(219 days)
Preat Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandbular arch to provide support for single-unit or multi-unit prosthetic restorations. The Titanium Base abutments consists of two major parts. Specifically, the titanium base and the mesostructured components make up a two-piece abutment.
All digitally designed custom abutments, superstructures, and/or hybrid crowns for use with Titanium Blanks are to be sent to a Preat validated milling center for manufacture.
Preat Abutments were previously cleared under K183518. The purpose of this submission is to obtain marketing clearance for additional compatible implant systems under the Preat Abutments device name. This submission for Preat Abutments is a dental implant abutment system that includes nine (9) abutment designs compatible with five (5) OEM implant systems. The Subject device abutment platform diameters range from 2.9 mm to 5.4 mm, and the corresponding compatible implant body diameters also range from 3.0 mm to 7.0 mm. The Subject device includes the following abutment designs: temporary engaging, multi-unit straight, multi-unit angled 17°, multi-unit angled 30°, engaging titanium base, titanium blank and healing abutments. The system also includes corresponding abutment screws.
All abutments and screws are manufactured from Ti-6Al-4V ELI alloy conforming to ASTM F136 and are provided non-sterile to the end user. All digitally designed custom abutments for use with Titanium Base (superstructures) or Titanium Blank are to be sent to a Preat validated milling center for manufacture. All superstructures are to be manufactured from zirconia conforming to ISO 13356. Digitally designed CAD/CAM abutments must have a 0.5 mm minimum gingival height dimension.
The Titanium Base abutment is composed of two-piece abutment that is a titanium base at the bottom and a zirconia superstructure (CAD/CAM patient specific superstructure) at the top. The zirconia superstructure is straight only and is not to be designed to provide an angle or divergence correction.
For the Titanium Base abutment, the design parameters for the CAD/CAM zirconia superstructure are: Minimum wall thickness - 0.5 mm; Minimum post height for single-unit restorations – 4.0 mm; Maximum gingival height – 5.0 mm; and All zirconia superstructures are for straight abutments only. The design parameters for the CAD/CAM Titanium Blank custom abutment are:
Minimum wall thickness – 0.5 mm to 0.9 mm (varies by implant line); Minimum post height for single-unit restoration – 4.0 mm; Maximum Angle - 30°*; and Minimum gingival height - 0.5 mm; Maximum gingival height – 2.0 mm to 4.5 mm (varies by implant line). * Astra Tech® OsseoSpeed™ Plus (OsseoSpeed™ EV) compatible are limited to 0° maximum correction angle.
The provided document describes the Preat Abutments and their substantial equivalence to predicate devices, based on non-clinical performance data. It does not contain information about studies involving human readers, ground truth establishment for a test or training set, or specific details on sample sizes for a test set in the context of AI/algorithm performance.
Here's the information that can be extracted relevant to acceptance criteria and device performance based on the provided text:
1. A table of acceptance criteria and the reported device performance:
The document describes non-clinical performance data used to demonstrate substantial equivalence, focusing on mechanical testing and material properties. The acceptance criteria are implicitly met by comparing the subject device to predicate and reference devices, and by conforming to relevant ISO standards where applicable.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Mechanical Strength & Durability: | |
| - Static Compression (ISO 14801) | Worst-case constructs for each compatible OEM implant line (except Astra Tech OsseoSpeed EV) were subjected to static compression testing according to ISO 14801. (Performance data is implied to be acceptable as part of demonstrating substantial equivalence). |
| - Compression Fatigue (ISO 14801) | Worst-case constructs for each compatible OEM implant line (except Astra Tech OsseoSpeed EV) were subjected to compression fatigue testing according to ISO 14801. (Performance data is implied to be acceptable as part of demonstrating substantial equivalence). |
| Biocompatibility: | Demonstrated through predicate device testing according to ISO 10993-1 and ISO 10993-5. (Implies the Preat Abutments meet these biocompatibility standards). |
| Sterilization Efficacy: | Demonstrated through and leveraged from predicate device testing according to ISO 17665-1 and ISO 14937. (Implies the Preat Abutments, and the recommended end-user sterilization method, meet these standards). |
| Magnetic Resonance (MR) Safety: | Non-clinical worst-case MRI review performed based on scientific rationale and published literature (e.g., Woods et al., 2019) and FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment." Rationale addressed parameters including magnetically induced displacement force and torque. (Implies the device is deemed safe for the MR environment based on this review). |
| Material Conformance: | Abutments and screws manufactured from Ti-6Al-4V ELI alloy conforming to ASTM F136. Zirconia superstructures manufactured from Zirconia conforming to ISO 13356. (Implies materials meet specified standards). |
| Design Parameters for CAD/CAM Components (e.g., Superstructure, Blank): | For Titanium Base abutment zirconia superstructure: Minimum wall thickness - 0.5 mm; Minimum post height for single-unit restorations – 4.0 mm; Maximum gingival height – 5.0 mm; and All zirconia superstructures are for straight abutments only. For CAD/CAM Titanium Blank custom abutment: Minimum wall thickness – 0.5 mm to 0.9 mm (varies); Minimum post height for single-unit restoration – 4.0 mm; Maximum Angle - 30°* (Astra Tech® OsseoSpeed™ Plus-compatible limited to 0° max. correction); Minimum gingival height - 0.5 mm; Maximum gingival height – 2.0 mm to 4.5 mm (varies). (Implies that these design parameters are met as part of manufactured components). |
| Compatibility with Implant Systems: | Demonstrated through reverse engineering of OEM implant bodies, OEM abutments, and OEM abutment screws, confirmed with mechanical testing. (Implied that the device is compatible with the listed OEM implant systems and their interfaces). |
| "Substantially Equivalent" (Overall): | The subject device is substantially equivalent to the predicate device (K183518) in indications, intended use, design principles, materials (Ti-6Al-4V alloy), and mode of operation. Differences are related to compatible implant systems and additional abutment designs, supported by reference devices and mitigated by mechanical performance testing. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not detail specific sample sizes for the mechanical testing ("worst-case constructs"). The data provenance is not explicitly stated in terms of country of origin, nor is it described as retrospective or prospective in the context of test sets. The studies are non-clinical (laboratory testing).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not applicable. The studies described are non-clinical performance and material conformance tests, not diagnostic studies or those requiring expert interpretation of results to establish ground truth in the way medical imaging algorithms might.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable. Adjudication methods typically apply to human interpretation of data, often in clinical studies or when establishing ground truth for AI algorithms, which is not the nature of the studies described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not applicable. An MRMC comparative effectiveness study is used for diagnostic AI devices involving human readers. This document describes non-clinical performance testing for dental abutments, which is a physical device, not an AI algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. The device is a physical dental abutment, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The concept of "ground truth" as typically used in the context of evaluating diagnostic algorithms (e.g., expert consensus, pathology) is not applicable here. For the non-clinical tests, the "ground truth" or reference for performance is the compliance with specified ISO and ASTM standards and the performance of the predicate/reference devices through comparative testing. For example:
- Mechanical Testing: The "ground truth" would be the passing criteria defined by ISO 14801.
- Material Conformance: The "ground truth" would be the specifications in ASTM F136 and ISO 13356.
