(88 days)
The High Retention Attachment System is designed to support fixed, partial or full arch restorations on endosseous dental implants in the mandible or maxilla for the purpose of restoring masticatory function. It is used in fixed hybrid restorations that can be attached with a snap-in system.
The High Retention Attachment System is a system that provides rigid connection of fixed partial and full arch restorations (fixed/detachable hybrid dentures) to endosseous dental implants. It is designed to accommodate a path of insertion on implants to accommodate a divergence of up to 20° per implant and no more than 40° of divergence between implants. The components are similar to the LOCATOR Implant Anchor Abutment, cleared in K072878; however, the retention and removal of the inserts is similar to that of the LOCATOR F-Tx Attachment System cleared in K151789.
The High Retention Attachment System consists of abutment housings, inserts, laboratory processing tools and seating and removal tools. Abutments, attachment housings and inserts are Class II subject devices (Product Code NHA) and laboratory processing tools and seating and removal tools are Class I accessories (Product Code NDP). The abutments are provided in various cuff heights with the implant/abutment connection specific to the OEM implant. The subject device abutments are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Allov for Surgical Implant Applications (UNS R56401) and are TiN (titanium nitride) coated.
This is a medical device, not an AI/ML device, so the requested information about acceptance criteria, study details, and training data for AI/ML models is not directly applicable.
Here's an analysis based on the provided document, addressing the principles of demonstrating substantial equivalence for a medical device:
The Zest Anchors, LLC "High Retention Attachment System" (K213391) is a Class II medical device (Endosseous Dental Implant Abutment, Product Code NHA). The FDA has determined it is substantially equivalent to legally marketed predicate devices.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" in the way one might for a specific performance metric of an AI/ML model (e.g., AUC > 0.9). Instead, substantial equivalence is demonstrated by comparing the new device's characteristics and performance to those of legally marketed predicate devices.
The table on page 7 outlines a comparison of the subject device with its primary predicate (K151789, LOCATOR F-Tx Attachment System) and two reference devices (K072878, LOCATOR Implant Anchor Abutment; K200827, LOCATOR R-Tx Attachment System).
| Feature | Subject Device (High Retention Attachment System) | Primary Predicate (LOCATOR F-Tx Attachment System, K151789) | Reference Device (LOCATOR Implant Anchor Abutment, K072878) | Reference Device (LOCATOR R-Tx Attachment System, K200827) | Comparison (Reported Performance) |
|---|---|---|---|---|---|
| Indications for Use | Supports fixed, partial or full arch restorations on endosseous dental implants for masticatory function; used in fixed hybrid restorations with a snap-in system. | Same | Appropriate for overdentures or partial dentures retained by endosseous implants. | Designed for overdentures or partial dentures retained by endosseous implants. | Same as Predicate and Reference |
| Design: Abutment Platform Diameter | 2.3 mm to 7.0 mm, Multiple Systems | 3.0 mm to 7.0 mm; Multiple Systems | 2.3 mm to 7.0 mm, Multiple Systems | 3.0 mm to 7.0 mm; Multiple Systems | Same as Reference (K072878) |
| Design: Abutment Angle | Straight | Straight | Straight | Straight | Same |
| Design: Abutment/Implant Interface | Conical, External Hex, Internal Hex, Internal Multi Lobe | Conical, External Hex, Internal Hex, Internal Multi Lobe | Conical, External Hex, Internal Hex, Internal Multi Lobe | Conical, External Hex, Internal Hex, Internal Multi Lobe | Same |
| Design: Divergence Allowance | 20°/40° (except when not allowed by the implant manufacturer) | 20° | 20° | 30°/60° | Same |
| Design: Prosthesis Attachment Type | PEEK Insert retained in Denture Attachment Housing | PEEK Retention Ball attached to Denture Attachment Housing | Nylon Insert retained in Denture Attachment Housing | Nylon Male Retention Cap | Same as Predicate (K151789) |
| Materials: Abutment | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Same |
| Materials: Abutment Coating | TiN | TiN, TiCN | TiN | TiN, TiCN | Same |
| Materials: Prosthetic Retention | PEEK | PEEK | Nylon | Nylon | Same as Predicate (K151789) |
Key Performance Demonstrations:
- Sterilization Validation and Biocompatibility Testing: The device undergoes these standard tests for medical devices. The materials and TiN coating are stated to have the "same specifications, processes, and are manufactured in the same facilities" as the predicate F-Tx Attachment System (K151789) and LOCATOR device (K072878). This implies the acceptance criteria for these tests were met as per established standards for similar devices.
