(93 days)
BioHorizons Tapered Internal Implants K143022
No
The description focuses on the physical components, materials, and mechanical testing of the dental implant system. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML.
Yes.
Explanation: The device, an Insight Dental Implant System, is intended for use as an artificial root structure for single tooth replacement or fixed bridgework and dental retention. Since it is replacing a missing body part, it is considered a therapeutic device.
No
Explanation: The device is described as an artificial root structure for tooth replacement and fixed bridgework, and its components include implants, abutments, and healing caps. It is used to support prosthetic devices, not to diagnose a condition.
No
The device description explicitly details physical components made of titanium (implants, abutments, healing caps) and mentions manufacturing processes, sterilization, and physical testing (fatigue, surface treatment, cytotoxicity, shelf life). This indicates it is a hardware medical device, not software-only.
Based on the provided information, the Insight Dental Implant System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for use in the mandible or maxilla as an artificial root structure. This is an in vivo application (within a living organism), not an in vitro application (outside the body, typically on biological samples).
- Device Description: The description details physical implants, abutments, and healing caps designed to be surgically placed in the jawbone.
- Performance Studies: The performance studies focus on mechanical fatigue, surface treatment, cytotoxicity of the materials, and sterilization – all relevant to a surgically implanted device. There are no studies related to analyzing biological samples or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Insight Dental Implant System does not perform this function.
N/A
Intended Use / Indications for Use
The Insight Dental Implant System is intended for use in the mandible or maxilla as an artificial root structure for single tooth replacement or fixed bridgework and dental retention. The Insight Dental Implant System is intended for delayed loading.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
The Insight Dental Implant System is an integrated system of endosseous dental implants which are designed to support prosthetic devices for partially or fully endetulous patients. The Insight Dental Implant System consists of one-stage and two-stage root form dental implants and abutments, which provide the dentist with screw retained restoration options. The devices covered by this submission are implants, abutments, and healing caps.
Implants are manufactured from titanium and feature a blasted finish on the threaded screw surface. The implants are provided in bone level and tissue level. The diameters of the implant fixtures are 3.5mm, 3.8mm, 4.6mm and 5.4mm; the lengths are 8.0mm, 10.0mm, and 12.0mm and is defined as the threaded implanted portion of the implant.
Abutments are available in both standard and angled configurations. Abutments are manufactured from titanium. Standard abutments are straight, 4.6mm in diameter and sized for every implant diameter including 3.5mm, 4.6mm and 5.4mm. Angled abutments are 17°, 4.9mm in diameter and sized for every implant diameter including 3.5mm, 3.8mm, 4.6mm and 5.4mm.
Healing caps are manufactured from titanium. The diameter of each healing cap matches an implant at 3.5mm, 3.8mm, 4.6mm and 5.4mm. Healing caps are straight.
The dental implants provided consist of a straight wall or tapered body type with a basic screw-type design in various platform options and feature an internal connection and antirotation feature. Insight Dental Implant System is available with either prevail platform switching feature or standard collar.
The Insight Dental System is packaged in a two section sterile tray with all of the implants and instruments needed for a single procedure included. All components of the system are intended for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandible or maxilla
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)
The technological characteristics of the Insight Dental Implant System have been verified to be essentially the same as the predicate devices based on assessments of material composition, dimensional features, mechanical properties and biocompatibility of the implant and instrument materials. Comparative Dynamic Fatigue testing was performed to show equivalence to the predicate device. This testing was performed according to ISO-14801-2007, Dynamic fatigue test for endosseous dental implants for both bone level and tissue level implants.
Surface treatment was evaluated using SEM images, X-ray spectroscopy and auger electron spectroscopy of titanium surfaces.
Cytotoxicity testing according to ISO 10993-5 was also done on the implants materials to demonstrate that the manufacturing process did not change the biocompatibility profile. No additional biocompatibility testing was deemed necessary since the devices are constructed from medical quality titanium.