- Biocompatibility & Sterilization: The "ground truth" would be the specifications in ISO 10993-1, ISO 10993-5, ISO 17665-1, and ISO 14937.
8. The sample size for the training set:
This information is not applicable. There is no AI algorithm being described, and therefore no training set.
9. How the ground truth for the training set was established:
This information is not applicable for the same reason as above.
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Preat Corporation % Chris Brown Manager Aclivi, LLC 3250 Brackley Drive Ann Arbor, Michigan 48105
Re: K220823
Trade/Device Name: Preat Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: September 21, 2022 Received: September 22, 2022
Dear Chris Brown:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name Preat Abutments
Indications for Use (Describe)
Preat Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandbular arch to provide support for single-unit or multi-unit prosthetic restorations. The Titanium Base abutments consists of two major parts. Specifically, the titanium base and the mesostructured components make up a two-piece abutment.
All digitally designed custom abutments, superstructures, and/or hybrid crowns for use with Titanium Blanks are to be sent to a Preat validated milling center for manufacture.
| Compatible Implant Systems | ||
|---|---|---|
| Compatible Implant Systems | Implant Body Diameter (mm) | Implant Platform Diameter (mm) |
| Astra Tech OsseoSpeed™ Plus(OsseoSpeed™ EV) | 3.0 (3.0S) | 3.0 |
| 3.6 (3.6S) | 3.6 | |
| 4.2 (4.2C, 4.2S) | 4.2 | |
| 4.8 (4.8C, 4.8S) | 4.8 | |
| 5.4 (5.4S) | 5.4 | |
| Keystone PrimaConnex™ | 3.5 | 3.5 (SD) |
| 4.1 | 4.1 (RD) | |
| 5.0 | 5.0 (WD) | |
| Neodent® GM™ Helix | 3.5, 3.75, 4.0, 4.3, 5.0, 6.0, 7.0 | 3.0 |
| Nobel Biocare™ NobelActive® 3.0 | 3.0 | 3.0 |
| Straumann® BLX | 3.75, 4.0, 4.5 (RB) | RB |
| 5.0, 5.5, 6.5 (WB) | WB |
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
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 K220823 Preat Corporation Preat Abutments October 26, 2022
ADMINISTRATIVE INFORMATION
| Manufacturer Name | Preat Corporation2625 Skyway Dr, Suite BSanta Maria, CA 93455 |
|---|---|
| Telephone: +1 800 232-7732 | |
| Fax: n/a | |
| Official Contact | Chris Bormes, President |
| Email: | chris@preat.com |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name: | Preat Abutments |
|---|---|
| Common Name: | Abutment, Implant, Dental, Endosseous |
| Regulation Name: | Endosseous dental implant abutment |
| Regulation Number: | 21 CFR 872.3630 |
| Device Class: | Class II |
| Product Code: | NHA |
| Review Panel: | Dental Products Panel |
| Reviewing Branch: | Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)Dental Devices (DHT1B) |
PREDICATE DEVICE INFORMATION
The devices within this submission are substantially equivalent in indications, intended use and design principles to the following predicate and reference devices:
| 510(k) | Predicate Device Name | Company Name |
|---|---|---|
| K183518 | Preat Abutments | Preat Corporation |
| 510(k) | Reference Device Name | Company Name |
| K120414 | OsseoSpeed™ Plus | Astra Tech AB |
| K051614 | PrimaConnex™ Internal Connection Implant System | Lifecore Biomedical, Inc. (Keystone) |
| K163194 | Neodent Implant System - GM Line | JJGC Industria e Comercio de Materiais Dentarios SA |
| K180536 | Neodent Implant System - GM Line | JJGC Industria e Comercio de Materiais Dentarios SA |
| K201225 | Neodent Implant System - GM Helix Implants 7.0 | JJGC Industria e Comercio de Materiais Dentarios SA |
| K102436 | NobelActive® 3.0 | Nobel Biocare |
| K173961 | Straumann® BLX Implant System | Institut Straumann AG |
| K181703 | Straumann BLX® Line Extension - Implants, SRAs, andAnatomic Abutments | Institut Straumann AG |
INTENDED USE / INDICATIONS FOR USE
Preat Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single-unit or multi-unit prosthetic restorations. The Titanium Base abutments consists of two major parts. Specifically, the titanium base and the mesostructured components make up a two-piece abutment.
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All digitally designed custom abutments, superstructures, and/or hybrid crowns for use with Titanium Bases or Titanium Blanks are to be sent to a Preat validated milling center for manufacture.
| Compatible Implant Systems | Implant Body Diameter (mm) | Implant Platform Diameter (mm) |
|---|---|---|
| Astra Tech OsseoSpeed™ Plus(OsseoSpeed™ EV) | 3.0 (3.0S) | 3.0 |
| Astra Tech OsseoSpeed™ Plus(OsseoSpeed™ EV) | 3.6 (3.6S) | 3.6 |
| Astra Tech OsseoSpeed™ Plus(OsseoSpeed™ EV) | 4.2 (4.2C, 4.2S) | 4.2 |
| Astra Tech OsseoSpeed™ Plus(OsseoSpeed™ EV) | 4.8 (4.8C, 4.8S) | 4.8 |
| Astra Tech OsseoSpeed™ Plus(OsseoSpeed™ EV) | 5.4 (5.4S) | 5.4 |
| Keystone PrimaConnex™ | 3.5 | 3.5 (SD) |
| Keystone PrimaConnex™ | 4.1 | 4.1 (RD) |
| Keystone PrimaConnex™ | 5.0 | 5.0 (WD) |
| Neodent® GM™ Helix | 3.5, 3.75, 4.0, 4.3, 5.0, 6.0, 7.0 | 3.0 |
| Nobel Biocare™ NobelActive® 3.0 | 3.0 | 3.0 |
| Straumann® BLX | 3.75, 4.0, 4.5 (RB) | RB |
| Straumann® BLX | 5.0, 5.5, 6.5 (WB) | WB |
Compatible Implant Systems
DEVICE DESCRIPTION
Preat Abutments were previously cleared under K183518. The purpose of this submission is to obtain marketing clearance for additional compatible implant systems under the Preat Abutments device name. This submission for Preat Abutments is a dental implant abutment system that includes nine (9) abutment designs compatible with five (5) OEM implant systems. The Subject device abutment platform diameters range from 2.9 mm to 5.4 mm, and the corresponding compatible implant body diameters also range from 3.0 mm to 7.0 mm. The Subject device includes the following abutment designs: temporary engaging, multi-unit straight, multi-unit angled 17°, multi-unit angled 30°, engaging titanium base, titanium blank and healing abutments. The system also includes corresponding abutment screws.
