(397 days)
The AnyRidge Octa 1 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.
The AnyRidge Octa 1 Fixture is a substructure of a dental implant system made of CP Ti Grade 4 with the surface treated by SLA method. The fixture offers two types: Normal Thread Type and Deep Thread Type. As the name indicates the Deep Thread Type has slightly deeper threads than the Normal Thread Type. The abutments are made of Ti-6AI-4V-ELI (ASTM F136-13) except the CCM Abutment. The CCM Abutment is made of Cobalt Chrome Molybdenum (ASTM F1537-11). Also for the Fuse Abutment, the post is covered with provisional restoration that is made of plastic (POM). The system offers various components including the AnyRidge Octa 1 Fixture, EZ Post Abutment, Angled Abutment, Milling Abutment, Octa Abutment, Multi-unit Abutment, Multi-unit Angled Abutment, Meg-Rhein Abutment, CCM Abutment, Cover Screw, Healing Abutment, Temporary Abutment, Fuse Abutment, Abutment Screw, and Multi-unit Abutment Screw, in various sizes.
The provided document is a 510(k) Premarket Notification from the FDA for the AnyRidge Octa 1 Implant System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific performance criteria through a standalone study with acceptance thresholds.
The document discusses non-clinical testing performed to support the substantial equivalence claim. Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria (e.g., minimum accuracy percentages, AUC values) or corresponding device performance results in the context of clinical effectiveness or diagnostic accuracy, as it is a 510(k) submission focusing on substantial equivalence to predicate devices rather than novel performance claims.
However, it mentions that fatigue tests were performed on the subject devices in accordance with ISO 14801. The acceptance criterion for this would be that the fatigue test results of the subject device are substantially equivalent to the predicate device. The document states:
- "The fatigue testing demonstrates that the results of the subject devices are substantially equivalent to the predicate device."
This indicates that the subject device met the implied acceptance criterion of demonstrating comparable mechanical durability to the predicate under the specified test conditions.
Other non-clinical tests mentioned also have implicit acceptance criteria:
- Sterilization validation testing (ISO 11137 and ISO 17665-1, 2): To verify a sterility assurance level (SAL) of 10^-6. The document states this was performed to verify SAL (10^-6), implying it met this standard.
- Shelf life validation testing (ASTM F1980): To validate a 5-year shelf life using accelerated aging. The document states "the test results validated 5 year shelf life," indicating the criterion was met.
- Surface Morphology (EDS), Surface Roughness, GC/LC Analysis, IC Analysis: These tests were done to evaluate SLA treatment. The implicit acceptance would be that the characteristics are consistent with acceptable dental implants and/or comparable to the predicate device's surface treatment.
- Endotoxin testing (USP 39 <85>): The testing limit is below 0.5 EU/mL. This will be conducted on every batch, implying this is the ongoing acceptance criterion for endotoxin levels.
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a "test set" in the context of patient data or a clinical study for performance evaluation. The "tests" performed are non-clinical, laboratory-based tests on the device itself. Therefore, information on sample size for patient data or data provenance (country of origin, retrospective/prospective) is not applicable or provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This is a non-clinical 510(k) submission, not a clinical study requiring expert ground truth for a test set.
4. Adjudication Method
Not applicable. This is a non-clinical 510(k) submission.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a non-clinical 510(k) submission for a dental implant system, not a diagnostic device typically evaluated with MRMC studies with human readers and AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This product is a physical medical device (dental implant system), not an algorithm or AI system.
7. Type of Ground Truth Used
For the non-clinical tests, the "ground truth" refers to established scientific standards and regulatory guidelines.
- Mechanical Fatigue: ISO 14801, and comparison to the performance of legally marketed predicate devices.
- Sterilization: ISO 11137 and ISO 17665-1, 2.
- Shelf Life: ASTM F1980.
- Biocompatibility: Likely established through previous 510(k) submissions for the predicate devices using similar materials.
- Endotoxin: USP 39 <85>.
8. Sample Size for the Training Set
Not applicable. This is a physical device, not an AI/algorithm-based product that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
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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.
October 9, 2019
MegaGen Implant Co., Ltd. % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 690 Roosevelt Irvine, California 92620
Re: K182448
Trade/Device Name: AnyRidge Octa 1 Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: August 26, 2019 Received: September 9, 2019
Dear Priscilla Chung:
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.
Srinivas Nandkumar, Ph.D. for Acting Division Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K182448
Device Name AnyRidge Octa 1 Implant System
Indications for Use (Describe)
The AnyRidge Octa 1 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 situations and with the clinical protocols:
- Delaved loading.
- Immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Larger implants are dedicated for the molar region.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
(K182448)
This summary of 510(K) is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: Oct 8, 2019
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
Priscilla Chung LK Consulting Group USA, Inc. 690 Roosevelt Irvine CA 92620 Tel: 714.202.5789 Fax: 714.409.3357 Email: juhee.c@LKconsultingGroup.com
3. Device
- י Trade Name: AnyRidge Octa 1 Implant System
- י Common Name: Endosseous Dental Implant
- י Classification Name: Implant, Endosseous, Root-Form
- Primary Product Code: DZE '
- י Secondary Product Code: NHA
- י Classification regulation: Class II, 21 CFR 872.3640
4. Predicate Device:
- Primary Predicate Device: K122231 - XPEED AnyRidge Internal Implant System
- Reference Devices:
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K140878 Straumann Bone Level Tapered Implants K170031 Internal Octa Implant System K153350 IBS Implant system K110955 AnyRidge Internal Implant System K171027 Octa Abutment K072570 NobelActive Multi Unit Abutment K123988 AnyOne Internal System K051636 Healing Cap
5. Description:
The AnyRidge Octa 1 Fixture is a substructure of a dental implant system made of CP Ti Grade 4 with the surface treated by SLA method. The fixture offers two types: Normal Thread Type and Deep Thread Type. As the name indicates the Deep Thread Type has slightly deeper threads than the Normal Thread Type.
The abutments are made of Ti-6AI-4V-ELI (ASTM F136-13) except the CCM Abutment. The CCM Abutment is made of Cobalt Chrome Molybdenum (ASTM F1537-11). Also for the Fuse Abutment, the post is covered with provisional restoration that is made of plastic (POM).
