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Found 772 results
510(k) Data Aggregation
(266 days)
Re: K251427*
Trade/Device Name: EK Multi Angled 30 Abutment
Regulation Number: 21 CFR 872.3630
30 Degree Abutments
- Classification Name: Endosseous dental implant abutment
- CFR Number: 872.3630
The EK Dental Abutments are indicated for use with EK Dental Implants to provide support to prosthetic restoration such as crowns, bridges and overdentures in partially or fully edentulous patients.
The EK Multi Angled 30 Dental Abutments are indicated for use with EK Dental Implants to provide support to prosthetic restoration such as crowns, bridges and overdentures in partially or fully edentulous patients. Manufactured from medical grade titanium alloy and delivered non-sterilized. The EK Multi Angled 30 Abutments are available in various lengths and diameters.
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(421 days)
92008
Re: K243732
Trade/Device Name: Multi-Unit DAS System
Regulation Number: 21 CFR 872.3630
Multi-Unit DAS System
Common Names: Endosseous dental implant abutment
Regulation Number: 21 CFR 872.3630
Multi-Unit DAS System is intended for use with dental implants as a support for single-unit or multi-unit prostheses in the maxillary or mandibular arch of a partially or fully edentulous patient.
Compatible Implant Systems
| Compatible Implant System (Connection) | Implant Body Diameter, mm | Implant Platform Diameter, mm or Name |
|---|---|---|
| Astra Tech EV (Internal Taper) | 3.6 | 3.6 |
| 4.2 | 4.2 | |
| 4.8 | 4.8 | |
| Osstem® TS Hiossen® ET (Internal Taper) | 3.5 | Mini |
| 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 | Regular | |
| Neodent GM (Morse taper) | 3.5, 3.75, 4.0, 4.3, 5.0, 6.0, 7.0 | GM |
| Straumann Bone Level (CrossFit® Morse Taper) | 3.3 | NC |
| 4.1, 4.8 | RC | |
| Straumann BLX (TorcFit™ Internal Hexalobular) | 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5 | RB/WB |
All digitally designed custom abutments for use with Multi-Unit DAS System are to be sent to a Talladium validated milling center for manufacture.
Multi-Unit DAS System abutments are two-piece abutments composed of a CAD-CAM fabricated zirconia superstructure and a prefabricated titanium base component where the final two-piece abutment (base and cemented superstructure) is the finished device used for the prosthetic restoration
Multi-Unit DAS system abutments are designed for retention of multi-unit or single-unit restorations. The multi-unit abutments are provided in a straight design (no angulation in the base portion) that threads directly to the OEM implant. For all compatible OEM implant lines, the multi-unit abutment components are provided with gingival heights ranging from 1 mm to 4 mm, a prosthetic platform diameter of 4 mm, and a prosthetic post height of 1.4 mm.
This submission includes one (1) abutment level Ti-Base (coping) Engaging Interface for use with the subject multi-unit abutments. The subject Ti-Base (coping) Engaging Interface is a straight prepable design with an additional gingival height of 1.5 mm and a prepable 10.5 mm prosthetic post. This Ti-Base (coping) Engaging Interface has an engaging interface to the multi-unit abutments and is to be used to fabricate a straight final abutment and a straight final restoration. The subject device is identical to the previously cleared abutment level Ti-base (Part 35.312.209.21-2, K231559), except the current subject device has an engaging interface. The previously cleared abutment level Ti-base (Part 35.312.209.21-2, K231559) is to be used to fabricate a straight final abutment and a straight final restoration.
The subject device multi-unit abutments may be used with the following components, all previously cleared in K231559: Straight Ti-base, non-engaging, part number 35.312.209.21-2; DAS Multi-Unit Engaging Dynamic Ti-Base, part number 31.312.209.01-2; DAS Multi-Unit Non-Engaging Dynamic Ti-Base, part number 31.322.209.01-2; DAS Multi-Unit Non-Engaging Dynamic Ti-Base, part number 31.322.209.21-2; DAS Multi-Unit Healing Cap Regular, part number 40.320.003.88-2; DAS Multi-Unit Healing Cap Wide, part number 40.320.003.89-2; DAS Multi-Unit Dynamic Screw 3.0, part number 41.320.040.01-2; DAS Multi-Unit Provisional Dynamic Screw, part number 41.320.050.02-2; and DAS Multi-Unit Straight Screw, part number 40.320.003.06-2.
