AnyOne Onestage Implant System
Device Facts
| Record ID | K210161 |
|---|---|
| Device Name | AnyOne Onestage Implant System |
| Applicant | Megagen Implant Co., Ltd. |
| Product Code | DZE · Dental |
| Decision Date | Jun 22, 2021 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3640 |
| Device Class | Class 2 |
Indications for Use
The AnyOne Onestage Implant System is intended to be surgically placed in the maxillary or mandibular arches for the purpose of providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function in the following situations and with the clinical protocols: -Delayed loading. -Immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated for the molar region.
Device Story
The AnyOne Onestage Implant System is an integrated endosseous dental implant system consisting of fixtures and abutments. Fixtures are surgically placed into the maxillary or mandibular jawbone to provide prosthetic support for dental restorations. The system utilizes an internal Octa connection interface. Components include fixtures (CP Ti Grade 4), various abutments (Ti-6Al-4V ELI, Co-Cr-Mo alloy, Gold alloy, POM), and connecting screws. The device is used by dental clinicians in a clinical setting to restore chewing function and improve appearance. The system supports both single and multiple prosthetic restorations. Benefits include restoration of chewing ability and aesthetic improvement. The device is provided non-sterile (except fixtures which are gamma sterilized) and is intended for single use.
Clinical Evidence
No clinical data submitted. Substantial equivalence is supported by bench testing, including static compression-strength tests and fatigue testing performed in accordance with ISO 14801 and FDA guidance for root-form endosseous dental implants.
Technological Characteristics
Materials: CP Ti Grade 4 (ASTM F67-13), Ti-6Al-4V ELI (ASTM F136-13), Co-Cr-Mo alloy, Gold alloy, POM, Stainless Steel (ASTM F899-20). Connection: Internal Octa. Surface treatment: SLA (Sand-blasted, Large grit, Acid-etched) and partial anodizing. Sterilization: Gamma (fixtures). Form factor: Tapered/straight body, self-tapping. Connectivity: None.
Indications for Use
Indicated for partially or fully edentulous patients requiring prosthetic support for dental restorations (crowns, bridges, overdentures) in maxillary or mandibular arches. Suitable for delayed loading or immediate loading when primary stability is achieved.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- AnyRidge Octa 1 Implant System (K182448)
Reference Devices
- ExFeel Dental Implant System (K052369)
- MiNi Internal Implant System (K150537)
- AnyOne Internal Implant System (K123988)
- ET US SS Prosthetic System (K160670)
- Dentis Dental Implant System (K171027)
- Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment (K192614)
- Osstem Abutment System (K182091)
Submission Summary (Full Text)
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
MegaGen Implant Co., Ltd. % You Kim Chief Researcher DaeGyeong Regulatory Affairs Institute 32. Innovallev-ro Daegu, Dong-gu 41065 REPUBLIC OF KOREA
Re: K210161
Trade/Device Name: AnyOne Onestage Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: April 20, 2021 Received: May 24, 2021
Dear You Kim:
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) K210161
Device Name AnyOne Onestage Implant System
The AnyOne Onestage Implant System is intended to be surgically placed in the maxillary or mandibular arches for the purpose of providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function in the following stuations and with the clinical protocols:
-Delayed loading.
-Immediate loading when good
primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated for the molar region.
Type of Use (Select one or both, as applicable)
| <span> <span style="text-decoration:overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span>□ Over-The-Counter Use (21 CFR 801 Subpart C)</span> |
|-----------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|
|-----------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|
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.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> 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 for K210161
Date: June 22, 2021
## 1. Applicant / Submitter
MegaGen Implant Co., Ltd. 45, Secheon-ro, 7-gil, Dasa-eup, Dalesong-gun, Daegu, Republic of Korea Tel: + 82-53-222-2828
# 2. Submission Correspondent
You Jung Kim DaeGyeong Regulatory affairs Institute 32, Innovalley-ro, Dong-gu, Daegu, 41065, Republic of Korea Tel: +82-53-247-2258 Fax: +82-53-247-2254 Email: ra3@dgri.co.kr
### 3. Device
- Trade Name: AnyOne Onestage Implant System ■ Common Name: Endosseous Dental Implant ■ Classification Name: Endosseous dental implant ■ Classification Product Code: DZE ■ Secondary Product Code: NHA ■ Classification regulation: Class II, 21 CFR 872.3640