The following table shows the Subject device abutments for each of the Compatible implant platforms.
| Preat | Subject Device Abutment Designs | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| AbutmentPlatformDiameter/CompatibleImplantSystem | TempEngaging | Temp Non-Engaging | Multi-UnitStraight | Multi-UnitAngled 17° | Multi-UnitAngled30° | TitaniumBaseEngaging | TitaniumBase Non-Engaging | TitaniumBlank | Healing | TitaniumScrews |
| Astra Tech® OsseoSpeed™ Plus (OsseoSpeed™ EV) | ||||||||||
| 3.0 | X | X | X | X | X | X | X | X | X | X |
| 3.6 | X | X | X | X | X | X | X | X | X | X |
| 4.2 | X | X | X | X | X | X | X | X | X | X |
| 4.8 | X | X | X | X | X | X | X | X | X | X |
| 5.4 | X | X | X | X | X | X | X | X | X | X |
| Keystone Prima Connex™ | ||||||||||
| 3.5 (SD) | X | X | X | X | X | X | X | X | X | X |
| 4.1 (RD) | X | X | X | X | X | X | X | X | X | X |
| 5.0 (WD) | X | X | X | X | X | X | X | X | X | X |
| Neodent® GM™ Helix | ||||||||||
| 3.0 | X | X | X | X | X | X | X | X | X | X |
| Nobel Biocare™ NobelActive® | ||||||||||
| 3.0 | X | X | X | X | X | X | X | X | X | X |
| Straumann™ BLX | ||||||||||
| RB | X | X | X | X | X | X | X | X | X | X |
| WB | X | X | X | X | X | X | X | X | X | X |
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All abutments and screws are manufactured from Ti-6Al-4V ELI alloy conforming to ASTM F136 and are provided non-sterile to the end user. All digitally designed custom abutments for use with Titanium Base (superstructures) or Titanium Blank are to be sent to a Preat validated milling center for manufacture. All superstructures are to be manufactured from zirconia conforming to ISO 13356. Digitally designed CAD/CAM abutments must have a 0.5 mm minimum gingival height dimension.
The Titanium Base abutment is composed of two-piece abutment that is a titanium base at the bottom and a zirconia superstructure (CAD/CAM patient specific superstructure) at the top. The zirconia superstructure is straight only and is not to be designed to provide an angle or divergence correction.
For the Titanium Base abutment, the design parameters for the CAD/CAM zirconia superstructure are: Minimum wall thickness - 0.5 mm; Minimum post height for single-unit restorations – 4.0 mm; Maximum gingival height – 5.0 mm; and All zirconia superstructures are for straight abutments only. The design parameters for the CAD/CAM Titanium Blank custom abutment are:
Minimum wall thickness – 0.5 mm to 0.9 mm (varies by implant line); Minimum post height for single-unit restoration – 4.0 mm; Maximum Angle - 30°*; and Minimum gingival height - 0.5 mm; Maximum gingival height – 2.0 mm to 4.5 mm (varies by implant line). * Astra Tech® OsseoSpeed™ Plus (OsseoSpeed™ EV) compatible are limited to 0° maximum correction angle.
PERFORMANCE DATA
Non-clinical data submitted to demonstrate substantial equivalence included: reverse engineering of OEM implant bodies, OEM abutments, and OEM abutment screws to confirm compatibility; static compression and compression fatigue testing according to ISO 14801 and an assessment performed for MR Safety. For each compatible OEM implant line, except Astra Tech OsseoSpeed EV, worst-case constructs were subjected to static compression and compression fatigue testing.
Biocompatibility has been demonstrated through Predicate device testing according to ISO 10993-1, and ISO 10993-5. Sterilization validation was demonstrated through and leveraged from Predicate device testing according to ISO 17665-1 and ISO 14937.
Non-clinical worst-case MRI review was performed to evaluate the Subject device including all compatible implant fixtures, abutments, bars, and fixation screws and their respective material composition in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry O., Jana G. Delfino, and Sunder Rajan, "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795). Rationale addressed parameters per the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque.
No clinical or animal data is included in this premarket notification.
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EQUIVALENCE TO MARKETED DEVICE
Overall, the Subject device is substantially equivalent in indications and design principles to the Predicate device listed above. Provided at the end of this summary are tables comparing the Indications for Use Statements and the technological characteristics of the Subject, Predicate device, and Reference devices.
Subject device abutments are substantially equivalent in intended use to the sponsor's K183518 Predicate device. They are both intended for use with endosseous dental implants in the maxilla and mandible to provide functional and esthetic rehabilitation of the maxilla and mandible to restore chewing function. Reference devices are also intended for use with endosseous dental implants in the maxilla and mandible to provide functional and esthetic rehabilitation of the maxilla and mandible to restore chewing function.
The Indications for Use Statement (IFUS) for the Subject device is substantially equivalent to that of the K183518 Predicate device. Differences in the list of compatible implant systems do not affect the intended use of the Subject and Predicate devices to provide support for single or multi-unit prosthetic restore chewing function.
Similarly, the differences between the Subject device IFUS and that of each Reference device are related to the specific device names and design features. None of these minor differences impact substantial equivalence with the Predicate device because all IFUS express equivalent intended use to facilitate dental prosthetic restorations, and the indications are expressed equivalently using different specific wording.
The following Subject device designs are substantially equivalent to the Predicate device K183518: temporary abutments (engaging and non-engaging); multi-unit straight abutments; multi-unit 17° angulated abutments; titanium base abutments (engaging and non-engaging); and titanium blank abutments.
The Subject and Predicate device abutment designs all have internace connections and are made of Ti-6Al-4V alloy (abutment screws). The Subject and Predicate devices each include titanium base abutment designs with a cut out region to allow for angled access to the abutment screw channel. The Predicate device supports abutment designs with angulation of 0° up to 30° by means of titanium blank abutments, validated through performance testing.
The Subject device includes designs for implant restorative platforms ranging from 2.9 mm. The Predicate K183518 similarly includes implant restorative platform sizes of 3.0 mm to 6.5 mm.
Reference Device K120414 Astra Tech AB OsseoSpeed™ Plus
The K120414 Reference device is for support of substantial equivalence in terms of the OsseoSpeed™ Plus implant/abutment interface, prosthetic platform diameters. The OsseoSpeed™ Plus was subsequently renamed OsseoSpeed™ EV by the manufacturer, so either name may appear in device labeling or regulatory documentation.
Reference Device K051614 Lifecore Biomedical, Inc. (Keystone)™ Internal Connection Implant System
The K051614 Reference device is for support of substantial equivalence in terms of the PrimaConnex™ Internal Connection Implant System implant/abutment interface, prosthetic platform diameters. Additionally, K051614 is used to support the addition of Multi-Unit Angled 30° abutments.
Reference Device K163194 JJGC Industria e Comercio de Materiais Dentarios SA Neodent Implant System - GM Line
The K163194 Reference device is for support of substantial equivalence in terms of the Neodent Implant System - GM Line implant/abutment interface, prosthetic platform diameters. Additionally, K163194 is used to support the addition of healing abutments.
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Reference Device K102436 Nobel Biocare Nobel Active 3.0
The K102436 Reference device is for support of substantial equivalence in terms of the Nobel Active 3.0 implant/abutment interface, prosthetic platform diameters and implant diameters.
Reference Device K173961 Institut Straumann AG Straumann® BLX Implant System
The K173961 Reference device is for support of substantial equivalence in terms of the Straumann® BLX lmplant System implant/abutment interface, prosthetic platform diameters and 4.5 mm, and 6.5 mm implant diameters. Furthermore, the K173961 Reference device provides support of substantial equivalence with respect to the use of 30° angulated Multi-Unit and healing abutments.