No new DAS Multi-Unit Dynamic Ti-Bases are included in this submission. The previously cleared DAS Multi-Unit Dynamic Ti-Base (coping) components (K231599), part numbers 31.312.209.01-2, 31.322.209.01-2, and 31.322.209.21-2 may be used with the subject device Angled Multi-Unit abutments to fabricate a final angled abutment.
A summary of the subject device Multi-Unit DAS System abutment compatibilities with the OEM implants is provided in the following Table 1 Summary of Compatibilities.
Table 1 Summary of Compatibilities
| Compatible Dental Implant Connections | Subject Device: Multi-Unit DAS System |
|---|---|
| Compatible Implant System (Connection) | Implant Body Diameter, mm |
| Astra Tech EV (Internal Taper) | 3.6 |
| 4.2 | |
| 4.8 | |
| Osstem® TS Hiossen® ET (Internal Taper) | 3.5 |
| 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 | |
| Neodent (Morse taper GM) | 3.5, 3.75, 4.0, 4.3, 5.0, 6.0, 7.0 |
| Straumann Bone Level (CrossFit® Morse Taper) | 3.3 |
| 4.1, 4.8 | |
| Straumann BLX (TorcFit™ Internal Hexalobular) | 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5 |
All zirconia superstructures for use with the subject device Multi-Unit DAS system will be made at a Talladium España, SL validated milling center under FDA quality system regulations, and the material will conform to ISO 13356.
The design parameters for the CAD-CAM zirconia superstructure for the subject Multi-Unit DAS Dynamic Ti-base are:
- Minimum wall thickness – 0.25 mm
- Minimum post height for single-unit restorations – 4.0 mm
(post height measured above the gingival height of the final patient-matched design) - Maximum gingival height – 4.90 mm
- Minimum gingival height – 3.89 mm
- Maximum angulation – 15°
The design parameters for the CAD-CAM zirconia superstructure for the subject device Multi-Unit DAS Ti-Base (coping) Engaging Interface are:
- Minimum wall thickness – 0.25 mm
- Minimum post height for single-unit restorations – 4.0 mm
(post height measured above the gingival height of the final patient-matched design) - Maximum gingival height – 4.90 mm
- Minimum gingival height – 3.89 mm
- Maximum angulation – 0°
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(114 days)
Trade/Device Name:** Straumann Variobase Abutments XC for Bridge/Bar
Regulation Number: 21 CFR 872.3630
Bridge/Bar
Classification Name: Endosseous dental implant abutment
Regulation Number: 21 CFR 872.3630
The Straumann Variobase Abutments XC for Bridge/Bar are prosthetic components placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann Variobase Abutments XC for Bridge/Bar are indicated for screw-retained or cement-retained bridge restorations. 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. Temporary restorations are indicated to be placed out of occlusion. Final abutments and restorations may be placed in occlusion when the implant is fully osseointegrated.
Straumann Variobase Abutments XC for Bars and Bridges are intended to be placed into Straumann implants to provide support for multi-unit restorations.
The prosthetic restoration (bar/bridge) must be cemented onto the Variobase abutments, which is then screwed onto the implants. 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.
The subject Variobase abutments are manufactured from Ti-6Al-7Nb (TAN) and are anodized in violet.
The Variobase Abutments for bar/bridges are non-engaging devices intended to support multiple-unit restorations.
