Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a dental implant abutment system and its mechanical properties and compatibility. There is no mention of AI or ML in the intended use, device description, or performance studies. The digital design mentioned refers to CAD/CAM processes, which are not inherently AI/ML.

Therapeutic

No.

The device, "Preat Abutments," is a dental implant abutment system intended to provide support for single-unit or multi-unit prosthetic restorations. It mechanically supports a prosthesis but does not directly treat a disease or condition, making it a prosthetic device rather than a therapeutic one.

Diagnostic

No

Explanation: The device description states that Preat Abutments are a dental implant abutment system intended to provide support for prosthetic restorations. This is a functional component, not a device used to diagnose a medical condition or disease.

SaMD (Software as a Medical Device)

No

The device is a dental implant abutment system consisting of physical components (titanium abutments, screws, zirconia superstructures) and is manufactured from physical materials. While digital design is mentioned, the core device is hardware.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the Preat Abutments are used in conjunction with dental implants to provide support for prosthetic restorations in the mouth (maxillary or mandibular arch). This is a mechanical function within the body.
Device Description: The description details the physical components of the abutment system (titanium, zirconia), their materials, and their compatibility with dental implants. It focuses on the structural and mechanical aspects of the device.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or compatibility testing. The device itself is implanted and supports a prosthesis.

In summary, the Preat Abutments are a medical device used for structural support in dental restorations, not for in vitro diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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 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.

Product codes (comma separated list FDA assigned to the subject device)

NHA

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 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).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

maxillary or mandibular arch

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: 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.

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K170588

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K120414, K161416, K151621, K100993

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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.)

Summary

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 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

2

Indications for Use

510(k) Number (if known)

K183518

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.

3

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4

510(k) Summary

K183518 – Preat Abutments

Preat Corporation

March 18, 2019

ADMINISTRATIVE INFORMATION

| Manufacturer Name | Preat Corporation
100 S. 4th Street
Grover Beach, CA 93433
Telephone: +1 805-202-3070
Fax: +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.

5

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 Platform
Diameter /

Compatible Implant System	Subject Device Abutment Designs
	Temporary
Engaging	Temporary
Non-Engaging	Esthetic
Angled 15°	Multi-Unit
Straight	Multi-Unit
Angled 17°	Clix Ball	O-Ring	Titanium Base
Engaging	Titanium Base
Non-Engaging	Titanium
Blank	Titanium
Screws
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

7

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

8

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.

9

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.

10

Comparison of Indications for Use Statements

Subject Device		Primary Predicate	Reference Device	Reference Device	Reference Device	Reference Device
Preat Abutments		K170588
DESS Dental Smart Solutions		K120414
OsseoSpeed™ Plus	K161416
Multi-unit Abutment Plus	K151621
BioHorizons CAD/CAM Abutments	K100993
Inclusive® Titanium Abutments for
Astra 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 in
the maxillary or mandibular arch to provide support for single-unit or multi-unit prosthetic
restorations.
All digitally designed custom abutments for use with Titanium Base or Titanium Blank are
to be sent to a Preat validated milling center for manufacture.		DESS Dental Smart Solutions abutments are intended to be used in conjunction
with endosseous dental implants in the maxillary or mandibular arch to provide
support for prosthetic restorations.
All digitally designed custom abutments for use with TiBase or Pre-milled
Blank are to be sent to a Terrats Medical validated milling center for
manufacture.		(Implant section of IFUS not applicable to
this submission)
Abutments:
Astra Tech Implant System Plus abutments
are intended to be used in conjunction with
Astra Tech Implant System Plus in fully
edentulous or partially edentulous
maxillary and/or mandibular arches to
provide support for crowns, bridges or
overdentures.

Atlantis Abutments:
The Atlantis™ Abutment is intended for
use with an endosseous implant to support
a prosthetic device in a partially or
completely edentulous patient. It is
intended for use to support single and
multiple tooth prostheses, in the mandible
or maxilla. The prosthesis can be
cemented, screw retained or friction fit to
the abutment. The abutment screw is
intended to secure the abutment to the
endosseous implant.