- Mechanical Denture Retention Testing: This was a specifically conducted non-clinical test. The reported performance is that "The mechanical testing demonstrated that the retention force of the High Retention Attachment System was greater than retention force of the predicate device K151789." This indicates superior performance in this regard.
- Abutment-Implant Interface Compatibility: Verified through OEM signed abutment drawings, OEM implant drawings, or contractual agreements, and "engineering analysis." No specific performance testing was required due to this established compatibility and demonstrated equivalence to the LOCATOR R-Tx Attachment System (K200827).
2. Sample size used for the test set and the data provenance
For the mechanical denture retention testing, the document states tests were conducted, but it does not specify the sample size used for this testing. It is a non-clinical test, so "data provenance" in terms of country of origin or retrospective/prospective is not applicable in the typical sense for patient data. It refers to laboratory/bench testing.
For sterilization validation and biocompatibility testing, these are typically conducted according to international standards (e.g., ISO standards) and involve specific sample sizes and protocols, but these details are not provided in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable as the device is not an AI/ML diagnostic tool that relies on expert interpretation to establish ground truth from patient data. The "ground truth" for this physical device is assessed through engineering specifications, material properties, and mechanical performance tests, not expert clinical interpretation of images or patient outcomes in the context of an AI study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable for the same reasons as point 3. There is no "test set" of clinical cases requiring expert adjudication.
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 question is not applicable. The device is a dental implant attachment system, not an AI-assisted diagnostic or treatment planning tool. Therefore, MRMC studies and "human readers improving with AI assistance" are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable as there is no algorithm, nor is it an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As explained above, "ground truth" for this device is established through:
- Engineering specifications and drawings: For device design, dimensions, and implant compatibility.
- Material specifications and standards: Conformance to ASTM standards (e.g., ASTM F136 for titanium alloy).
- Laboratory performance testing: Such as mechanical denture retention force testing.
- Biocompatibility and sterilization standards: Demonstrating safety.
8. The sample size for the training set
This question is not applicable as this is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
This question is not applicable as there is no training set.
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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.
Zest Anchors, LLC % Melissa Burbage RA Sr Specialist PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130
Re: K213391
Trade/Device Name: High Retention Attachment System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: October 15, 2021 Received: October 15, 2021
Dear Melissa Burbage:
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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
High Retention Attachment System
Indications for Use (Describe)
The High Retention Attachment System is designed to support fixed, partial or full arch restorations on endosseous dental implants in the mandible or maxilla for the purpose of restoring masticatory finction. It is used in fixed hybrid restorations that can be attached with a snap-in system.