The Variobase abutments are provided non-sterile with instructions for end user steam sterilization. The Variobase abutments are fixed in the implant by means of a basal screw which is also manufactured from Ti-6Al-7Nb (TAN). The subject Straumann Variobase Abutments XC for Bridge/Bar is provided in two different platform models, both available with straight and angled screw channel solutions:
Table 10.4.a - Straumann Variobase Abutments XC for Bridge/Bar characteristics
| Platform | Ø (mm) | Gingival heights (mm) | Chimney height (mm) |
|---|---|---|---|
| RB/WB | 3.8 / 4.5 | 1.5 / 2.5 / 3.5 | 7 |
| WB | 5.5 | 0.75 / 1.5 | 7 |
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(115 days)
), 08338
SPAIN
Re: K253253
Trade/Device Name: IPDmilled Blanks
Regulation Number: 21 CFR 872.3630
January 22, 2026
Re: K253253
Trade/Device Name: IPDmilled Blanks
Regulation Number: 21 CFR 872.3630
ENDOSSEOUS DENTAL IMPLANT ABUTMENT
Classification Name: Endosseous Dental Implant Abutment (21 CFR 872.3630
ENDOSSEOUS DENTAL IMPLANT ABUTMENT
Classification Name: Endosseous Dental Implant Abutment (21 CFR 872.3630
IPDmilled Blanks 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 CAD/CAM customizations for the IPDmilled Blanks are to be designed and manufactured according to digital dentistry workflow or to be sent to an IPD validated milling center for manufacture. 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. Compatible Implant Systems: Dentium Co., Ltd Implantium, Friadent Implant Systems, Neoss ProActive Implant, SPI® Dental Implant, Inicell®, BEGO Semados® S-Line, ANKYLOS® C/X Implant System, MIS V3 Conical Connection Dental Implant System, Conical Connection Implants (MIS® C1), MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical Connection Abutments, PRAMA White Implant Systems, Altatec GmbH CAMLOG®/CONELOG® PROGRESSIVE-LINE Implants, Straumann TLX Implant System, Kontact Dental Implant System, ICX-Implant System, Tapered Pro Conical Implant System, Straumann® Tissue Level, Zimmer Tapered Screw-Vent®, Nobel Biocare® Nobel Active®, Straumann® Bone Level Tapered Implants, Neodent Implant System – GM Line, Osstem Implant System, Xpeed AnyRidge Internal Implant System, 3i Osseotite® Certain® Dental Implants, Astra Tech Implant System (Osseospeed®), OsseoSpeed™ Plus, BioHorizons Tapered Internal Implant System, MIS Internal Hex Dental Implant System (MIS® Seven®), Straumann BLX Ø3.5 mm Implants, Straumann® BLX Implant System, ALTATEC Camlog Screwline Implant System, Replace TiUnite Endosseous Implant.
The purpose of this submission is to expand abutment categories of IPD Dental Implant Abutments, which were previously cleared.
IPDmilled Blanks is a dental implant abutment system composed of dental abutments and screws intended to be placed into dental implants to provide support for dental prosthetic restorations. Abutments provide basis for single or multiple tooth prosthetic restorations. They are available in a variety of connection types to enable compatibility with commercially available dental implants systems. IPDmilled Blanks have a pre-manufactured connection interface that fits directly with a pre-specified dental implant. The customized shape of the abutment is intended to be designed and manufactured according to a digital dentistry workflow or to be sent to an IPD validated milling center for manufacture. IPDmilled Blank is delivered non-sterile and the final restoration, including the screw, is intended to be sterilized at the dental clinic before it is placed in the patient.
The IPDmilled Blanks are blistered together with their specific screw. The screws are intended to attach the prosthesis to the dental implant.
The metallic components of the subject abutments and screws are made of titanium alloy conforming to ISO 5832-3 "Implants for surgery – Metallic materials – Part 3: Wrought titanium 6-aluminium 4-vanadium alloy".
The design and manufacturing of the custom abutment will be conducted using a digital dentistry workflow requiring the use of the following equipment and software:
Intraoral Scanner: 3Shape TRIOS A/S Series
Desktop Scanner: 3Shape E Series.
Design Software: 3Shape Abutment Designer Software, K151455.
AbutmentCAD, K193352.
Milling unit: CORiTEC 350i PRO / CORiTEC 350i Loader PRO with MillBox CAM software.