The system offers the following components.
| No | Component |
|---|---|
| 1 | AnyRidge Octa 1 FixtureØ 3.60 x 7.00, 7.70, 9.20, 10.70, 12.20, 14.20, 17.20 mmØ 3.70 x 7.00, 7.70, 9.20, 10.70, 12.20, 14.20, 17.20 mmØ 4.00 x 7.00, 7.70, 9.20, 10.70, 12.20, 14.20, 17.20 mmØ 4.10 x 7.00, 7.70, 9.20, 10.70, 12.20, 14.20, 17.20 mmØ 4.40 x 7.00, 7.70, 9.20, 10.70, 12.20, 14.20, 17.20 mmØ 4.80 x 7.00, 7.70, 9.20, 10.70, 12.20, 14.20, 17.20 mmØ 5.00 x 7.00, 7.70, 9.20, 10.70, 12.20, 14.20, 17.20 mmØ 5.50 x 7.00, 7.70, 9.20, 10.70, 12.20, 14.20, 17.20 mm |
| 2 | EZ Post AbutmentØ 4.00 x 7.85, 8.85, 9.35, 9.85, 10.35, 10.85, 11.35, 11.85, 12.35, 12.85, 13.35, 13.85, 14.85mmØ 5.00 x 7.85, 8.85, 9.35, 9.85, 10.35, 10.85, 11.35, 11.85, 12.35, 12.85, 13.35, 13.85, 14.35,14.85, 15.35, 16.35 mmØ 6.00 x 9.35, 10.35, 10.85, 11.35, 11.85, 12.35, 12.85, 13.35, 13.85, 14.35, 14.85, 15.35,16.35 mmØ 7.00 x 9.35, 10.35, 10.85, 11.35, 11.85, 12.35, 12.85, 13.35, 13.85, 14.35, 14.85, 15.35,16.35 mm |
| 3 | Angled Abutment (15, 25°)Ø 4.00 x 10.85, 11.85, 12.85, 13.85, 14.85 mmØ 5.00 x 10.85, 11.85, 12.35, 12.85, 13.35, 13.85, 14.35, 14.85, 15.35, 16.35 mmØ 6.00 x 12.35, 13.35, 14.35, 15.35, 16.35 mmØ 7.00 x 12.35, 13.35, 14.35, 15.35, 16.35 mm |
| 4 | Milling Abutment(Only be for Hand Milling with no CAD/CAM)Ø 6.00 x 12.85, 13.85, 14.85, 15.85, 16.85 mm |
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| Ø 8.00 x 14.35, 15.35, 16.35, 17.35, 18.35 mm | |
|---|---|
| 5 | Octa AbutmentØ 3.80 x 7.85, 8.85, 9.85, 10.85, 11.85 mmØ 4.80 x 9.35, 10.35, 11.35, 12.35, 13.35 mmØ 5.80 x 10.85, 11.85, 12.85, 13.85, 14.85 mm |
| 6 | Multi-unit AbutmentØ 4.80 x 9.80, 10.80, 11.80, 12.80 mm |
| 7 | Multi-unit Angled Abutment (17, 30°)Ø 4.8 x 5.35, 6.35, 6.85, 7.35, 7.85, 8.85mm |
| 8 | Meg-Rhein AbutmentØ 2.907 x 8.30, 8.80, 9.80, 10.80, 11.80, 12.80, 13.80 mmØ 3.407 x 8.30, 8.80, 9.80, 10.80, 11.80, 12.80, 13.80 mm |
| 9 | CCM AbutmentØ 3.80 x 14.65, 16.15 mm |
| 10 | Cover ScrewØ 3.00 x 6.60, 7.10 mmØ 3.70 x 6.60, 7.10 mmØ 5.00 x 6.60 mmØ 6.00 x 6.60 mm |
| 11 | Healing AbutmentØ 3.20 x 8.60, 9.60, 10.60, 11.60, 12.60, 13.60, 14.60, 15.60 mmØ 4.20 x 8.60, 9.60, 10.60, 11.60, 12.60, 13.60, 14.60, 15.60 mmØ 5.20 x 8.60, 9.60, 10.60, 11.60, 12.60, 13.60, 14.60, 15.60 mmØ 6.20 x 8.60, 9.60, 10.60, 11.60, 12.60, 13.60, 14.60, 15.60 mm |
| 12 | Temporary AbutmentØ 4.00 x 14.85, 15.85 mmØ 4.50 x 16.35, 17.35 mmØ 5.00 x 16.35, 17.35 mm |
| 13 | Fuse AbutmentØ 5.40 x 12.05, 13.55 mm |
| 14 | Abutment ScrewØ 2.20 x 7.90 mm |
| 15 | Multi-unit Abutment ScrewØ 2.10 x 7.00 mm |
The following abutment models have anodized surface treatment.
▪ EZ Post Abutment, Angled Abutment, Milling Abutment, Octa Abutment, Multi-unit Abutment, Multi-unit Angled Abutment, Cover Screw, Healing Abutment, Temporary Abutment, Fixture Mount.
6. Indication for use:
The AnyRidge Octa 1 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
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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.
7. Basis for Substantial Equivalence
AnyRidge Octa 1 Implant System is substantially equivalent to the predicate devices in terms of intended use and technical characteristics. They are made of the same material and have similar design. The size range of the predicate device encompasses the size range of the subject device. There are slight differences in design, however, it is very minor not affecting substantial equivalence. There are some verbiage differences in the indications for use statements but it is a difference in language and the indications for use of the two devices are identical.
We have performed the fatigue test to make sure the difference in design does not raise an issue in safety and effectiveness and the test result of the test supported substantial equivalence.
Based on the information and test results provided in submission, we conclude that the subject device is substantially equivalent to the predicate devices.
