(321 days)
MegaGen Prosthetics are intended for use as an aid in prosthetic rehabilitation.
The Healing Abutment is designed to aid in soft tissue contouring the healing period after implant placement, creating an emergence profile before a final restoration is placed. The Scan Healing Abutment Screw is used to connect the Healing Abutment to the endosseous implant. The Healing Abutments are several types depending on the anatomic location. There are Incisor Type, Canine Type, Molar Type, Special type suitable for the patient's oral environment. The Cover Screw is used for protecting the inner structure of a fixture, and exposed fixture platform after fixture placement. It is used for submerged type surgery. It is sterilized using gamma irradiation during manufacturing process. It is single use devices.
The provided text is a 510(k) Summary for the MegaGen Implant Co., Ltd.'s Healing Abutment and Cover Screw. This document is a regulatory submission to the FDA demonstrating substantial equivalence to legally marketed predicate devices, not a study reporting on specific acceptance criteria and performance data in the traditional sense of a clinical trial or performance study against pre-defined metrics.
Therefore, the information required for topics like acceptance criteria, reported device performance (with quantifiable metrics), sample sizes for test sets, data provenance, expert ground truth, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, and training set details are not explicitly present or applicable in the provided regulatory summary.
Here's an analysis of what can be extracted and what is explicitly not available based on your request:
1. Table of acceptance criteria and the reported device performance
This information is not provided in the document. The 510(k) summary focuses on demonstrating "substantial equivalence" to predicate devices, meaning it argues that the new device is as safe and effective as a device already on the market. It does not typically present a table of quantitative acceptance criteria and then report the device's performance against those specific criteria with numerical results.
Instead, the document details physical and material similarities to predicate devices and states that non-clinical testing data "support demonstrating substantial equivalence."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not explicitly stated with numerical values. For the "Precision Fit Test," it mentions that "the test was conducted by selecting randomly among the subject devices in each Implant System." It does not specify the number of devices tested.
- Data provenance: Not specified. The non-clinical tests mention adherence to international standards (ISO, ASTM, USP) but do not detail the origin of the test data (e.g., country where testing was conducted, whether it was retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable/not provided. The document is about physical dental devices (healing abutments and cover screws) and their material/mechanical properties, not an AI or diagnostic device that requires expert-established ground truth from medical images or patient data. The non-clinical tests relate to biocompatibility, surface treatment, pyrogen/endotoxin, sterilization, shelf life, and precision fit, which are typically assessed through laboratory tests against established standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/not provided for the same reasons as #3. Adjudication methods are relevant for studies involving human interpretation or subjective assessments, which are not described here.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable/not provided. This document pertains to physical dental devices, not an AI-assisted diagnostic tool. Therefore, MRMC studies are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/not provided. This document pertains to physical dental devices, not an algorithm or AI system.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This information is not applicable/not provided in the context of the device's non-clinical testing. The "ground truth" for non-clinical tests (like biocompatibility, sterility, material properties) is typically defined by reference standards (e.g., ISO, ASTM specifications, USP limits for endotoxin) rather than expert consensus on clinical cases or pathology.
8. The sample size for the training set
This information is not applicable/not provided. The device is a physical medical device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable/not provided for the same reason as #8.
In summary, the provided document is a regulatory submission (510(k) Summary) demonstrating substantial equivalence for physical dental devices. It focuses on comparing the new device to existing predicate devices based on design, materials, manufacturing processes, and non-clinical performance (biocompatibility, sterility, etc.), rather than reporting on a clinical or performance study with detailed acceptance criteria, quantitative performance metrics, and specific study designs typical for AI or diagnostic devices.
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
MegaGen Implant Co., Ltd. % Hyo Eun Lee Research Engineer DaeGyeong Regulatory Affairs Institute 32. Innovallev-ro Daegu, Dong-gu 41065 REPUBLIC OF KOREA
Re: K210826
Trade/Device Name: Healing Abutment, Cover Screw Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: December 28, 2021 Received: January 5, 2022
Dear Hyo Eun Lee:
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K210826
Device Name Healing Abutment, Cover Screw
Indications for Use (Describe) MegaGen Prosthetics are intended for use as an aid in prosthetic rehabilitation.
