Search Results
Found 3 results
510(k) Data Aggregation
K Number
K243824Device Name
Preat Abutments
Manufacturer
Preat Corporation
Date Cleared
2025-05-08
(147 days)
Product Code
NHA
Regulation Number
872.3630Why did this record match?
Applicant Name (Manufacturer) :
Preat Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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.
All digitally designed CAD/CAM customizations for Preat Abutments are intended to be sent to a Preat validated Milling Center for manufacture or to be designed and manufactured according to a validated digital dentistry workflow. The workflow system integrates multiple components of the digital dentistry workflow: scan files from intra-oral and lab (desktop) scanners, CAD software, CAM software, milling machine and associated tooling and accessories.
Preat Abutments are compatible with the following third-party implant restorative platforms:
| Compatible Third-Party Implant Systems | 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 |
| 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 |
| 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 |
| Keystone PrimaConnex™ | 3.5 | 3.5 (SD) |
| | 4.1 | 4.1 (RD) |
| | 5.0 | 5.0 (WD) |
| MegaGen AnyRidge | 3.5, 4.0, 4.5, 5.0, 5.5 | 3.5 |
| Neodent® GM™ Helix | 3.5, 3.75, 4.0, 4.3, 5.0, 6.0, 7.0 | 3.0 |
| Neoss | 3.5, 4.0, 4.5, 5.0, 5.5 | 4.1 |
| Nobel Biocare™ NobelActive® | 3.0 | 3.0 |
| | 3.5 | NP |
| | 4.3, 5.0 | RP |
| Nobel Biocare™ NobelReplace® | 3.5 | NP |
| | 4.0, 4.3, 5.0 | RP |
| | 5.0 | WP |
| | 6.0 | 6.0 |
| Straumann™ BLX | 3.75, 4.0, 4.5 (RB) | RB |
| | 5.0, 5.5, 6.5 (WB) | WB |
| 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 |
Device Description
The purpose of this submission is to expand the use of Preat Abutments, specifically the titanium blank abutment design, to be used in a validated equipment CAD/CAM workflow where specific abutment design software, milling machines and tooling have been validated to work with the previously cleared components in K220823 and K183518.
This submission includes a titanium blank design which is compatible with sixteen (16) implant system, with a distinct connection platform, as well as varying implant diameters and implant platform diameters, for each system.
The Subject device abutments may be placed in implants located in the mandibular or maxillary arches. The Subject device abutments are compatible with implant body diameters that range from 3.0 mm to 7.0 mm and implant platform diameters which range from 2.9 to 6.0 mm.
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.
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 restorations (length above the abutment collar / gingival height)– 4.0 mm;
- Maximum Angle – 30°*; and
- Minimum gingival height – 0.5 mm;
- Maximum gingival height – 1.5 mm to 4.5 mm (varies by implant line).
*Astra Tech® OsseoSpeed™ Plus (OsseoSpeed™ EV) compatible are limited to 0° maximum correction angle.
The minimum and maximum abutment design parameters listed above correspond to the abutment designs used in the mechanical testing data provided in the sponsor's K220823 and K183518 device submissions.
All digitally designed CAD/CAM customizations for Preat Abutments are intended to be sent to a Preat validated Milling Center for manufacture or to be designed and manufactured according to a validated digital dentistry workflow which includes: Scan files from Intra-Oral and Desktop Scanners, CAD software, CAM software, a Milling machine and associated tooling and accessories.
Ask a Question
K Number
K220823Device Name
Preat Abutments
Manufacturer
Preat Corporation
Date Cleared
2022-10-26
(219 days)
Product Code
NHA
Regulation Number
872.3630Why did this record match?
Applicant Name (Manufacturer) :
Preat Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
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.
Ask a Question
K Number
K183518Device Name
Preat Abutments
Manufacturer
Preat Corporation
Date Cleared
2019-03-18
(90 days)
Product Code
NHA
Regulation Number
872.3630Why did this record match?
Applicant Name (Manufacturer) :
Preat Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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.
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).
Ask a Question
Page 1 of 1