(100 days)
No
The 510(k) summary describes dental implants and their physical characteristics, materials, and compatibility with existing components. There is no mention of AI or ML technology in the intended use, device description, or performance studies.
Yes.
The device is intended to restore the patient's chewing function by providing support for prosthetic devices (artificial teeth) in the jawbone, which directly alleviates a medical condition (loss of chewing function).
No
Explanation: The SuperLine implants are prosthetic devices designed to support artificial teeth and restore chewing function. They are not used to diagnose a medical condition.
No
The device description clearly details physical dental implants made of titanium, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for surgical and restorative applications in the jawbone to support prosthetic devices and restore chewing function. This is a direct therapeutic and structural application within the body.
- Device Description: The description details the physical characteristics of dental implants, including materials, dimensions, and surface treatments. These are all components of a medical device intended for implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. IVDs are used in vitro (outside the body) for analysis.
Therefore, the SuperLine® implants described are medical devices, specifically dental implants, and not IVDs.
N/A
Intended Use / Indications for Use
SuperLine® implants are indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. SuperLine® implants are indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Single tooth cases on 7 mm length implants are indicated for delayed loading.
Product codes
DZE
Device Description
The purpose of this submission is to add dental implants to the SuperLine components cleared in K160965. This submission includes two series of implants: SuperLine FXSxxxxB Series and SuperLine FXSxxxx Series.
The FXSxxxB Series has a machined collar height that ranges from 0.03 mm (on the 3.6 mm body diameter implant) to 0.6 mm (on the 5.0 mm body diameter implant). All FXSxxxxB Series implants have an endosseous length of 7 mm, and threaded lengths ranging from of 6.98 mm to 6.4 mm. Other than the endosseous length of 7 mm, the subject device FXSxxxB implants are identical in design and sizes to SuperLine implants cleared in K160965.
The FXSxxxx Series has machined collar 1.5 mm in height for all implant body diameter sizes. For body diameters 4.0 mm to 5.8 mm, the collar has a reverse taper. All FXSxxxx Series implants have an endosseous length of 7 mm, and a threaded length of 5.5 mm. The FXSxxxx series implant design has not been cleared previously by FDA for any body diameter or length.
| Implant Series | Body Ø, mm | Platform Ø, mm | Collar Height, mm | Total Length, mm |
|---|---|---|---|---|
| FXSxxxxB Series | 3.6 | 3.6 | 0.03 | 7 |
| 4.0 | 4.0 | 0.2 | 7 | |
| 4.5 | 4.5 | 0.35 | 7 | |
| 5.0 | 5.0 | 0.6 | 7 | |
| FXSxxxx Series | 3.6 | 3.6 | 1.5 | 7 |
| 4.0 | 4.0 | 1.5 | 7 | |
| 4.5 | 4.5 | 1.5 | 7 | |
| 5.0 | 5.0 | 1.5 | 7 | |
| 5.0 | 6.0 | 1.5 | 7 | |
| 5.8 | 7.0 | 1.5 | 7 |
The subject device SuperLine dental implants are summarized in the following table.
All subject device implants are manufactured from the same unalloyed titanium conforming to ASTM F67 and have the same surface treatment (S.L.A., Al2O3 blasted and acid etched) as the dental implants cleared in K160965.
All subject device implants are compatible with previously-cleared abutments and prosthetic components from Dentium Co., Ltd., including those cleared in K192436, K141457, and K041368.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone of the upper or lower jaw
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 included:
gamma irradiation sterilization for all subject devices (to a sterility assurance level of 10th by selecting and substantiating a 25 kGy dose using method VDmax25, according to ISO 11137-1 and ISO 11137-2, referenced from K160965);
bacterial endotoxin testing (referenced from K160965) including Limulus amebocyte lysate (LAL) test according to ANSI/AAMI ST72 on samples of water used in manufacturing on a bimonthly basis and on samples from sterilized product on a quarterly basis to demonstrate all sterile product meets a limit of
§ 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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Dentium Co., Ltd. % Kevin Thomas Vice President and Director of Regulatory Affairs PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130
Re: K213599
Trade/Device Name: SuperLine Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: January 21, 2022 Received: January 24, 2022
Dear Kevin Thomas:
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 (QS) 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.
