(219 days)
No
The document describes a dental implant abutment system and its compatibility with various implant systems. It mentions digital design and validated milling centers, but there is no mention of AI or ML being used in the design process, manufacturing, or any other aspect of the device's function. The performance studies focus on mechanical testing and biocompatibility, not algorithmic performance.
No
The device, Preat Abutments, is described as a dental implant abutment system intended to provide support for single-unit or multi-unit prosthetic restorations. It is a structural component of a dental implant system, not a device directly used to treat or cure a disease or condition.
No
Explanation: The document states that the Preat Abutments are intended to provide support for prosthetic restorations in dental implants in the maxillary or mandibular arch. This describes a supportive, restorative, or prosthetic function, not a diagnostic one. Diagnostic devices are used to identify or detect a disease, condition, or its risk factors.
No
The device is a dental implant abutment system, which is a physical medical device made of titanium and zirconia. While it mentions digitally designed components, these are manufactured into physical parts.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used "in conjunction with endosseous dental implants... to provide support for single-unit or multi-unit prosthetic restorations." This describes a physical component used in a surgical and restorative dental procedure.
- Device Description: The description details the physical components of the abutments (titanium base, zirconia superstructure, screws), the materials used, and how they are manufactured and used in a dental setting.
- Performance Studies: The performance studies focus on mechanical testing (static compression, fatigue), biocompatibility, sterilization, and MRI safety. These are all relevant to a physical implant component, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the human body (blood, tissue, etc.), detecting specific analytes, or providing information for diagnosis or monitoring of a disease or condition.
The device is a dental implant abutment system, which is a medical device used in the treatment of tooth loss.
N/A
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.
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.
Product codes
NHA
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillary or mandibular arch (dentition)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K120414, K051614, K163194, K180536, K201225, K102436, K173961, K181703
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.)
0
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.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
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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3
510(k) Summary K220823 Preat Corporation Preat Abutments October 26, 2022
ADMINISTRATIVE INFORMATION
| Manufacturer Name | Preat Corporation
2625 Skyway Dr, Suite B
Santa 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, and | |
| Anatomic 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.
4
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 | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Abutment | ||||||||||
| Platform | ||||||||||
| Diameter/ | ||||||||||
| Compatible | ||||||||||
| Implant | ||||||||||
| System | Temp | |||||||||
| Engaging | Temp Non- | |||||||||
| Engaging | Multi-Unit | |||||||||
| Straight | Multi-Unit | |||||||||
| Angled 17° | Multi-Unit | |||||||||
| Angled | ||||||||||
| 30° | Titanium | |||||||||
| Base | ||||||||||
| Engaging | Titanium | |||||||||
| Base Non- | ||||||||||
| Engaging | Titanium | |||||||||
| Blank | Healing | Titanium | ||||||||
| Screws | ||||||||||
| 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 |
5
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.
6
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.
7
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.
8
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 endosseous | |||||||
| dental 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 for | |||||||
| single-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 the | |||||
| following situations and with the following clinical | or fully edentulous mandibles and | ||||||
| maxillae, 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 Tech | |||||||
| OsseoSpeed™ Plus | 3.6 (3.6S) | ||||||
| 4.2 (4.2C, 4.2S) | 3.6 | ||||||
| 4.2 | 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 is | ||||
| intended 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 Line | ||
| JJGC Industria e Comercio de Materiais | |||
| Dentarios SA | |||
| 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 | |||
| Preat Corporation | |||
| 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. | |||
| 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. | Indications for Use for GM implants and | ||
| conventional abutments: | |||
| The Neodent Implant System is intended to be | |||
| surgically placed in the bone of the upper or | |||
| lower jaw to provide support for prosthetic | |||
| devices such as artificial teeth, to restore | |||
| chewing function. It may be used with single- | |||
| stage or two-stage procedures, for single or | |||
| multiple unit restorations, and may be loaded | |||
| immediately when good primary stability is | |||
| achieved and with appropriate occlusal loading. |
Indications for Use for GM Titanium Base
abutments:
Titanium Base Abutment is a titanium base
placed onto Neodent dental implants to
provide support for customized prosthetic
restorations. It is used with a coping and crown,
or crown alone, and is indicated for cement-
retained single or multi-unit restorations, or
screw-retained single restorations.