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| Subject Device | Predicate Device | Reference Device 1 | Reference Device 2 | |
|---|---|---|---|---|
| 510(k)Number | K182448 | K122231 | K140878 | K170031 |
| Device Name | AnyRidge Octa 1Implant Fixture | XPEED AnyRidgeInternal ImplantSystem | Straumann BoneLevel TaperedImplants | Internal Octa ImplantSystem |
| Manufacturer | MegaGen ImplantCo., Ltd. | MegaGen ImplantCo., Ltd. | Straumann USA, LLC | EBI Inc. |
| Indications forUse Statement | The AnyRidge Octa 1Implant System isintended to besurgically placed in themaxillary ormandibular arches forthe purpose ofproviding prostheticsupport for dentalrestorations (Crown,bridges, andoverdentures) inpartially or fullyedentulous individuals.It is used to restore apatient's chewingfunction in thefollowing situationsand with the clinicalprotocols:- Delayed loading.- Immediate loadingwhen good primarystability is achievedand with appropriateocclusal loading.Larger implants arededicated for the molarregion. | The Xpeed AnyRidgeInternal ImplantSystem is intended tobe surgically placed inthe maxillary ormandibular molarareas for the purposeproviding prostheticsupport for dentalrestorations (Crown,bridges, andoverdentures) inpartially or fullyedentulousindividuals. It is usedto restore a patientschewing function.Smaller implants (lessthan 6.0 mm) arededicated forimmediate loadingwhen good primarystability is achievedand with appropriateocclusal loading.Larger implants arededicated for themolar region and areindicated for delayedloading. | Straumann dentalimplants are indicatedfor oral endostealimplantation in theupper and lower jawand for the functionaland esthetic oralrehabilatation ofendentulous andpartially dentatepatients. Straumanndental implants canalso be used forimmediate or earlyimplantationfollowing extractionor loss of naturalteeth. Implants can beplaced withimmediate function onsingle-tooth and/ormultiple toothapplications whengood primary stabilityis achieved and withappropriate occlusalloading, to restorechewing function. Theprosthetic restorationused are singlecrowns, bridges andpartial or fulldentures, which areconnected to theimplants by thecorrespondingelements (abutments). | The Internal OctaImplant System isintended forplacement in themaxillary and/ormandibular arched tosupport crowns,bridges, oroverdentures inedentulous patients.The Internal OctaImplant System isintended forimmediate loadingwhen good primarystability is achievedand with appropriateocclusal loading. |
| Appearance | Image: blue dental implant | Image: blue dental implant | Image: gray dental implant | Image: gray dental implant |
| Material | CP Ti Grade 4 | CP Ti Grade 4 | CP Ti Grade 4 | CP Ti Grade 4 |
| Sterilization | Gamma sterilization | Gamma sterilization | Gamma sterilization | Gamma sterilization |
| Diameter(Ø) | 3.6, 4.0, 4.4, 4.7, 4.8 mm | 4.0, 4.4, 4.9, 5.4, 5.9 mm | 3.3, 4.1, 4.8mm | 4.1, 4.8mm |
| 5.0, 5.5mm | 6.4, 6.9, 7.4, 7.9, 8.4mm | 8, 10, 12, 14mm | 7.2~14.2mm | |
| Length (mm) | 7.0, 7.7, 9.2, 10.7,12.2, 14.2, 17.2mm | 7.7, 7.9, 9.2, 9.4, 10.7,10.9, 12.2, 12.4,14.20, 14.4, 17.2mm | 8, 10, 12, 14mm | 7.2~14.2mm |
| Surfacetreatment | Sand-blasted, Largegrit, Acid-etched(S.L.A) | Sand-blasted, Largegrit, Acid-etched(S.L.A) | Sand-blasted, Largegrit, Acid-etched(SLA) | Sand-blasted, Largegrit, Acid-etched(S.L.A) |
| Implant-to-abutmentconnection | Octa | Hex | Narrow CrossFitRegular CrossFit | Octa |
| Feature | - Submerged implant- Tapered body- cutting edge withself tapping- 0.8mm thread pitch | - Submerged implant- Tapered body- No cutting edge withself tapping- 0.8mm thread pitch | - Submerged implant- Tapered body- cutting edge withself-tapping- 0.8mm thread pitch | - Submerged implant- Parallel walled body- cutting edge withself-tapping- Thread pitch :unknown |
| Principle ofoperation | This product is atapered body fixturewhich is inserted inthe alveolar bone. Itreplaces the functionsof the missing teeth asa dental implantfixture. | This product is atapered body fixturewhich is inserted inthe alveolar bone. Itreplaces the functionsof the missing teeth asa dental implantfixture. | - | - |
| Shelf Life | 5 Years | 5 Years | - | 5 Years |
| Substantial Equivalence Discussion | ||||
| The subject device has the same material, surface treatment, indication for use, and principle of opeartion as thepredicate device. |
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The differences between the subject device and the predicate device is that the subject device has the diameter 3.6mm and cutting edge. The connection type is also different.
The subject device does not include the diameter larger than 5.5mm so the corresponding indication for use of the predicate device for larger implant was excluded. Other than this difference, the IFU statement is the same as the predicate device.
The cutting edge functions as self-tapping by creating a screw path. This difference is covered by the reference device 1 and 2.
The difference in connection type is covered by the reference device 2.
The 3.6mm implant size is covered by the reference device 1.
Despite these differences, the test result of fatigue test supported that the subject device is substantially equivalent to the predicate device.
