(90 days)
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 mesostructured components make up a two-piece abutment.
All digitally designed custom abutments, superstructures, and/or hybrid crowns for use with Titanium Blank are to be sent to a Preat validated milling center for manufacture.
Preat Abutments is a dental implant abutment system that includes ten (10) abutment designs compatible with twelve (12) OEM implant systems. The subject device abutment platform diameters range from 3.0 mm to 6.5 mm, and the corresponding compatible implant body diameters also range from 3.0 mm to 6.5 mm. The subject device includes the following abutment designs: temporary, esthetic angled 15°, multi unit straight, multi-unit angled 17°, ball (Clix Ball and O-Ring), titanium base, and titanium blank. The system also includes corresponding abutment screws.
All abutments and screws are manufactured from Ti-6Al-4V alloy conforming to ASTM F136 and are provided non-sterile to the end user. All digitally designed custom abutments, superstructures, and/or hybrid crowns for use with Titanium Base 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.
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; 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).
The provided document is a 510(k) Premarket Notification for dental implant abutments. It focuses on demonstrating substantial equivalence to previously cleared devices rather than providing detailed performance data from a clinical or standalone study. Therefore, most of the requested information regarding acceptance criteria for an AI/device performance study, sample sizes for test/training sets, expert qualifications, and ground truth establishment is not available in this document.
The document details the technical and material characteristics of the Preat Abutments and compares them to predicate devices to argue for their equivalence. It includes non-clinical performance data related to mechanical testing, sterilization, and biocompatibility, but not data related to an AI's diagnostic performance or human reader improvement with AI assistance.
Here's an attempt to answer the questions based on the provided text, indicating when the information is not present:
Analysis of Device Performance and Acceptance Criteria (Based on Substantial Equivalence)
This 510(k) submission for Preat Abutments relies on demonstrating substantial equivalence to existing legally marketed predicate devices. The "acceptance criteria" here are implicitly related to meeting the performance characteristics and safety profiles of these predicates, rather than specific statistical thresholds for a new diagnostic algorithm's accuracy or efficacy. The "study" proving acceptance is primarily the non-clinical testing performed and the comparison to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (Method/Finding) |
|---|---|
| Sterilization Efficacy(Device can be effectively sterilized by end-user) | Demonstrated: Sterilization validation performed according to ISO 17665-1 and ISO 14937. (Same method as predicate K170588) |
| Biocompatibility(Device materials are safe for human contact) | Demonstrated: Confirmatory biocompatibility testing performed according to ISO 10993-12 (and ANSI / AAMI / ISO 10993-5, though 10993-12 refers to sample preparation and reference materials, and 10993-5 refers to in vitro cytotoxicity, suggesting this was the specific test performed). |
| Mechanical Strength/Fatigue Resistance(Device can withstand forces in intended use) | Demonstrated: Mechanical performance testing performed according to ISO 14801 (static compression and compression fatigue testing). Worst-case constructs for each compatible OEM implant line were tested. For Astra Tech OsseoSpeed™ and BioHorizons Tapered Internal (3.0 mm implant body/platform), a fatigue limit of 133 N was established, supported by reference device K100993. Other implant lines demonstrated sufficient strength for intended use. |
| Compatible Implant System Fit/Function(Device interfaces correctly with implants) | Demonstrated: Reverse engineering of OEM implant bodies and abutment screws was performed to confirm compatibility. |
| Equivalence in Intended Use | Demonstrated: "Subject device abutments are substantially equivalent in intended use to the primary predicate K170588, and the reference devices K120414, K161416, K151621, and K100993. All are intended for use with endosseous dental implants in the maxilla and mandible to provide functional and esthetic rehabilitation of the edentulous maxilla and mandible." Minor language differences were deemed not to affect intended use. |
| Equivalence in Technological Characteristics | Demonstrated: The device is made of the same materials (Ti-6Al-4V alloy), has similar abutment designs (with some additions justified by reference devices), similar restoration types (single/multi-unit), and platform diameters, and is sterilized similarly. (Details provided in comparison tables on pages 10-11) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of an AI/diagnostic performance study. For the mechanical testing, the document states "worst-case constructs were subjected to static compression fatigue testing," but does not specify the number of samples or "test set" size.