All digitally designed copings and/or crowns for
use with the Neodent Titanium Base Abutment
System are intended to be sent to Straumann
for manufacture at a validated milling center.
Indications for Use for GM Pro Peek
Abutments:
The Pro PEEK Abutments are indicated to be
used on Neodent implants to provide
temporary support for prosthesis structure for
up to 6 months. They can be used in one or two
stage procedures and also immediate load
when there is good primary stability. | Indications for Use for GM Helix implants and
conventional abutments:
The Neodent Implant System is intended to be surgically
placed in the bone of the upper or lower jaw to provide
support for prosthetic devices such as artificial teeth, to
restore chewing function. It may be used with single-
stage or two-stage procedures, for single or multiple unit
restorations, and may be loaded immediately when good
primary stability is achieved and with appropriate
occlusal loading.
Indications for Use for GM Exact Titanium Block for
Medentika Holder:
GM Exact Titanium Block for Medentika Holder is a
titanium abutment to be used in fabricating a full custom
abutment and placed onto Neodent dental implants to
provide support for customized prosthetic restorations.
The GM Exact Titanium Block for Medentika Holder
abutments are indicated for screw-retained single
restorations or cement-retained single or multi-unit
restorations. All digitally designed abutments for use
with the GM Exact Titanium Block for Medentika Holder
are intended to be sent to Straumann for manufacture at
a validated milling center.
Indications for Use for GM Exact Titanium Base
abutments:
Titanium Base Abutment is a titanium base placed onto
Neodent dental implants to provide support for
customized prosthetic restorations. It is used with a
coping and crown, or crown alone, and is indicated for
cement-retained single or multi-unit restorations, or
screw-retained single restorations. All digitally designed
copings and/or crowns for use with the Neodent
Titanium Base Abutment System are intended to be sent
to Straumann for manufacture at a validated milling
center.
Indications for Use for Titanium Base C for GM Exact
abutments:
The Titanium Base C for GM Exact abutments is a
titanium component that is placed over Neodent
implants to provide support for custom prosthetic
restorations, such as copings or crowns. It is indicated for
single-tooth screw-retained restorations. All digitally
designed copings and/or crowns for use with the
Titanium Base C for GM Exact abutments are to be
designed using Sirona inLab software or Sirona CEREC
Software and manufactured using a Sirona CEREC or | The Neodent Implant System is intended to be
surgically placed in the bone of the upper or lower
jaw to provide support for prosthetic devices, such as
artificial teeth, to restore chewing function. It may be
used with single-stage or two-stage procedures, for
single or multiple unit restorations, and may be
loaded immediately when good primary stability is
achieved and with appropriate occlusal loading. |
| Compatible
Implant Systems | Implant Body
Diameter (mm) | Implant Platform
Diameter (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 | |
| Keystone
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) | |
| Subject Device | Reference Device | Reference Device | Reference Device |
| Preat Abutments | NobelActive 3.0 | Straumann® BLX Implant System | Straumann® BLX Line Extension - Implants, SRAs
and Anatomic Abutments |
| Preat Corporation | Nobel Biocare | Institut Straumann AG | Institut Straumann AG |
| | K102436 | K173961 | K181703 |
| 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. | The NobelActive. 3.0mm
Implant Is Indicated for use in
the treatment of missing
maxillary lateral incisors or
the mandibular central and
lateral incisors to support
prosthetic devices, such as
artificial teeth, in order to
restore chewing function in
partially edentulous patients.
The NobelActive 3.0 implants
may be put into immediate
function provided that
stability requirements
detailed in the manual are
satisfied. | Straumann® BLX Implants
Straumann® BLX Implants are suitable for endosteal implantation in the upper
and lower jaw and for the functional and esthetic oral rehabilitation of
edentulous and partially edentulous patients. BLX Implants can be placed with
immediate function on single-tooth applications when good primary stability is
achieved and with appropriate occlusal loading to restore chewing function.