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EZ Post Abutment
| Subject Device | Predicate Device | |
|---|---|---|
| 510(k) Number | K182448 | K110955 |
| Device Name | EZ Post Abutmentfor AnyRidge Octa 1 System | EZ Postfor AnyRidge Internal System |
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indications forUse Statement | The AnyRidge Octa 1 Implant System isintended to be surgically placed in themaxillary or mandibular arches for thepurpose of providing prosthetic support fordental restorations (Crown, bridges, andoverdentures) in partially or fully edentulousindividuals. It is used to restore a patient'schewing function in the following situationsand with the clinical protocols:- Delayed loading.- Immediate loading when good primarystability is achieved and with appropriateocclusal loading.Larger implants are dedicated for the molarregion. | The Xpeed AnyRidge Internal Implant Systemis intended to be surgically placed in themaxillary or mandibular molar areas for thepurpose providing prosthetic support fordental restorations (Crown, bridges, andoverdentures) in partially or fully edentulousindividuals. It is used to restore a patientschewing function. Smaller implants (less than6.0 mm) are dedicated for immediate loadingwhen good primary stability is achieved andwith appropriate occlusal loading. Largerimplants are dedicated for the molar regionand are indicated for delayed loading. |
| Appearance | Image: EZ Post Abutment | Image: EZ Post |
| Diameter | 4.0, 5.0, 6.0, 7.0mm | 4.0, 5.0, 6.0, 7.0mm |
| Post Height | 4, 5.5, 7 mm | 5.5, 7mm |
| Gingival Height | 0.8, 1.8, 2.8, 3.8, 4.8mm | 1.8, 2.8, 3.8, 4.8mm |
| ConnectionInterface | Octa, non-octa | Hex, non-hex |
| Surfacetreatment | Anodizing | Anodizing |
| Sterility | Non-sterile; intended for terminal sterilizationvia moist heat(autoclave) | Non-sterile; intended for terminal sterilizationvia moist heat(autoclave) |
| Angulation | 0° | 0° |
| Material | Ti-6A1-4V ELI | Ti-6A1-4V ELI |
| Principle ofoperation | This product is a superstructure which isconnects with the fixtures using the AbutmentScrew. It replaces the functions of the missingteeth as a dental abutment. | This product is a superstructure which isconnects with the fixtures using the AbutmentScrew. It replaces the functions of the missingteeth as a dental abutment. |
| Substantial Equivalence Discussion | ||
| The subject device has the same intended use, material, surface treatment, and design as the predicate device.The diameter range of the subject device is same as the predicate device, yet the subject device has slightlywider range of post height and gingival height. This wider range is to meet each patient needs and does not raisean issue in performance or safety since the size difference is very minor.The connection interface is also different but both features of Octa and Hex provides anti-rotational feature. |
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Milling Abutment
| Subject Device | Predicate Device | |
|---|---|---|
| 510(k) Number | K182448 | K110955 |
| Device Name | Milling Abutmentfor AnyRidge Octa 1 System | Milling Abutmentfor AnyRidge Internal System |
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indications forUse Statement | The AnyRidge Octa 1 Implant System isintended to be surgically placed in themaxillary or mandibular arches for thepurpose of providing prosthetic support fordental restorations (Crown, bridges, andoverdentures) in partially or fully edentulousindividuals. It is used to restore a patient'schewing function in the following situationsand with the clinical protocols:- Delayed loading.- Immediate loading when good primarystability is achieved and with appropriateocclusal loading.Larger implants are dedicated for the molarregion. | The Xpeed AnyRidge Internal ImplantSystem is intended to be surgically placed inthe maxillary or mandibular molar areas forthe purpose providing prosthetic support fordental restorations (Crown, bridges, andoverdentures) in partially or fully edentulousindividuals. It is used to restore a patientschewing function. Smaller implants (lessthan 6.0 mm) are dedicated for immediateloading when good primary stability isachieved and with appropriate occlusalloading. Larger implants are dedicated forthe molar region and are indicated fordelayed loading. |
| Appearance | Image: Milling Abutment | Image: Milling Abutment |
| Diameter | 6.0, 8.0mm | 4.0, 5.0, 6.0, 7.0mm |
| Post Height | 9.0mm | 9.2mm |
| Gingival Height | 0.8, 1.8, 2.8, 3.8, 4.8mm | 1.6, 2.6, 3.6, 4.6mm |
| ConnectionInterface | Octa, non-octa | Hex, non-hex |
| Surface treatment | Anodizing | Anodizing |
| Sterility | Non-sterile; intended for terminal sterilizationvia moist heat(autoclave) | Non-sterile; intended for terminalsterilization via moist heat(autoclave) |
| Angulation | 0° | 0° |
| Material | Ti-6Al-4V ELI | Ti-6Al-4V ELI |
| Principle ofoperation | This product is a superstructure which isconnects with the fixtures using the AbutmentScrew. It replaces the functions of the missingteeth as a dental abutment. | This product is a superstructure which isconnects with the fixtures using theAbutment Screw. It replaces the functions ofthe missing teeth as a dental abutment. |
| Substantial Equivalence Discussion | ||
| The subject device has the same intended use, material, surface treatment, and design as the predicate device.The size range of the subject device is slightly different from the predicate device. This wider range is to meeteach patient needs and does not raise an issue in performance or safety since the size difference is very minor.The connection interface is also different but both features of Octa and Hex provides anti-rotational feature. |
Octa Abutment
| Subject Device | Reference Device 1 | Reference Device 2 | |
|---|---|---|---|
| 510(k) Number | K182448 | K110955 | K171027 |
| Device Name | Octa AbutmentFor AnyRidge Octa 1 System | Octa Abutmentfor AnyRidge Internal System | Octa AbutmentFor Dental Implant System |
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | Dentis Co., Ltd. |
{11}------------------------------------------------
| The AnyRidge Octa 1 Implant | The Xpeed AnyRidge Internal | The Dentis Dental Implant | |
|---|---|---|---|
| Indications forUse Statement | The AnyRidge Octa 1 ImplantSystem is intended to besurgically placed in themaxillary or mandibulararches for the purpose ofproviding prosthetic supportfor dental restorations(Crown, bridges, andoverdentures) in partially orfully edentulous individuals. Itis used to restore a patient'schewing function in thefollowing situations and withthe clinical protocols:- Delayed loading.- Immediate loading whengood primary stability isachieved and with appropriateocclusal loading.Larger implants are dedicatedfor the molar region. | The Xpeed AnyRidge InternalImplant System is intended tobe surgically placed in themaxillary or mandibularmolar areas for the purposeproviding prosthetic supportfor dental restorations(Crown, bridges, andoverdentures) in partially orfully edentulous individuals. Itis used to restore a patientschewing function. Smallerimplants (less than 6.0 mm)are dedicated for immediateloading when good primarystability is achieved and withappropriate occlusal loading.Larger implants are dedicatedfor the molar region and areindicated for delayed loading. | The Dentis Dental ImplantSystem is an endosseousdental implant that isindicated for surgicalplacement in the upper andlower jaw arches, to provide aroot form means for single ormultiple-unitsprosthetic applianceattachment to restore apatient's chewing function.Implants can be placed with aconventional two stagesurgical process with anoption for transmucosalhealing or they can be placedin a single stage surgicalprocess for immediateloading when good primarystability has been achievedand with appropriate occlusalloading. |
| Appearance | Image: AnyRidge Octa 1 Implant appearance | Image: Xpeed AnyRidge Internal Implant appearance | Image: Dentis Dental Implant appearance |
| Diameter | 3.8mm | 4.8mm | 3.5, 4.3mm |
| Gingival Height | 0.8, 1.8, 2.8, 3.8, 4.8mm | 1, 2, 3, 4, 5mm | Unknown |
| ConnectionInterface | Internal Conical connection | Internal Conical connection | Internal Conical connection |
| Surfacetreatment | Color anodization | Color anodization | Machined |
| Sterility | Non-sterile; intended forterminal sterilization viamoist heat(autoclave) | Non-sterile; intended forterminal sterilization viamoist heat(autoclave) | Non-sterile; intended forterminal sterilization viamoist heat(autoclave) |
| Angulation | 0° | 0° | 0° |
| Material | Ti-6A1-4V ELI | Ti-6Al-4V ELI | Ti-6Al-4V ELI |
| Principle ofoperation | This product is asuperstructure which isconnects with the fixturesusing the Abutment Screw. Itreplaces the functions of themissing teeth as a dentalabutment. | This product is asuperstructure which isconnects with the fixturesusing the Abutment Screw. Itreplaces the functions of themissing teeth as a dentalabutment. | This product is asuperstructure which isconnects with the fixturesusing the Abutment Screw. Itreplaces the functions of themissing teeth as a dentalabutment. |
The subject device has the same intended use, material, surface treatment, connection interface, and design as the predicate device.