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | |||||
|---|---|---|---|---|---|---|
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | ||||||
| This section applies only to requirements of the Paperwork Reduction Act of 1995. | ||||||
| DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. | ||||||
| of this information collection, including suggestions for reducing this burden, to: | The burden time for this collection of information is estimated to average 79 hours per response, including thetime to review instructions, search existing data sources, gather and maintain the data needed and completeand review the collection of information. Send comments regarding this burden estimate or any other aspect | |||||
| Food and Drug AdministrationOffice of Chief Information OfficerPaperwork Reduction Act (PRA) StaffPRAStaff(@fda.hhs.gov | Department of Health and Human Services | |||||
| information unless it displays a currently valid OMB number." | "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of | |||||
| FABILEBI AGAL (AIAA | D--- 1 -- 1 -- 1 |
Type of Use (Select one or both, as applicable)
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.
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510(k) Summary for K210826
Date: February 3, 2022
1. Applicant / Submitter
MegaGen Implant Co., Ltd. 45, Secheon-ro, 7-gil, Dasa-eup, Dalseong-gun, Daegu, Republic of Korea Tel: + 82-53-222-2828
2. Submission Correspondent
Hyo-Eun Lee DaeGyeong Regulatory affairs Institute 32, Innovalley-ro, Dong-gu, Daegu, Republic of Korea Tel: +82-53-247-2262 Fax: +82-53-247-2254 Email: ra7@dgri.co.kr
3. Device
- Trade Name: Healing Abutment, Cover Screw
- Endosseous dental implant abutment
- Classification Name:
Common Name:
Endosseous dental implant abutment
- . Classification Product Code:
- NHA Class II, 21 CFR 872.3630 Classification regulation:
4. Predicate Device
.
•
- Primary Predicate Device: .
K192436 - Healing Abutments and Cover Screws
Reference Device: .
K110955 – AnyRidge Internal Implant System K123988 – AnyOne™ Internal Implant System K182448 – AnyRidge Octa 1 Implant System K181138 - IS-III active System K150537 – MiNi Internal Implant System
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5. Description
The Healing Abutment is designed to aid in soft tissue contouring the healing period after implant placement, creating an emergence profile before a final restoration is placed. The Scan Healing Abutment Screw is used to connect the Healing Abutment to the endosseous implant.
The Healing Abutments are several types depending on the anatomic location. There are Incisor Type, Canine Type, Molar Type, Special type suitable for the patient's oral environment.
Image /page/4/Figure/3 description: The image shows four different types of dental abutments. The abutments are labeled as "Incisor type", "Canine type", "Molar type", and "Special type". Each abutment has a different shape and size, which is designed to fit different teeth. The abutments are made of a metallic material and have a hole in the top for attaching a dental crown.
The Healing Abutment and Scan Healing Abutment screw are compatible with following MEGAGEN Implants cleared under:
| Manufacturer | Compatible ImplantSystem | Device Name | 510(k)Number | Connection | Diameter (mm) |
|---|---|---|---|---|---|
| MegaGenImplant Co.,Ltd. | Xpeed AnyRidgeInternal Implant System | Xpeed AnyRidgeInternal Fixture | K123870K140091 | InternalHex | 4.0, 4.4, 4.9, 5.4, 5.9,6.4, 6.9, 7.4, 7.9, 8.4 |
| AnyOneInternal Implant System | AnyOneInternal Fixture | K123988 | InternalHex | 3.9, 4.3, 4.8, 5.3, 5.8,6.3, 6.8, 7.3, 7.8, 8.3 | |
| BLUEDIAMONDIMPLANT System | BLUEDIAMONDIMPLANT | K182448 | InternalOcta | 3.6, 3.7, 4.0, 4.1, 4.4,4.8, 5.0, 5.5 |
The Cover Screw is used for protecting the inner structure of a fixture, and exposed fixture platform after fixture placement. It is used for submerged type surgery. It is sterilized using gamma irradiation during manufacturing process. It is single use devices.
| Manufacturer | Compatible ImplantSystem | Device Name | 510(k)Number | Connection | Diameter (mm) |
|---|---|---|---|---|---|
| MegaGenImplant Co.,Ltd. | Xpeed AnyRidgeInternal Implant System | Xpeed AnyRidgeInternal Fixture | K123870K140091 | InternalHex | 4.0, 4.4, 4.9, 5.4, 5.9,6.4, 6.9, 7.4, 7.9, 8.4 |
| AnyOneInternal Implant System | AnyOneInternal Fixture | K123988 | InternalHex | 3.9, 4.3, 4.8, 5.3, 5.8,6.3, 6.8, 7.3, 7.8, 8.3 |
The Cover Screw is compatible with following MEGAGEN Implants cleared under:
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The Healing Abutment, Scan Healing Abutment Screw are consisted of the following devices.