IPDmilled Blank libraries' have built-in design limitations, and the user isn't allowed to exceed these limitations. The custom abutment design limitation specifications are as follows:
Minimum gingival height: 0.5 mm
Maximum gingival height: 6.0 mm
Minimum wall thickness: 0.4 mm
Minimum post height: 4.0 mm
All IPDmilled Blanks are for straight abutments only.
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(84 days)
01810
Re: K253341
Trade/Device Name: Custom Abutment AS
Regulation Number: 21 CFR 872.3630
01810
Re: K253341
Trade/Device Name: Custom Abutment AS
Regulation Number: 21 CFR 872.3630
abutment
Classification Name: Endosseous dental implant abutment
Regulation Number: 21 CFR 872.3630
Medentika Custom Abutments AS (Angulated Screw Channel) are intended for use with dental implants as a support for single or multiple tooth protheses in the maxilla or mandible of a partially or fully edentulous patient. Medentika Custom Abutments AS are intended for use with the Straumann® CARES® System. All digitally designed Medentika Custom Abutments AS are intended to be manufactured at a Straumann® validated milling center. The final patient matched form is a Custom Abutment AS.
Medentika abutments for the Nobel Biocare Nobel Active® 3.0 mm, Dentsply Sirona Astra Tech OsseoSpeed EV® 3.0 mm and TX® 3.0 mm, and Straumann Bone Level 2.9 implant bodies are indicated for maxillary lateral and mandibular central/lateral incisors only.
The Custom Abutments (previously named MedentiCAD and PreFace abutments) can be used in combination with cemented prosthetics, e.g., crowns and superstructures, to reconstruct the function and esthetics of lost teeth. The Custom Abutment is a one-piece abutment, which is a customized abutment that is digitally designed by the customer with Straumann® CARES® Visual and can be only milled and ordered from the Straumann validated milling center. The abutments have an implant-specific connection interface for the respective compatible implant. The previously cleared Custom Abutments feature a straight screw channel for the abutment screw which fixes the abutment to the respective implant. The purpose of this submission is to add Custom Abutments AS (Angulated Screw Channel) to the Medentika Custom Abutment Portfolio. The subject Medentika Custom Abutments AS can be designed and manufactured with an angled screw channel (as opposed to the predicate straight screw-channel), so that the screw-exit is located in a favorable position (away from the incisal/occlusal edge and tooth cusps) for esthetic and functional results. The screw channel can be angulated to allow screwdriver access at an angle up to 25°.
Each of the abutment to implant connection geometries (in terms of Series and implant diameter) currently exists for the existing marketed Medentika Custom Abutments (with straight screw channel). No new compatible implant is added, in terms of series, implant diameter, and implant platform diameter within this submission.
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(209 days)
) | Endosseous Dental Implant Abutments (872.3630) |
| Product Code | NHA | NHA |
| Material
) | Endosseous Dental Implant Abutments (872.3630) |
| Product Code | NHA | NHA |
| Material
) | Endosseous Dental Implant Abutments (872.3630) |
| Product Code | NHA | NHA |
| Material
) | Endosseous Dental Implant Abutments (872.3630) |
| Product Code | NHA | NHA |
| Material
) | Endosseous Dental Implant Abutments (872.3630) |
| Product Code | NHA | NHA |
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The DIMPLO Implant System is intended for use in the maxilla or mandible of partially or fully edentulous patients to support single or multiple-unit restorations, including cemented, screw-retained, or overdenture restorations, as well as terminal or intermediate abutment support for fixed bridgework. It is intended for two-stage surgical procedures and may be used for immediate loading when good primary stability and appropriate occlusal loading conditions are achieved.
- Ø3.3 mm implants are for replacing maxillary lateral incisors and mandibular incisors with delayed loading only.
- Ø5.0 mm and larger implants are intended for delayed loading in the molar region.
All digitally designed custom components (including Ti-Base and Pre-milled Blanks) for use with the DIMPLO Implant System are to be manufactured at a DIMPLO validated milling center.