The diameter of the subject device is covered by the reference device 2, yet the subject device has slightly wider range of gingival height. This wider range is to meet each patient needs and does not raise an issue in performance or safety since the size difference is very minor.
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Multi-unit Abutment
| Subject Device | Predicate Device 1 | Predicate Device 2 | |
|---|---|---|---|
| 510(k)Number | K182448 | K072570 | K123988 |
| Device Name | Multi-unit Abutmentfor AnyRidge Octa 1 System | NobelActive Multi UnitAbutment | Multi-unit Abutmentfor AnyOne Internal System |
| Manufacturer | MegaGen Implant Co., Ltd. | NOBEL BIOCARE AB | MegaGen Implant Co., Ltd. |
| Indications forUse Statement | The AnyRidge Octa 1 ImplantSystem is intended to besurgically placed in themaxillary or mandibular archesfor the purpose of providingprosthetic support for dentalrestorations (Crown, bridges,and overdentures) in partiallyor fully edentulous individuals.It is used to restore a patient'schewing function in thefollowing situations and withthe clinical protocols:- Delayed loading.- Immediate loading whengood primary stability isachieved and with appropriateocclusal loading.Larger implants are dedicatedfor the molar region. | NobelActive Multi UnitAbutment is apre-manufactured prostheticcomponent directly connectedto the endosseous dentalimplant and is intended for useas an aid in prostheticrehabilitation. | The Xpeed AnyRidge InternalImplant System is intended tobe surgically placed in themaxillary or mandibular molarareas for the purpose providingprosthetic support for dentalrestorations (Crown, bridges,and overdentures) in partiallyor fully edentulous individuals.It is used to restore a patientschewing function. Smallerimplants (less than 6.0 mm)are dedicated for immediateloading when good primarystability is achieved and withappropriate occlusal loading.Larger implants arededicated for the molar regionand are indicated for delayedloading. |
| Appearance | Image: Abutment | Image: Abutment | Image: Abutment |
| Diameter | 4.8mm | 4.8mm | 5.0mm |
| GingivalHeight | 1.3, 2.3, 3.3, 4.3mm | 1.5, 2.5, 3.5, 4.5mm | 1.8, 2.8, 3.8, 4.8mm |
| ConnectionInterface | Internal Conical connection | Internal Conical connection | Hex, non-hex |
| Surfacetreatment | Color anodization | Machined | Color anodization |
| Sterility | Non-sterile; intended forterminal sterilization via moistheat(autoclave) | Non-sterile; intended forterminal sterilization via moistheat(autoclave) | Non-sterile; intended forterminal sterilization via moistheat(autoclave) |
| Angulation | 0° | 0° | 0° |
| Material | Ti-6A1-4V ELI | Ti-6A1-4V ELI | Ti-6A1-4V ELI |
| Principle ofoperation | Multi-unit Abutment is a pre-manufactured prostheticcomponent directly connectedto the endosseous dentalimplant and is intended for useas an aid in prostheticrehabilitation. | NobelActive Multi UnitAbutment is a pre-manufactured prostheticcomponent directly connectedto the endosseous dentalimplant and is intended for useas an aid in prostheticrehabilitation. | Multi-unit Abutment is a pre-manufactured prostheticcomponent directly connectedto the endosseous dentalimplant and is intended for useas an aid in prostheticrehabilitation. |
| Substantial Equivalence Discussion | |||
| Subject Device | Predicate Device | ||
| 510(k)Number | K182448 | K123988 | |
| Device Name | Meg-Rhein Abutmentfor AnyRidge Octa 1 System | Meg-Rhein Abutmentfor AnyOne Internal System | |
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | |
| Indications forUse Statement | The AnyRidge Octa 1 Implant System isintended to be surgically placed in themaxillary or mandibular arches for the purposeof providing prosthetic support for dentalrestorations (Crown, bridges, and overdentures)in partially or fully edentulous individuals. It isused to restore a patient's chewing function inthe following situations and with the clinicalprotocols:- Delayed loading.- Immediate loading when good primarystability is achieved and with appropriateocclusal loading.Larger implants are dedicated for the molarregion. | The AnyOne™ Internal Implant System isintended to be surgically placed in themaxillary or mandibular molar areas for thepurpose providing prosthetic support for dentalrestorations (Crown, bridges, andoverdentures) in partially or fully edentulousindividuals. It is used to restore a patient'schewing function. Smaller implants (less than6.0 mm) are dedicated for immediate loadingwhen good primary stability is achieved andwith appropriate oclusal loading. Largerimplants arededicated for the molar region and areindicated for delayed loading. | |
| Appearance | Image: Subject Device Appearance | Image: Predicate Device Appearance | |
| Head Diameter | 2.5mm | 2.5mm | |
| Head Height | 1.7mm | 1.7mm | |
| ConnectionInterface | Internal Conical connection | Internal Conical connection | |
| Surfacetreatment | Machined | Machined | |
| Sterility | Non-sterile; intended for terminal sterilizationvia moist heat(autoclave) | Non-sterile; intended for terminal sterilizationvia moist heat(autoclave) | |
| Angulation | 0° | 0° | |
| Principle ofoperation | Meg-Rhein Abutment is designed as anendosseous dental implant retentivecomponent used to retain a complete or partialdenture. The Meg-Rhein Abutment is screwedinto an endosseous implant in the mandible ormaxilla. | Meg-Rhein Abutment is designed as anendosseous dental implant retentivecomponent used to retain a complete or partialdenture. The Meg-Rhein Abutment is screwedinto an endosseous implant in the mandible ormaxilla. | |
| Material | Ti-6A1-4V ELI | Ti-6A1-4V ELI | |
| Substantial Equivalence Discussion | |||
| The subject device has the same intended use, size, material, surface treatment, connection interface, and design asthe predicate devices. | |||
| Subject Device | Predicate Device | Reference Device | |
| 510(k)Number | K182448 | K161244 | K153350 |
| Device Name | CCM Abutmentfor AnyRidge Octa 1 System | CCM AbutmentFor s-Clean OneQ-SL NarrowImplant System | IBS Implant system |
| Manufacturer | MegaGen Implant Co., Ltd. | Dentis Co.,Ltd | Innobiosurg Co.,Ltd |