Shelf life testing has been conducted by accelerated aging according to ASTMF1980-07 and a 1 year shelf life has been established. Shelf life testing included visual inspection, seal strength and bubble testing.
Insight Dental Implant kits are sterilized by gamma irradiation was done to IS01137-1. The Sterility Assurance Level (SAL) for the product sterilization process is 10. Dosage is a minimum of 25 kGy exposure. Validation was done using the VDmax 25 method (ISO 11137-2). Devices are not labeled as non-pyrogenic.
No clinical test data was used to support the decision of substantial equivalence.
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.
BioHorizons Tapered Internal Implants K143022
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.
BioHorizons Laser-Lok 3.0 Implant System K093321, BioHorizons Tapered Internal Implant System K071638
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
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
0
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 27, 2017
Insight Dental System c/o David Furr Regulatory Correspondent FDC Services 8708 Capehart Cove Austin, Texas 78733
Re: K170211
Trade/Device Name: Insight Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: March 31, 2017 Received: April 3, 2017
Dear David Furr:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K170211
Device Name Insight Dental Implant System
The Insight Dental Implant System is intended for use in the mandible or maxilla as an artificial root structure for single tooth replacement or fixed bridgework and dental retention. The Insight Dental Implant System is intended for delayed loading.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary Pursuant to 21 CFR 807.92
Date: April 17, 2017 K170211
| 1. | Submitted By: | Insight Dental System
4766 Research Drive
San Antonio, Texas 78240
888-255-7935 |
|----|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. | Contact: | David C. Furr
FDC Services, LLC
8708 Capehart Cove
Austin, Texas 78733
512-906-9654 |
| 3. | Product: | Insight Dental Implant System
Regulation:
21CFR§872.3640 Class II
Product Codes:
DZE Implant, Endosseous, Root Form
NHA Abutment, Implant, Dental, Endosseous |
| 4. | Trade Name:
Common Name:
Regulation Name: | Insight Dental Implant System
Dental Implant & Abutment System
Endosseous Dental Implant |
| 5. | Primary Predicate: | BioHorizons Tapered Internal Implants K143022 |
| 6. | Reference Predicates: | BioHorizons Laser-Lok 3.0 Implant System K093321
BioHorizons Tapered Internal Implant System K071638 |
Description:
The Insight Dental Implant System is an integrated system of endosseous dental implants which are designed to support prosthetic devices for partially or fully endetulous patients. The Insight Dental Implant System consists of one-stage and two-stage root form dental implants and abutments, which provide the dentist with screw retained restoration options. The devices covered by this submission are implants, abutments, and healing caps.
Implants are manufactured from titanium and feature a blasted finish on the threaded screw surface. The implants are provided in bone level and tissue level. The diameters of the implant fixtures are 3.5mm, 3.8mm, 4.6mm and 5.4mm; the lengths are 8.0mm, 10.0mm, and 12.0mm and is defined as the threaded implanted portion of the implant.
4
510(k) Premarket Notification Insight Dental Implant System
Abutments are available in both standard and angled configurations. Abutments are manufactured from titanium. Standard abutments are straight, 4.6mm in diameter and sized for every implant diameter including 3.5mm, 4.6mm and 5.4mm. Angled abutments are 17°, 4.9mm in diameter and sized for every implant diameter including 3.5mm, 3.8mm, 4.6mm and 5.4mm.
Healing caps are manufactured from titanium. The diameter of each healing cap matches an implant at 3.5mm, 3.8mm, 4.6mm and 5.4mm. Healing caps are straight.
The dental implants provided consist of a straight wall or tapered body type with a basic screw-type design in various platform options and feature an internal connection and antirotation feature. Insight Dental Implant System is available with either prevail platform switching feature or standard collar.
The Insight Dental System is packaged in a two section sterile tray with all of the implants and instruments needed for a single procedure included. All components of the system are intended for single use only.