### Predicate Device 4.
. Primary Predicate Device: K182448- AnyRidge Octa 1 Implant System
## . Reference Devices:
K052369 - ExFeel Dental Implant System K150537 - MiNi Internal Implant System K123988 - AnyOne Internal Implant System K160670 - ET US SS Prosthetic System K171027 - Dentis Dental Implant System K192614 - Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment K182091 - Osstem Abutment System
{4}------------------------------------------------
### 5. Description
- AnyOne Onestage Implant System is an integrated system of endosseous dental implants which designed to support prosthetic devices for partially or fully edentulous patients and consists of fixtures and abutments. The dental implants which used in conjunction with other prosthesis restore the lost chewing ability and improve the appearance.
- AnyOne Onestage Fixture is a substructure of a dental implant system made of CP Ti Grade 4 with the . surface treated by SLA method. It is placed in the anterior or posterior site of maxillary or mandibular jawbone considering bone quality and bone quantity. The fixtures have Octa connection, and various cuff height with consideration for soft tissue level (gingival height). These fixtures can be used the one-stage and two-stage surgical procedure. This device is a tissue level implant.
- . Dental prosthesis is an abutment of a dental implant system and connecting elements between the dental implant and the restoration. The abutment is fixed to the implant and is permanently or temporary in
contact with the gum in the surgical cavity. These abutments are made of alloy and POM, and intended to be placed on the fixture allows single & multiple prosthetic restorations to restore a patient's chewing function.
- The proposed AnyOne Onestage Implant System is consisted of the following components. For reference, . all the subject device in this submission are to be added Megagen's existing implant and prosthetic portfolio which had been FDA cleared.
| Content | | | |
|---------------------------------------------------|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. Fixture Products | AnyOne Onestage Fixture | Description AnyOne Onestage Fixture is a substructure of a dental implant system made of titanium and have the interface connection for Internal Octa. It is used in conjunction with other prosthetic and restore lost chewing ability, improve appearance. | |
| | | Material CP Ti Grade 4 (ASTM F67-13) | |
| | | Dimension (Diameter & Length) Ø 3.9 x 7.0, 8.0, 9.5, 11.0, 12.5, 14.5 mm<br>Ø 4.3 x 7.0, 8.0, 9.5, 11.0, 12.5, 14.5 mm<br>Ø 4.8 x 7.0, 8.0, 9.5, 11.0, 12.5, 14.5 mm<br>Ø 5.3 x 7.0, 8.0, 9.5, 11.0, 12.5, 14.5 mm | |
| | | Gingival (Cuff) Height 1.2, 1.8, 2.2 mm | |
| 2. Closing Screw & Cover Screw & Healing Abutment | Closing Screw | Description The Closing Screw is used in conjunction with fixture for protecting the inner structure of a fixture, and exposed fixture platform after fixture placement. | |
| | | Material Ti-6Al-4V ELI (ASTM F136-13) | |
| | | Dimension (Diameter & Length) Ø 3.5 x 6.0 mm | |
| | | Gingival (Cuff) Height 1.5mm | |
| | | Angulation Straight | |
| | Cover Screw | Description The Cover Screw is used in conjunction with fixture for protecting the inner structure of a fixture, and exposed fixture platform after fixture placement. | |