- Data Provenance: Not applicable for location (country of origin), as this is a physical device testing submission. The data is from laboratory testing (mechanical, biocompatibility, sterilization validation). The testing is prospective in nature, as it was conducted specifically for this submission.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not applicable. There is no "ground truth" established by experts in the context of a diagnostic performance study. The ground truth for mechanical and material properties is based on established engineering standards and test methods (e.g., ISO 14801, ISO 10993, ISO 17665).
4. Adjudication Method for the Test Set
- Not applicable. No human-based adjudication was performed for a diagnostic test set.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
- No. This is not a submission for a diagnostic AI device, so an MRMC comparative effectiveness study was not performed.
- Effect Size: Not applicable.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an AI algorithm submission. The "standalone" performance here relates to the physical device's mechanical and material properties, which were tested in a laboratory setting as described under "Performance Data."
7. The Type of Ground Truth Used
- For physical device performance: The "ground truth" is defined by international standards (e.g., ISO 14801 for mechanical testing, ISO 10993 for biocompatibility, ISO 17665 for sterilization) and engineering specifications derived from predicate device performance and design. It's not clinical outcomes data or expert consensus in the diagnostic sense.
8. The Sample Size for the Training Set
- Not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set was Established
- Not applicable. There is no "training set." The understanding of predicate device performance and design parameters, which inform the design and testing of the subject device, is derived from existing regulatory clearances and documented technical specifications of those predicate devices.
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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 includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 18, 2019
Preat Corporation % Kevin Thomas Vice President and Director of Regulatory Affairs PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130
Re: K183518
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: December 17, 2018 Received: December 18, 2018
Dear Kevin Thomas:
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.
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
{1}------------------------------------------------
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Digitally signed by Mary S. Mary S. Runner -S3 Runner -S3 3 Date: 2019.03.18
16:42:18 -04'00' For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation 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 prosthetions. The Tianium Base abutments consists of two major parts. Specifically, the titanium base and mesostructured components make up a two-piece abutment.
All digitally designed custom abutments, superstructures, and/or hybrid crowns for use with Titanium Blank are to be sent to a Preat validated milling center for manufacture.
| Compatible Implant System | Implant Body Diameter(mm) | Implant Platform Diameter(mm) |
|---|---|---|
| 3i OSSEOTITE® Certain® | 3.25 | 3.4 |
| 4.0 | 4.1 | |
| 5.0 | 5.0 | |
| 6.0 | 6.0 | |
| Astra Tech OsseoSpeed™ | 3.0 | 3.0 |
| 3.5, 4.0 | 3.5/4.0 | |
| 4.5, 5.0 | 4.5/5.0 | |
| BioHorizons Tapered Internal | 3.0 | 3.0 |
| 3.5 | 3.5 | |
| 4.0 | 4.5 | |
| HIOSSEN ET III | 3.5 | Mini |
| 4.0, 4.5, 5.0, 6.0, 7.0 | Regular | |
| Implant Direct Legacy | 3.2 | 3.0 |
| 3.7, 4.2 | 3.5 | |
| 4.7, 5.2 | 4.5 | |
| 5.7, 7.0 | 5.7 | |
| MegaGen AnyRidge | 3.5, 4.0, 4.5, 5.0, 5.5 | 3.5 |