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT 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) K213599
Device Name
SuperLine
Indications for Use (Describe)
SuperLine® implants are indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. SuperLine® implants are indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Single tooth cases on 7 mm length implants are indicated 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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510(k) Summary K213599 SuperLine Dentium Co., Ltd. February 23, 2022
ADMINISTRATIVE INFORMATION
| Manufacturer Name | Dentium Co., Ltd. |
|---|---|
| 76, Changnyong-daero 256beon-gil | |
| Suwon-si, Gyeonggi-do, 16229, Korea | |
| Telephone +82-070-7098-7568 | |
| Fax +82-31-888-5595 | |
| Official Contact | Eunsang Lee, Team Manager of Regulatory Affairs |
| Representative/Consultant | Kevin A. Thomas, PhD |
| Floyd G. Larson, MS, MBA | |
| PaxMed International, LLC | |
| 12264 El Camino Real, Suite 400 | |
| San Diego, CA 92130 | |
| Telephone +1 858-792-1235 | |
| Fax +1 858-792-1236 | |
| Email kthomas@paxmed.com | |
| flarson@paxmed.com |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name | SuperLine |
|---|---|
| Common Names | Endosseous dental implant |
| Regulation Number | 21 CFR 872.3640 |
| Regulation Name | Endosseous dental implant |
| Regulatory Class | Class II |
| Product Code | DZE |
| Classification Panel | Dental |
| Reviewing Office | Office of Health Technology 1 (Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices) |
| Reviewing Division | Division of Health Technology 1 B (Dental Devices) |
PREDICATE DEVICE INFORMATION
Primary Predicate Device K160965, SuperLine, Dentium Co., Ltd.
Additional Predicate Devices K123988, AnyOne™ Internal Implant System, MegaGen Implant Co., Ltd K120414, OsseoSpeedTM Plus, Astra Tech AB K023113, Replace TiUnite Endosseous Implant, Nobel Biocare USA, Inc. K092035, Bicon Implants with a 2.5mm Internal Connection, Bicon, LLC
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510(k) Summary Page 2 of 5
INDICATIONS FOR USE STATEMENT
SuperLine® implants are indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. SuperLine® implants are indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Single tooth cases on 7 mm length implants are indicated for delayed loading.
SUBJECT DEVICE DESCRIPTION
The purpose of this submission is to add dental implants to the SuperLine components cleared in K160965. This submission includes two series of implants: SuperLine FXSxxxxB Series and SuperLine FXSxxxx Series.
The FXSxxxB Series has a machined collar height that ranges from 0.03 mm (on the 3.6 mm body diameter implant) to 0.6 mm (on the 5.0 mm body diameter implant). All FXSxxxxB Series implants have an endosseous length of 7 mm, and threaded lengths ranging from of 6.98 mm to 6.4 mm. Other than the endosseous length of 7 mm, the subject device FXSxxxB implants are identical in design and sizes to SuperLine implants cleared in K160965.
The FXSxxxx Series has machined collar 1.5 mm in height for all implant body diameter sizes. For body diameters 4.0 mm to 5.8 mm, the collar has a reverse taper. All FXSxxxx Series implants have an endosseous length of 7 mm, and a threaded length of 5.5 mm. The FXSxxxx series implant design has not been cleared previously by FDA for any body diameter or length.
| Implant Series | Body Ø, mm | Platform Ø, mm | Collar Height, mm | Total Length, mm |
|---|---|---|---|---|
| FXSxxxxB Series | 3.6 | 3.6 | 0.03 | 7 |
| 4.0 | 4.0 | 0.2 | 7 | |
| 4.5 | 4.5 | 0.35 | 7 | |
| 5.0 | 5.0 | 0.6 | 7 | |
| FXSxxxx Series | 3.6 | 3.6 | 1.5 | 7 |
| 4.0 | 4.0 | 1.5 | 7 | |
| 4.5 | 4.5 | 1.5 | 7 | |
| 5.0 | 5.0 | 1.5 | 7 | |
| 5.0 | 6.0 | 1.5 | 7 | |
| 5.8 | 7.0 | 1.5 | 7 |
The subject device SuperLine dental implants are summarized in the following table.
All subject device implants are manufactured from the same unalloyed titanium conforming to ASTM F67 and have the same surface treatment (S.L.A., Al2O3 blasted and acid etched) as the dental implants cleared in K160965.
All subject device implants are compatible with previously-cleared abutments and prosthetic components from Dentium Co., Ltd., including those cleared in K192436, K141457, and K041368.
5
PERFORMANCE DATA
Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence included:
gamma irradiation sterilization for all subject devices (to a sterility assurance level of 10th by selecting and substantiating a 25 kGy dose using method VDmax25, according to ISO 11137-1 and ISO 11137-2, referenced from K160965);
bacterial endotoxin testing (referenced from K160965) including Limulus amebocyte lysate (LAL) test according to ANSI/AAMI ST72 on samples of water used in manufacturing on a bimonthly basis and on samples from sterilized product on a quarterly basis to demonstrate all sterile product meets a limit of