| Device | Content | ||
|---|---|---|---|
| 1. Abutment | HealingAbutment | Description | The Healing Abutment helps to form suitable emergenceprofile during period of gingival healing.There are five types of Healing Abutments, Incisor, Canine, Pre-molar, Molar and Special type. |
| Material | Ti-6Al-4V ELI of ASTM F136-13 | ||
| Dimension(Diameter,Total Length) | Diameter: Ø 4.0 ~ 10.0 mmTotal Length: 4.4 ~ 11.35 mm | ||
| Angulation | Straight | ||
| CompatibleImplant System | Xpeed AnyRidge Internal Implant SystemAnyOne Internal Implant SystemBLUEDIAMOND IMPLANT System | ||
| ScanHealingAbutmentScrew | Description | The Scan Healing Abutment Screw is used for connectingHealing Abutment to the endosseous implant. | |
| Used with | Healing Abutment | ||
| Material | Ti-6Al-4V ELI of ASTM F136-13 | ||
| Dimension(Diameter &Total Length) | Ø1.95 x 7.8 ~ 12.8 mmØ2.0 x 6.9 ~ 10.9 mmØ2.1 x 8.0 ~ 13.0 mm | ||
| CompatibleImplant System | Xpeed AnyRidge Internal Implant SystemAnyOne Internal Implant SystemBLUEDIAMOND IMPLANT System | ||
| 2. Cover Screw | Description | The Cover Screw is used for protecting the inner structure of afixture, and exposed fixture platform after fixture placement. Itis used for submerged type surgery. | |
| Material | Ti-6Al-4V ELI of ASTM F136-13 | ||
| Dimension(Diameter,Total Length) | Ø6.0 x 7.2 ~ 8.3 mm | ||
| Angulation | Straight | ||
| CompatibleImplant System | Xpeed AnyRidge Internal Implant SystemAnyOne Internal Implant System |
6. Indication for use
MegaGen Prosthetics are intended for use as an aid in prosthetic rehabilitation.
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7. Basis for Substantial Equivalence
The Healing Abutment and Scan Healing Abutment Screw are substantially equivalent to the predicate device in terms of indication for use, technical characteristic and function. They are made of the same material and have similar design. The size range of the subject device slightly differ from the predicate device however it is very minor not affecting substantial equivalence.
Based on the comparison charts below and test results provided in this submission, we conclude that the subject device is substantially equivalent to the predicate device.
| Healing Abutment | ||||||
|---|---|---|---|---|---|---|
| Subject Device | Primary PredicateDevice | Reference Device | ||||
| 510k | K210826 | K192436 | K110955 | K123988 | K182448 | K181138 |
| Device Name | Healing Abutment | Healing Abutment | Healing Abutmentfor AnyRidgeInternal ImplantSystem | Healing Abutmentfor AnyOneInternal ImplantSystem | Healing Abutmentfor AnyRidge Octa1 Implant System | IS Encoded HealingAbutment for IS-IIIactive System |
| Manufacturer | MegaGen ImplantCo., Ltd. | Dentium Co., Ltd. | MegaGen ImplantCo., Ltd. | MegaGen ImplantCo., Ltd. | MegaGen ImplantCo., Ltd. | Neobiotech Co.,Ltd. |
| Design | Image: Healing Abutment | Image: Healing Abutment | Image: Healing Abutment | Image: Healing Abutment | Image: Healing Abutment | Image: Healing Abutment |
| Diameter(Ø, mm) | 4.0 ~ 10.0 | 3.70 ~ 9.64 | 4.2 ~ 10.0 | 4.2 ~ 9.7 | 3.2 ~ 7.2 | 4.0 ~ 9.0 |
| GingivalHeight(Cuff Height,mm) | 2.0 ~ 7.0 | unknown | 3.5 ~ 9.5 | 2.3 ~ 8.8 | 2.5 ~ 9.5 | 2.3 ~ 7.3 |
| Total Length(mm) | 4.4 ~ 11.35 | 6.15 ~ 14.66 | 8.4 ~ 14.4 | 8.7 ~ 15.2 | 8.6 ~ 15.6 | 2.5 ~ 7.5 |
| Use withScrew | Use with Screw | N/A | N/A | N/A | N/A | Use with Screw |
| Male Screw xPitch(mm) | M1.8x0.35P,M2.0x0.40P,M1.6x0.35P | unknown | M1.8x0.35P | M2.0x0.4P | M1.6x0.35P | unknown |
| Connection | Internal Hex | Internal | Internal Conicalconnection | Internal Conicalconnection | Internal Conicalconnection | Internal Hex |
| Materials | Ti-6Al-4V ELI ofASTM F136 | Ti-6Al-4V ELI ofASTM F136 | Ti-6Al-4V ELI ofASTM F136 | Ti-6Al-4V ELI ofASTM F136 | Ti-6Al-4V ELI ofASTM F136 | Ti-6Al-4V ELI ofASTM F136 |
| SurfaceTreatment | Machined(Abutment)Anodizing (Screw) | Machined | Machined | Machined | Anodizing | Machined |
| Sterilization | GammaSterilization | GammaSterilization | Gamma Sterilization | GammaSterilization | Gamma Sterilization | GammaSterilization |
| Shelf Life | 5 years | unknown | 5 years | 5 years | 5 years | 5 years |