| Neoss | 3.5, 4.0, 4.5, 5.0, 5.5 | 4.1 |
| NobelActive® | 3.5 | NP |
| 4.3, 5.0 | RP | |
| Nobel Replace™ | 3.5 | NP |
| 4.0, 4.3, 5.0 | RP | |
| 5.0 | WP | |
| 6.0 | 6.0 | |
| Straumann® Bone Level | 3.3 | NC |
| 4.1, 4.8 | RC | |
| Straumann® Tissue Level | 3.3, 4.1, 4.8 | RN |
| 4.8, 6.5 | WN | |
| Zimmer Screw-Vent®/Tapered Screw-Vent® | 3.3, 3.7, 4.1 | 3.5 |
| 4.7 | 4.5 | |
| 6.0 | 5.7 |
Compatible Implant Systems
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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510(k) Summary
K183518 – Preat Abutments
Preat Corporation
March 18, 2019
ADMINISTRATIVE INFORMATION
| Manufacturer Name | Preat Corporation100 S. 4th StreetGrover Beach, CA 93433Telephone: +1 805-202-3070Fax: +1 805-202-3076 |
|---|---|
| Official Contact | Chris Bormes, President and CEO |
Representative/Consultant
Kevin A. Thomas, PhD Floyd G. Larson, MS. MBA PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, CA 92130 Telephone: +1 858-792-1235 Fax: +1 858-792-1236 Email: kthomas@paxmed.com flarson@paxmed.com
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name | Preat Abutments |
|---|---|
| Common Name | Dental implant abutment |
| Regulation Number | 21 CFR 872.3630 |
| Regulation Name | Endosseous dental implant abutment |
| Regulatory Class | Class II |
| Product Code | NHA |
| Classification Panel | Dental Products Panel |
| Reviewing Branch | Dental Devices Branch |
PREDICATE DEVICE INFORMATION
Primary Predicate K170588, DESS Dental Smart Solutions, Terrats Medical SL
Reference Devices K120414, OsseoSpeed™ Plus, Astra Tech AB K161416, Multi-unit Abutment Plus, Nobel Biocare AB K151621, BioHorizons CAD/CAM Abutments, BioHorizons Implant Systems, Inc. K100993, Inclusive® Titanium Abutments for Astra OsseoSpeed™, Prismatik Dentalcraft, Inc.
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INDICATIONS FOR USE STATEMENT
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 mesostructured components make up a two-piece abutment.
All digitally designed custom abutments, superstructures, and/or hybrid crowns for use with Titanium Base or Titanium Blank are to be sent to a Preat validated milling center for manufacture.
| Compatible Implant System | Implant Body Diameter(mm) | Implant Platform Diameter(mm) |
|---|---|---|
| 3i OSSEOTITE® Certain® | 3.25 | 3.4 |
| 4.0 | 4.1 | |
| 5.0 | 5.0 | |
| 6.0 | 6.0 | |
| Astra Tech OsseoSpeed™ | 3.0 | 3.0 |
| 3.5, 4.0 | 3.5/4.0 | |
| 4.5, 5.0 | 4.5/5.0 | |
| BioHorizons Tapered Internal | 3.0 | 3.0 |
| 3.5 | 3.5 | |
| 4.0 | 4.5 | |
| HIOSSEN ET III | 3.5 | Mini |
| 4.0, 4.5, 5.0, 6.0, 7.0 | Regular | |
| Implant Direct Legacy | 3.2 | 3.0 |
| 3.7, 4.2 | 3.5 | |
| 4.7, 5.2 | 4.5 | |
| 5.7, 7.0 | 5.7 | |
| MegaGen AnyRidge | 3.5, 4.0, 4.5, 5.0, 5.5 | 3.5 |
| Neoss | 3.5, 4.0, 4.5, 5.0, 5.5 | 4.1 |
| NobelActive® | 3.5 | NP |
| 4.3, 5.0 | RP | |
| Nobel Replace™ | 3.5 | NP |
| 4.0, 4.3, 5.0 | RP | |
| 5.0 | WP | |
| 6.0 | 6.0 | |
| Straumann® Bone Level | 3.3 | NC |
| 4.1, 4.8 | RC | |
| Straumann® Tissue Level | 3.3, 4.1, 4.8 | RN |
| 4.8, 6.5 | WN | |
| Zimmer Screw-Vent®/Tapered Screw-Vent® | 3.3, 3.7, 4.1 | 3.5 |
| 4.7 | 4.5 | |
| 6.0 | 5.7 |
| Compatible Implant Systems |
|---|
SUBJECT DEVICE DESCRIPTION
Preat Abutments is a dental implant abutment system that includes ten (10) abutment designs compatible with twelve (12) OEM implant systems. The subject device abutment platform diameters range from 3.0 mm to 6.5 mm, and the corresponding compatible implant body diameters also range from 3.0 mm to 6.5 mm. The subject device includes the following abutment designs: temporary, esthetic angled 15°, multi
{6}------------------------------------------------
unit straight, multi-unit angled 17°, ball (Clix Ball and O-Ring), titanium base, and titanium blank. The system also includes corresponding abutment screws.