The prosthetic restorations are connected to the implants through the
corresponding abutment components.
Straumann® BLX Closure Caps and Healing Abutments Straumann® Closure
Caps and Healing Abutments are indicated to be placed in the patient's mouth
at the end of the implant placement to protect the inner configuration of the
implant and to shape, maintain and stabilize the soft tissue during the healing
process. Closure caps and healing abutments should be used only with suitable
implant connections. Straumann Closure Caps and Healing Abutments have a
maximum duration of usage of 6 months.
Straumann® BLX Basal Screws and Temporary Abutments
Prosthetic components directly or indirectly connected to the endosseous
dental implant are intended for use as an aid in prosthetic rehabilitations.
Temporary components can be used prior to the insertion of the final
components to maintain, stabilize and shape the soft tissue during the healing
phase; they may not be placed into occlusion. Final abutments may be placed
into occlusion when the implant is fully osseointegrated. BLX Temporary
Abutments have a maximum duration of usage of 180 days.
Straumann® BLX Variobases
Straumann® Variobase® prosthetic components directly or indirectly connected
to the endosseous dental implant are intended for use as an aid in prosthetic
rehabilitations. The prosthetic restoration (crowns) can be cemented onto the
Straumann® Variobase® prosthetic components. A temporary restoration can
be used prior to the insertion of the final components to maintain, stabilize and
shape the soft tissue during the healing phase; they must be placed out of
occlusion. Final abutments and restorations may be placed into occlusion when
the implant is fully osseointegrated. All digitally designed copings and/or
crowns for use with the Straumann® Variobase® Abutment system are
intended to be sent to Straumann for manufacture at a validated milling | Straumann® BLX Implants
Straumann® BLX Implants are suitable for endosteal
implantation in the upper and lower jaw and for the
functional and esthetic oral rehabilitation of edentulous
and partially edentulous patients. BLX Implants can be
placed with immediate function on single-tooth,
bar and bridges applications when good primary stability is
achieved and with appropriate occlusal loading to restore
chewing function. The prosthetic restorations are
connected to the implants through the corresponding
abutment components.
Straumann® BLX SRAs and Antomic Abutments
Prosthetic components directly or indirectly connected to
the endosseous dental implant are intended for use as an
aid in prosthetic rehabilitations. Temporary components
can be used prior to the insertion of the final components
to maintain, stabilize and shape the soft tissue during the
healing phase; they may not be placed into occlusion. Final
abutments may be placed into occlusion when the implant
is fully osseointegrated. BLX Temporary Abutments have a
maximum duration of usage of 180 days. |
| Compatible Implant Systems | | | |
| Compatible
Implant Systems | Implant Body
Diameter (mm) | Implant Platform
Diameter (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 Device
Preat Abutments
Preat Corporation | Predicate Device
Preat Abutments
Preat Corporation
K183518 | Reference Device
OsseoSpeed™ Plus
(OsseoSpeed™ EV)
Astra Tech AB
K120414 | Reference Device
PrimaConnex™ Internal
Connection Implant System
Lifecore Biomedical, Inc.