Healing Abutment
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| Subject Device | Primary PredicateDevice | Reference Device | |
|---|---|---|---|
| indication foruse | MegaGenProsthetics areintended for use asan aid in prostheticrehabilitation. | DentiumProsthetics areintended for useas an aid inprostheticrehabilitation. | The AnyRidgeInternal ImplantSystem is intendedto be surgicallyplaced in themaxillary ormandibular molarareas for thepurpose providingprosthetic supportfor dentalrestorations (Crown,bridges, andoverdentures) inpartially or fullyedentulousindividuals. It is usedto restore apatient's chewingfunction. Smallerimplants (less thanØ6.0 mm) arededicated forimmediate loadingwhen good primarystability is achievedand withappropriate occlusalloading. Largerimplants arededicated for themolar region andare indicated fordelayed loading.The AnyOne™Internal ImplantSystem isintended to besurgically placedin the maxillary ormandibular molarareas for thepurpose providingprostheticsupport for dentalrestorations(Crown, bridges,and overdentures)in partially or fullyedentulousindividuals. It isused to restore apatient's chewingfunction. Smallerimplants (lessthan Ø6.0 mm)are dedicated forimmediateloading whengood primarystability isachieved and withappropriateocclusal loading.Larger implantsare dedicated forthe molar regionand are indicatedfor delayedloading.The AnyRidge Octa 1Implant System isintended to besurgically placed inthe maxillary ormandibular archesforthe purpose ofproviding prostheticsupport for dentalrestorations (Crown,bridges, andoverdentures) inpartially or fullyedentulousindividuals. It isused to restore apatient's chewingfunction in thefollowing situationsand with the clinicalprotocols:- Delayed loading.- Immediate loadingwhen good primarystability is achievedand withappropriate occlusalloading. Largerimplants arededicated for themolar region.The IS-III activeSystem isindicated for usein partially or fullyedentulousmandibles andmaxillae, insupport of singleor multiple-unitrestorationsincluding;cementedretained, screwretained, oroverdenturerestorations, andterminal orintermediateAbutment supportfor fixedbridgework.IS-III activeSystem isdedicated for twostage surgicalprocedures andfor immediateloading whenthere is goodprimary stabilityand anappropriateocclusal load.Also, implantswith diameterslarger than 5mmare indicated formolar regions. |
| Substantial Equivalence Discussion | |||
| 1. SimilaritiesThe subject device has the same characteristic for the followings compared to the primary predicate device and prior cleared reference devices.- Design, Use with Screw, male Screw x Pitch, Connection, Materials, Surface Treatment, Sterilization, Shelf Life and Indication for use | |||
| 2. DifferencesThe subject device has the different characteristic for the followings compared to the primary predicate device and prior cleared reference devices.- Diameter, Gingival Height and Total LengthThe Dimensions of subject device are slightly different with predicate and reference devices, but they are lie within the range of predicate device. But it does not cause a matter in substantial equivalence since these size differences are very minor, and the variety of the size can be possible to operate more precise treatment to meet each patient's condition. | |||
| 3. DiscussionSome of Healing Abutments had been FDA cleared with K110955, K123988 and K182448 but this submission is being submitted to add new dimensions with five different types to the patient's oral environment in the compatible implant system. Therefore, the proposed Healing Abutment and all prior cleared devices have common in Indication for Design, Diameter, Total Length, Use with Screw, Male Screw x Pitch, Connection, Material, Surface Treatment, Sterilization, Shelf Life and Indication for use. The differences are explained not affecting on the substantial equivalence.Also, the fatigue testing is not considered since they help to form suitable emergence profile during period of gingival healing and are not placed into occlusion. |
- On the basis of the discussion above, it is concluded that the substantially equivalent to the predicate devices.