| | | Material Ti-6Al-4V ELI (ASTM F136-13) | |
| | | Dimension (Diameter & Length) Ø 4.85 x 7.0 mm | |
| | | Gingival (Cuff) Height 1.5mm | |
| | | Angulation Straight | |
| | Healing Abutment | Description The Healing Abutment is used in conjunction with fixture and helps to form suitable emergence profile during period of gingival healing. | |
| | | Material Ti-6Al-4V ELI (ASTM F136-13) | |
| | | Dimension (Diameter & Length) Ø 5.5 x 6.5, 7.5, 8.5 mm | |
| | | Gingival (Cuff) Height 2.0, 3.0, 4.0 mm | |
| | | Angulation Straight | |
| 3. Fixture Level Prosthesis | Multi Post | Description The Multi Post is used in conjunction with fixture to provide support for cement retained type final prosthesis. It is connected to the Fixture using Multi Post Screw. | |
| | | Material Ti-6Al-4V ELI (ASTM F136-13) | |
| | | Dimension (Diameter & Length) Ø 5.5 x 8.7 mm | |
| | | Gingival (Cuff) Height | 1.0 mm |
| | | Post Height | 5.5 mm |
| | | Angulation | Straight |
| | Multi Post<br>Cap | Description | The Multi Post Cap is used to protect Multi Post, minimizes<br>discomfort of oral cavity and relieve feeling of irritation and<br>protect until the prosthesis is produced after the impression<br>is taken. |
| | | Material | POM |
| | | Dimension<br>(Diameter & Length) | Ø 5.9 x6.5 mm |
| | | Post Height | 5.5 mm |
| | EZ Post<br>Abutment | Description | The EZ Post Abutment is used in conjunction with fixture to<br>provide support for cement and screw retained type final<br>prosthesis. It is connected to the Fixture using Multi Post<br>Screw. |
| | | Material | Ti-6Al-4V ELI (ASTM F136-13) |
| | | Dimension<br>(Diameter & Length) | Ø 4.8 x 6.2, 7.2,10) 7.7, 8.2, 8.7, 9.2, 9.7, 10.2, 10.7, 11.2, 12.2<br>mm |
| | | Gingival (Cuff) Height | 0.0, 1.0, 2.0, 3.0 mm |
| | | Post Height | 4.0, 5.5, 7.0 mm |
| | | Angulation | Straight |
| | Angled<br>Abutment | Description | The Angled Abutment is used in conjunction with fixture and<br>used for correcting the prosthetic angulation of implant. It is<br>connected to the Fixture using Abutment Screw. |
| | | Material | Ti-6Al-4V ELI (ASTM F136-13) |
| | | Dimension<br>(Diameter & Length) | Ø 3.7 x 9.0 mm |
| | | Post Height | 6.5 mm |
| | | Angulation | 15°, 25° |
| | Gold<br>Abutment | Description | The Gold Abutment is used in conjunction with fixture and<br>used for fabrication of abutment for either screw or cement<br>retained restorations by casting with precious metal alloy<br>(Gold alloy). It is connected to the Fixture using Multi Post<br>Screw. |
| | | Material | Body: Gold Alloy / Sleeve: POM |
| | | Dimension<br>(Diameter & Length) | Ø 5.5 x 13.65 mm |
| | | Gingival (Cuff) Height | 1.5 mm |
| | | Post Height | 10.0 mm |
| | | Angulation | Straight |
| | CCM<br>Abutment | Description | The CCM Abutment is used in conjunction with fixture and<br>used for fabrication of abutment for either screw or cement<br>retained restorations by casting with non-precious metal<br>alloy (Co-Cr-Mo alloy). It is connected to the Fixture using<br>Multi Post Screw. |
| | | Material | Body: Co-Cr-Mo Alloy / Sleeve: POM |
| | | Dimension<br>(Diameter & Length) | Ø 5.5 x 13.65 mm |
| | | Gingival (Cuff) Height | 1.5 mm |