The following table shows the subject device abutments platform sizes for each of the OEM implant lines and sizes.
| Preat Abutment PlatformDiameter /Compatible Implant System | Subject Device Abutment Designs | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| TemporaryEngaging | TemporaryNon-Engaging | EstheticAngled 15° | Multi-UnitStraight | Multi-UnitAngled 17° | Clix Ball | O-Ring | Titanium BaseEngaging | Titanium BaseNon-Engaging | TitaniumBlank | TitaniumScrews | |
| 3i OSSEOTITE® Certain® | |||||||||||
| 3.4 | X | X | X | X | X | X | X | X | X | X | |
| 4.1 | X | X | X | X | X | X | X | X | X | X | |
| 5.0 | X | X | X | X | X | X | X | X | |||
| 6.0 | X | X | X | X | X | X | |||||
| Astra Tech OsseoSpeed™ | |||||||||||
| 3.0 | X | X | X | X | X | X | |||||
| 3.5/4.0 | X | X | X | X | X | X | X | X | X | X | X |
| 4.5/5.0 | X | X | X | X | X | X | X | X | X | X | X |
| BioHorizons Tapered Internal | |||||||||||
| 3.0 | X | X | X | X | X | X | X | X | |||
| 3.5 | X | X | X | X | X | X | X | X | X | ||
| 4.5 | X | X | X | X | X | X | X | X | X | ||
| HIOSSEN ET III | |||||||||||
| Mini | X | X | X | X | X | X | X | X | |||
| Regular | X | X | X | X | X | X | X | X | |||
| Implant Direct Legacy | |||||||||||
| 3.0 | X | X | X | X | X | X | |||||
| 3.5 | X | X | X | X | X | X | X | X | X | ||
| 4.5 | X | X | X | X | X | X | X | X | X | ||
| 5.7 | X | X | X | X | X | X | |||||
| MegaGen AnyRidge | |||||||||||
| 3.5 | X | X | X | X | X | X | X | X | |||
| Neoss | |||||||||||
| 4.1 | X | X | X | X | X | X | X | X | X | X | |
| NobelActive® | |||||||||||
| NP | X | X | X | X | X | X | X | X | X | X | |
| RP | X | X | X | X | X | X | X | X | X | X | |
| Nobel Replace™ | |||||||||||
| NP | X | X | X | X | X | X | X | X | X | X | |
| RP | X | X | X | X | X | X | X | X | X | X | |
| WP | X | X | X | X | X | X | X | X | X | ||
| 6.0 | X | X | |||||||||
| Straumann® Bone Level | |||||||||||
| NC | X | X | X | X | X | X | X | X | X | X | |
| RC | X | X | X | X | X | X | X | X | X | X | |
| Straumann® Tissue Level | |||||||||||
| RN | X | X | X | X | X | X | X | X | |||
| WN | X | X | |||||||||
| Zimmer Screw-Vent®/Tapered Screw-Vent® | |||||||||||
| 3.5 | X | X | X | X | X | X | X | X | X | X | |
| 4.5 | X | X | X | X | X | X | X | X | X | X |
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All abutments and screws are manufactured from Ti-6Al-4V alloy conforming to ASTM F136 and are provided non-sterile to the end user. All digitally designed custom abutments, superstructures, and/or hybrid crowns for use with Titanium Base 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.
