(90 days)
No
The 510(k) summary describes a standard dental implant system and its components, materials, and performance testing. There is no mention of AI, ML, image processing, or any data sets typically associated with AI/ML development or validation.
Yes
The device is a dental implant system intended for implantation to support dental prostheses and restore chewing function, which are therapeutic actions.
No
This device is an XL Dental Implant System intended for implantation and support for fixed or removable dental prostheses. It is a therapeutic device, not a diagnostic one.
No
The device description clearly outlines physical components made of titanium alloy, such as implants, cover screws, and abutments, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device implanted in the body to support dental prostheses and restore chewing function. This is a therapeutic and structural function, not a diagnostic one performed on samples taken from the body.
- Device Description: The device is a physical implant and associated components made of titanium alloy. This is consistent with a medical device for implantation, not a reagent, instrument, or system used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVD devices are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
The XL Dental Implant System is intended for implantation in the maxillary or mandibular molar region where bone exists and the surgeon has determined that the placement of a narrower diameter implant would increase the probability of failure due to poor primary stability, or increased surgical procedures leading to complications. This XL implant system provides support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses or full arch prostheses. It further adds the option for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
This submission includes threaded root-form dental implants with large diameter for use in the molar region. The implants are provided in diameters of 7, 8 and 9mm and lengths of 7, 9 and 11mm. This submission also includes mating components: Cover screws; Healing Abutments in varying diameters and cuff heights; Titanium Cylinder abutments for temporary restorations; Titanium Abutments in varying diameters and cuff heights for permanent restorations; and the abutment screw. The XL implants are manufactured from titanium alloy conforming to ASTM F136. The implants have a is grit blasted, acid etched (SLA) surface. The Cover Screw, Abutments and Abutment Screw are manufactured from titanium alloy conforming to ASTM F136.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Maxillary or mandibular molar region
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)
Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence include:
- sterilization validation according to ISO 11137-1, ISO 11137-2 and shelf life testing . referenced from K112795, as the packaging materials, process, and sterilization process are the same;
- biocompatibility evaluation in accordance with International Standard ISO 10993-1. ● "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process";
- Bacterial endotoxin (LAL) testing performed in accordance with the FDA guidance Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled Sterile on representative implants undergoing the same manufacturing, surface and packaging process (reference K112795), to ensure the devices meet established endotoxin limits. The test results met acceptance criteria of less than 20 endotoxin units (EU)/Device.
- . Modified surface analysis in accordance with the FDA guidance, Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments referenced from K112795, as the implant material and surface are the same.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Bacterial endotoxin (LAL) testing results met acceptance criteria of less than 20 endotoxin units (EU)/Device.
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.
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.
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.
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August 18, 2020
Keystone Dental Inc. Linda Jalbert VP, QARA 154 Middlesex Turnpike Burlington, Massachusetts 01803
Re: K201334
Trade/Device Name: Keystone Dental XL Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: May 15, 2020 Received: May 20, 2020
Dear Linda Jalbert:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for
Srinivas Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name Keystone Dental XL Dental Implant System
Indications for Use (Describe)
The XL Dental Implant System is intended for implantation in the maxillary or mandibular molar region where bone exists and the surgeon has determined that the placement of a narrower diameter implant would increase the probability of failure due to poor primary stability, or increased surgical procedures leading to complications. This XL implant system provides support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses or full arch prostheses. It further adds the option for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| [X] Prescription Use (Part 21 CFR 801 Subpart D) | [ ] Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for Keystone Dental. The logo consists of a blue circular graphic with white lines inside, followed by the word "Keystone" in blue, and the word "DENTAL" in red below it. The logo is simple and modern, and the colors are eye-catching.
K201334
510(k) SUMMARY Keystone Dental XL Dental Implant System
ADMINISTRATIVE INFORMATION
| Manufacturer Name | Keystone Dental, Inc.
154 Middlesex Turnpike
Burlington, MA 01803 USA
Telephone 781-328-3660 |
|--------------------------------|-------------------------------------------------------------------------------------------------------|
| Official Contact | Linda Jalbert
Email: ljalbert@keystonedental.com |
| Date Prepared: | 8/18/2020 |
| DEVICE NAME AND CLASSIFICATION | |
| Trade/Proprietary name | Keystone Dental XL Dental Implant System |
| Common name | Dental Implant |
| Classification name | Endosseous dental implant |
| Classification regulation | 21 CFR 872.3640, Class II |
| Product Code | DZE, NHA |
| Classification Panel | Dental Products Panel |
| Reviewing Branch | Dental Devices Branch |
LEGALLY MARKETED PREDICATE DEVICE
The primary predicate device is Southern Implants Ltd. Max Implant System, K071161. The reference devices are the Paltop Advanced Dental Implant System, K112795, the Keystone
4
Dental Genesis Implant System, K101545, and the Southern Implants Max Implant System, K191054.