(Keystone)
K051614 | Reference Device
Neodent Implant System - GM Line
JJGC Industria e Comercio de
Materiais Dentarios SA
K163194 | Reference Device
Neodent Implant System - GM Line
JJGC Industria e Comercio de
Materiais Dentarios SA
K180536 | Reference Device
Neodent Implant System - GM Helix
Implants 7.0
JJGC Industria e Comercio de
Materiais Dentarios SA
K201225 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|-------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|--|--|--------------------------------------------------------------------------|--|-----|-----|--|--|-----|--|--|--|--|--|--|-------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|-----|-----|
| Intended Use | Functional and esthetic rehabilitation of
the edentulous maxilla and mandible | Functional and esthetic
rehabilitation of the edentulous
maxilla and mandible | Functional and esthetic
rehabilitation of the edentulous
maxilla and mandible | Functional and esthetic
rehabilitation of the
edentulous maxilla and
mandible | Functional and esthetic
rehabilitation of the edentulous
maxilla and mandible | Functional and esthetic rehabilitation
of the edentulous maxilla and
mandible | Functional and esthetic rehabilitation
of the edentulous maxilla and
mandible | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Reason for
Predicate/Reference | Not Applicable | Abutment configurations listed, 30°
post angle correction, sterilization,
biocompatibility | Implant/Restorative interface | Implant/Restorative interface,
30 degree Multi-Unit Abutment
design. | Helix implant, Implant/Restorative
interface, straight screw channel Ti-
base configuration, Healing
Abutment design | 6 mm Helix Implant,
Implant/Restorative interface | 7 mm Helix Implant,
Implant/Restorative interface | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Abutment Designs | Temporary Engaging
PD = 2.9 - 5.4 mm
GH = 1 mm
GD = 3.3 - 6.0 mm
PH = 10.9 mm (4 mm min) | Temporary Engaging
PD = 3.0 - 6.6 mm
GH = 1 mm
GD = 3.0 - n/d mm
PH = 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 Engaging
PD 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-Engaging
PD = 2.9 - 5.4 mm
GH = 1 mm
GD = 3.0 - 6.0 mm
PH = 10.9 mm (4 mm min) | Temporary Non-Engaging
PD = 3.0 - 6.6 mm
GH = 1 mm
GD = 3.0 - n/d mm
PH = 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 Straight
PD = 2.9 - 5.4 mm
GH = 1 - 5 mm
GD = 4.8 mm
PH = 2.2 mm | Multi-Unit Straight
PD = 3.0 - 6.6 mm
GH = 2 - 5 mm
GD = 4.8 mm
PH = 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 mm
GH = 2 - 5 mm
GD = 4.8 mm
PH = 2.2 mm | Multi-Unit 17°
PD = 3.0 - 6.6 mm
GH = 3.5 - 4.5 mm
GD = 4.8 mm
PH = 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 mm
GH = 3 - 4.5 mm
GD = 4.8 mm
PH = 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 Engaging
Minimum wall thickness - 0.5 mm;
Minimum post height for single-unit
restorations - 4.0 mm;
Minimum gingival height - 0.5 mm;
Maximum gingival height - 5.0 mm; and
Straight and Angulated Screw Channel
(ASC) variations.
All zirconia superstructures are for
straight abutments only. | Titanium Base Engaging
Minimum wall thickness - 0.5 mm;
Minimum post height for single-unit
restorations - 4.0 mm;
Maximum gingival height - 5.0 mm;
and Angulated Screw Channel (ASC)
All zirconia superstructures are for
straight 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 mm
Straight 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 mm
Straight screw channel | | | | | | | | | | n/a | | | | | | | | | | | | | | | | | | |
| | Titanium Base Non-Engaging
Minimum wall thickness - 0.5 mm;
Minimum post height for single-unit
restorations - 4.0 mm;
Minimum gingival height - 0.5 mm;
Maximum gingival height - 5.0 mm; and
Straight and Angulated Screw Channel
(ASC) variations.
All zirconia superstructures are for
straight abutments only. | Titanium Base Non-Engaging
Minimum wall thickness - 0.5 mm;
Minimum post height for single-unit
restorations - 4.0 mm;
Maximum gingival height - 5.0 mm;
and Angulated Screw Channel (ASC
)All zirconia superstructures are for
straight abutments only. | n/a | n/a | n/a | n/a | n/a | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
12
| | Titanium Blank
Minimum wall thickness - 0.5 mm;
Minimum post height for single-unit
restoration - 4.0 mm;
Maximum Angle - 30° *;
Minimum gingival height - 0.5 mm; and
Maximum gingival height - 2.0 mm to
4.5 mm (varies by implant line).
