(315 days)
No
The 510(k) summary describes physical dental implants and abutments and does not mention any software, algorithms, or AI/ML capabilities.
No
The device is a dental implant system, which is a medical device for tooth replacement and restoration, not typically classified as a "therapeutic device" in the conventional sense of treating a disease or condition. While it rehabilitates function, its primary purpose is replacement.
No
This device is a dental implant system used for supporting dental restorations in edentulous or partially edentulous patients. Its intended use is for implantation and support, not for diagnosis.
No
The device description and performance studies clearly indicate that this is a physical dental implant and associated hardware (fixture-mounts/abutments), not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as dental implants and abutments used for surgical procedures in the mouth to support dental restorations. This is a direct medical intervention within the body.
- Device Description: The description details the physical characteristics of the implants and abutments, which are physical devices implanted into bone.
- Performance Studies: The performance studies focus on mechanical properties (fatigue, pull-out, insertion torque), biocompatibility, sterilization, and shelf life – all relevant to an implanted medical device, not an in vitro diagnostic test.
- Anatomical Site: The anatomical site is the upper and lower jaws, which are parts of the human body.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (like blood, urine, tissue), detecting specific analytes, or providing diagnostic information based on in vitro testing.
In vitro diagnostics are tests performed on samples taken from the body to provide information about a person's health. This device is a physical implant used to replace missing teeth, which falls under the category of a medical device, not an IVD.
N/A
Intended Use / Indications for Use
Legacy2, simplyLegacy2, Legacy3, simplyLegacy3, and Legacy4 dental implants are two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.
- Narrow (3.2mmD) implants: Indicated for single-tooth replacement (mandibular central and lateral incisors; maxillary lateral incisors), multiple-tooth replacements or denture stabilization.
- Short (
§ 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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services-USA. To the right, the FDA logo is displayed in blue, with the words "U.S. FOOD & DRUG" above the word "ADMINISTRATION".
June 25, 2020
Implant Direct Sybron Manufacturing, LLC % Kelliann Payne Partner Hogan & Lovells US LPP 1735 Market Street Floor 23 Philadelphia, Pennsylvania 19103
Re: K192221
Trade/Device Name: Legacy2, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture-mounts Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: May 27, 2020 Received: May 27, 2020
Dear Kelliann Payne:
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
542 of the Act); 21 CFR 1000-1050.
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-
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
510(k) Number (if known)
Device Name
Legacy2, Legacy4, simplyLeaacy2, simplyLegacy3 dental implants; Legacy2, Legacy4 fixture-mounts Indications for Use (Describe)
Legacy2, simplyLegacy2, Legacy3, simplyLegacy3, and Legacy4 dental implants for one-stage of two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
Implants can be indicated for immediate loading when stability has been achieved and with appropriate occlusal loading.
- Narrow (3.2mmD) implants: Indicated for single-tooth replacement (mandibular central and lateral incisors), multiple-tooth replacements or denture stabilization.
- . Short ( Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) SUMMARY
Implant Direct LLC's
Legacy2, Legacy3, Legacy4, simplyLegacy2, and simplyLegacy3 Dental Implants; Legacy2, Legacy3, and Leqacy4 Fixture-mounts
| Submitter:
Address: | Implant Direct Sybron Manufacturing LLC
3050 East Hillcrest Drive
Thousand Oaks, CA 91362 | | | |
|------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|
| Phone:
Contact Person: | 818-444-3306
Reina Choi, Regulatory Affairs Manager | | | |
| Date Prepared: | June 25, 2020 | | | |
| Name of Device: | Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental
implants; Legacy2, Legacy3, Legacy4 fixture-mounts | | | |
| Common or Usual Name:
Classification Name:
Regulatory Class:
Primary Product Code:
Secondary Product Code: | Endosseous dental implants
21 C.F.R. § 872.3640 (Endosseous dental implants);
Class II
DZE
NHA | | | |
| Predicate Device: | Implant Direct LLC's Spectra-System Dental Implants 2008 (now
Legacy3 Dental Implant) (K090234) | | | |
| Reference Devices: | lmplant Direct LLC's Legacy3 Implants (6mm Length) (K131097);
Implant Direct LLC's Legacy Abutment System (K060063);
Implant Direct LLC's Custom Legacy and Custom InterActive
Titanium Abutments (K192218) | | | |
Device Description
The Legacy2, Legacy4, and simplyLegacy2 implants have implant body and are supplied in similar dimensions. This 510(k) notice includes the Legacy3 dimensions previously cleared in K090234 and K131097; the Legacy3 (7.0mmD) is the same as the previously cleared Legacy3, but in a wider diameter.