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; 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).
PERFORMANCE DATA
Non-clinical data submitted to demonstrate substantial equivalence included: sterilization validation according to ISO 17665-1 and ISO 14937; biocompatibility according to ISO 10993-12; reverse engineering of OEM implant bodies, abutment screws to confirm compatibility; and static compression and compression fatigue testing according to ISO 14801. No clinical data were included in this submission.
EQUIVALENCE TO MARKETED DEVICES
The subject device is substantially equivalent in indications and design principles to the primary predicate device and the reference devices listed above. Provided at the end of this summary are tables comparing the Indications for Use Statements and the technological characteristics of the subject device, the primary predicate device, and the reference devices.
Subject device abutments are substantially equivalent in intended use to the primary predicate K170588, and the reference devices K120414, K161416, K151621, and K100993. All are intended for use with endosseous dental implants in the maxilla and mandible to provide functional and esthetic rehabilitation of the edentulous maxilla and mandible.
The Indications for Use Statement (IFUS) for the subject device is substantially equivalent to that of the primary predicate K170588. Slight differences in language of the subject device and primary predicate device Indications for Use statements do not affect the intended use as an endosseous dental implant abutment for support of a prosthesis to restore chewing function. The minor differences between the IFUS for the subject device and the primary predicate include: the subject device IFUS includes the term "single-unit or multi-unit" and the primary predicate IFUS does not. The other minor differences are
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related to the specific device names, validated milling centers, and the compatible OEM implant lines. None of these minor differences impact substantial equivalence because both IFUS express equivalent intended use to facilitate dental prosthetic restorations, and the indications are expressed equivalently using different specific wording.
Similarly, the differences between the subject device IFUS and that of each of the reference devices are related to the specific device names and design features, validated milling centers, and the compatible implant lines. None of these minor differences impact substantial equivalence 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 primary predicate device K 170588: temporary abutments; multi-unit straight abutments; titanium base abutments; and titanium blank abutments. The subject device and the primary predicate device K170588 are for single-unit or multi-unit restorations, have internal implant interface connections, and are made of Ti-6Al-4V alloy (abutments and abutment screws). The primary predicate includes straight abutments only. The subject device includes angled abutments up to 30° and the substantial equivalence of this angulation is supported by each of the reference devices.
The subject device includes designs for implant platforms ranging from 3.0 mm to 6.5 mm. The primary predicate K170588 includes implant platform sizes of 3.4 mm. Substantial equivalence of the smaller implant platform sizes of the subject device are supported by the reference devices K120414, K151621, and K100993.
The following subject device designs are substantially equivalent to those of the reference device K120414: temporary abutments; esthetic abutments (angled 15°); multi-unit straight abutments; and ball abutments. The subject device and the reference device K120414 abutments are for single-unit or multiunit restorations, include angulations up to 30°, have internal implant interface connections, and are made of Ti-6A1-4V alloy (abutments and abutment screws).
The subject device multi-unit angled abutments are substantially equivalent to those of the reference device K161416. The subject device and the reference device K161416 each include multi-unit abutments angled 17°, have internal implant interface connections, and are made of Ti-6AI-4V alloy (abutments and abutment screws).
The subject device titanium base abutments are substantially equivalent to those of the reference device K151621. The subject device and the reference device K151621 each include titanium base abutment designs with a cut out region to allow for angled access to the screw channel for multi-unit restorations. The subject device and the reference device K151621 titanium base designs have internal implant interface connections, and are made of Ti-6Al-4V alloy (abutments and abutment screws). The reference device K100993 is for support of substantial equivalence in terms of mechanical performance as discussed below. The subject device and the reference device K100993 titanium blank abutment designs with angulation of up to 30°, are for internal implant interface connections, and are made of Ti-6Al-4V alloy (abutments and abutment screws).