The DIMPLO Implant System consists of fixtures, abutments, and attachments designed for dental implant procedures.
Fixture: Made of unalloyed titanium (Grade 4, ASTM F67), these dental implants are available in a range of diameters and lengths to accommodate various clinical applications in the maxilla and mandible. The surface is treated with SLA (Sandblasted, Large grit, and Acid-etched) and provided sterile via gamma irradiation. Available in two platform sizes: Mini and Regular.
Abutment: These components aid in prosthetic restorations. This category includes Cover Screws, Healing Abutments, Temporary Abutments, Cemented Abutments, Angled Abutments, Ti-Base, Pre-milled Blanks, Screws, Multi-unit Abutments, Healing Caps, and Cylinders.
Attachments: Includes Locatus Male Cap and Locatus Retention Male. The Locatus Male Cap is made of titanium alloy (Ti-6Al-4V ELI), while the Locatus Retention Male is made of nylon.
Fixtures and cover screws are supplied sterile. All other abutments and attachments are provided non-sterile and must be sterilized by the end user before use.
Ti-Base consists of a two-piece abutment that includes a titanium base at the bottom and a zirconia superstructure (CAD/CAM patient-specific superstructure) at the top, composing the final abutment.
Superstructure and Bonding Materials
- Zirconia material: InCoris Zi (ZrO₂) (K123664, Sirona Dental Systems GmbH)
- Bonding agent: RelyX Unicem 2 Automix (K100756, 3M ESPE)
Design Envelope for Zirconia superstructure
| Dimensional Characteristics | Range/Limit |
|---|---|
| Post Angle (°) | 0~20 |
| Cuff Height (mm) | 0.5~5.0 |
| Abutment Post Height (mm) | 4.0~6.0 |
| Diameter (Ø , mm) | 5.0~8.0 |
| Wall Thickness (mm) | 0.4~ |
Design Envelope for Pre-milled Blank
| Dimensional Characteristics | Range/Limit |
|---|---|
| Post Angle (°) | 0~30 |
| Cuff Height (mm) | 0.5~6.0 |
| Abutment Post Height (mm) | 4.0~7.0 |
| Diameter (Ø , mm) | 3.5~6.5 |
| Wall Thickness (mm) | 0.4~ |
Note: Abutment Post Height is defined as the minimum cementable post height for single-unit restoration, measured as the height above the restorative margin.
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(146 days)
OF KOREA
Re: K252320
Trade/Device Name: SIMDA Abutments
Regulation Number: 21 CFR 872.3630
) | Endosseous Dental Implant Abutments (872.3630) |
| Product Code | NHA | NHA |
| Material
) | Endosseous Dental Implant Abutments (872.3630) |
| Product Code | NHA | NHA |
| Material
) | Endosseous Dental Implant Abutments (872.3630) |
| Product Code | NHA | NHA |
| Material
) | Endosseous Dental Implant Abutments (872.3630) |
| Product Code | NHA | NHA |
| Material
SIMDA Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
It is compatible with the following systems:
Pre-Milled Blank, Patient-specific abutment
| Compatible System | Implant Body Diameter(mm) | Implant Platform |
|---|---|---|
| Astra OsseoSpeed® EV (K120414, K130999) | 3.0, 3.6, 4.2, 4.8, 5.4 | 3.0, 3.6, 4.2, 4.8, 5.4 |
| Astra Tech Implant System (K101732) Astra Tech OsseoSpeed Astra Tech Fixture MicroMacro (New indication) (K024111) | 3.0S, 3.5S, 4.0S, 4.5, 5.0, 5.0S | 3.0(x-small), 3.5/4.0(small), 4.5/5.0(large) |
| BioHorizons Laser-Lok 3.0 Implant System (K093321) BioHorizons Tapered Internal Implant System (K143022, K071638) | 3.0, 3.4, 3.8, 4.6, 5.8 | 3.0, 3.4, 3.8, 4.6, 5.8 |
| Biomet 3i Certain® (K130949) | 3.25, 4.0, 5.0, 6.0 | 3.25, 4.0, 5.0, 6.0 |
| Straumann BLX Implant (K173961, K181703, K191256) | 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5 | RB, WB |
Ti-Base abutment
| Compatible System | Implant Body Diameter(mm) | Implant Platform |
|---|---|---|
| BioHorizons Laser-Lok 3.0 Implant System (K093321) BioHorizons Tapered Internal Implant System (K143022, K071638) | 3.0, 3.4, 3.8, 4.6, 5.8 | 3.0, 3.4, 3.8, 4.6, 5.8 |
| Biomet 3i Certain® (K130949) | 3.25, 4.0, 5.0, 6.0 | 3.25, 4.0, 5.0, 6.0 |
| Straumann BLX Implant (K173961, K181703, K191256) | 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5 | RB, WB |
Multi-unit abutment
| Compatible System | Implant Body Diameter(mm) | Implant Platform |
|---|---|---|
| Straumann BLX Implant (K173961, K181703, K191256) | 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5 | RB, WB |
Multi-unit Abutment is only compatible with Straumann BLX Implant System.