INDICATIONS FOR USE STATEMENT
The XL Dental Implant System is intended for implantation in the maxillary or mandibular molar region where bone exists and the surgeon has determined that the placement of a narrower diameter implant would increase the probability of failure due to poor primary stability, or increased surgical procedures leading to complications. This XL implant system provides support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses or full arch prostheses. It further adds the option for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.
SUBJECT DEVICE DESCRIPTION
This submission includes threaded root-form dental implants with large diameter for use in the molar region. The implants are provided in diameters of 7, 8 and 9mm and lengths of 7, 9 and 11mm. This submission also includes mating components: Cover screws; Healing Abutments in varying diameters and cuff heights; Titanium Cylinder abutments for temporary restorations; Titanium Abutments in varying diameters and cuff heights for permanent restorations; and the abutment screw.
The XL implants are manufactured from titanium alloy conforming to ASTM F136. The implants have a is grit blasted, acid etched (SLA) surface. The Cover Screw, Abutments and Abutment Screw are manufactured from titanium alloy conforming to ASTM F136.
PERFORMANCE DATA
Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence include:
- sterilization validation according to ISO 11137-1, ISO 11137-2 and shelf life testing . referenced from K112795, as the packaging materials, process, and sterilization process are the same;
- biocompatibility evaluation in accordance with International Standard ISO 10993-1. ● "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process";
- Bacterial endotoxin (LAL) testing performed in accordance with the FDA guidance Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled Sterile on representative implants undergoing the same manufacturing, surface and packaging process (reference K112795), to ensure the devices meet established endotoxin limits. The test results met acceptance criteria of less than 20 endotoxin units (EU)/Device.
- . Modified surface analysis in accordance with the FDA guidance, Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments referenced from K112795, as the implant material and surface are the same.
5
EQUIVALENCE TO MARKETED DEVICE
The subject device is substantially equivalent in intended use, indications and design to the following legally marketed devices:
K071161, Endosseous Dental Implant, Southern Implants (Pty) Ltd
K112795, Paltop Dental Implant System
K101545, Keystone Dental Endosseous Dental Implant System
K191054, Max Dental Implant System, Southern Implants (Pty) Ltd
A comparison of the technological characteristics of the subject device and the primary predicate device K071161 and reference device, K191054 is provided in the following table.
| Comparison | Subject device | Primary Predicate device | Reference Predicate device |
|---|---|---|---|
| K201334, XL Dental Implant | |||
| System, | |||
| Keystone Dental | K071161, Endosseous Dental | ||
| Implant, Southern Implants | |||
| (Pty) Ltd | K191054, Max Dental | ||
| Implant, Southern | |||
| Implants (Pty) Ltd | |||
| Indications for use | |||
| statement | The XL Dental Implant System | ||
| is intended for implantation in | |||
| the maxillary or mandibular | |||
| molar region where bone exists | |||
| and the surgeon has determined | |||
| that the placement of a narrower | |||
| diameter implant would | |||
| increase the probability of | |||
| failure due to poor primary | |||
| stability, or increased surgical | |||
| procedures leading to | |||
| complications. This XL implant | |||
| system provides support for | |||
| fixed or removable dental | |||
| prostheses in a single tooth, | |||
| partially edentulous prostheses | |||
| or full arch prostheses. It further | |||
| adds the option for immediate | |||
| loading on single and | |||
| splinted multiple unit restorations | |||
| when good primary stability is | |||
| achieved and with appropriate | |||
| occlusal loading, to restore | |||
| chewing function. | MAX implant is intended for | ||
| implantation in the maxillary or | |||
| mandibular molar region where | |||
| bone exists and the surgeon has | |||
| determined that the placement of | |||
| a narrower diameter implant | |||
| would increase the probability of | |||
| failure due to poor primary | |||
| stability, or increased surgical | |||
| procedures leading to | |||
| complications. This MAX | |||
| implant provides support for | |||
| fixed or removable dental | |||
| prostheses in a single tooth, | |||
| partially edentulous prostheses or | |||
| full arch prostheses. It further | |||