The subject device is to be sterilized by the end-user, the same as the primary predicate device K170588. Sterilization validation for the subject device was performed according to ISO 17665-1 and ISO TR 17665-2. This sterilization validation method is the same as the primary predicate device K170588.
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Confirmatory biocompatibility testing of the subject device was performed according to ANSI / AAMI / ISO 10993-5 and 10993-12.
Mechanical performance testing was performed according to ISO 14801. For each compatible OEM implant line, worst-case constructs were subjected to static compression fatigue testing. The reference device K100993 is to support substantial equivalence of the fatigue limit of 133 N for the Astra Tech OsseoSpeed™ and BioHorizons Tapered Internal implant lines (each with 3.0 mm implant body and platform diameters). The fatigue limit data for all other implant lines demonstrated the construct strengths to be sufficient for their intended use.
Minor differences in the designs, dimensions, sizes, or compatible OEM implant lines among the subject device, the primary predicate device, and the reference devices do not affect substantial equivalence. These minor differences do not impact substantial equivalence because these differences are related to the compatible OEM implant designs, or are mitigated by the mechanical performance testing.
CONCLUSION
The subject device, the primary predicate device, and the reference devices have the same intended use, have similar technological characteristics, and are materials. The subject device, the primary predicate, and reference devices encompass the same range of physical dimensions, are packaged in similar materials, and are to be sterilized using similar methods. The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.
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Comparison of Indications for Use Statements
| Subject Device | Primary Predicate | Reference Device | Reference Device | Reference Device | Reference Device | ||||
|---|---|---|---|---|---|---|---|---|---|
| Preat Abutments | K170588DESS Dental Smart Solutions | K120414OsseoSpeed™ Plus | K161416Multi-unit Abutment Plus | K151621BioHorizons CAD/CAM Abutments | K100993Inclusive® Titanium Abutments forAstra OsseoSpeed™ | ||||
| Preat Corporation | Terrats Medical SL | Astra Tech AB | Nobel Biocare | BioHorizons Implant Systems, Inc. | Prismatik Dentalcraft, Inc. | ||||
| Preat Abutments are intended to be used in conjunction with endosseous dental implants inthe maxillary or mandibular arch to provide support for single-unit or multi-unit prostheticrestorations.All digitally designed custom abutments for use with Titanium Base or Titanium Blank areto be sent to a Preat validated milling center for manufacture. | DESS Dental Smart Solutions abutments are intended to be used in conjunctionwith endosseous dental implants in the maxillary or mandibular arch to providesupport for prosthetic restorations.All digitally designed custom abutments for use with TiBase or Pre-milledBlank are to be sent to a Terrats Medical validated milling center formanufacture. | (Implant section of IFUS not applicable tothis submission)Abutments:Astra Tech Implant System Plus abutmentsare intended to be used in conjunction withAstra Tech Implant System Plus in fullyedentulous or partially edentulousmaxillary and/or mandibular arches toprovide support for crowns, bridges oroverdentures.Atlantis