*Astra Tech® OsseoSpeed™ Plus (OsseoSpeed™
EV)-compatible 3.0 mm and larger diameter
abutments are limited to 0° maximum correction
angle. | Titanium Blank
Minimum wall thickness - 0.5 mm;
Minimum post height for single-unit
restoration - 4.0 mm;
Maximum Angle – 30°; and
Maximum gingival height - 1.5 mm
to 2.65 mm (varies by implant line). | n/a | n/a | Titanium Blank
Maximum Angle - 30° | Titanium Blank
Maximum Angle - 30° | n/a | | | | | | | | | | | | | | | | | | |
|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|-----------------------------------|--------------------------------------------------------------------------------------------------------------------|---------------------------------------|-----------------------------------|--|--|--|--|--|--|--|----------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|-----|
| | Healing
PD = 2.9 - 5.4 mm
GH = 2 - 4 mm
GD = 3.5 - 6.5 mm
PH = 0 mm | n/a | Healing
PD = 3.0 - 5.4 mm
GH = n/d
GD = 3.0-5.4 mm
PH = n/d | n/a | Healing
PD 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 | | | | | | | | | | Healing
PD 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 and
Screw) | Ti-6AL-4V Alloy | Ti-6AL-4V Alloy | Titanium Alloy | Titanium Alloy | Titanium Alloy | Titanium Alloy | Titanium Alloy | | | | | | | | | | | | | | | | | | |
| Abutment/Implant
Interface | Internal Connection | Internal Connection | Internal Connection | Internal Connection | Internal Connection | Internal Connection | Internal Connection | | | | | | | | | | | | | | | | | | |
| Prosthesis
Attachment | Cement-retained
Screw-retained | Cement-retained
Screw-retained | Cement-retained
Screw-retained | Cement-retained
Screw-retained | Cement-retained
Screw-retained | Cement-retained
Screw-retained | Cement-retained
Screw-retained | | | | | | | | | | | | | | | | | | |
| Restoration | Single-unit
Multi-unit | Single-unit
Multi-unit | Single-unit
Multi-unit | Single-unit
Multi-unit | Single-unit
Multi-unit | Single-unit
Multi-unit | Single-unit | | | | | | | | | | | | | | | | | | |
| Implant Restorative
Platform 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 Line | ||||||||||||||||
| Extension - Implants, SRAs and Anatomic | |||||||||||||||||||
| Abutments | |||||||||||||||||||
| Preat Corporation | Nobel Biocare | ||||||||||||||||||
| K102436 | Institut Straumann AG | ||||||||||||||||||
| K173961 | Institut Straumann AG | ||||||||||||||||||
| K181703 | |||||||||||||||||||
| Intended Use | Functional and esthetic rehabilitation of the edentulous maxilla and mandible | Functional and esthetic | |||||||||||||||||
| rehabilitation of the | |||||||||||||||||||
| edentulous maxilla and | |||||||||||||||||||
| mandible | Functional and esthetic rehabilitation | ||||||||||||||||||
| of the edentulous maxilla and | |||||||||||||||||||
| mandible | Functional and esthetic rehabilitation of the | ||||||||||||||||||
| edentulous maxilla and mandible | |||||||||||||||||||
| Reason for | |||||||||||||||||||
| Predicate/Reference | Not Applicable | Implant/Restorative interface | Implant/Restorative interface, 30° | ||||||||||||||||
| Multi-Unit Abutment design, straight | |||||||||||||||||||
| screw channel Ti-base configuration, | |||||||||||||||||||
| Healing Abutment design | Implant/Restorative interface, 3.75 mm implant | ||||||||||||||||||
| compatibility, and 4.0 mm by being | |||||||||||||||||||
| encompassed within 3.75 mm diameter and | |||||||||||||||||||
| K173961 | |||||||||||||||||||
| Abutment Designs | Temporary Engaging | ||||||||||||||||||
| PD = 2.9 - 5.4 mm | |||||||||||||||||||