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The Cover Screw is substantially equivalent to the predicate device in terms of indication for use, technical characteristic and function. They are made of the same material and have similar design. The size of the subject device slightly differ from the predicate device however it is very minor not affecting substantial equivalence.
Based on the comparison charts below provided in this submission, we conclude that the subject device is substantially equivalent to the predicate device.
| Subject Device | Primary PredicateDevice | Reference Device | |||
|---|---|---|---|---|---|
| 510k | K210826 | K192436 | K110955 | K123988 | K150537 |
| Device Name | Cover Screw | Cover Screw | Cover Screw forAnyRidge InternalImplant System | Cover Screw forAnyOne InternalImplant System | Cover Screw for MiNiInternal Implant System |
| Manufacturer | MegaGen ImplantCo., Ltd. | Dentium Co., Ltd. | MegaGen Implant Co.,Ltd. | MegaGen ImplantCo., Ltd. | MegaGen Implant Co.,Ltd. |
| Design | Image: Screw | Image: Screw | Image: Screw | Image: Screw | Image: Screw |
| Diameter(Ø, mm) | 6.0 | 3.10 ~ 4.30 | 3.5 | 3.5 ~ 4.1 | 2.6, 3.5 |
| Total Length(mm) | 7.2 ~ 8.3 | 4.70 ~ 8.92 | 5.7 ~ 7.5 | 6.75 ~ 8.75 | 3.1 ~ 10.25 |
| Male Screw xPitch(mm) | M1.8x0.35P,M2.0x0.40P | unknown | M1.8x0.35P | M2.0x0.40P | M1.4x0.30P,M1.6x0.35P,M1.8x0.35P,M2.0x0.40P |
| Materials | Ti-6Al-4V ELI ofASTM F136 | Ti-6Al-4V ELI of ASTMF136 | Ti-6Al-4V ELI of ASTMF136 | Ti-6Al-4V ELI of ASTMF136 | Ti-6Al-4V ELI of ASTMF136 |
| SurfaceTreatment | Machined | TiN Coated | Anodizing | Anodizing | Anodizing, Machined |
| Sterilization | Gamma Sterilization | Gamma Sterilization | Gamma Sterilization | Gamma Sterilization | Gamma Sterilization |
| Shelf Life | 5 years | unknown | 5 years | 5 years | 5 years |
| Subject Device | Primary Predicate Device | Reference Device | |||
| indication foruse | MegaGenProsthetics areintended for use asan aid in prostheticrehabilitation. | Dentium Prostheticsare intended for useas an aid in prostheticrehabilitation. | The AnyRidge InternalImplant System isintended to besurgically placed in themaxillary ormandibular molarareas for the purposeproviding prostheticsupport for dentalrestorations (Crown,bridges, andoverdentures) inpartially or fullyedentulous individuals.It is used to restore apatient's chewingfunction. Smallerimplants (less than$Ø$ 6.0 mm) arededicated forimmediate loadingwhen good primarystability is achievedand with appropriateocclusal loading. Largerimplants are dedicatedfor the molar regionand are indicated fordelayed loading. | The AnyOne™Internal ImplantSystem is intendedto be surgicallyplaced in themaxillary ormandibular molarareas for thepurpose providingprosthetic supportfor dentalrestorations (Crown,bridges, andoverdentures) inpartially or fullyedentulousindividuals. It isused to restore apatient's chewingfunction. Smallerimplants (less than$Ø$ 6.0 mm) arededicated forimmediate loadingwhen good primarystability is achievedand withappropriate occlusalloading. Largerimplants arededicated for themolar region andare indicated fordelayed loading. | The MiNi InternalImplant System isintended for two-stage surgicalprocedures in thefollowing situationsand with the followingclinical protocols:- The intended use forthe 3.0 mm diameterMiNi implant is limitedto the replacement ofmaxillary lateralincisors andmandibular incisors.- Immediateplacement inextraction sites and insituations with apartially or completelyhealed alveolar ridge.- It is intended fordelayed loading. |
| Substantial Equivalence Discussion | |||||
| 1. | SimilaritiesThe subject device has the same characteristic for the followings compared to the primary predicate devices.Design, Male Screw x Pitch, Materials, Surface Treatment, Sterilization, Shelf Life and Indication for use | ||||
| 2. | DifferencesThe subject device has the different characteristic for the followings compared to the primary predicate devices.- DiameterThe Diameter of subject device is slightly different with predicate and reference devices. But it does not cause a matter in substantialequivalence since the difference is very minor, and the variety of the size can be possible to operate more precise treatment to meeteach patient's condition.- Total LengthThe Total Length of subject device are slightly different with predicate and reference devices, but they are lie within the range ofpredicate device. But it does not cause a matter in substantial equivalence since these size differences are very minor, and the varietyof the size can be possible to operate more precise treatment to meet each patient's condition. | ||||
