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.

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.

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.

AI/ML Overview

The provided document is a 510(k) summary for a medical device (SuperLine dental implants) and does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document discusses substantial equivalence to predicate devices based on non-clinical data and design comparisons.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study demonstrating device performance against those criteria.

Summary

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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.

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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

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Indications for Use

510(k) Number (if known) K213599

Device Name

SuperLine

Indications for Use (Describe)

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, LLC12264 El Camino Real, Suite 400San 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

SUBJECT DEVICE DESCRIPTION

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 compatible with previously-cleared abutments and prosthetic components from Dentium Co., Ltd., including those cleared in K192436, K141457, and K041368.

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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 < 20 EU/device;

shelf life testing (referenced from K160965) including testing of samples according to ASTM F1929 and F88/F88M (packaging sterile barrier) and sterility testing of product:

and surface area analysis showing substantial equivalence to K092035.

No clinical data were included in this submission.

EQUIVALENCE TO MARKETED DEVICES

The subject device is substantially equivalent in indications and design principles to the primary predicate device and the additional predicate devices listed above. Provided at the end of this summary is a table comparing the Indications for Use Statements and the technological characteristics of the subject device, the primary predicate device, and the additional predicate devices.

The Indications for Use Statement (IFUS) for the subject device is identical to that of the primary predicate device K160965, except for the addition of the language regarding delayed loading for single tooth cases on 7 mm length implants.

All IFUS include language regarding placement in the mandible or maxilla for support of prosthetic devices; differences in the specific wording do not change the intended use (functional and esthetic rehabilitation of the edentulous mandible or maxilla) of these devices. The IFUS for K123988, K120414, K023113, and K092035 include language regarding surgical protocols, immediate and delayed loading, and limitations for specific device sizes. These differences in the specific wording of the IFUS also do not change the intended use of these devices.

The subject device FXSxxxB Series implants are identical in design and sizes (implant body diameter, platform diameter) to SuperLine implants cleared in K160965 except for the leneth of 7 mm. The FXSxxxxB Series implants have 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); this feature is the same as the implants cleared in K160965. All FXSxxxxB Series implants have a total (overall) length of 7 mm, and endosseous threaded and surface treated lengths ranging from of 6.98 mm to 6.4 mm.

The subject device FXSxxxx Series implants are provided in the same body diameters and platform diameters as implants cleared in K160965, but have a total (overall) length of 7 mm, and have a machined collar height of 1.5 mm (for all implant sizes). This machined collar height is substantially equivalent to that of implants cleared in K023113 (Replace TiUnite Endosseous Implant, Nobel Biocare USA, Inc.).

The subject device implants are provided in body diameters of 3.6 mm to 5.8 mm, each with an overall length of 7 mm. This range of subject device implant diameters, with 7 mm length, is substantially

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equivalent to that of implants cleared in K120414 (diameters 3-5.4 mm in lengths 6-17mm, OsseoSpeed™ Plus, Astra Tech AB), and to that of implants cleared in K123988 (diameters 4.8-7.3 mm with a length of 7 mm, AnyOne™ Internal Implant System, MegaGen Implant Co., Ltd).

The subject device implants with the overall length of 7 mm are substantially equivalent in surface area to Bicon implants cleared in K092035. An analysis was performed comparing the surface area of the subject device implant with smallest implantable surface area of the Bicon implant with a diameter of 4 mm and length of 5 mm.

All subject device implants are manufactured from the same unalloyed titanium and have the same gritblasted and acid-etched surface treatment as the dental implants cleared in K160965. The subject device implants are compatible with previously-cleared abutments and prosthetic components from Dentium Co., Ltd., including those cleared in K192436, K141457, and K041368.

All subject device implants components are provided sterile by gamma irradiation, the same sterilization method used in K160965.

CONCLUSION

The subject device, the primary predicate device, and the additional predicate devices have the same intended use, have similar technological characteristics, and are made of identical materials. The subject device, the primary predicate device, and the additional predicate devices encompass the same range of physical dimensions, are packaged in similar materials, and are sterilized using similar methods.

The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.

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Table of Substantial Equivalence