The High Retention Attachment System is compatible with the following implants:
| Implant Manufacturer | Implant System | Implant Diameter |
|---|---|---|
| Ace Surgical | Infinity OCTAGON | 3.3, 4.1, 4.8 |
| Infinity TRI-CAM | 3.5, 4.3, 5.0 | |
| Infinity Internal Hex | 3.7, 4.1, 4.7, 5.1 | |
| BioHorizons | Tapered Internal | 3.0 |
| Tapered Plus | 3.8 | |
| Laser-Lok | 3.0 | |
| Biomet 3i | 3iT3, NanoTite, OSSEOTITE | 3.25, 3.75, 4.0 |
| Blue Sky Bio | Quattro | 3.3, 4.1, 4.8 |
| One Stage | 3.3, 4.1, 4.8 | |
| Camlog | SCREW-LINE ROOT-LINE 2 | 3.3, 3.8, 4.3, 5.0 |
| SCREW-LINE | 3.3, 3.8, 4.3, 5.0 | |
| Dentsply | Astra Tech OsseoSpeed EV | 3.6, 4.2, 4.8 |
| Xive Frialit-2 | 3.4, 3.8, 4.5, 5.5 | |
| Ankylos C/X | 3.5 | |
| Astra Tech OsseoSpeed TX | 3.5, 4.0, 4.5, 5.0 | |
| Hiossen, Inc. | SS | 3.5, 4.0, 4.5 |
| ET, TS | 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 | |
| US | 3.5, 3.3, 4.5, 4.0, 5.0, 6.0, 7.0 | |
| Implant Direct | Swish Plus | 4.1, 4.8 |
| SwishTapered | 4.1, 4.8 | |
| InterActive | 3.2, 3.7, 4.3, 5.0 | |
| ReActive | 3.7, 4.2, 4.7, 5.7 | |
| RePlant | 3.5, 4.3, 5.0 | |
| Legacy 1, 2, 3, 4 | 3.7, 4.2 | |
| Legacy 2, 3, 4 | 3.2, 4.7, 5.2 | |
| Legacy 1, 3 | 5.7 | |
| Legacy 2, 4 | 5.7, 7.0 | |
| Legacy 1 | 4.7 | |
| IDS | MegaGen Any Ridge | 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0 |
| Keystone | PrimaConnex | 3.5, 4.1, 5.0 |
| Genesis | 3.5 | |
| TILOBEMAXX | 7.0, 8.0, 9.0 | |
| MIS | C1 | 3.3, 3.75, 4.2 |
| V3 | 3.3, 3.9, 4.3, 5.0 | |
| SEVEN | 3.3 | |
| M4 | 3.3 | |
| Nobel | Replace, Replace Select, NobelSpeedy | 3.5, 4.3, 5.0 |
| NobelActive, NobelParallel CC, NobelReplace CC | 3.5, 4.3, 5.5 | |
| Branemark, Nobel Speedy, Groovy | 3.3, 3.75, 4.0, 5.0 | |
| OCO Biomedical | Engage | 3.25, 4.0, 5.0 |
| Southern Implants | Tri-Nex | 3.5, 4.3, 5.0 |
| Tri-MAX7 | 7.0 | |
| Straumann | Roxolid SLActive, Roxolid SLA | 3.3, 4.1, 4.8 |
| Zimmer Dental | Trabecular Metal, Tapered Screw-Vent, Screw-Vent, Advent | 3.7, 4.1, 4.7, 6.0 |
| Spline Reliance Cylinder | 3.25, 4.0, 5.0 | |
| Spline Twist | 3.75 |
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Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
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510(k) Summary
K213391
High Retention Attachment System
Zest Anchors, LLC
January 10, 2022
ADMINISTRATIVE INFORMATION
| Manufacturer Name | Zest Anchors, LLC2875 Loker Ave. EastCarlsbad, CA 92010 |
|---|---|
| Telephone: | +1 (442) 244-4835 |
| Official Contact | Mark Stavro, Regulatory Affairs Director |
|---|---|
| Representative/Consultant | Melissa BurbageKevin A. Thomas, PhD; Floyd G. Larson, MS, MBAPaxMed International, LLC12264 El Camino Real, Suite 400San Diego, CA 92130Telephone: +1 858-792-1235Fax: +1 858-792-1236Email: mburbage@paxmed.comkthomas@paxmed.com; flarson@paxmed.com |
DEVICE NAME AND CLASSIFICATION
| Trade/Device Name | High Retention Attachment System |
|---|---|
| Common Name | Dental implant abutment |
| Regulation Number | 21 CFR 872.3630 |
| Regulation Name | Endosseous dental implant abutment |
| Regulatory Class | Class II |
| Product Code | NHA |
| Classification Panel | Dental Products Panel |
| Reviewing Branch | Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices(OHT1) Dental Devices (DHT1B) |
PREDICATE DEVICE INFORMATION
Primary Predicate Device K151789, LOCATOR F-Tx Attachment System, Zest Anchors, LLC
Reference Devices K072878, LOCATOR Implant Anchor Abutment, Zest Anchors, LLC K200827, LOCATOR R-Tx Attachment System, Zest Anchors, LLC
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INDICATIONS FOR USE STATEMENT
The High Retention Attachment System is designed to support fixed, partial or full arch restorations on endosseous dental implants in the mandible or maxilla for the purpose of restoring masticatory function. It is used in fixed hybrid restorations that can be attached with a snap-in system.