| Indications forUse Statement | The AnyRidge Octa 1 ImplantSystem is intended to besurgically placed in themaxillary or mandibular archesfor the purpose of providingprosthetic support for dentalrestorations (Crown, bridges,and overdentures) in partiallyor fully edentulous individuals.It is used to restore a patient'schewing function in thefollowing situations and withthe clinical protocols:- Delayed loading.- Immediate loading whengood primary stability isachieved and with appropriateocclusal loading.Larger implants are dedicatedfor the molar region. | The s-Clean OneQSL NarrowImplant System (3.0, 3.3mm)may be used as an artificialroot structure for single toothreplacement of mandibularcentral and lateral incisorsand maxillary lateral incisors.The implants may be restoredImmediately1) with a temporary prosthesisthat is not in functionalocclusion,2) when splinted together as anartificial root structure formultiple tooth replacement ofmandibular incisors, or3) for denture stabilizationusing multiple implants inthe anterior mandible andmaxilla.The implants may be placed inimmediate function when goodprimary stability has beenachieved and with appropriateocclusal loading. | The CCM Abutment System isintended to replace missingteeth to restore chewingfunction. The CCM AbutmentSystem can be placed insupport of single ormultipleunit restorationsincluding;cement retained,screw retained, and terminal orimmediate abutment supportfor fixed bridgework. Thissystem is for one or two stagesurgical procedures. Thissystem is intended for delayedloading. |
| Appearance | Image: Abutment | Image: Abutment | Image: Abutment |
| Diameter | 3.8mm | 4.0mm | 3.5, 4, 4.5, 5, 5.5mm |
| Length | 14.65, 16.15 | 14.5, 15mm | 14, 15, 16, 17mm |
| ConnectionInterface | Octa, non-octa | Hex, non-hex | Hex, non-hex |
| Angulation | 0° | 0° | 0° |
| Principle ofoperation | a screw retained restorationtype of abutment using ascrew to fix a prosthesis | a screw retained restorationtype of abutment using ascrew to fix a prosthesis | a screw retained restorationtype of abutment using ascrew to fix a prosthesis |
| Material | Cobalt Chrome Molybdenum | Cobalt Chrome Molybdenum | Titanium Alloy Poly Diacetate |
| Substantial Equivalence Discussion | |||
| The subject device has the same intended use, material, and design as the predicate devices. | |||
| Subject Device | Predicate Device 1 | Predicate Device 2 | |
| 510(k)Number | K182448 | K110955 | K051636 |
| Device Name | Healing Abutmentfor AnyRidge Octa 1 System | Healing Abutmentfor AnyRidge Internal System | Healing Cap |
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | Altatec |
| Indications forUse Statement | The AnyRidge Octa 1 ImplantSystem is intended to besurgically placed in themaxillary or mandibular archesfor the purpose of providingprosthetic support for dentalrestorations (Crown, bridges,and overdentures) in partiallyor fully edentulous individuals.It is used to restore a patient'schewing function in thefollowing situations and withthe clinical protocols:- Delayed loading.- Immediate loading whengood primary stability isachieved and with appropriateocclusal loading.Larger implants are dedicatedfor the molar region. | The AnyRidge InternalImplant System is intended tobe surgically placed in themaxillary or mandibular molarareas for the purpose providingprosthetic support for dentalrestorations (Crown, bridges,and overdentures) in partiallyor fully edentulous individuals.It is used to restore a patientschewing function. Smallerimplants (less than 6.0 mm)are dedicated for immediateloading when good primarystability is achieved and withappropriate occlusal loading.Larger implants are dedicatedfor the molar region and areindicated for delayed loading. | CAMLOG Healing Caps(Cylindrical, wide body,Bottleneck) displace thegingiva from the space abovethe CAMLOG implant or barabutment during theCAMLOG implant or barabutment during theCAMLOG implant healingtime and serve for propergingiva shaping. |
| Appearance | Image: Healing abutment | Image: Healing abutment | Image: Healing cap |
| Diameter | 3.2, 4.2, 5.2, 6.2mm | 4.2, 5.2, 6.2, 7.2, 8.0, 10.0mm | 3.3, 3.8, 4.3, 5, 6mm |
| GingivalHeight | 2.5, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5,9.5mm | 3.5, 4.5, 5.5, 6.5,7.5mm | 2, 4, 6mm |
| Sterilization | Gamma irradiation | Gamma irradiation | Gamma irradiation |
| ConnectionInterface | Internal Conical connectionInternal | Internal Conical connection | Internal Conical connection |
| Surfacetreatment | Color Anodization | Machined | Machined |
| Principle ofoperation | The Healing Abutment isfastened into the female screwof dental implant and supportthe gingival shaping. | The Healing Abutment isfastened into the female screwof dental implant and supportthe gingival shaping. | Unknown |
| Material | Ti-6A1-4V ELI | Ti-6Al-4V ELI | Ti-6Al-4V ELI |
| Substantial Equivalence Discussion | |||
| The subject device has the same intended use, material, connection interface, and design as the predicate devices.The subject device has slightly wider range of size to meet each patient needs and does not raise an issue inperformance or safety since the size difference is very minor.The other difference is in surface treatment but we already presented multiple predicate devices for anodizing in theother component comparison charts. | |||
| Subject Device | Primary Predicate Device | ||
| 510(k) Number | K182448 | K110955 | |
| Device Name | Temporary Abutmentfor AnyRidge Octa 1 System | Temporary Abutmentfor AnyRidge Internal System | |
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | |
| Indications forUse Statement | The AnyRidge Octa 1 Implant System isintended to be surgically placed in themaxillary or mandibular arches for thepurpose of providing prosthetic support fordental restorations (Crown, bridges, andoverdentures) in partially or fully edentulousindividuals. It is used to restore a patient'schewing function in the following situationsand with the clinical protocols:- Delayed loading.- Immediate loading when good primarystability is achieved and with appropriateocclusal loading.Larger implants are dedicated for the molarregion. | The AnyRidge Internal Implant System isintended to be surgically placed in themaxillary or mandibular molar areas for thepurpose providing prosthetic support fordental restorations (Crown, bridges, andoverdentures) in partially or fully edentulousindividuals. It is used to restore a patientschewing function. Smaller implants (less than6.0 mm) are dedicated for immediate loadingwhen good primary stability is achieved andwith appropriate occlusal loading. Largerimplants are dedicated for the molar regionand are indicated for delayed loading. | |