| | | Post Height | 10.0 mm |
| | | Angulation | Straight |
| | Multi Post<br>Screw | Description | The Multi Post Screw is used for connecting Fixture to Multi<br>Post, EZ Post Abutment, Gold Abutment or CCM Abutment |
| | | Material | Ti-6Al-4V ELI (ASTM F136-13) |
| | | Dimension<br>(Diameter & Length) | Ø 2.5 x 8.1 mm |
| | Abutment<br>Screw | Description | The Abutment Screw is used for connecting Fixture to Angled<br>Abutment. |
| | | Material | Ti-6Al-4V ELI (ASTM F136-13) |
| | | Dimension<br>(Diameter & Length) | Ø 2.6 x 5.5 mm |
| 4. Abutment<br>Level<br>Prosthesis | Solid<br>Abutment | Description | The Solid Abutment is used in conjunction with fixture to<br>provide support for final prosthesis, and used in cement<br>retained restoration only. It is connected to the Fixture by its<br>threaded part. |
| | | Material | Ti-6Al-4V ELI (ASTM F136-13) |
{5}------------------------------------------------
{6}------------------------------------------------
| | (Diameter & Length) | | | | | |
|------------------------------|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Post Height | 4.0, 5.5, 7.0 mm | | | | |
| | Angulation | Straight | | | | |
| Solid Cap | Description | The Solid Cap is used for protecting a Solid Abutment after taking impression, and minimizing irritation to tongue and oral mucosa. | | | | |
| | Material | POM | | | | |
| | Dimension | Ø 5.7 x 6.5, 8.0, 9.5 mm | | | | |
| | (Diameter & Length) | | | | | |
| | Post Height | 4.0, 5.5, 7.0 mm | | | | |
| Solid Post<br>Abutment | Description | The Solid Post Abutment is used in conjunction with fixture to provide support for final prosthesis, and used in cement retained restoration only. It is connected to the Fixture by its threaded part. | | | | |
| | Material | Ti-6Al-4V ELI (ASTM F136-13) | | | | |
| | Dimension | Ø 4.9 x 9.5, 10.5, 11.0, 11.5, 12.0, 12.5, 13.0, 13.5, 14.5 mm | | | | |
| | (Diameter & Length) | | | | | |
| | Gingival (Cuff) Height | 1.0, 2.0, 3.0 mm | | | | |
| | Post Height | 4.0, 5.5, 7.0 mm | | | | |
| | Angulation | Straight | | | | |
| Solid Post<br>Cap | Description | The Solid Post Cap is used for protecting a Solid Post Abutment after taking impression, and minimizing irritation to tongue and oral mucosa. | | | | |
| | Material | POM | | | | |
| | Dimension | Ø 5.3 x 6.5, 7.5, 8.0, 8.5, 9.0, 9.5, 10.0, 10.5, 11.5 mm | | | | |
| | (Diameter & Length) | | | | | |
| | Gingival (Cuff) Height | 1.0, 2.0, 3.0 mm | | | | |
| | Post Height | 4.0, 5.5, 7.0 mm | | | | |
| Octa<br>Abutment | Description | The Octa Abutment is used in conjunction with fixture for fabricating screw-retained prosthesis. It is connected to the Fixture by its threaded part. | | | | |
| | Material | Ti-6Al-4V ELI (ASTM F136-13) | | | | |
| | Dimension | Ø 3.5 x 6.5 mm | | | | |
| | (Diameter & Length) | | | | | |
| | Post Height | 1.5 mm | | | | |
| | Angulation | Straight | | | | |
| Healing Cap | Description | The Healing Cap is used for protecting Octa Abutment and minimizing irritation to tongue and oral mucosa during period of gingival healing. It is connected to the Octa Abutment using Abutment Screw. | | | | |
| | Material | Ti-6Al-4V ELI (ASTM F136-13) | | | | |
| | Dimension | Ø 5.2 x 4.0 mm | | | | |
| | (Diameter & Length) | | | | |…