All digitally designed abutments for use with SIMDA Abutments are intended to be sent to a SIMDA validated milling center for manufacture.
SIMDA Abutment is intended for use as an aid in prosthetic restoration. It consists of Pre-Milled Blank, Ti-Base, Multi-unit Abutment, Multi-unit Base. It has a pre-manufactured connection interface that fits directly to an endosseous dental implant.
Pre-milled Blank Design
This device is a patient-specific abutment composed of titanium alloy (Ti-6Al-4V ELI, ASTM F136) which is designed by a clinician or lab, and milled at a SIMDA validated milling center.
Pre-Milled Blank Design Limitation for Patient-specific abutment:
| Design parameter (Patient-specific abutment) | Subject System Design Limit |
|---|---|
| Minimum and Maximum Gingival (Cuff) Height | 0.5~5mm |
| Minimum and Maximum diameter at abutment/implant interface | 4.0~8.0 |
| Minimum and Maximum length of abutment | 6~12mm |
| Minimum and Maximum length of abutment post (length above the abutment collar/gingival height) | 4~8mm |
| Minimum wall thickness at abutment/implant interface | 0.32 (Astra EV), 0.32 (Astra TX), 0.39 (BioHorizons), 0.4 (Biomet 3i), 0.42 (Straumann BLX) |
| Minimum and Maximum abutment angle | 0 |
Pre-Milled Blank Design Limitation for Patient-specific abutment:
Astra OsseoSpeed EV, Astra Tech OsseoSpeed TX is minimum and maximum abutment angle 0~15 º
Ti-Base Abutment
Ti Base consists of a two-piece abutment, where the titanium base is a pre-manufactured titanium component that will be used to support a CAD/CAM-designed zirconia superstructure (the second part of the two-piece abutment) that composes the final abutment.
Ti Base are provided non-sterile therefore must be sterilized after the cementation of the patient-specified superstructure.
Raw material blanks
- InCoris Zi (ZrO2) by Sirona Dental Systems GmbH, L size blanks, cleared under K123664.
Cement
- RelyX Unicem 2Automix by 3M ESPE, cleared under K100756.
Design Limitation for Zirconia superstructure:
| Design Parameter | Limit (Min.~Max.) |
|---|---|
| Minimum and Maximum abutment angle | 0~15 |
| Minimum and Maximum Gingival (Cuff) Height | 0.5~5.0 |
| Minimum and Maximum length of abutment post (length above the abutment collar/gingival height) | 4.0~6.0 |
| Minimum and Maximum diameter at abutment/implant interface | 5.0~8.0 |
| Minimum wall thickness at abutment/implant interface | 0.33 |
Multi-unit Abutment and Base
Multi-unit Abutment which are placed into the dental implant to provide support for the prosthetic restoration. The abutments are made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F136). The Multi-unit Abutment has a post height less than 4mm and are always combined with Multi-unit Base, increasing the post height to a minimum of 4.5mm.
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