Indications for Use:
The Insight Dental Implant System is intended for use in the mandible or maxilla as an artificial root structure for single tooth replacement or for fixed bridgework and dental retention. The Insight Dental Implant System is intended for delayed loading.
Substantial Equivalence/Technological Characteristics:
The subject device is substantially equivalent to the BioHorizons Tapered Internal Implant System which is based on BioHorizons premarket notification (K143022). BioHorizon premarket notifications K071638 and K093321 were also used as reference predicate devices.
The subject device and the predicate devices have a similar intended use, design, technological characteristics, principals of operation, and are made of the same materials. The subject device and predicate devices encompass a similar range of physical dimensions, including diameter and length of the implants and diameter, height, and angle of the abutments. The subject and predicate devices are packaged in similar materials and sterilized using irradiation. Any differences do not raise new issues of substantial equivalence.
5
510(k) Premarket Notification Insight Dental Implant System
| Element of
Comparison | 510(k) Device:
Insight Dental System | Primary Predicate Device:
BioHorizons Tapered Internal
Implant System K143022 | Reference Device:
BioHorizons Laser-Lok 3.0
Implant System K093321 | Reference Device:
BioHorizons Tapered
Internal Implant System
K071638 | Explanation of
Differences |
|-------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation and
Product
Classification
Code | 21 CFR 872.3640
DZE
NHA | 21 CFR 872.3640
DZE
21 CFR 872.3630
NHA | 21 CFR 872.3640
DZE
21 CFR 872.3630
NHA | 21 CFR 872.3640
DZE
21 CFR 872.3630
NHA | None |
| Indications for Use | The Insight Dental Implant
System is intended for use in
the mandible or maxilla as an
artificial root structure for
single tooth replacement or
for fixed bridgework and
dental retention. The Insight
Dental Implant System is
intended for delayed loading. | The BioHorizons
Tapered Internal Implant
System is intended for use in
the mandible or maxilla as an
artificial root structure for
single tooth replacement or for
fixed bridgework and dental
retention. The BioHorizons
Tapered Implant System may
be restored immediately (1)
with a temporary prosthesis
that is not in functional
occlusion or (2) when splinted
together for multiple
tooth replacement or when
stabilized with an overdenture
supported by multiple
implants. | The BioHorizons
Tapered Internal Implant
System is intended for use in
the mandible or maxilla as an
artificial root structure for
single tooth replacement or
for fixed bridgework and
dental retention. The
BioHorizons Tapered Implant
System may be restored
immediately (1) with a
temporary prosthesis that is
not in functional occlusion or
(2) when splinted together for
multiple
tooth replacement or when
stabilized with an overdenture
supported by multiple
implants. | The BioHorizons
Tapered Internal Implant
System is intended for use in
the mandible or maxilla as
an artificial root structure for
single tooth replacement or
for fixed bridgework and
dental retention. The
BioHorizons Tapered
Implant System may be
restored immediately (1)
with a temporary prosthesis
that is not in functional
occlusion or (2) when
splinted together for multiple
tooth replacement or when
stabilized with an
overdenture supported by
multiple implants. | The IDS device is
intended for
delayed loading but
differences are not
significant when
used. |
| Principal Material
Formulation of
Implants | Ti-6AL-4V-ELI | Ti-6AL-4V-ELI | Ti-6AL-4V-ELI | Ti-6AL-4V-ELI | Identical |
| Implant Shape,
Diameters and
Length | Tapered Shape
3.5, 3.8, 4.6, 5.4mm diameters
8.0, 10.0, 12.0 mm implanted
Lengths | Tapered Shape
3.0, 3.5, 4.5mm diameters
9.0, 10.5, 12.0, 15, 18mm