The Atlantis™ Crown Abutment in
Zirconia is intended for use with an
endosseous implant to function as a
substructure that also serves as the final
restoration, in partially or completely
edentulous patients. The prosthesis is
screw retained. The abutment screw is
intended to secure the crown abutment to
the endosseous implant. | The Multi-unit Abutment Plus is a pre-
manufactured prosthetic component
directly connected to the endosseous dental
implant and is intended for use as an aid in
prosthetic rehabilitation. | BioHorizons CAD/CAM Abutments are
dental abutments placed onto a dental
implant to provide support for dental
prosthetic restorations. The abutments
include: 1) Titanium abutment blanks with
a pre-machined implant connection where
the upper portion may be custom-milled in
accordance with a patient-specific design
using CAD/CAM techniques; and 2)
Titanium bases with a pre-machined
implant connection upon which a
CAD/CAM designed superstructure may
be fitted to complete a two-piece dental
abutment. The abutments include an
abutment screw for fixation to the
underlying implant. The abutments may be
used for single-unit (single-tooth) or
multiple-unit (bridges and bars)
restorations and are compatible for use
with BioHorizons Internal and Tapered
Internal implant systems and Zimmer®
Dental Screw-Vent® and Tapered Screw-
Vent® implants with 3.5mm, 4.5mm and
5.7mm internal hex-connection mating
platform diameters.
All digitally designed abutments and/or
copings for use with BioHorizons
CAD/CAM Abutments are intended to be
sent to a BioHorizons-validated milling
center for manufacture. BioHorizons
abutments designed using CAD/CAM
techniques must fulfill the BioHorizons
allowable range of design parameters. | The Inclusive® Titanium Abutments for
Astra OsseoSpeed™ Implants are
premanufactured prosthetic components
directly connected to endosseous dental
implants and are intended for use as an aid
in prosthetic rehabilitation. They are
compatible with the Astra Tech
OsseoSpeed™ 3.0, 3.5, 4.0, 4.5, 5.0
implants. |
| Compatible Implant System | Implant Body Diameter
(mm) | Implant Platform Diameter
(mm) | Compatible Implant Systems | Implant Diameter (mm) | Platform Diameter (mm) | | | | |
| 3i OSSEOTITE® Certain® | 3.25
4.0
5.0
6.0 | 3.4
4.1
5.0
6.0 | 3i Certain® | 3.25, 4.0, 5.0 | 3.4, 4.1, 5.0 | | | | |
| Astra Tech OsseoSpeed™ | 3.0
3.5, 4.0
4.5, 5.0 | 3.0
3.5/4.0
4.5/5.0 | 3i OSSEOTITE® | 3.25, 3.75, 4.0, 5.0 | 3.4, 4.1, 5.0 | | | | |
| BioHorizons Tapered Internal | 3.0
3.5
4.0 | 3.0
3.5
4.5 | OsseoSpeed™ | 3.5, 4.0, 5.0 | 3.5/4.0, 4.5/5.0 | | | | |
| HIOSSEN ET III | 3.5
4.0, 4.5, 5.0, 6.0, 7.0 | Mini
Regular | FRIADENT XiVE | 3.4, 3.8, 4.5 | 3.4, 3.8, 4.5 | | | | |
| Implant Direct Legacy | 3.2
3.7, 4.2
4.7, 5.2
5.7, 7.0 | 3.0
3.5
4.5
5.7 | 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® | 3.5
4.3, 5.0 | NP
RP | Brånemark | 3.5, 3.75/4.0, 5.0 | NP, RP, WP | | | | |
| Nobel Replace™ | 3.5
4.0, 4.3, 5.0
5.0
6.0 | NP
RP
WP
6.0 | Straumann® Bone Level | 3.3, 4.1, 4.8 | NC, RC | | | | |
| Straumann® Bone Level | 3.3
4.1, 4.8 | NC
RC | Straumann® Tissue Level | 3.3, 4.1, 4.8 | RN, WN | | | | |
| Straumann® Tissue Level | 3.3, 4.1, 4.8
4.8, 6.5 | RN
WN | 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, 4.1
4.7
6.0 | 3.5
4.5
5.7 | | | | | | | |

11

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 Astra
OsseoSpeed™
	Preat Corporation	Terrats Medical SL	Astra Tech AB	Nobel Biocare	BioHorizons Implant Systems, Inc.	Prismatik Dentalcraft, Inc.
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
Reason for
Predicate/Reference	Not applicable	Abutment designs listed	Abutment designs listed	Abutment design listed	Abutment design listed	Abutment design listed
Performance 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-retained
Screw-retained	Not stated in 510(k) Summary	Not stated in 510(k) Summary	Screw-retained	Cement-retained	Cement-retained
Restoration	Single-unit
Multi-unit	Single-unit
Multi-unit	Single-unit
Multi-unit	Multi-unit	Single-unit
Multi-unit	Not stated in 510(k) Summary
Abutment/Implant
Platform 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°, and
30° 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/ Implant
Interface	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