| 3. | DiscussionThe proposed Cover Screw had been FDA cleared under K110955, K123988 and K150537 but this submission is being submitted to addnew dimensions in the compatible implant system. Therefore, the proposed Cover Screw and prior cleared devices have common inIndication for Design, Dimensions, Male Screw x Pitch, Materials, Surface Treatment, Sterilization, Shelf Life and Indication for use.The differences are explained not affecting on the substantial equivalence. | ||||
| 4. | On the basis of the discussion above, it is concluded that the subject device is substantially equivalent to the predicate device. |
Cover Screw
{9}------------------------------------------------
-
- On the basis of the discussion above, it is concluded that the subject device is substantially equivalent to the predicate device.
{10}------------------------------------------------
8. Summary of Non-Clinical Testing
The non-clinical testing data which are submitted, referenced, or relied on in this submission support demonstrating substantial equivalence.
Biocompatibility
The biocompatibility evaluation has been performed in accordance with International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".
The additional biocompatibility testing is not required on the Healing Abutment and Cover Screw since these have same material composition, manufacturing process and patient contacting parts as the prior cleared Healing Abutment and Cover Screw for AnyRidge Internal Implant System(K110955), AnyOne Internal Implant System(K123988), AnyRidge Octa 1 Implant System(K182448) and MiNi Internal Implant System(K150537).
Modified Surface Treatment
The Healing Abutment is non surface-treated as predicate devices, IS Encoded Healing Abutment(K181138) and Healing Abutment for AnyRidge Internal Implant System(K110955), AnyOne Internal Implant System(K123988) and AnyRidge Octa 1 Implant System(K182448).
For Scan Healing Abutment Screw, the surface treatment evaluation has been performed in accordance with 'Section 11 of Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutment'.
The Scan Healing Abutment Screw has same surface treatment and manufacturing process as prior cleared device, AnyRidge Octa 1 Implant System (K182448) for Anodizing. The purpose of Anodizing for Scan Healing abutment Screw is to distinguish the sizes with the naked eyes for convenience. And It doesn't affect device's fundamental functions, safety and effectiveness.
Pyrogen and Endotoxin Test
The subject device will not be labeled as "non-pyrogenic", and the endotoxin testing will be conducted on every batch for the subject device with the testing limit of below 0.5 EU/mL in accordance with the USP 39 <85>.
Sterilization validation and Shelf Life
Sterilization validating testing has been performed in accordance with ISO 11137 to verify the sterility assurance level (10 %). The tests to validate the Shelf Life of the device through the proposed Shelf Life were conducted using the accelerated aging method in accordance to ASTM F1980 and the test results validated 5 years Shelf Life.
Also, the following guidance documents were referred to:
- Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile.
- Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling
Performance test
The five types of Healing Abutment in each Implant System have similar design and same indication for use, principle of operation, technical characteristics and function. And since the connection dimensions of D1, the Healing Abutment and Implant of each implant system, are all the same, so it was not necessary to consider the worst-case scenario when selecting a sample for the performance test of the subject device such as the precision fit test. Therefore, the test was conducted by selecting randomly among the subject devices in each Implant System.
▪ Precision Fit Test
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9. Summary of Clinical Testing
No clinical studies are submitted.
10. Conclusion
Based on the information provided in this premarket notification, We, MegaGen Implant Co., Ltd. conclude that the Healing Abutment and Cover Screw is substantially equivalent to the predicate device as herein.
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)