| GH = 1 mm | |||||||||||||||||||
| GD = 3.3 - 6.0 mm | |||||||||||||||||||
| PH = 10.9 mm (4 mm min) | n/a | Temporary Engaging | |||||||||||||||||
| PD 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-Engaging | |||||||||||||||||||
| PD = 2.9 - 5.4 mm | |||||||||||||||||||
| GH = 1 mm | |||||||||||||||||||
| GD = 3.0 - 6.0 mm | |||||||||||||||||||
| PH = 10.9 mm (4 mm min) | n/a | n/a | |||||||||||||||||
| Multi-Unit Straight | |||||||||||||||||||
| PD = 2.9 - 5.4 mm | |||||||||||||||||||
| GH = 1 - 5 mm | |||||||||||||||||||
| GD = 4.8 mm | |||||||||||||||||||
| PH = 2.2 mm | n/a | Multi-Unit Straight | |||||||||||||||||
| PD GH GD 2.9 (RB/WB) 1.5,2.5,3.5,4.5 4.6 | Multi-Unit Straight | ||||||||||||||||||
| PD GH GD 2.9 (RB/WB) 1.5,2.5,3.5,4.5 4.6 | |||||||||||||||||||
| Multi-Unit 17° | |||||||||||||||||||
| PD = 2.9 - 5.4 mm | |||||||||||||||||||
| GH = 2 - 5 mm | |||||||||||||||||||
| GD = 4.8 mm | |||||||||||||||||||
| PH = 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 mm | |||||||||||||||||||
| GH = 3 - 4.5 mm | |||||||||||||||||||
| GD = 4.8 mm | |||||||||||||||||||
| PH = 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 Engaging | |||||||||||||||||||
| Minimum wall thickness - 0.5 mm; | |||||||||||||||||||
| Minimum post height for single-unit | |||||||||||||||||||
| restorations - 4.0 mm; | |||||||||||||||||||
| Minimum gingival height - 0.5 mm; | |||||||||||||||||||
| Maximum gingival height - 5.0 mm; and | |||||||||||||||||||
| Straight and Angulated Screw Channel | |||||||||||||||||||
| (ASC) variations. | |||||||||||||||||||
| All zirconia superstructures are for | |||||||||||||||||||
| straight abutments only. | n/a | Titanium Base Engaging (Variobase) | |||||||||||||||||
| Up to 30° Correction Angle | |||||||||||||||||||
| PD 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-Engaging | |||||||||||||||||||
| Minimum wall thickness - 0.5 mm; | |||||||||||||||||||
| Minimum post height for single-unit | |||||||||||||||||||
| restorations – 4.0 mm; | |||||||||||||||||||
| Minimum gingival height - 0.5 mm; | |||||||||||||||||||
| Maximum gingival height - 5.0 mm; and | |||||||||||||||||||
| Straight and Angulated Screw Channel | |||||||||||||||||||
| (ASC) variations. | |||||||||||||||||||
| All zirconia superstructures are for | |||||||||||||||||||
| straight abutments only. | n/a | n/a | n/a |
14
| | Titanium Blank
Minimum wall thickness - 0.5 mm;
Minimum post height for single-unit
restoration - 4.0 mm;
Maximum Angle - 30° *;
Minimum gingival height - 0.5 mm; and
Maximum gingival height – 2.0 mm to
4.5 mm (varies by implant line).
*Astra Tech® OsseoSpeed™ Plus (OsseoSpeed™
EV)-compatible 3.0 mm and larger diameter
abutments are limited to 0° maximum correction
angle.
Healing
PD = 2.9 - 5.4 mm
GH = 2 - 4 mm
GD = 3.5 - 6.5 mm
PH = 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 and
Screw) | Ti-6AL-4V Alloy | Titanium Alloy | Titanium Alloy | Titanium Alloy | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Abutment/Implant
Interface | Internal Connection | Internal Connection | Internal Connection | Internal Connection | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Prosthesis
Attachment | Cement-retained
Screw-retained | Cement-retained
Screw-retained | Cement-retained
Screw-retained | Cement-retained
Screw-retained | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Restoration | Single-unit
Multi-unit | Single-unit | Single-unit
Multi-unit | Single-unit
Multi-unit | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Implant Restorative
Platform 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