Abutments:The Atlantis™ Abutment is intended foruse with an endosseous implant to supporta prosthetic device in a partially orcompletely edentulous patient. It isintended for use to support single andmultiple tooth prostheses, in the mandibleor maxilla. The prosthesis can becemented, screw retained or friction fit tothe abutment. The abutment screw isintended to secure the abutment to theendosseous implant.The Atlantis™ Crown Abutment inZirconia is intended for use with anendosseous implant to function as asubstructure that also serves as the finalrestoration, in partially or completelyedentulous patients. The prosthesis isscrew retained. The abutment screw isintended to secure the crown abutment tothe endosseous implant. | The Multi-unit Abutment Plus is a pre-manufactured prosthetic componentdirectly connected to the endosseous dentalimplant and is intended for use as an aid inprosthetic rehabilitation. | BioHorizons CAD/CAM Abutments aredental abutments placed onto a dentalimplant to provide support for dentalprosthetic restorations. The abutmentsinclude: 1) Titanium abutment blanks witha pre-machined implant connection wherethe upper portion may be custom-milled inaccordance with a patient-specific designusing CAD/CAM techniques; and 2)Titanium bases with a pre-machinedimplant connection upon which aCAD/CAM designed superstructure maybe fitted to complete a two-piece dentalabutment. The abutments include anabutment screw for fixation to theunderlying implant. The abutments may beused for single-unit (single-tooth) ormultiple-unit (bridges and bars)restorations and are compatible for usewith BioHorizons Internal and TaperedInternal implant systems and Zimmer®Dental Screw-Vent® and Tapered Screw-Vent® implants with 3.5mm, 4.5mm and5.7mm internal hex-connection matingplatform diameters.All digitally designed abutments and/orcopings for use with BioHorizonsCAD/CAM Abutments are intended to besent to a BioHorizons-validated millingcenter for manufacture. BioHorizonsabutments designed using CAD/CAMtechniques must fulfill the BioHorizonsallowable range of design parameters. | The Inclusive® Titanium Abutments forAstra OsseoSpeed™ Implants arepremanufactured prosthetic componentsdirectly connected to endosseous dentalimplants and are intended for use as an aidin prosthetic rehabilitation. They arecompatible with the Astra TechOsseoSpeed™ 3.0, 3.5, 4.0, 4.5, 5.0implants. | ||||
| Compatible Implant System | Implant Body Diameter(mm) | Implant Platform Diameter(mm) | Compatible Implant Systems | Implant Diameter (mm) | Platform Diameter (mm) | ||||
| 3i OSSEOTITE® Certain® | 3.254.05.06.0 | 3.44.15.06.0 | 3i Certain® | 3.25, 4.0, 5.0 | 3.4, 4.1, 5.0 | ||||
| Astra Tech OsseoSpeed™ | 3.03.5, 4.04.5, 5.0 | 3.03.5/4.04.5/5.0 | 3i OSSEOTITE® | 3.25, 3.75, 4.0, 5.0 | 3.4, 4.1, 5.0 | ||||
| BioHorizons Tapered Internal | 3.03.54.0 | 3.03.54.5 | OsseoSpeed™ | 3.5, 4.0, 5.0 | 3.5/4.0, 4.5/5.0 | ||||
| HIOSSEN ET III | 3.54.0, 4.5, 5.0, 6.0, 7.0 | MiniRegular | FRIADENT XiVE | 3.4, 3.8, 4.5 | 3.4, 3.8, 4.5 | ||||
| Implant Direct Legacy | 3.23.7, 4.24.7, 5.25.7, 7.0 | 3.03.54.55.7 | NobelActive® | 3.5, 4.3, 5.0 | NP, RP | ||||
| MegaGen AnyRidge | 3.5, 4.0, 4.5, 5.0, 5.5 | 3.5 | NobelReplace Conical | 3.5, 4.3, 5.0 | NP, RP | ||||
| Neoss | 3.5, 4.0, 4.5, 5.0, 5.5 | 4.1 | Nobel Replace Trilobe | 3.5, 4.3, 5.0 | NP, RP, WP | ||||
| NobelActive® | 3.54.3, 5.0 | NPRP | Brånemark | 3.5, 3.75/4.0, 5.0 | NP, RP, WP | ||||