Features	Subject DeviceK213599	Primary Predicate DeviceK160965	Additional Predicate DeviceK123988	Additional Predicate DeviceK120414	Additional Predicate DeviceK023113	Additional Predicate DeviceK092035
	SuperLineDentium Co., Ltd.	SuperLineDentium Co., Ltd.	AnyOne™ Internal Implant SystemMegaGen Implant Co., Ltd	OsseoSpeed™ PlusAstra Tech AB	Replace TiUnite Endosseous ImplantNobel Biocare USA, Inc.	Bicon Implants with a 2.5mmInternal ConnectionBicon, LLC
Indications for UseStatement	SuperLine® implants are indicated for use insurgical and restorative applications forplacement in the bone of the upper or lower jawto provide support for prosthetic devices, suchas artificial teeth, in order to restore the patient'schewing function. SuperLine® implants areindicated also for immediate loading when goodprimary stability is achieved and withappropriate occlusal loading. Single tooth caseson 7 mm length implants are indicated fordelayed loading.	SuperLine is indicated for use in surgical andrestorative applications for placement in thebone of the upper or lower jaw to providesupport for prosthetic devices, such as artificialteeth, in order to restore the patient's chewingfunction. SuperLine is indicated also forimmediate loading when good primary stabilityis achieved and with appropriate occlusalloading.	The AnyOne™ Internal Implant System isintended to be surgically placed in the maxillaryor mandibular molar areas for the purposeproviding prosthetic support for dentalrestorations (Crown, bridges, and overdentures)in partially or fully edentulous individuals. It isused to restore a patient's chewing function.Smaller implants (less than Ø6.0 mm) arededicated for immediate loading when goodprimary stability is achieved and withappropriate occlusal loading. Larger implants arededicated for the molar region and are indicatedfor delayed loading	Implants:The Astra Tech Dental Implants are intended forboth one- and two-stage surgical procedures inthe following situations and with the followingclinical protocols:• replacing single and multiple missing teeth inthe mandible and maxilla,• immediate placement in extraction sites and insituations with a partially or completely healedalveolar ridge,• especially indicated for use in soft boneapplications where implants with other implantsurface treatments may be less effective,• immediate loading in all indications, except insingle tooth situations on implants shorter than 8mm or in soft bone (type IV) where implantstability may be difficult to obtain andimmediate loading may not be appropriate.The intended use for OsseoSpeed™ Plus 3.0S islimited to replacement of maxillary lateralincisors and mandibular incisors.Complete Indications for Use statement isprovided in this section.	The Nobel Biocare Replace TiUnite EndosseousImplant is intended to be placed in the upper orlower jaw to support prosthetic devices such asartificial teeth, and to restore patient's chewingfunction. This may be accomplished using a twostage surgical procedure or a single stagesurgical procedure.If the single stage surgical procedure is used,these implants may be loaded immediatelyfollowing insertion - provided - at least fourimplants are placed and splinted with a bar.These implants must be placed predominantly inthe anterior mandible (between the mentalforaminae) where good initial stability of theimplants with or without bi-cortical anchorage,can most often be obtained.	The Bicon implant is designed for use inedentulous sites in the mandible or maxilla forsupport of a complete denture prosthesis, a finalor intermediate abutment for fixed bridgeworkor for partial dentures, or as a single toothreplacement.
Reason for Predicate Device	Not applicable	Implant designs, materials,manufacturing, sterilization	Implant design, diameters and shorterlength	Implant design, diameters and shorterlength	Implant body with machined collar	Performance testing data(surface area analysis)
Product Codes	DZE	DZE	DZE, NHA	DZE	DZE	DZE, NHA
Intended Use	Functional and esthetic rehabilitation ofthe edentulous mandible or maxilla	Functional and esthetic rehabilitation of theedentulous mandible or maxilla	Functional and esthetic rehabilitation of theedentulous mandible or maxilla	Functional and esthetic rehabilitation of theedentulous mandible or maxilla	Functional and esthetic rehabilitation of theedentulous mandible or maxilla	Functional and esthetic rehabilitation ofthe edentulous mandible or maxilla
Implant Designs
Prosthetic InterfaceConnection	Tapered conical hex	Tapered conical hex	Internal hex	Internal taper	Internal Tri-Channel	Internal
Implant SizesBody/Platform DiameterandLength	SuperLine FXSxxxB SeriesBody/Platform Diameters3.6/3.6; 4.0/4.0; 4.5/4.5; 5.0/5.0 mmEach in 7 mm length only	SuperLine II (US Marketing Name)Body/Platform Diameters3.6/3.6; 4.0/4.0; 4.5/4.5; 5.0/5.0 mmEach in lengths of 8, 10, 12, 14 mmandBody/Platform Diameters5.0/6.0; 5.8/7.0 mmEach in lengths of 8, 10, 12 mm	Body diameters3.9 mm - 7.3 mm ('normal thread')4.8 mm - 8.3 mm ('deep thread')4.8, 5.3, 6.3, 7.3 mm ('special length')Lengths ('Height' in 510(k) Summary)7.0 - 14.5 mm (normal and deep thread)7.0 mm (special length)	Body diameters 3.0 mm - 5.4 mmLengths 6 mm - 17 mmBody diameter 3.0 mm, lengths 8-15 mmBody diameter 3.6 mm, lengths 6-17 mmBody diameter 4.2 mm, lengths 6-17 mmBody diameter 4.8 mm, lengths 6-17 mmBody diameter 5.4 mm, lengths 6-17 mm	Body diameters 3.5, 4.3, 5.0, 6.0 mmLengths 10, 13, 16 mm	2.5 mm Well Short ImplantsBody diameter 4.0 mm, lengths 5, 8, 11mmBody diameter 4.5 mm, lengths 8, 11 mm
Body/Platform DiametersLength	SuperLine FXSxxxx Series3.6/3.6; 4.0/4.0; 4.5/4.5; 5.0/5.0; 5.0/6.0;5.8/7.0 mmEach in 7 mm length only
Implant Material	All implants: unalloyed titanium, ASTMF67	All implants: unalloyed titanium, ASTMF67	Commercially pure titanium, grade 4	Commercially pure titanium, grade 4	Commercially pure titanium, grade 4	Ti-6Al-4V alloy
Implant Endosseous Surface	All implants:S.L.A., Al2O3 blasted and acid etched	All implants:S.L.A., Al2O3 blasted and acid etched	S.L.A.	OsseoSpeed (micro-roughened andfluoride-modified surface)	TiUnite (titanium oxide layer)	Integra-CP® (hydroxyapatite coated),Integra-Ti® (grit-blasted and acid etched)

Regulation Number and Section

§ 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.