platform | Zimmer Tapered
ScrewVent
Implants* | Zimmer
ScrewVent
Implants* | Simple Solutions
Healing
Abutments | Simple Solutions
Abutments |
|------------------------------|------------------------------------------|----------------------------------|------------------------------------------|-------------------------------------------------------|
| 3.5mm Internal
Connection | TSVBx
TSV4Bx
TSVHx
TSV4Hx | SVMBx
SVBx
SVMHx
SVHx | PYHA08L
PYHA18L
PYHA28L | PY4008L PY5508L
PY4018L PY5518L
PY4028L PY5528L |
| 4.5mm Internal
Connection | TSVWBx
TSVWHx | SVWBx
SVWHx | PGHA08L
PGHA18L
PGHA28L | PG4008L PG5508L
PG4018L PG5518L
PG4028L PG5528L |
| 5.7mm Internal
Connection | TSV6Bx
TSV6Hx | N/A | PBHA08L
PBHA18L
PBHA28L | PB4008L PB5508L
PB4018L PB5518L
PB4028L PB5528L |
- Where variable x = implant length
Technological Characteristics
The fundamental scientific technology of the BioHorizons Simple Solutions with Laser-Lok is substantially equivalent to the existing abutments that are designed to mate with the implant components of the referenced predicate devices. The devices are further processed by applying Laser-Lok to a specified region of the abutment margin.
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 (K073282, K073268 and K071638), and the Laser-Lok feature is substantially equivalent to that cleared for the BioHorizons Laser-Lok 3.0 Implant System (K093321). The BioHorizons Simple Solutions with Laser-Lok, which is the subject of this 510(k), is substantially
2
equivalent to all features of the predicate implant devices which could affect safety or effectiveness because of the similarities in design, materials and intended use.
Summary of Testing
The data presented in this 510(k) submission supports the substantial equivalence of the BioHorizons Simple Solutions with Laser-Lok 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 internal-connection implants that were either fully RBT treated or 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 0.7-mm laser-ablated microchanneled zone consistently enabled intense fibroblastic activity to occur on the abutment-orooved surface, resulting in an interlacing complex of connective tissue fibers onented perpendicular to the abutment surface that served as a physiologic barrier to apical JE migration.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Michael Davis Regulatory Affairs Specialist Biohorizons Implant Systems, Incorporated 2300 Riverchase Center Birmingham, Alabama 35244
SEP 0 9 2010
Re: K100985
Trade/Device Name: Bio-Horizons Simple Solutions with Laser-Lok Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: August 25, 2010 Received: August 30, 2010
Dear Mr. Davis:
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.
4
Page 2- Mr. Davis
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 (OS) 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/CDRHQffices/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,
Susan Runner
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
Enclosure
5
510(k) Number: K100985
K100985 SEP 0 9 2010
Device Name: BioHorizons Simple Solutions with Laser-Lok®
Indications for Use:
BioHorizons Simple Solutions with Laser-Lok is an abutment system that includes healing abutments for contouring tissue and final restorative abutments for cementing a prositiesis. The abutment system may be used for a single or multiple unit restoration and is compatible for use with BioHorizons Internal and Tapered Internal implant systems and Zimmer Dental ScrewVent and Tapered ScrewVent implants with 3:5mm, 4.5mm and 5.7mm internal hex-connection, mating platform diameters.
Prescription Use × (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)
Suen Runner
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number. K100985