Lengths | Parallel wall with 2.5mm
apical taper
3.0mm diameter
10.5, 12.0, 15mm Lengths | Tapered Shape
3.5, 4.5, 5.7mm diameters
7.5, 9.0, 10.5, 12.0, 15mm
Lengths | BioHorizons has a
slightly smaller and
larger size, but
subject device is
bracketed within the
limits of the
predicate. No
significant
differences. |
| Element of
Comparison | 510(k) Device:
Insight Dental System | Primary Predicate Device:
BioHorizons Tapered Internal
Implant System K143022 | Reference Device:
BioHorizons Laser-Lok 3.0
Implant System K093321 | Reference Device:
BioHorizons Tapered
Internal Implant System
K071638 | Explanation of
Differences |
| Abutments | Abutment diameters
3.5, 3.8, 4.6, 5.4mm | N/A (references to K093321) | Abutment diameters
3.5, 3.8, 4.2, 4.5, 4.7, 5.5, 5.8,
5.9, 6.6, 6.8mm | N/A | BioHorizons has
slightly different
and larger sizes, but
subject device is
bracketed within the
limits of the
predicate. No
significant
differences. |
| Principal Material
Formulation of
Abutments | Ti-6AL-4V-ELI | Ti-6AL-4V-ELI | Ti-6AL-4V-ELI | Ti-6AL-4V-ELI | Identical |
| Healing caps | Healing cap diameters
3.5, 3.8, 4.6 and 5.4mm | N/A (references to K093321) | Healing cap diameters
3, 3.5, 4.5, 5.7mm | N/A | BioHorizons has
slightly different
and larger sizes, but
subject device is
bracketed within the
limits of the
predicate. No
significant
differences. |
| Principal Material
Formulation of
Healing caps | Ti-6AL-4V-ELI | Ti-6AL-4V-ELI | Ti-6AL-4V-ELI | Ti-6AL-4V-ELI | Identical |
| Principal Material
Formulation of
Class I Accessories | Stainless Steel | Stainless Steel | Stainless Steel | Stainless Steel | No significant
differences |
| Packaging | Tyvek Lidded Blister Tray | Tyvek Lidded Blister Tray | Tyvek Lidded Blister Tray | Tyvek Lidded Blister Tray | No significant
differences |
| Sterility | Single Use Gamma Sterilized | Single Use Gamma Sterilized | Single Use Gamma Sterilized | Single Use Gamma Sterilized | Identical |
6
510(k) Premarket Notification Insight Dental Implant System
7
Summary of Testing
The technological characteristics of the Insight Dental Implant System have been verified to be essentially the same as the predicate devices based on assessments of material composition, dimensional features, mechanical properties and biocompatibility of the implant and instrument materials. Comparative Dynamic Fatigue testing was performed to show equivalence to the predicate device. This testing was performed according to ISO-14801-2007, Dynamic fatigue test for endosseous dental implants for both bone level and tissue level implants.
Surface treatment was evaluated using SEM images, X-ray spectroscopy and auger electron spectroscopy of titanium surfaces.
Cytotoxicity testing according to ISO 10993-5 was also done on the implants materials to demonstrate that the manufacturing process did not change the biocompatibility profile. No additional biocompatibility testing was deemed necessary since the devices are constructed from medical quality titanium.
Shelf life testing has been conducted by accelerated aging according to ASTMF1980-07 and a 1 year shelf life has been established. Shelf life testing included visual inspection, seal strength and bubble testing.
Insight Dental Implant kits are sterilized by gamma irradiation was done to IS01137-1. The Sterility Assurance Level (SAL) for the product sterilization process is 10 . Dosage is a minimum of 25 kGy exposure. Validation was done using the VDmax 25 method (ISO 11137-2). Devices are not labeled as non-pyrogenic.
No clinical test data was used to support the decision of substantial equivalence.
Conclusion:
In accordance with the Federal Food. Drug and Cosmetic Act. 21 CFR Part 807, and based on the information provided in this premarket notifications the Insight Dental Implant System is substantially equivalent to predicate devices as described herein.