| Nobel Replace™ | 3.54.0, 4.3, 5.05.06.0 | NPRPWP6.0 | Straumann® Bone Level | 3.3, 4.1, 4.8 | NC, RC | ||||
| Straumann® Bone Level | 3.34.1, 4.8 | NCRC | Straumann® Tissue Level | 3.3, 4.1, 4.8 | RN, WN | ||||
| Straumann® Tissue Level | 3.3, 4.1, 4.84.8, 6.5 | RNWN | Tapered Screw-Vent® | 3.7, 4.1, 4.7, 6.0 | 3.5, 4.5, 5.7 | ||||
| Zimmer Screw-Vent®/Tapered Screw-Vent® | 3.3, 3.7, 4.14.76.0 | 3.54.55.7 |
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Comparison of Technological Characteristics
| Comparison | Subject Device | Primary Predicate | Reference Device | Reference Device | Reference Device | Reference Device | |
|---|---|---|---|---|---|---|---|
| K170588 | K120414 | K161416 | K151621 | K100993 | |||
| Preat Abutments | DESS Dental Smart Solutions | OsseoSpeed™ Plus | Multi-unit Abutment Plus | BioHorizons CAD/CAM Abutments | Inclusive® Titanium Abutments for AstraOsseoSpeed™ | ||
| Preat Corporation | Terrats Medical SL | Astra Tech AB | Nobel Biocare | BioHorizons Implant Systems, Inc. | Prismatik Dentalcraft, Inc. | ||
| Intended Use | Functional and esthetic rehabilitation ofthe edentulous maxilla and mandible | Functional and esthetic rehabilitation ofthe edentulous maxilla and mandible | Functional and esthetic rehabilitation of theedentulous maxilla and mandible | Functional and esthetic rehabilitationof the edentulous maxilla and mandible | Functional and esthetic rehabilitation ofthe edentulous maxilla and mandible | Functional and esthetic rehabilitation ofthe edentulous maxilla and mandible | |
| Reason forPredicate/Reference | Not applicable | Abutment designs listed | Abutment designs listed | Abutment design listed | Abutment design listed | Abutment design listedPerformance testing data | |
| Abutment Designs | Temporary Engaging | Temporary Engaging | Temporary | ||||
| Temporary Non-Engaging | Temporary Non-Engaging | ||||||
| Esthetic Angled 15° | Esthetic 15° | ||||||
| Multi-Unit Straight | Multi-unit Straight | Multi-unit Straight | |||||
| Multi-Unit Angled 17° | Multi-unit 17° | ||||||
| Ball (Clix, O-Ring) | Ball | ||||||
| Titanium Base Engaging | Titanium Base Engaging | Titanium Base | |||||
| Titanium Base Non-Engaging | Titanium Base Non-Engaging | ||||||
| Titanium Blank (Engaging) | Titanium Blank (Engaging) | Titanium Blank (Engaging) | |||||
| Prosthesis Attachment | Cement-retainedScrew-retained | Not stated in 510(k) Summary | Not stated in 510(k) Summary | Screw-retained | Cement-retained | Cement-retained | |
| Restoration | Single-unitMulti-unit | Single-unitMulti-unit | Single-unitMulti-unit | Multi-unit | Single-unitMulti-unit | Not stated in 510(k) Summary | |
| Abutment/ImplantPlatform Diameter (mm) | 3.0 - 6.5 | 3.4 - 6.5 | 3.0 - 5.4 | NP, RP, WP (3.5 - 5.0) | 3.0 - 5.7 | 3.0 - 5.0 | |
| Abutment Angle | Straight (0°), 15°, 17°, and30° maximum (Titanium Blank) | Straight (0°) | Straight (0°), angled to 30° | Straight (0°), 17°, 30° | Straight (0°), angled to 30° | Straight (0°), angled to 30° | |
| Abutment/ ImplantInterface | Internal connection | Internal connection;External connection | Internal connection | Internal connection | Internal connection | Internal connection | |
| Materials | Abutment | Ti-6Al-4V alloy | Ti-6Al-4V alloy | Ti-6Al-4V alloy, Zirconia, Gold, PEEK | Ti-6Al-4V alloy | Ti-6Al-4V alloy | Ti-6Al-4V alloy |
| Screw | Ti-6Al-4V alloy | Ti-6Al-4V alloy | Ti-6Al-4V alloy | Ti-6Al-4V alloy | Ti-6Al-4V alloy | Ti-6Al-4V alloy |
§ 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.)