| Appearance | Image: abutment | Image: abutment | |
| Diameter | 4.0, 5.0mm | 4.0mm | |
| Post Height | 10mm | 10mm | |
| Gingival Height | 2.0, 3.0mm | 2.0mm | |
| Sterilization | Non-sterile; intended for terminal sterilizationvia moist heat(autoclave) | Non-sterile; intended for terminal sterilizationvia moist heat(autoclave) | |
| ConnectionInterface | Octa, non-octa | He, non-hex | |
| Surfacetreatment | Color Anodization | Machined | |
| Angulation | 0° | 0° | |
| Principle of | Temporary Abutment is used in conjunction | Temporary Abutment is used in conjunction | |
| operation | with fixture to provide support for provisionalrestoration. | with fixture to provide support for provisionalrestoration. | |
| Material | Ti-6A1-4V ELI | Ti-6A1-4V ELI | |
| Substantial Equivalence Discussion | |||
| The subject device has the same intended use, material, and design as the predicate devices. | |||
| The subject device has slightly wider range of size to meet each patient needs and does not raise an issue inperformance or safety since the size difference is very minor.The other difference is in surface treatment but we already presented multiple predicate devices for anodizing inthe other component comparison charts. | |||
| Subject Device | Primary Predicate Device | ||
| 510(k) Number | K182448 | K123988 | |
| Device Name | Fuse Abutmentfor AnyRidge Octa 1 System | Fuse Abutmentfor AnyOne Internal System | |
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | |
| Indications forUse Statement | The AnyRidge Octa 1 Implant System isintended to be surgically placed in themaxillary or mandibular arches for thepurpose of providing prosthetic support fordental restorations (Crown, bridges, andoverdentures) in partially or fully edentulousindividuals. It is used to restore a patient'schewing function in the following situationsand with the clinical protocols:- Delayed loading.- Immediate loading when good primarystability is achieved and with appropriateocclusal loading.Larger implants are dedicated for the molarregion. | The AnyOne Internal Implant System isintended to be surgically placed in themaxillary or mandibular molar areas for thepurpose providing prosthetic support fordental restorations (Crown, bridges, andoverdentures) in partially or fully edentulousindividuals. It is used to restore a patientschewing function. Smaller implants (less than6.0 mm) are dedicated for immediate loadingwhen good primary stability is achieved andwith appropriate occlusal loading. Largerimplants are dedicated for the molar regionand are indicated for delayed loading. | |
| Appearance | Image: Abutment | Image: Abutment | |
| Diameter | 5.4mm | 5.3mm | |
| Post Height | 5.5, 7.0mm | 5.5, 7.0mm | |
| Gingival Height | 4.0mm | 4.0mm | |
| Sterilization | Non-sterile; intended for terminal sterilizationvia moist heat(autoclave) | Non-sterile; intended for terminal sterilizationvia moist heat(autoclave) | |
| ConnectionInterface | Octa, non-octa | He, non-hex | |
| Angulation | 0° | 0° | |
| Principle ofoperation | Fuse Abutment is used in conjunction withfixture to provide support for provisionalrestoration. | Fuse Abutment is used in conjunction withfixture to provide support for provisionalrestoration. | |
| Material | Ti-6A1-4V ELI, POM | Ti-6A1-4V ELI, POM | |
| Substantial Equivalence Discussion | |||
| The subject device has the same intended use, material, and similar design as the predicate devices. | |||
| The subject device has slightly wider diameter than the predicate device but the difference is very minor. | |||
| The connection interface is also different but both features of Octa and Hex provides anti-rotational feature. | |||
| Subject Device | Primary Predicate Device | ||
| 510(k) Number | K182448 | K110955 | |
| Angled Abutment | Angled Abutment | ||
| Device Name | for AnyRidge Octa 1 System | for AnyRidge Internal System | |
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | |
| Indications forUse Statement | The AnyRidge Octa 1 Implant System isintended to be surgically placed in themaxillary or mandibular arches for thepurpose of providing prosthetic support fordental restorations (Crown, bridges, andoverdentures) in partially or fully edentulousindividuals. It is used to restore a patient'schewing function in the following situationsand with the clinical protocols:- Delayed loading.- Immediate loading when good primarystability is achieved and with appropriateocclusal loading.Larger impalnts are dedicated for the molarregion. | The AnyRidge Internal Implant System isintended to be surgically placed in themaxillary or mandibular molar areas for thepurpose providing prosthetic support fordental restorations (Crown, bridges, andoverdentures) in partially or fully edentulousindividuals. It is used to restore a patientschewing function. Smaller implants (less than6.0 mm) are dedicated for immediate loadingwhen good primary stability is achieved andwith appropriate occlusal loading. Largerimplants are dedicated for the molar regionand are indicated for delayed loading. | |
| Appearance | Image: Angled Abutment | Image: Angled Abutment | |
| Diameter | 4.0, 5.0, 6.0, 7.0mm | 3.85, 4.2, 5.0, 6.0mm | |
| Post Height | 7.0mm | 7.0mm | |
| Gingival Height | 0.8, 1.8, 2.8, 3.8, 4.8mm | 1.8, 2.8, 3.8, 4.8mm | |
| ConnectionInterface | Octa, non-octa | Hex, non-hex | |
| Surfacetreatment | Machined, Color anodization | Color anodization | |
| Sterility | Non-sterile; intended for terminal sterilizationvia moist heat(autoclave) | Non-sterile; intended for terminal sterilizationvia moist heat(autoclave) | |
| Angulation | 15°, 25° | 15°, 25° | |