Reference Device K181703 Institut Straumann® BLX Line Extension – Implants, SRAs and Anatomic Abutments
The K181703 Reference device is for support of substantial equivalence in terms of the Straumann® BLX Implant System implant/abutment interface, prosthetic platform diameters and the 3.75 mm implant diameter.
The Subject device is to be sterilized by the end-user, following the same process as the Predicate device K183518. Validation of the sterilization methods according to ISO 14937 are leveraged from the K183518 Predicate device.
The Subject device abutment designs are substantially equivalent to those of the K183518 Predicate device. Additional abutment designs, implant/abutment interfaces and dimensions are supported by Reference devices. Minor differences in the abutment designs, dimensions, sizes, or compatible OEM implant lines among the Subject device, the Predicate device, and the Reference devices do not affect substantial equivalence. These minor differences are related to the compatible OEM implant designs and are mitigated by mechanical performance testing.
CONCLUSION
Overall, the Indications for Use statements for the Subject and Predicate devices are substantially equivalent differing only in the list of compatible implant system systems.
Overall, the Technological Characteristics, mode of operation and materials of the Subject device are substantially equivalent to that of the Predicate device with additional compatible implant systems and abutment designs supported by Reference devices.
Overall, the data included in this premarket notification demonstrate substantial equivalence of Preat Abutments to the sponsor's Predicate device.
The basis for the belief that the Subject device is substantially equivalent to the Predicate device and is summarized in the following comparison tables.
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Comparison of Indications for Use Statements
| Comparison of Indications for Use Statements | |||||||
|---|---|---|---|---|---|---|---|
| Subject Device | Predicate Device | Reference Device | Reference Device | ||||
| Preat Abutments | Preat Abutments | OsseoSpeed™ Plus (OsseoSpeed™ EV) | PrimaConnex™ Internal Connection | ||||
| Preat Corporation | Preat Corporation | Astra Tech AB | Implant System | ||||
| K183518 | K120414 | Lifecore Biomedical, Inc. (Keystone) | |||||
| K051614 | |||||||
| Preat Abutments are intended to be used in | |||||||
| Preat Abutments are intended to be used in conjunction with endosseousdental implants in the maxillary or mandibular arch to provide support for | Implants: | Lifecore Biomedical Dental Implant System | |||||
| conjunction with endosseous dental implants in the | single-unit or multi-unit prosthetic restorations. The Titanium Base | The Astra Tech Dental Implants are intended for | implants are intended for use in partially | ||||
| maxillary or mandibular arch to provide support forsingle-unit or multi-unit prosthetic restorations. The | abutments consists of two major parts. Specifically, the titanium base and | both one- and two-stage surgical procedures in thefollowing situations and with the following clinical | or fully edentulous mandibles andmaxillae, in support of single or multiple-unit restorations including; cement | ||||
| Titanium Base abutments consists of two major parts. | mesostructured components make up a two-piece abutment. | protocols: | |||||
| Specifically, the titanium base and the mesostructured | • replacing single and multiple missing teeth in in | retained, screw retained, or overdenture | |||||
| components make up a two-piece abutment. | All digitally designed custom abutments, superstructures, and/or hybrid | the mandible or maxilla, | restorations, and terminal or intermediate | ||||
| crowns for use with Titanium Base or Titanium Blank are to be sent to a | • immediate placement in extraction sites and in | abutment support for fixed bridgework. | |||||
| All digitally designed custom abutments, | Preat validated milling center for manufacture. | situations with a partially or completely healed | |||||
| superstructures, and/or hybrid crowns for use with | alveolar ridge, | The PrimaConnex Internal Connection | |||||
| Titanium Bases or Titanium Blanks are to be sent to a | Compatible Implant Systems | · especially indicated for use in soft bone | Implant is a threaded internal connection | ||||
| Preat validated milling center for manufacture. | Compatible Implant | Implant Body Diameter | Implant Platform | applications where implants with other implant | implant. The PrimaConnex Internal | ||
| Systems | (mm) | Diameter (mm) | surface treatments may be less effective, | Connection Implant is intended for | |||
| Compatible Implant Systems | 3i OSSEOTITE® Certain® | 3.25 | 3.4 | • immediate loading for all indications, except in | immediate placement, where immediate | ||
| Compatible | Implant Body | Implant Platform | 4.0 | 4.1 | single tooth situations on implants shorter than 8 | implant placement is defined by the | |
| Implant Systems | Diameter (mm) | Diameter (mm) | 5.0 | 5.0 | mm or in soft bone (type IV) where implant | International Congress of Oral | |
| 3.0 (3.0S) | 3.0 | 6.0 | 6.0 | stability may be difficult to obtain and immediate | Implantologists (ICOI) as the placement of | ||
| Astra TechOsseoSpeed™ Plus | 3.6 (3.6S)4.2 (4.2C, 4.2S) | 3.64.2 | Astra Tech | 3.0 | 3.0 | loading may not be appropriate. | an implant at the time of tooth extraction, |
| (OsseoSpeed™ EV) | 4.8 (4.8C, 4.8S) | 4.8 | OsseoSpeed™ | The intended use for OsseoSpeed™ Plus 3.0S is | into the extraction socket. | ||
| 5.4 (5.4S) | 5.4 | 3.5, 4.0 | 3.5, 4.0 | limited to replacement of maxillary lateral | |||
| Keystone | 3.5 | 3.5 | 4.5, 5.0 | 4.5, 5.0 | incisors and mandibular incisors. | The PrimaConnex Internal Connection | |
| PrimaConnex | 4.1 | 4.1 | BioHorizons Tapered | 3.0 | 3.0 | Implant is intended for immediate | |
| 5.0 | 5.0 | Internal | Abutments:Astra Tech Implant System Plus abutments are | provisionalization, non-occlusal load.Immediate Provisionalization is defined by | |||
| Neodent GM Helix | 3.5, 3.75, 4.0, 4.3,5.0, 6.0, 7.0 | 3.0 | 3.5 | 3.5 | intended to be used in conjunction with Astra Tech | the International Congress of Oral | |