The High Retention Attachment System is compatible with the following implants:
| Implant Manufacturer | Implant System | Implant Diameter |
|---|---|---|
| Ace Surgical | Infinity OCTAGON | 3.3, 4.1, 4.8 |
| Infinity TRI-CAM | 3.5, 4.3, 5.0 | |
| Infinity Internal Hex | 3.7, 4.1, 4.7, 5.1 | |
| BioHorizons | Tapered Internal | 3.0 |
| Tapered Plus | 3.8 | |
| Laser-Lok | 3.0 | |
| Biomet 3i | 3iT3, NanoTite, OSSEOTITE | 3.25, 3.75, 4.0 |
| Blue Sky Bio | Quattro | 3.3, 4.1, 4.8 |
| One Stage | 3.3, 4.1, 4.8 | |
| Camlog | SCREW-LINE ROOT-LINE 2 | 3.3, 3.8, 4.3, 5.0 |
| SCREW-LINE | 3.3, 3.8, 4.3, 5.0 | |
| Dentsply | Astra Tech OsseoSpeed EV | 3.6, 4.2, 4.8 |
| Xive, Frialit-2 | 3.4, 3.8, 4.5, 5.5 | |
| Ankylos C/X | 3.5 | |
| Astra Tech OsseoSpeed TX | 3.5, 4.0, 4.5, 5.0 | |
| Hiossen, Inc. | SS | 3.5, 4.0, 4.5 |
| ET, TS | 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 | |
| US | 3.5, 3.3, 4.5, 4.0, 5.0, 6.0, 7.0 | |
| Implant Direct | Swish Plus | 4.1, 4.8 |
| SwishTapered | 4.1, 4.8 | |
| InterActive | 3.2, 3.7, 4.3, 5.0 | |
| ReActive | 3.7, 4.2, 4.7, 5.7 | |
| RePlant | 3.5, 4.3, 5.0 | |
| Legacy 1, 2, 3, 4 | 3.7,4.2 | |
| Legacy 2, 3, 4 | 3.2, 4.7, 5.2 | |
| Legacy 1, 3 | 5.7 | |
| Legacy 2, 4 | 5.7, 7.0 | |
| Legacy 1 | 4.7 | |
| IDS | MegaGen Any Ridge | 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0 |
| Keystone | PrimaConnex | 3.5, 4.1, 5.0 |
| Genesis | 3.5 | |
| TILOBEMAXX | 7.0, 8.0, 9.0 | |
| MIS | C1 | 3.3, 3.75, 4.2 |
| V3 | 3.3, 3.9, 4.3, 5.0 | |
| SEVEN | 3.3 | |
| M4 | 3.3 | |
| Nobel | Replace, Replace Select, NobelSpeedy | 3.5, 4.3, 5.0 |
| NobelActive, NobelParallel CC, NobelReplace CC | 3.5, 4.3, 5.5 | |
| Branemark, Nobel Speedy, Groovy | 3.3, 3.75, 4.0, 5.0 | |
| OCO Biomedical | Engage | 3.25, 4.0, 5.0 |
| Southern Implants | Tri-Nex | 3.5, 4.3, 5.0 |
| Tri-MAX7 | 7.0 | |
| Straumann | Roxolid SLActive, Roxolid SLA | 3.3, 4.1, 4.8 |
| Zimmer Dental | Trabecular Metal, Tapered Screw-Vent, Screw-Vent, Advent | 3.7, 4.1, 4.7, 6.0 |
| Spline Reliance Cylinder | 3.25, 4.0, 5.0 | |
| Spline Twist | 3.75 |
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510(k) Summary Page 3 of 4
SUBJECT DEVICE DESCRIPTION
The High Retention Attachment System is a system that provides rigid connection of fixed partial and full arch restorations (fixed/detachable hybrid dentures) to endosseous dental implants. It is designed to accommodate a path of insertion on implants to accommodate a divergence of up to 20° per implant and no more than 40° of divergence between implants. The components are similar to the LOCATOR Implant Anchor Abutment, cleared in K072878; however, the retention and removal of the inserts is similar to that of the LOCATOR F-Tx Attachment System cleared in K151789.
The High Retention Attachment System consists of abutment housings, inserts, laboratory processing tools and seating and removal tools. Abutments, attachment housings and inserts are Class II subject devices (Product Code NHA) and laboratory processing tools and seating and removal tools are Class I accessories (Product Code NDP). The abutments are provided in various cuff heights with the implant/abutment connection specific to the OEM implant. The subject device abutments are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Allov for Surgical Implant Applications (UNS R56401) and are TiN (titanium nitride) coated.
