FDA.reportPublic FDA data

NA

Primary DI
07630031711427
Brand
NA
Company
Institut Straumann AG
Model
Plan Abutments
Catalog number
025.2613-04
Device description
NC PLAN Cementable Abutment, D 3.5mm, GH 3mm, AH 4mm, POM
Published
2022-12-02
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
NDPAccessories, implant, dental, endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630031711427PrimaryGS10
07630031756374Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630031711427076300317114277630031711427
07630031756374076300317563747630031756374

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, temporary, preformed, reusableA prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue healing and sculpturing period, prior to the fabrication/rehabilitation and installation of the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes fixture impression pick-ups and replica devices and is available in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height0
Outer Diameter0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)448-8168info.usa@straumann.com

Regulatory Flags#

DUNS number
483599259
Device count
4
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07630031711366NAPlan Abutments025.2602-042022-12-02
07630031711410NAPlan Abutments025.2612-042022-12-02
07630031711465NAPlan Abutments025.2621-042022-12-02
07630031712639NATransfer aids025.4913-042022-12-02
07630031722645NAPlan Abutments048.073V42022-12-02
07630031723000NAConventional impression048.122V42022-12-02
07630031723970NAPlan Abutments048.276V42022-12-02
07630031724021NAPlan Abutments048.283V42022-12-02
07630031724038NAPlan Abutments048.284V42022-12-02
07630031724045NAPlan Abutments048.285V42022-12-02
07630031724052NAPlan Abutments048.286V42022-12-02
07630031724069NAPlan Abutments048.287V42022-12-02
07630031734884N!CE Glass Ceramic Blocks For Amann GirrbachMilling Materials010.71352023-08-24
07630031734921N!CE Glass Ceramic Blocks For Amann GirrbachMilling Materials010.71392022-04-14
07630031731012n!ce Glass Ceramic Blocks for Amann GirrbachMilling Materials010.70522019-06-18
07630031731029n!ce Glass Ceramic Blocks for Amann GirrbachMilling Materials010.70532019-06-18
07630031731050n!ce Glass Ceramic Blocks for Amann GirrbachMilling Materials010.70562019-06-18
07630031731067n!ce Glass Ceramic Blocks for Amann GirrbachMilling Materials010.70572019-06-18
07630031731081n!ce Glass Ceramic Blocks for Amann GirrbachMilling Materials010.70592019-06-18
07630031739704JUVORA Dental Disc, Ceramill PEEK by JUVORABridges (tooth borne)010.41332019-08-23

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00844868052548T3® ShortZimVie US Corp LLCNDP2026-05-28
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08435389830443SURGICAL GUIDE TEMPORARY BALL ATTACHMENT; MULTI-IM; Ø4,1 mmBIOTECHNOLOGY INSTITUTE SLNDP2026-05-27
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