| Nobel Biocare™ | 4.0 | 4.5 | Implant System Pus in fully edentulous or partially | lmplantologists (ICOI) as a clinical protocol | |||
| NobelActive® 3.0 | 3.0 | 3.0 | HIOSSEN ET III | 3.5 | Mini | edentulous maxillary and/or mandibular arches to | for the placement of an interim prosthesis |
| 3.75, 4.0, 4.5, 5.0,5.5, 6.5 (RB/WB) | 2.9 (RB/WB) | 4.0, 4.5, 5.0, 6.0, 7.0 | Regular | provide support for crowns, brides or overdentures. | with or without occlusal contact with the | ||
| Straumann™ BLX | 5.0, 5.5, 6.5 (WB) | 2.9 (WB) | Implant Direct Legacy | 3.2 | 3.0 | opposing dentition, at the same clinical | |
| 3.7, 4.2 | 3.5 | Atlantis Abutments: | visit of implant placement. The | ||||
| 4.7, 5.2 | 4.5 | The Atlantis™ Abutment is intended for use with an | PrimaConnex Internal Connection Implant | ||||
| 5.7, 7.0 | 5.7 | endosseous implant to support a prosthetic device | can be restored with a temporary | ||||
| MegaGen AnyRidge | 3.5, 4.0, 4.5, 5.0, 5.5 | 3.5 | in a partially or completely edentulous patient. It is | prosthesis in single tooth and multiple | |||
| Neoss | 3.5, 4.0, 4.5, 5.0, 5.5 | 4.1 | intended for use to support single and multiple | tooth applications with good quality bone. | |||
| NobelActive® | 3.5 | NP | tooth prostheses, in the mandible or maxilla. The | ||||
| 4.3, 5.0 | RP | prosthesis can be cemented, screw retained or | |||||
| Nobel Replace™ | 3.5 | NP | friction fit to the abutment. The abutment screw isintended to secure the abutment to the endosseous | ||||
| 4.0, 4.3, 5.0 | RP | implant. | |||||
| 5.0 | WP | ||||||
| 6.0 | 6.0 | The Atlantis™ Crown Abutment in Zirconia is | |||||
| Straumann® Bone Level | 3.3 | NC | intended for use with an endosseous implant to | ||||
| 4.1, 4.8 | RC | function as a substructure that also serves as the | |||||
| Straumann® Tissue | 3.3, 4.1, 4.8 | RN | final restoration, in partially or completely | ||||
| Level | edentulous patients. The prosthesis is screw | ||||||
| 4.8, 6.5 | WN | retained. The abutment screw is intended to secure | |||||
| Zimmer Screw- | 3.3, 3.7, 4.1 | 3.5 | the crown abutment to the endosseous implant. | ||||
| Vent®/Tapered Screw- | |||||||
| Vent® | |||||||
| 4.7 | 4.5 | ||||||
| 6.0 | 5.7 | ||||||
{9}------------------------------------------------
| Subject Device | Reference Device | Reference Device | Reference Device |
|---|---|---|---|
| Preat Abutments | Neodent Implant System - GM LineJJGC Industria e Comercio de MateriaisDentarios SAK163194 | Neodent Implant System - GM LineJJGC Industria e Comercio de Materiais Dentarios SAK180536 | Neodent Implant System - GM LineJJGC Industria e Comercio de Materiais Dentarios SAK201225 |
| Preat Corporation | |||
| Preat Abutments are intended to be used in conjunctionwith endosseous dental implants in the maxillary ormandibular arch to provide support for single-unit ormulti-unit prosthetic restorations. The Titanium Baseabutments consists of two major parts. Specifically, thetitanium base and the mesostructured componentsmake up a two-piece abutment.All digitally designed custom abutments,superstructures, and/or hybrid crowns for use withTitanium Bases or Titanium Blanks are to be sent to aPreat validated milling center for manufacture. | Indications for Use for GM implants andconventional abutments:The Neodent Implant System is intended to besurgically placed in the bone of the upper orlower jaw to provide support for prostheticdevices such as artificial teeth, to restorechewing function. It may be used with single-stage or two-stage procedures, for single ormultiple unit restorations, and may be loadedimmediately when good primary stability isachieved and with appropriate occlusal loading.Indications for Use for GM Titanium Baseabutments:Titanium Base Abutment is a titanium baseplaced onto Neodent dental implants toprovide support for customized prostheticrestorations. It is used with a coping and crown,or crown alone, and is indicated for cement-retained single or multi-unit restorations, orscrew-retained single restorations.All digitally designed copings and/or crowns foruse with the Neodent Titanium Base AbutmentSystem are intended to be sent to Straumannfor manufacture at a validated milling center.Indications for Use for GM Pro PeekAbutments:The Pro PEEK Abutments are indicated to beused on Neodent implants to providetemporary support for prosthesis structure forup to 6 months. They can be used in one or twostage procedures and also immediate loadwhen there is good primary stability. | Indications for Use for GM Helix implants andconventional abutments:The Neodent Implant System is intended to be surgicallyplaced in the bone of the upper or lower jaw to providesupport for prosthetic devices such as artificial teeth, torestore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unitrestorations, and may be loaded immediately when goodprimary stability is achieved and with appropriateocclusal loading.Indications for Use for GM Exact Titanium Block forMedentika Holder:GM Exact Titanium Block for Medentika Holder is atitanium abutment to be used in fabricating a full customabutment and placed onto Neodent dental implants toprovide support for customized prosthetic restorations.The GM Exact Titanium Block for Medentika Holderabutments are indicated for screw-retained singlerestorations or cement-retained single or multi-unitrestorations. All digitally designed abutments for usewith the GM Exact Titanium Block for Medentika Holderare intended to be sent to Straumann for manufacture ata validated milling center.Indications for Use for GM Exact Titanium Baseabutments:Titanium Base Abutment is a titanium base placed ontoNeodent dental implants to provide support forcustomized prosthetic restorations. It is used with acoping and crown, or crown alone, and is indicated forcement-retained single or multi-unit restorations, orscrew-retained single restorations. All digitally designedcopings and/or crowns for use with the NeodentTitanium Base Abutment System are intended to be sentto Straumann for manufacture at a validated millingcenter.Indications for Use for Titanium Base C for GM Exactabutments:The Titanium Base C for GM Exact abutments is atitanium component that is placed over Neodentimplants to provide support for custom prostheticrestorations, such as copings or crowns. It is indicated forsingle-tooth screw-retained restorations. All digitallydesigned copings and/or crowns for use with theTitanium Base C for GM Exact abutments are to bedesigned using Sirona inLab software or Sirona CERECSoftware and manufactured using a Sirona CEREC or | The Neodent Implant System is intended to besurgically placed in the bone of the upper or lowerjaw to provide support for prosthetic devices, such asartificial teeth, to restore chewing function. It may beused with single-stage or two-stage procedures, forsingle or multiple unit restorations, and may beloaded immediately when good primary stability isachieved and with appropriate occlusal loading. |