| Material | Ti-6A1-4V ELI | Ti-6A1-4V ELI | |
| Principle ofoperation | This product is a superstructure which isconnects with the fixtures using the AbutmentScrew. It replaces the functions of the missingteeth as a dental abutment. | This product is a superstructure which isconnects with the fixtures using the AbutmentScrew. It replaces the functions of the missingteeth as a dental abutment. | |
| Substantial Equivalence Discussion | |||
| The subject device has the same intended use, material, and design as the predicate devices.The subject device has slightly wider range of size to meet each patient needs and does not raise an issue inperformance or safety since the size difference is very minor.The connection interface is also different but both features of Octa and Hex provides anti-rotational feature.Despite these differences, the test result of fatigue test supported that the subject device is substantially equivalentto the predicate device. | |||
| Subject Device | Primary Predicate Device | ||
| 510(k) Number | K182448 | K072570 | |
| Device Name | Multi-unit Angled Abutmentfor AnyRidge Octa 1 System | Nobel Active Multi Unit Abutment | |
| Manufacturer | MegaGen Implant Co., Ltd. | Nobel BioCare | |
| Indications forUse Statement | The AnyRidge Octa 1 Implant System isintended to be surgically placed in themaxillary or mandibular arches for thepurpose of providing prosthetic support fordental restorations (Crown, bridges, andoverdentures) in partially or fully edentulousindividuals. It is used to restore a patient'schewing function in the following situationsand with the clinical protocols:- Delayed loading.- Immediate loading when good primarystability is achieved and with appropriateocclusal loading.Larger impalnts are dedicated for the molarregion. | NobelActive Multi Unit Abutment is a pre-manufactured prosthetic component directlyconnected to the endosseous dental implantand is intended for use as an aid in prostheticrehabilitation. | |
| Appearance | Image: Multi-unit Angled Abutment for AnyRidge Octa 1 System | Image: Nobel Active Multi Unit Abutment | |
| Diameter | 4.8mm | 4.8mm | |
| Gingival Height | 2.3, 3.3, 4.3mm | 1.5, 2.5, 3.5, 4.5mm | |
| ConnectionInterface | Octa, non-octa | Hex | |
| Surfacetreatment | Machined | Machined | |
| Sterility | Non-sterile; intended for terminal sterilizationvia moist heat(autoclave) | Non-sterile; intended for terminal sterilizationvia moist heat(autoclave) | |
| Angulation | 17°, 30° | 17°, 30° | |
| Material | Ti-6A1-4V ELI | Ti-6A1-4V ELI | |
| Principle ofoperation | Multi-unit Angled Abutment is a pre-manufactured prosthetic component directlyconnected to the endosseous dental implantand is intended for use as an aid in prostheticrehabilitation. | NobelActive Multi Unit Abutment is a pre-manufactured prosthetic component directlyconnected to the endosseous dental implantand is intended for use as an aid in prostheticrehabilitation. | |
| Substantial Equivalence Discussion | |||
| The subject device has the same intended use, material, and design as the predicate devices.The subject device has slightly wider range of size to meet each patient needs and does not raise an issue inperformance or safety since the size difference is very minor. The connection interface is also different but bothfeatures of Octa and Hex provides anti-rotational feature. |
{13}------------------------------------------------
The subject device has the same intended use, material, surface treatment, connection interface, and design as the predicate devices.
The diameter of the subject device is the same as the reference device 2, yet the subject device has slightly wider range of gingival height. This wider range is to meet each patient needs and does not raise an issue in performance or safety since the size difference is very minor.
Meg-Rhein Abutment
{14}------------------------------------------------
CCM Abutment
The size fally of the subject device is covered by the releved 2.
The connection interface is also different but both features of Octa and Hex provides anti-rotational featur
{15}------------------------------------------------
Healing Abutment
{16}------------------------------------------------
Temporary Abutment
The connection interface is also different but both features of Octa and Hex provides anti-rotational feature.
{17}------------------------------------------------
Fuse Abutment
{18}------------------------------------------------
Angled Abutment
{19}------------------------------------------------
Multi-unit Angled Abutment
{20}------------------------------------------------
8. Non-Clinical Testing
- · Sterilization validating testing has been performed in accordance with ISO 11137 and ISO 17665-1, 2 to verify the sterility assurance level (10th).
- · 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 year shelf life.
- . The following tests were done to evaluate the fixtures that have SLA treatment: Surface Morphology by energy dispersive spectrometer (EDS), Surface Roughness Analysis, GC(Gas Chromatography)/LC (Liquid chromatography) Analysis, and IC Analvsis.
- · The fatigue tests were performed on the subject devices in accordance with ISO 14801. The worst case scenarios were chosen based on the FDA guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments". The fatigue testing demonstrates that the results of the subject devices are substantially equivalent to the predicate device.
- · The fixture has the same material as the predicate device (K122231), and the abutments including the Fuse Abutment have the same material as the predicate device (K123988). The CCM Abutment also has the same material as the predicate device (K123988) made by our company. The biocompatibility of the predicate final products was evaluated under the previous 510K submissions.
- · The endotoxin testing will be conducted on every batch for the subject device with the testing limit of below 0.5 EU/mL which was referenced from the USP 39 <85>.
9. Conclusion
Based on the similarities, we conclude that the AnyRidge Octa 1 Implant System is substantially equivalent to the predicate devices.
§ 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.