PERFORMANCE DATA
Non-clinical testing data referenced/relied upon to demonstrate substantial equivalence included: sterilization validation and biocompatibility testing. Both the material and Titanium Nitride (TiN) coating have the same specifications, processes, and are manufactured in the same facilities as the predicate F-Tx Attachment System (K151789) and predicate LOCATOR device (K072878).
Non-clinical testing data submitted to demonstrate substantial equivalence included: mechanical denture retention testing. The mechanical testing demonstrated that the retention force of the High Retention Attachment System was greater than retention force of the predicate device K151789.
The subject abutment-implant interface of the High Retention Attachment System is verified to be compatible through either OEM signed abutment drawings, OEM implant drawings, or established compatibility demonstrated with the use of LOCATOR abutments through mutual contractual agreements with the OEM, Once the specifications and tolerances have been identified, the R-Tx abutment-implant interface is then verified through engineering analysis and documented per Zest internal procedures for Line Extensions. No performance testing is required, as demonstrated for the predicate LOCATOR R-Tx Attachment System (K200827).
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| Subject Device | Primary PredicateDevice | Reference Device | Reference Device | Comparison | |
|---|---|---|---|---|---|
| Zest Anchors, Inc.High RetentionAttachment SystemK213391 | Zest Anchors, LLCLOCATOR® F-TxAttachment SystemK151789 | Zest Anchors, Inc.LOCATOR® ImplantAnchor AbutmentK072878 | Zest Anchors, Inc.LOCATOR R-Tx®Attachment SystemK200827 | ||
| Indicationsfor Use | The High RetentionAttachment System isdesigned to support fixed,partial or full archrestorations on endosseousdental implants in themandible or maxilla forthe purpose of restoringmasticatory function. It isused in fixed hybridrestorations that can beattached with a snap-insystem. | The LOCATOR® F-TxAttachment System isdesigned to support fixed,partial or full archrestorations on endosseousdental implants in themandible or maxilla forthe purpose of restoringmasticatory function. It isused in fixed hybridrestorations that can beattached with a snap-insystem. | The Locator ImplantAnchor Abutment forEndosseous DentalImplants is appropriate foruse with overdentures orpartial dentures retained inwhole or in part byendosseous implants inthe mandible or maxilla. | The LOCATOR R-Tx®Attachment System isdesigned for use withoverdentures or partialdentures, retained inwhole or in part, byendosseous implants inthe mandible or maxilla. | Same asPredicate andReference |
| Design | |||||
| AbutmentPlatformDiameter | 2.3 mm to 7.0 mm,Multiple Systems | 3.0 mm to 7.0 mm;Multiple Systems | 2.3 mm to 7.0 mm,Multiple Systems | 3.0 mm to 7.0 mm;Multiple Systems | Same asReference |
| AbutmentAngle | Straight | Straight | Straight | Straight | Same |
| Abutment/ImplantInterface | Conical, External Hex,Internal Hex, InternalMulti Lobe | Conical, External Hex,Internal Hex, InternalMulti Lobe | Conical, External Hex,Internal Hex, InternalMulti Lobe | Conical, External Hex,Internal Hex, InternalMulti Lobe | Same |
| DivergenceAllowance | 20°/40°(except when not allowedby the implantmanufacturer) | 20° | 20° | 30°/60° | Same |
| ProsthesisAttachmentType | PEEK Insert retained inDenture AttachmentHousing | PEEK Retention Ballattached to DentureAttachment Housing | Nylon Insert retained inDenture AttachmentHousing | Nylon MaleRetention Cap | Same asPredicate |
| Materials | |||||
| Abutment | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Same |
| AbutmentCoating | TiN | TiN, TiCN | TiN | TiN, TiCN | Same |
| ProstheticRetention | PEEK | PEEK | Nylon | Nylon | Same asPredicate |
EQUIVALENCE TO MARKETED DEVICES
CONCLUSION
The subject devices, the primary predicate device and reference devices have the same intended use and similar technological characteristics. They encompass a similar range of physical dimensions, are manufactured from the same materials, and are to be sterilized using identical methods. The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.
§ 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.)