The top approximate one-third of the implant body is straight, and the lower approximate two-thirds is tapered with progressively deeper buttress-threads. The Legacy3 implant body also features progressively deeper buttress threads, with quadruple-lead micro-threads at the coronal aspect; this implant body is evenly tapered. Each implant features a color-coded internal hex with a lead-in bevel. The simplyLegacy2 and simplyLegacy3 implants are identical to the Legacy3 implants, respectively, except that they are supplied without the corresponding fixturemount/abutment.
The table below outlines the body diameters, platform diameters, and lengths in which each Legacy implant model is available.
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Dimensions of Subject Implants
| Subject Implants | Body
Diameter | Platform
Diameter | Implant Length |
|---------------------------------------------------------------------|------------------|----------------------|----------------------------------------------|
| Legacy2,
simplyLegacy2,
Legacy3,
simplyLegacy3,
Legacy4 | 3.2mmD | 3.0mmD | 8, 10, 11.5, 13, 16mm |
| | 3.7mmD | 3.5mmD | 8, 10, 11.5, 13, 16mm |
| | 4.2mmD | 3.5mmD | 8, 10, 11.5, 13, 16mm |
| | 4.7mmD | 4.5mmD | 6 (only simplyLegacy), 8, 10, 11.5, 13, 16mm |
| | 5.2mmD | 4.5mmD | 6 (only simplyLegacy), 8, 10, 11.5, 13, 16mm |
| Legacy2,
simplyLegacy2,
Legacy3,
simplyLegacy3,
Legacy4 | 5.7mmD | 5.7mmD | 6 (only simplyLegacy), 8, 10, 11.5, 13, 16mm |
| Legacy2,
simplyLegacy2,
Legacy3,
simplyLegacy3,
Legacy4 | 7.0mmD | 5.7mmD | 6 (only simplyLegacy), 8, 10, 11.5, 13mm |
The Legacy2 and Legacy3 implants have a one-piece fixture-mount, and the Legacy4 implant has a two-piece fixture-mount. The Legacy fixture-mounts serve (1) as a transfer, to carry the implant to the ostectory and help with placement if desired; (2) to take an impression after implant placement, to guide fabrication of the patient-specific dental restoration; and (3) as an abutment.
All of the subject devices are made of Titanium alloy, are single-use, and come into contact with patient tissue/bone for a long-term or permanent duration. The implants are supplied with one of two surface modifications/coatings:
- . Soluble Blast Media (SBM);
- Hydroxyapatite (HA) per ASTM F1185. ●
Legacy2, Legacy3, and Legacy4 implants are available with either surface modification/coating; simplyLegacy2 and simplyLegacy3 are only available with SBM.
The devices are supplied sterile; the fixture-mounts, if modified for use as abutments, must also be sterilized by the end user prior to intra-oral use.
Intended Use / Indications for Use
Legacy2, simplyLegacy2, Legacy3, simplyLegacy3, and Legacy4 dental implants are two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.
- . Narrow (3.2mmD) implants: Indicated for single-tooth replacement (mandibular central and lateral incisors; maxillary lateral incisors), multiple-tooth replacements or denture stabilization.
- Short (