| CompatibleImplant Systems | Implant BodyDiameter (mm) | Implant PlatformDiameter (mm) | |
| 3.0 (3.05) | 3.0 | ||
| Astra Tech | 3.6 (3.65) | 3.6 | |
| OsseoSpeed™ Plus(OsseoSpeed™ EV) | 4.2 (4.2C, 4.2S) | 4.2 | |
| 4.8 (4.8C, 4.8S) | 4.8 | ||
| 5.4 (5.45) | 5.4 | ||
| 3.5 | 3.5 | ||
| KeystonePrimaConnex | 4.1 | 4.1 | |
| 5.0 | 5.0 | ||
| Neodent GM Helix | 3.5, 3.75, 4.0, 4.3,5.0, 6.0, 7.0 | 3.0 | |
| Nobel Biocare™ | 3.0 | 3.0 | |
| NobelActive® 3.0 | |||
| Straumann™ BLX | 3.75, 4.0, 4.5, 5.0,5.5, 6.5 (RB/WB) | 2.9 (RB/WB) | |
| 5.0, 5.5, 6.5 (WB) | 2.9 (WB) | ||
| Subject Device | Reference Device | Reference Device | Reference Device |
| Preat Abutments | NobelActive 3.0 | Straumann® BLX Implant System | Straumann® BLX Line Extension - Implants, SRAsand Anatomic Abutments |
| Preat Corporation | Nobel Biocare | Institut Straumann AG | Institut Straumann AG |
| K102436 | K173961 | K181703 | |
| Preat Abutments are intended to be used in conjunctionwith endosseous dental implants in the maxillary ormandibular arch to provide support for single-unit ormulti-unit prosthetic restorations. The Titanium Baseabutments consists of two major parts. Specifically, thetitanium base and the mesostructured componentsmake up a two-piece abutment. | The NobelActive. 3.0mmImplant Is Indicated for use inthe treatment of missingmaxillary lateral incisors orthe mandibular central andlateral incisors to supportprosthetic devices, such asartificial teeth, in order torestore chewing function inpartially edentulous patients.The NobelActive 3.0 implantsmay be put into immediatefunction provided thatstability requirementsdetailed in the manual aresatisfied. | Straumann® BLX ImplantsStraumann® BLX Implants are suitable for endosteal implantation in the upperand lower jaw and for the functional and esthetic oral rehabilitation ofedentulous and partially edentulous patients. BLX Implants can be placed withimmediate function on single-tooth applications when good primary stability isachieved and with appropriate occlusal loading to restore chewing function.The prosthetic restorations are connected to the implants through thecorresponding abutment components.Straumann® BLX Closure Caps and Healing Abutments Straumann® ClosureCaps and Healing Abutments are indicated to be placed in the patient's mouthat the end of the implant placement to protect the inner configuration of theimplant and to shape, maintain and stabilize the soft tissue during the healingprocess. Closure caps and healing abutments should be used only with suitableimplant connections. Straumann Closure Caps and Healing Abutments have amaximum duration of usage of 6 months.Straumann® BLX Basal Screws and Temporary AbutmentsProsthetic components directly or indirectly connected to the endosseousdental implant are intended for use as an aid in prosthetic rehabilitations.Temporary components can be used prior to the insertion of the finalcomponents to maintain, stabilize and shape the soft tissue during the healingphase; they may not be placed into occlusion. Final abutments may be placedinto occlusion when the implant is fully osseointegrated. BLX TemporaryAbutments have a maximum duration of usage of 180 days.Straumann® BLX VariobasesStraumann® Variobase® prosthetic components directly or indirectly connectedto the endosseous dental implant are intended for use as an aid in prostheticrehabilitations. The prosthetic restoration (crowns) can be cemented onto theStraumann® Variobase® prosthetic components. A temporary restoration canbe used prior to the insertion of the final components to maintain, stabilize andshape the soft tissue during the healing phase; they must be placed out ofocclusion. Final abutments and restorations may be placed into occlusion whenthe implant is fully osseointegrated. All digitally designed copings and/orcrowns for use with the Straumann® Variobase® Abutment system areintended to be sent to Straumann for manufacture at a validated milling | Straumann® BLX ImplantsStraumann® BLX Implants are suitable for endostealimplantation in the upper and lower jaw and for thefunctional and esthetic oral rehabilitation of edentulousand partially edentulous patients. BLX Implants can beplaced with immediate function on single-tooth,bar and bridges applications when good primary stability isachieved and with appropriate occlusal loading to restorechewing function. The prosthetic restorations areconnected to the implants through the correspondingabutment components.Straumann® BLX SRAs and Antomic AbutmentsProsthetic components directly or indirectly connected tothe endosseous dental implant are intended for use as anaid in prosthetic rehabilitations. Temporary componentscan be used prior to the insertion of the final componentsto maintain, stabilize and shape the soft tissue during thehealing phase; they may not be placed into occlusion. Finalabutments may be placed into occlusion when the implantis fully osseointegrated. BLX Temporary Abutments have amaximum duration of usage of 180 days. |
| Compatible Implant Systems | |||
| CompatibleImplant Systems | Implant BodyDiameter (mm) | Implant PlatformDiameter (mm) | |
| 3.0 | 3.0 | ||
| Astra Tech® EV "S"(OsseoSpeed™Profile EV) | 3.6 | 3.6 | |
| 4.2 | 4.2 | ||
| 4.8 | 4.8 | ||
| 5.4 | 5.4 | ||
| Keystone | 3.5 | 3.5 | |
| PrimaConnex™ | 4.1 | 4.1 | |
| 5.0 | 5.0 | ||
| Neodent® GM™Helix | 3.5, 3.75, 4.0, 4.3,5.0, 6.0, 7.0 | 3.0 | |
| Nobel Biocare™ | 3.0 | 3.0 | |
| NobelActive® 3.0 | |||