| adds the option for immediate | |||
| loading on single and splinted | |||
| multiple unit | |||
| restorations when good primary | |||
| stability is achieved and with | |||
| appropriate occlusal loading, | |||
| to restore chewing function. | Southern Implants MAX | ||
| implant is intended for | |||
| implantation in the | |||
| maxillary or mandibular | |||
| molar region where bone | |||
| exists and the surgeon has | |||
| determined that the | |||
| placement of a narrower | |||
| diameter implant would | |||
| increase the probability of | |||
| failure due to poor primary | |||
| stability, or increased | |||
| surgical procedures leading | |||
| to complications. This | |||
| MAX implant provides | |||
| support for fixed or | |||
| removable dental | |||
| prostheses in a single tooth | |||
| partially edentulous | |||
| prostheses or full arch | |||
| prostheses. It further adds | |||
| the option for immediate | |||
| loading on single and | |||
| splinted multiple unit | |||
| restorations when good | |||
| primary stability is | |||
| achieved and with | |||
| appropriate occlusal | |||
| loading, to restore chewing | |||
| function. | |||
| Implant Design | |||
| Implant Diameter | 7, 8, 9mm | 8, 9mm | 6, 7, 8, 9mm |
| Implant Length | 7, 9, 11mm | 7, 9, 11, 13mm | 6, 7, 9, 11mm |
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| Implant Connection | Internal Hex | External hex | External hex, internal hex and internal tri-lobe |
|---|---|---|---|
| Material | Titanium Alloy (ASTM F136) | Unalloyed titanium (ASTM F67) | CPTiGr4 (Grade 4 Ti) |
| Implant endosseous surface | Grit-blasted, Acid Etched | Grit-blasted | Grit-blasted |
| Platform diameter | Ø5.7, 6.5, 7.5 mm | 6.5, 7.5mm | Ø4.5, 5.5, 5.7, 6.5, 7.5mm |
| Packaging*/steriliza | |||
| tion | Sealed implant vial/ Gamma Radiation | Implant vial in sealed tray/ Gamma Radiation | Implant vial in sealed tray/ |
| Gamma Radiation | |||
| Cover Screw | |||
| Material | Titanium Alloy (ASTM F136) | Unalloyed titanium (ASTM F67) | Unalloyed titanium |
| (ASTM F67) | |||
| Healing Abutment | |||
| Collar height | 3, 5mm | 4, 5.5, 7mm | 3, 5, 6mm |
| Collar diameter | 7, 8, 9mm | 8mm | 6, 7, 7.8mm |
| Material | Titanium Alloy (ASTM F136) | Unalloyed titanium (ASTM F67) | Unalloyed titanium |
| (ASTM F67) | |||
| Titanium | |||
| Abutments | |||
| Collar height | 1, 3mm | 1mm | 1, 3mm |
| Abutment Angle | 0° | 0° | 0° |
| Abutment Material | Titanium Alloy (ASTM F136) | Unalloyed titanium (ASTM F67) | Unalloyed titanium |
| (ASTM F67), anodized | |||
| Abutment Screw | |||
| Material | Titanium Alloy (ASTM F136) | Titanium Alloy (ASTM F136) | Titanium Alloy (ASTM |
| F136) or Gold Alloy | |||
| Temporary | |||
| Abutment | |||
| Design | Cylinder with retention grooves | Cylinder with retention grooves | N/A |
| Collar height | 1 mm | 1 mm | N/A |
| Abutment Angle | 0° | 0° | N/A |
| Abutment Material | Titanium Alloy (ASTM F136) | Grade 3 or Grade 4 Ti | N/A |
| * Packaging of subject device is the same as that of reference predicate device, Paltop Dental Implant System, K112795 |
7
The Indications for Use for the subject device is the same as that of the primary predicate device K071161 and reference predicate device K191054, the Southern Implants Max Dental implant system. The subject device implants have the same design as the implants in K071161 and K191054 with the use of Titanium Alloy in accordance with ASTM F136 as the implant material. This Titanium Alloy material is common in the dental implant industry and the same as is used in other predicate devices.
The subject device has the same material, surface, internal hex connection and packaging as the reference device K112795, Paltop Dental Implants (a Keystone Dental Group company). The subject device has the same abutment design as the reference predicate device K101565.
Like the predicate devices, the subject device components are for single use and are provided sterile. Substantial equivalence of the subject device components in terms of biocompatibility is supported by the fact that materials are identical in formulation. processing, and component interfaces to reference devices K112795.
CONCLUSION
The subject device and the predicate and reference devices have the same intended use, technological characteristics, and materials. The subject device and the predicate and reference devices encompass the same range of physical dimensions, including diameter and length of the implants, and the design of the abutments. The subject device and the reference predicate devices are packaged in the same materials and sterilized using the same method and processes.
The data included in this submission demonstrate substantial equivalence to the predicate and reference devices listed above.