| Straumann™ BLX | 3.75, 4.0, 4.5, 5.0,5.5, 6.5 (RB/WB) | 2.9 (RB/WB) | |
| 5.0, 5.5, 6.5 (WB) | 2.9 (WB) |
{10}------------------------------------------------
{11}------------------------------------------------
Comparison of Technological Characteristics
| Comparison | Subject DevicePreat AbutmentsPreat Corporation | Predicate DevicePreat AbutmentsPreat CorporationK183518 | Reference DeviceOsseoSpeed™ Plus(OsseoSpeed™ EV)Astra Tech ABK120414 | Reference DevicePrimaConnex™ InternalConnection Implant SystemLifecore Biomedical, Inc.(Keystone)K051614 | Reference DeviceNeodent Implant System - GM LineJJGC Industria e Comercio deMateriais Dentarios SAK163194 | Reference DeviceNeodent Implant System - GM LineJJGC Industria e Comercio deMateriais Dentarios SAK180536 | Reference DeviceNeodent Implant System - GM HelixImplants 7.0JJGC Industria e Comercio deMateriais Dentarios SAK201225 | |||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Intended Use | Functional and esthetic rehabilitation ofthe edentulous maxilla and mandible | Functional and estheticrehabilitation of the edentulousmaxilla and mandible | Functional and estheticrehabilitation of the edentulousmaxilla and mandible | Functional and estheticrehabilitation of theedentulous maxilla andmandible | Functional and estheticrehabilitation of the edentulousmaxilla and mandible | Functional and esthetic rehabilitationof the edentulous maxilla andmandible | Functional and esthetic rehabilitationof the edentulous maxilla andmandible | |||||||||||||||||||||||||||||||||||||||
| Reason forPredicate/Reference | Not Applicable | Abutment configurations listed, 30°post angle correction, sterilization,biocompatibility | Implant/Restorative interface | Implant/Restorative interface,30 degree Multi-Unit Abutmentdesign. | Helix implant, Implant/Restorativeinterface, straight screw channel Ti-base configuration, HealingAbutment design | 6 mm Helix Implant,Implant/Restorative interface | 7 mm Helix Implant,Implant/Restorative interface | |||||||||||||||||||||||||||||||||||||||
| Abutment Designs | Temporary EngagingPD = 2.9 - 5.4 mmGH = 1 mmGD = 3.3 - 6.0 mmPH = 10.9 mm (4 mm min) | Temporary EngagingPD = 3.0 - 6.6 mmGH = 1 mmGD = 3.0 - n/d mmPH = 10.9 mm (4 mm min) | Temporary Engaging*PD GH GD 3.0 1 3.3 3.6 1 4.0 4.2 1 4.5 4.8 1 5.0 5.4 1 5.5 | Temporary EngagingPD GH GD 3.5 n/d 3.5 4.1 n/d 4.1 5.0 n/d 5.0 | Temporary Engaging PD GH GD 3 0.8,1.5,2.5,3.5 3.5 3 0.8,1.5,2.5,3.5 4.5 | n/a | n/a | |||||||||||||||||||||||||||||||||||||||
| Temporary Non-EngagingPD = 2.9 - 5.4 mmGH = 1 mmGD = 3.0 - 6.0 mmPH = 10.9 mm (4 mm min) | Temporary Non-EngagingPD = 3.0 - 6.6 mmGH = 1 mmGD = 3.0 - n/d mmPH = 10 mm (4 mm min) | n/a | Temporary Non-Engaging PD GH GD 3.5 n/d 3.5 4.1 n/d 4.1 5.0 n/d 5.0 | n/a | n/a | n/a | ||||||||||||||||||||||||||||||||||||||||
| Multi-Unit StraightPD = 2.9 - 5.4 mmGH = 1 - 5 mmGD = 4.8 mmPH = 2.2 mm | Multi-Unit StraightPD = 3.0 - 6.6 mmGH = 2 - 5 mmGD = 4.8 mmPH = 2.2 mm | n/a | Multi-Unit Straight PD GH GD 3.5 1,2,3 3.5 4.1 1,2,3,4 4.1 5.0 1,2,3,4 5.0 | Multi-Unit Straight (Mini Conical) PD GH GD 3 0.8,1.5,2.5,3.5,4.5,5.5 4.8 | n/a | n/a | ||||||||||||||||||||||||||||||||||||||||
| Multi-Unit 17°PD = 2.9 - 5.4 mmGH = 2 - 5 mmGD = 4.8 mmPH = 2.2 mm | Multi-Unit 17°PD = 3.0 - 6.6 mmGH = 3.5 - 4.5 mmGD = 4.8 mmPH = 2.2 mm | Multi-Unit 17° PD GH GD 3.5 3,4 3.5 4.1 3,4 4.1 5.0 3,4 5.0 | Multi-Unit 17° (Mini Conical) PD GH GD 3 3.9,4.9,5.9 4.8 | n/a | n/a | |||||||||||||||||||||||||||||||||||||||||
| Multi-Unit 30°PD = 2.9 - 5.4 mmGH = 3 - 4.5 mmGD = 4.8 mmPH = 2.2 mm | n/a | n/a | Multi-Unit 30° PD GH GD 3.5 3,4,5 3.5 4.1 3,4,5 4.1 5.0 3,4 5.0 | Multi-Unit 30° (Mini Conical) PD GH GD 3 3.9,4.9,5.9 4.8 | n/a | n/a | ||||||||||||||||||||||||||||||||||||||||
| Titanium Base EngagingMinimum wall thickness - 0.5 mm;Minimum post height for single-unitrestorations - 4.0 mm;Minimum gingival height - 0.5 mm;Maximum gingival height - 5.0 mm; andStraight and Angulated Screw Channel(ASC) variations.All zirconia superstructures are forstraight abutments only. | Titanium Base EngagingMinimum wall thickness - 0.5 mm;Minimum post height for single-unitrestorations - 4.0 mm;Maximum gingival height - 5.0 mm;and Angulated Screw Channel (ASC)All zirconia superstructures are forstraight abutments only. | n/a | n/a | Titanium Base Engaging (GM TiBase)Up to 30° Correction Angle PD GH GD 3 0.8,1.5,2.5,3.5,4.5 3.5 3 0.8,1.5,2.5,3.5,4.5 4.5 3 0.8,1.5,2.5,3.5,4.5 5.5 PH = 4, 6 mmStraight screw channel. | Titanium Base Engaging(GM Exact Titanium Base,Titanium Base C)Up to 30° Correction Angle PD GH GD 3 0.8,1.5,2.5,3.5,4.5,5.5 4.65 (C) 3 0.8,1.5,2.5,3.5,4.5,5.5 5.5 PH = 4 - 6 mmStraight screw channel | n/a | ||||||||||||||||||||||||||||||||||||||||
| Titanium Base Non-EngagingMinimum wall thickness - 0.5 mm;Minimum post height for single-unitrestorations - 4.0 mm;Minimum gingival height - 0.5 mm;Maximum gingival height - 5.0 mm; andStraight and Angulated Screw Channel(ASC) variations.All zirconia superstructures are forstraight abutments only. | Titanium Base Non-EngagingMinimum wall thickness - 0.5 mm;Minimum post height for single-unitrestorations - 4.0 mm;Maximum gingival height - 5.0 mm;and Angulated Screw Channel (ASC)All zirconia superstructures are forstraight abutments only. | n/a | n/a | n/a | n/a | n/a |
{12}------------------------------------------------
| Titanium BlankMinimum wall thickness - 0.5 mm;Minimum post height for single-unitrestoration - 4.0 mm;Maximum Angle - 30° *;Minimum gingival height - 0.5 mm; andMaximum gingival height - 2.0 mm to4.5 mm (varies by implant line).*Astra Tech® OsseoSpeed™ Plus (OsseoSpeed™EV)-compatible 3.0 mm and larger diameterabutments are limited to 0° maximum correctionangle. | Titanium BlankMinimum wall thickness - 0.5 mm;Minimum post height for single-unitrestoration - 4.0 mm;Maximum Angle – 30°; andMaximum gingival height - 1.5 mmto 2.65 mm (varies by implant line). | n/a | n/a | Titanium BlankMaximum Angle - 30° | Titanium BlankMaximum Angle - 30° | n/a | |||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| HealingPD = 2.9 - 5.4 mmGH = 2 - 4 mmGD = 3.5 - 6.5 mmPH = 0 mm | n/a | HealingPD = 3.0 - 5.4 mmGH = n/dGD = 3.0-5.4 mmPH = n/d | n/a | HealingPD GH GD 3 0.8,1.5,2.5,3.5,4.5,5.5 4.5 3 0.8,1.5,2.5,3.5,4.5,5.5 6.0 PH = n/d | HealingPD GH GD 3 1.5,2.5,3.5,4.5,5.5 5.5 3 2.5,3.5,4.5,5.5,6.5 7.0 PH = n/d | n/a | |||||||||||||||||||
| Material(Abutment andScrew) | Ti-6AL-4V Alloy | Ti-6AL-4V Alloy | Titanium Alloy | Titanium Alloy | Titanium Alloy | Titanium Alloy | Titanium Alloy | ||||||||||||||||||
| Abutment/ImplantInterface | Internal Connection | Internal Connection | Internal Connection | Internal Connection | Internal Connection | Internal Connection | Internal Connection | ||||||||||||||||||
| ProsthesisAttachment | Cement-retainedScrew-retained | Cement-retainedScrew-retained | Cement-retainedScrew-retained | Cement-retainedScrew-retained | Cement-retainedScrew-retained | Cement-retainedScrew-retained | Cement-retainedScrew-retained | ||||||||||||||||||
| Restoration | Single-unitMulti-unit | Single-unitMulti-unit | Single-unitMulti-unit | Single-unitMulti-unit | Single-unitMulti-unit | Single-unitMulti-unit | Single-unit | ||||||||||||||||||
| Implant RestorativePlatform Diameters(mm) | 2.9-5.4 | 3.0-6.6 | 3.0, 4.2, 4.8, 5.4 | 3.5, 4.1, 5.0 | 3.0 | 3.0 | 3.0 | ||||||||||||||||||
| Sterilization Method | Steam sterilization - End User | Steam sterilization - End User | n/d | Steam sterilization - End User | Steam sterilization - End User | Steam sterilization - End User |
{13}------------------------------------------------
| Comparison | Subject Device | Reference Device | Reference Device | Reference Device | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Preat Abutments | NobelActive 3.0 | Straumann® BLX Implant System | Straumann® BLX LineExtension - Implants, SRAs and AnatomicAbutments | ||||||||||||||||
| Preat Corporation | Nobel BiocareK102436 | Institut Straumann AGK173961 | Institut Straumann AGK181703 | ||||||||||||||||
| Intended Use | Functional and esthetic rehabilitation of the edentulous maxilla and mandible | Functional and estheticrehabilitation of theedentulous maxilla andmandible | Functional and esthetic rehabilitationof the edentulous maxilla andmandible | Functional and esthetic rehabilitation of theedentulous maxilla and mandible | |||||||||||||||
| Reason forPredicate/Reference | Not Applicable | Implant/Restorative interface | Implant/Restorative interface, 30°Multi-Unit Abutment design, straightscrew channel Ti-base configuration,Healing Abutment design | Implant/Restorative interface, 3.75 mm implantcompatibility, and 4.0 mm by beingencompassed within 3.75 mm diameter andK173961 | |||||||||||||||
| Abutment Designs | Temporary EngagingPD = 2.9 - 5.4 mmGH = 1 mmGD = 3.3 - 6.0 mmPH = 10.9 mm (4 mm min) | n/a | Temporary EngagingPD GH GD 2.9 (RB/WB) 1.5,2.5,3.5 3.8 2.9 (RB/WB) 1.5,2.5,3.5 4.5 2.9 (RB/WB) 2.5,3.5 6.0 2.9 (WB) 0.75,1.5 5.5 | n/a | |||||||||||||||
| Temporary Non-EngagingPD = 2.9 - 5.4 mmGH = 1 mmGD = 3.0 - 6.0 mmPH = 10.9 mm (4 mm min) | n/a | n/a | |||||||||||||||||
| Multi-Unit StraightPD = 2.9 - 5.4 mmGH = 1 - 5 mmGD = 4.8 mmPH = 2.2 mm | n/a | Multi-Unit StraightPD GH GD 2.9 (RB/WB) 1.5,2.5,3.5,4.5 4.6 | Multi-Unit StraightPD GH GD 2.9 (RB/WB) 1.5,2.5,3.5,4.5 4.6 | ||||||||||||||||
| Multi-Unit 17°PD = 2.9 - 5.4 mmGH = 2 - 5 mmGD = 4.8 mmPH = 2.2 mm | n/a | Multi-Unit 17°PD GH GD 2.9 (RB/WB) 3.5,4.5,5.5 4.6 | Multi-Unit 17°PD GH GD 2.9 (RB/WB) 2.5,3.5,4.5 4.6 | ||||||||||||||||
| Multi-Unit 30°PD = 2.9 - 5.4 mmGH = 3 - 4.5 mmGD = 4.8 mmPH = 2.2 mm | n/a | Multi-Unit 30°PD GH GD 2.9 (RB/WB) 3.5,4.5,5.5 4.6 | Multi-Unit 30°PD GH GD 2.9 (RB/WB) 2.5,3.5,4.5 4.6 | ||||||||||||||||
| Titanium Base EngagingMinimum wall thickness - 0.5 mm;Minimum post height for single-unitrestorations - 4.0 mm;Minimum gingival height - 0.5 mm;Maximum gingival height - 5.0 mm; andStraight and Angulated Screw Channel(ASC) variations.All zirconia superstructures are forstraight abutments only. | n/a | Titanium Base Engaging (Variobase)Up to 30° Correction AnglePD GH GD 2.9 (RB/WB) 1.5,2.5 3.8 2.9 (RB/WB) 1.5,2.5 4.5 2.9 (RB/WB) 0.75,1.5 5.5 2.9 (WB) 0.75,1.5 5.5 Straight screw channel. | n/a. | ||||||||||||||||
| Titanium Base Non-EngagingMinimum wall thickness - 0.5 mm;Minimum post height for single-unitrestorations – 4.0 mm;Minimum gingival height - 0.5 mm;Maximum gingival height - 5.0 mm; andStraight and Angulated Screw Channel(ASC) variations.All zirconia superstructures are forstraight abutments only. | n/a | n/a | n/a |
{14}------------------------------------------------
| Titanium BlankMinimum wall thickness - 0.5 mm;Minimum post height for single-unitrestoration - 4.0 mm;Maximum Angle - 30° *;Minimum gingival height - 0.5 mm; andMaximum gingival height – 2.0 mm to4.5 mm (varies by implant line).*Astra Tech® OsseoSpeed™ Plus (OsseoSpeed™EV)-compatible 3.0 mm and larger diameterabutments are limited to 0° maximum correctionangle.HealingPD = 2.9 - 5.4 mmGH = 2 - 4 mmGD = 3.5 - 6.5 mmPH = 0 mm | n/a | n/a | n/a | ||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| n/a | n/a | Healing PD GD GH AH 2.9 (RB/WB) 4.0 1.5 2, 4 2.5 2, 4 5.0 1.5 2, 4 2.5 2, 4 2.9 (WB) 6.5 2.5 2, 4 3.5 2, 4 6.0 0.75 2, 4 1.5 2, 4 7.5 0.75 2, 4 1.5 2, 4 | n/a | ||||||||||||||||||||||||||||||||||||||||
| Material(Abutment andScrew) | Ti-6AL-4V Alloy | Titanium Alloy | Titanium Alloy | Titanium Alloy | |||||||||||||||||||||||||||||||||||||||
| Abutment/ImplantInterface | Internal Connection | Internal Connection | Internal Connection | Internal Connection | |||||||||||||||||||||||||||||||||||||||
| ProsthesisAttachment | Cement-retainedScrew-retained | Cement-retainedScrew-retained | Cement-retainedScrew-retained | Cement-retainedScrew-retained | |||||||||||||||||||||||||||||||||||||||
| Restoration | Single-unitMulti-unit | Single-unit | Single-unitMulti-unit | Single-unitMulti-unit | |||||||||||||||||||||||||||||||||||||||
| Implant RestorativePlatform Diameters(mm) | 2.9-5.4 | 3.0 | 2.9 (RB/WB)2.9 (WB) | 2.9 (RB/WB) | |||||||||||||||||||||||||||||||||||||||
| Sterilization Method | Steam sterilization - End User | Steam sterilization - End User | Steam sterilization - End User | Steam sterilization - End User |
PD = Abutment/Implant Platform diameter
GH = Gingival Height
GD = Gingival Diameter (Prosthetic Diameter)
n/d = not defined in literature or 510(k) summary
*According to device labeling
§ 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.)